Archive for the ‘Cardiac Stem Cells’ Category

Heart problems associated with spinal muscular atrophy(SMA) may be caused partially by calcium dysregulation in heart muscle cells in the absence of the survival motor neuron(SMN) protein, a study suggests.

These findings shed light not only on the underlying mechanisms of heart problems in SMA which may open new therapeutic avenues but also support the monitoring of heart function in this patient population.

The study, SMN-deficiency disrupts SERCA2 expression and intracellular Ca2+ signaling in cardiomyocytes from SMA mice and patient-derived iPSCs, was published in the journal Skeletal Muscle.

SMA is caused by the loss of SMN, a protein produced in several cell types throughout the body and involved inmultiple and fundamental cellular processes. While SMN deficiency in motor nerve cells is considered the diseases root cause, increasing evidence suggests that other cells and organs in the body also are particularly affected, including the heart.

Cardiovascular problems have been reported in patients with the most severe severeforms of SMA and in mouse models of the disease. Moreover, a previous study supported by theSMA Foundation showed that SMA patients have higher-than-normal levels of several heart failure markers, suggesting that sufficient levels of SMN are essential for normal heart function.

However, the mechanisms behind these SMA-associated heart problems remain largely unknown and no study has established that SMN deficiency directly affects heart function.

Researchers have now evaluated whether SMN deficiency compromised the contractile function of heart cells isolated from a mouse model of a severe form of SMA and also those generated from SMA patients-derived induced pluripotent stem cells (iPSCs).

iPSCs are fully matured cells that researchers can reprogram in a lab dish to revert them back to a stem cell state that has the capacity to differentiate into almost any type of cell.

Results showed that the levels of three heart failure markers atrial natriuretic peptide, brain natriuretic peptide, and skeletal alpa-actin were significantly increased in heart tissue from SMA mice prior to considerable neuromuscular degeneration, compared with that from healthy mice.

This suggested that mechanical function of the heart may be altered early in the disease progression of this severe SMA mouse model, the researchers wrote.

In agreement, heart cells from SMA mice showed impaired contractile function, compared with cells from healthy mice. The team noted that contraction problems in the heart often are associated with calcium dysregulation and lower levels of SERCA2, an enzyme that controls calcium levels inside cells.

Further analysis showed that SMN-deficient heart cells, from both SMA mice and SMA patients, had a significant drop in SERCA2 levels and impaired calcium dynamics, compared with healthy cells.

Notably, these deficits were at least partially corrected when patient-derived cells were modified to increase their production of SMN protein. Conversely, heart cells derived from healthy individuals and forced to lower their SMN production mimicked the deficits seen in SMN-deficient heart cells.

These results demonstrate that SMN regulates SERCA2 [levels] and intracellular [calcium dynamics] in [heart cells] that may impair cardiac function and lead to elevation of heart failure markers, as observed in mice and patients with SMA, the researchers wrote.

The data also suggest that heart cell dysfunction occurs early in the disease course and therefore is likely to be a direct result of SMN loss and not secondary to neurodegeneration, the team noted.

Since deficits in calcium dynamics also were previously reported to occur in SMN-deficient motor nerve cells, the researchers hypothesized that calcium dysregulation may be a common disease mechanism in SMA.

Finally, while neuromuscular degeneration remains the hallmark feature of the disease, impaired heart function may be a contributing factor in disease progression that will require monitoring in light of new therapies that are improving motor function and extending survival, the researchers wrote.

Marta Figueiredo holds a BSc in Biology and a MSc in Evolutionary and Developmental Biology from the University of Lisbon, Portugal. She is currently finishing her PhD in Biomedical Sciences at the University of Lisbon, where she focused her research on the role of several signalling pathways in thymus and parathyroid glands embryonic development.

Total Posts: 85

Ana holds a PhD in Immunology from the University of Lisbon and worked as a postdoctoral researcher at Instituto de Medicina Molecular (iMM) in Lisbon, Portugal. She graduated with a BSc in Genetics from the University of Newcastle and received a Masters in Biomolecular Archaeology from the University of Manchester, England. After leaving the lab to pursue a career in Science Communication, she served as the Director of Science Communication at iMM.

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Study: Heart Problems in SMA May Be Tied to Calcium Dysregulation - SMA News Today

Latest Patent Further Strengthens Intellectual Property Portfolio Covering Novel Platform for Precisely Controlling Core Cell Migration Mechanisms

Decelerator Technology Has Key Potential Applications in Treatment of Cancer and Fibrosis and Serves as Key Complement to Companys Cell Motility Accelerator Platform for Enhanced Tissue Repair

NEW YORK, May 20, 2020 (GLOBE NEWSWIRE) -- MicroCures, a biopharmaceutical company developing novel therapeutics that harness the bodys innate regenerative mechanisms to accelerate tissue repair, today announced the issuance of a new European patent providing broad protection for the companys first-of-its-kind cell movement decelerator technology, which has potential therapeutic applications in combating cancer metastases and fibrosis. The companys decelerator technology is being developed alongside MicroCures accelerator technology, which is designed to enhance repair of tissue, nerves, and organs following trauma. With the newly issued patent in the European Union (#3052117), the companys global patent estate now includes eight issued and 12 pending patents covering its underlying technology, as well as the therapeutic programs that have emerged from the platform.

Our proprietary platform technology represents a fundamentally new way of thinking about how to harness the bodys natural cell movement processes to drive therapeutic outcomes in response to a range of medical challenges. Whether it is removing the brakes from cells to accelerate their migration and drive tissue, nerve and organ repair, or putting the brakes on cell movement to combat tumor metastases and fibrosis, we are pioneering an entirely new treatment paradigm, said Derek Proudian, co-founder and chief executive officer of MicroCures. While we clearly recognize the importance of the development work we are undertaking in support of this platform, it is equally important to build a strong, wide-reaching intellectual property portfolio to protect it. This latest patent issuance provides us yet another key piece of intellectual property, bringing our total number of issued and pending patents to 20.

MicroCures technology is based on foundational scientific research at Albert Einstein College of Medicine regarding the fundamental role that cell movement plays as a driver of the bodys innate capacity to repair tissue, nerves, and organs. The company has shown that complex and dynamic networks of microtubules within cells crucially control cell migration, and that this cell movement can be reliably modulated to achieve a range of therapeutic benefits. Based on these findings, the company has established a first-of-its-kind proprietary platform to create siRNA-based therapeutics capable of precisely controlling the speed and direction of cell movement by selectively silencing microtubule regulatory proteins.

The company has developed a broad pipeline of therapeutic programs with an initial focus in the area of tissue, nerve and organ repair. Unlike regenerative medicine approaches that rely upon engineered materials or systemic growth factor/stem cell therapeutics, MicroCures technology directs and enhances the bodys inherent healing processes through local, temporary modulation of cell motility. Additionally, the company is developing a decelerator technology based on the same foundational science. Instead of accelerating cell movement for therapeutic repair and regeneration, this technology is designed to slow or halt the movement of cells, potentially offering a unique, natural approach to preventing cancer metastases and fibrosis.

About MicroCures

MicroCures develops biopharmaceuticals that harness innate cellular mechanisms within the body to accelerate and improve recovery after traumatic injury. MicroCures has developed a first-of-its-kind therapeutic platform that precisely controls the rate and direction of cell migration, offering the potential to deliver powerful therapeutic benefits for a variety of large and underserved medical applications.

MicroCures has developed a broad pipeline of novel therapeutic programs with an initial focus in the area of tissue, nerve and organ repair. The companys lead therapeutic candidate, siFi2, targets excisional wound healing, a multi-billion dollar market inadequately served by current treatments. Additional applications for the companys cell migration accelerator technology include dermal burn repair, corneal burn repair, cavernous nerve repair/regeneration, spinal cord repair/regeneration, and cardiac tissue repair. Cell migration decelerator applications include combatting cancer metastases and fibrosis. The company protects its unique platform and proprietary therapeutic programs with a robust intellectual property portfolio including eight issued patents, as well as 12 pending patent applications.

For more information please visit: http://www.microcures.com

Contact:

MicroCuresinfo@microcures.com

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MicroCures Announces Issuance of New European Patent Providing Broad Protection for First-of-its-Kind Cell Movement Decelerator Technology -...

Four of six patients in case series were weaned off respiratory support

An investigational allogeneic cell therapy using cardiosphere-derived cells (CDC) showed an acceptable safety profile with early evidence of efficacy in the treatment of very severe Covid-19 in a case series involving six patients treated at Cedars-Sinai Medical Center in Los Angeles.

All six patients treated with the intravenous allogeneic CDC formulation CAP-1002 (Capricor Therapeutics) as a compassionate therapy required respiratory support prior to treatment, with five on mechanical ventilation.

No adverse events related to the treatment were reported, and four of the six patients were successfully weaned from respiratory support and were discharged from the hospital as of late April.

The other two patients are still alive, but remain intubated, Cedars-Sinai cardiologist Raj Makkar, MD, confirmed to BreakingMED Wednesday, May 13.

While we are encouraged by these findings, it is important to point out that the only way that we can assess the efficacy of this treatment in a definitive way is with a randomized clinical trial, and that is what we intend to do, Makkar said.

He added that the clinical trial, which is in the planning stages, is likely to include Covid-19 patients who are not as critically ill as the six in the case series.

All of these patients required respiratory support and they were all on a downward trajectory when treated, he said. They were getting worse and we had nothing else to offer them.

Cardiosphere-derived cells are stromal/progenitor cells from heart tissue with a distinctive antigenic profile (CD105+, CD45-, CD90low).

In their case series, published in the journal Basic Research in Cardiology, Makkar and colleagues noted that the cells are entirely distinct from the controversial c-kit+ putative cardiac progenitors, which have been the subject of various retracted studies.

Since CDCs were first isolated in 2007, the cells have been tested in more than 200 patients in clinical trials for a variety of conditions with a good safety profile, including in young boys with Duchenne muscular dystrophy.

Makkar said the anti-inflammatory and antifibrotic properties of CDCs in animal models make them a possible target therapy for Covid-19.

The prior testing gave us reasonable confidence that this treatment was safe, he said, adding that there is also evidence of a favorable effect on the same type of proinflammatory cytokines that are up-regulated in Covid-19.

Comparisons to mesenchymal stem cells (MSCs) in pre-clinical models suggest that CDCs may also be more effective for paracrine factor secretion and myocardial remodeling.

Given the safety record of CDCs in humans, and the substantial body of evidence confirming relevant disease-modifying bioactivity, applicability to Covid-19 seemed compelling, particularly in the hyperinflammatory stage of the illness, the researchers wrote.

All six patients treated with the intravenous CDC formulation had severe, confirmed Covid-19 with respiratory failure and they were not receiving any other experimental agent, with the exception of hydroxychloroquine and tocilizumab.

Lack of clinical improvement or deterioration despite standard care was the primary reason for considering patients for treatment with CAP-1002. Exclusion criteria included known hypersensitivity to DMSO, which is a component of CAP-1002; prior stem cell therapy; pre-existing terminal illness; and need for mechanical circulatory support and dialysis.

In general, patients with multi-organ failure who were deemed to be too sick for any intervention were excluded from the study, Makkar and colleagues wrote.

All patients had acute respiratory distress syndrome (ARDS) prior to infusion, with decreased PaO2/FiO2 ratios (range 69-198; median 142), diffuse bilateral pulmonary infiltrates on chest imaging and evidence of preserved cardiac function on transthoracic echocardiography (LVEF range, 50-75%). SOFA scores ranged from 2 to 8 prior to stem cell treatment.

The six patients (age range, 19-75 years) had IV infusions of CAP-1002 containing 150 million allogeneic CDCs, and two of the six had a second dose of the treatment.

Following treatment, four patients (67%) were weaned from respiratory support and discharged from the hospital.

A contemporaneous control group of critically ill Covid-19 patients (n = 34) at our institution showed 18% overall mortality at a similar stage of hospitalization, the researchers wrote.

Ferritin was elevated in all patients at baseline (range of all patients 605.43-2991.52 ng/ml) and decreased in five of the six patients (range of all patients 252.891029.90 ng/ml).

Absolute lymphocyte counts were low in five of the six patients at baseline (range 0.260.82 103/l) but had increased in 3 of these five at last follow-up (range 0.231.02 103/l).

Administration of CAP-1002 as a compassionate therapy for patients with severe Covid-19 and significant comorbidities was safe, well tolerated without serious adverse events, and associated with clinical improvement, as evidenced by extubation (or prevention of intubation, the researchers wrote.

Stem cell therapy utilizing cardiosphere-derived cells (CDC) showed an acceptable safety profile with early evidence of efficacy in the treatment of very severe Covid-19 in an early case series involving 6 patients treated at Cedars-Sinai Medical Center, Los Angeles.

No adverse events related to the treatment were reported, and four of the six patients were successfully weaned from respiratory support and were discharged from the hospital.

Salynn Boyles, Contributing Writer, BreakingMED

Funding for this story was provided by the Smidt Family Foundation. The cell product, CAP-1002, was provided by manufacturer Capricor Therapeutics.

ResearcherEduardo Marban reported owning founders equity in Cariricor Therapeutics, and researcher Linda Marban reported being an employee and owning equity in the company.

Cat ID: 125

Topic ID: 79,125,254,930,287,728,932,570,574,730,933,125,190,926,192,927,151,928,925,934

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Cardio Stem Cell Therapy Used to Treat Critically Ill Covid-19 Patients - Physician's Weekly

This discovery may have clinical importance in management of heart failure.

This discovery may have clinical importance in management of heart failure.Many heart diseases are linked to oxidative stress, an overabundance of reactive oxygen species. The body reacts to reduce oxidative stress where the redox teeter-totter has gone too far up through production of endogenous antioxidants that reduce the reactive oxygen species. This balancing act is called redox homeostasis.

But what happens if the redox teeter-totter goes too far down, creating antioxidative stress, also known as reductive stress? Rajasekaran Namakkal-Soorappan, Ph.D., associate professor in the University of Alabama at Birmingham Department of Pathology, and colleagues have found that reductive stress, or RS/AS, is also pathological. This discovery, they say, may have clinical importance in management of heart failure.

They report that RS causes pathological heart enlargement and diastolic dysfunction in a mouse model. This study, published in the journal Antioxidants and Redox Signaling, was led by Namakkal-Soorappan and Pei Ping, Ph.D., David Geffen School of Medicine at the University of California-Los Angeles.

Antioxidant-based therapeutic approaches for human heart failure should consider a thorough evaluation of antioxidant levels before the treatment, they said. Our findings demonstrate that chronic RS is intolerable and adequate to induce heart failure.

The study used transgenic mice that had upregulated genes for antioxidants in the heart, which increased the amounts of antioxidant proteins and reduced glutathione, creating RS. One mouse line had low upregulation, and one had high upregulation, creating chronic low RS and chronic high RS, respectively, in the hearts of the mice.

The mice with high RS showed pathological heart changes called hypertrophic cardiomyopathy, and had an abnormally high heart ejection fraction and diastolic dysfunction at 6 months of age. Sixty percent of the high-RS mice died by 18 months of age.

The mice with low RS had normal survival rates, but they developed the heart changes at about 15 months of age, suggesting that even moderate RS can lead to irreversible damage in the heart over time.

Giving high-RS mice a chemical that blocked biosynthesis of glutathione, beginning at about 6 weeks of age, prevented RS and rescued the mice from pathological heart changes.

Gobinath Shanmugam, Ph.D., postdoctoral fellow in the UAB Department of Pathology, and Namakkal-Soorappan point out that a 2019 survey found about 77 percent of Americans are consuming dietary supplements every day, and within this group, about 58 percent are consuming antioxidants as multivitamins. Thus, a chronic consumption of antioxidant drugs by any individual without knowing their redox state might result in RS, which can induce pathology and slowly damage the heart.

In a related study, published in the journal Redox Biology, Namakkal-Soorappan looked at the impact of RS on myosatellite cells, which are also known as muscle stem cells. These cells, located near skeletal muscle fibers, are able to regenerate and differentiate into skeletal muscle after acute or chronic muscle injury. The regulation of myosatellite cells is of interest given the loss of skeletal muscle mass during aging or in chronic conditions like diabetes and AIDS.

Recently, Namakkal-Soorappan reported that tilting the redox teeter-totter to oxidative stress impaired regeneration of skeletal muscle. Now, in the Redox Biology paper, he has shown that tilting the redox to RS also causes significant inhibition of muscle satellite cell differentiation.

Rather than genetic manipulation to induce RS, as was done in the heart study, the researchers used the chemical sulforaphane or direct augmentation of intracellular glutathione to induce RS in cultured mouse myoblast cells. Both treatments inhibited myoblast differentiation. Finally, authors attempted to withdraw antioxidative stress by growing cells in medium without sulforaphane, which removes the RS and accelerates the differentiation. Namakkal-Soorappan and colleagues found that a pro-oxidative milieu, through a mild generation of reactive oxygen species, was required for myoblast differentiation.

The researchers also showed that genetic silencing of a negative regulator of the antioxidant genes also inhibited myoblast differentiation.

Co-authors with Namakkal-Soorappan and Ping, and first-author Shanmugam, in the Antioxidants and Redox Signaling study, Reductive stress causes pathological cardiac remodeling and diastolic dysfunction, are Silvio H. Litovsky and Rajesh Kumar Radhakrishnan, UAB Department of Pathology; Ding Wang, UCLA; Sellamuthu S. Gounder, Kevin Whitehead, Sarah Franklin and John R. Hoidal, University of Utah School of Medicine; Jolyn Fernandes and Dean P. Jones, Emory University, Atlanta, Georgia; Thomas W. Kensler, Fred Hutch Cancer Research Center, Seattle, Washington; Louis DellItalia, UAB Department of Medicine; Victor Darley-Usmar, UAB Department of Pathology; and E. Dale Abel, University of Iowa.

In the Redox Biology study, Reductive stress impairs myogenic differentiation, co-authors with Namakkal-Soorappan are Sandeep Balu Shelar, UAB Department of Pathology; Dean P. Jones, Emory University; and John R. Hoidal, University of Utah School of Medicine.

Support for both studies came from National Institutes of Health grants HL118067 and AG042860, American Heart Association grant BGIA 0865015F, the University of Utah, and UAB.

In the two studies, Namakkal-Soorappans name is listed as Namakkal S. Rajasekaran.

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Surplus antioxidants are pathogenic for hearts and skeletal muscle - The Mix

The report on the global Progenitor Cell Product market is comprehensively prepared with main focus on the competitive landscape, geographical growth, segmentation, and market dynamics, including drivers, restraints, and opportunities. It sheds light on key production, revenue, and consumption trends so that players could improve their sales and growth in the GlobalProgenitor Cell Product Market.It brings to light key factors affecting the growth of different segments and regions in the global Progenitor Cell Product market. It also offers SWOT, Porters Five Forces, and PESTLE analysis to thoroughly examine the global Progenitor Cell Product market.It offers a detailed analysis of the competition and leading companies of the global Progenitor Cell Product market. Here, it concentrates on the recent developments, sales, market value, production, gross margin, and other important factors of the business of top players operating in the global Progenitor Cell Product market.

Key companies operating in the global Progenitor Cell Product market include:NeuroNova AB, StemCells, ReNeuron Limited, Asterias Biotherapeutics, Thermo Fisher Scientific, STEMCELL Technologies, Axol Bio, R&D Systems, Lonza, ATCC, Irvine Scientific, CDI

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With deep quantitative and qualitative analysis, the report provides encyclopedic and accurate research study on important aspects of the global Progenitor Cell Product market. It gives a detailed study on manufacturing cost, upstream and downstream buyers, distributors, marketing strategy, and marketing channel development trends of the global Progenitor Cell Product market. Furthermore, it provides strategic bits of advice and recommendations for players to ensure success in the global Progenitor Cell Product market.

Segmental Analysis

The report has classified the global Progenitor Cell Product industry into segments including product type and application. Every segment is evaluated based on growth rate and share. Besides, the analysts have studied the potential regions that may prove rewarding for the Progenitor Cell Product manufcaturers in the coming years. The regional analysis includes reliable predictions on value and volume, thereby helping market players to gain deep insights into the overall Progenitor Cell Product industry.

Global Progenitor Cell Product Market Segment By Type:

, Pancreatic progenitor cells, Cardiac Progenitor Cells, Intermediate progenitor cells, Neural progenitor cells (NPCs), Endothelial progenitor cells (EPC), Others

Global Progenitor Cell Product Market Segment By Application:

Progenitor Cell Product

Competitive Landscape

It is important for every market participant to be familiar with the competitive scenario in the global Progenitor Cell Product industry. In order to fulfil the requirements, the industry analysts have evaluated the strategic activities of the competitors to help the key players strengthen their foothold in the market and increase their competitiveness.

Key companies operating in the global Progenitor Cell Product market includeNeuroNova AB, StemCells, ReNeuron Limited, Asterias Biotherapeutics, Thermo Fisher Scientific, STEMCELL Technologies, Axol Bio, R&D Systems, Lonza, ATCC, Irvine Scientific, CDI

Regions and Countries

The Middle East and Africa(GCC Countries and Egypt)North America(the United States, Mexico, and Canada)South America(Brazil etc.)Europe(Turkey, Germany, Russia UK, Italy, France, etc.)Asia-Pacific(Vietnam, China, Malaysia, Japan, Philippines, Korea, Thailand, India, Indonesia, and Australia)

Key Questions Answered

What is the size and CAGR of the global Progenitor Cell Product market?

Which are the leading segments of the global Progenitor Cell Product market?

What are the key driving factors of the most profitable regional market?

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What are the main strategies adopted in the global Progenitor Cell Product market?

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Table of Contents

Table of Contents 1 Progenitor Cell Product Market Overview1.1 Progenitor Cell Product Product Overview1.2 Progenitor Cell Product Market Segment by Type1.2.1 Pancreatic progenitor cells1.2.2 Cardiac Progenitor Cells1.2.3 Intermediate progenitor cells1.2.4 Neural progenitor cells (NPCs)1.2.5 Endothelial progenitor cells (EPC)1.2.6 Others1.3 Global Progenitor Cell Product Market Size by Type1.3.1 Global Progenitor Cell Product Sales and Growth by Type1.3.2 Global Progenitor Cell Product Sales and Market Share by Type1.3.3 Global Progenitor Cell Product Revenue and Market Share by Type1.3.4 Global Progenitor Cell Product Price by Type1.4 North America Progenitor Cell Product by Type1.5 Europe Progenitor Cell Product by Type1.6 South America Progenitor Cell Product by Type1.7 Middle East and Africa Progenitor Cell Product by Type 2 Global Progenitor Cell Product Market Competition by Company2.1 Global Progenitor Cell Product Sales and Market Share by Company (2014-2019)2.2 Global Progenitor Cell Product Revenue and Share by Company (2014-2019)2.3 Global Progenitor Cell Product Price by Company (2014-2019)2.4 Global Top Players Progenitor Cell Product Manufacturing Base Distribution, Sales Area, Product Types2.5 Progenitor Cell Product Market Competitive Situation and Trends2.5.1 Progenitor Cell Product Market Concentration Rate2.5.2 Global Progenitor Cell Product Market Share of Top 5 and Top 10 Players2.5.3 Mergers & Acquisitions, Expansion 3 Progenitor Cell Product Company Profiles and Sales Data3.1 NeuroNova AB3.1.1 Company Basic Information, Manufacturing Base and Competitors3.1.2 Progenitor Cell Product Product Category, Application and Specification3.1.3 NeuroNova AB Progenitor Cell Product Sales, Revenue, Price and Gross Margin(2014-2019)3.1.4 Main Business Overview3.2 StemCells3.2.1 Company Basic Information, Manufacturing Base and Competitors3.2.2 Progenitor Cell Product Product Category, Application and Specification3.2.3 StemCells Progenitor Cell Product Sales, Revenue, Price and Gross Margin(2014-2019)3.2.4 Main Business Overview3.3 ReNeuron Limited3.3.1 Company Basic Information, Manufacturing Base and Competitors3.3.2 Progenitor Cell Product Product Category, Application and Specification3.3.3 ReNeuron Limited Progenitor Cell Product Sales, Revenue, Price and Gross Margin(2014-2019)3.3.4 Main Business Overview3.4 Asterias Biotherapeutics3.4.1 Company Basic Information, Manufacturing Base and Competitors3.4.2 Progenitor Cell Product Product Category, Application and Specification3.4.3 Asterias Biotherapeutics Progenitor Cell Product Sales, Revenue, Price and Gross Margin(2014-2019)3.4.4 Main Business Overview3.5 Thermo Fisher Scientific3.5.1 Company Basic Information, Manufacturing Base and Competitors3.5.2 Progenitor Cell Product Product Category, Application and Specification3.5.3 Thermo Fisher Scientific Progenitor Cell Product Sales, Revenue, Price and Gross Margin(2014-2019)3.5.4 Main Business Overview3.6 STEMCELL Technologies3.6.1 Company Basic Information, Manufacturing Base and Competitors3.6.2 Progenitor Cell Product Product Category, Application and Specification3.6.3 STEMCELL Technologies Progenitor Cell Product Sales, Revenue, Price and Gross Margin(2014-2019)3.6.4 Main Business Overview3.7 Axol Bio3.7.1 Company Basic Information, Manufacturing Base and Competitors3.7.2 Progenitor Cell Product Product Category, Application and Specification3.7.3 Axol Bio Progenitor Cell Product Sales, Revenue, Price and Gross Margin(2014-2019)3.7.4 Main Business Overview3.8 R&D Systems3.8.1 Company Basic Information, Manufacturing Base and Competitors3.8.2 Progenitor Cell Product Product Category, Application and Specification3.8.3 R&D Systems Progenitor Cell Product Sales, Revenue, Price and Gross Margin(2014-2019)3.8.4 Main Business Overview3.9 Lonza3.9.1 Company Basic Information, Manufacturing Base and Competitors3.9.2 Progenitor Cell Product Product Category, Application and Specification3.9.3 Lonza Progenitor Cell Product Sales, Revenue, Price and Gross Margin(2014-2019)3.9.4 Main Business Overview3.10 ATCC3.10.1 Company Basic Information, Manufacturing Base and Competitors3.10.2 Progenitor Cell Product Product Category, Application and Specification3.10.3 ATCC Progenitor Cell Product Sales, Revenue, Price and Gross Margin(2014-2019)3.10.4 Main Business Overview3.11 Irvine Scientific3.12 CDI 4 Progenitor Cell Product Market Status and Outlook by Regions4.1 Global Progenitor Cell Product Market Status and Outlook by Regions4.1.1 Global Progenitor Cell Product Market Size and CAGR by Regions4.1.2 North America4.1.3 Europe4.1.4 Asia-Pacific4.1.5 South America4.1.6 Middle East and Africa4.2 Global Progenitor Cell Product Sales and Revenue by Regions4.2.1 Global Progenitor Cell Product Sales Market Share by Regions (2014-2019)4.2.2 Global Progenitor Cell Product Revenue Market Share by Regions (2014-2019)4.2.3 Global Progenitor Cell Product Sales, Revenue, Price and Gross Margin (2014-2019)4.3 North America Progenitor Cell Product Sales, Revenue, Price and Gross Margin4.3.1 North America Progenitor Cell Product Sales by Countries4.3.2 United States4.3.3 Canada4.3.4 Mexico4.4 Europe Progenitor Cell Product Sales, Revenue, Price and Gross Margin4.4.1 Europe Progenitor Cell Product Sales by Countries4.4.2 Germany4.4.3 France4.4.4 UK4.4.5 Italy4.4.6 Russia4.5 Asia-Pacific Progenitor Cell Product Sales, Revenue, Price and Gross Margin4.5.1 Asia-Pacific Progenitor Cell Product Sales by Regions4.5.2 China4.5.3 Japan4.5.4 South Korea4.5.5 India4.5.6 Australia4.5.7 Indonesia4.5.8 Thailand4.5.9 Malaysia4.5.10 Philippines4.5.11 Vietnam4.6 South America Progenitor Cell Product Sales, Revenue, Price and Gross Margin4.6.1 South America Progenitor Cell Product Sales by Countries4.6.2 Brazil4.7 Middle East and Africa Progenitor Cell Product Sales, Revenue, Price and Gross Margin4.7.1 Middle East and Africa Progenitor Cell Product Sales by Countries4.7.2 Turkey4.7.3 GCC Countries4.7.4 Egypt4.7.5 South Africa 5 Progenitor Cell Product Application5.1 Progenitor Cell Product Segment by Application5.1.1 Medical care5.1.2 Hospital5.1.3 Laboratory5.2 Global Progenitor Cell Product Product Segment by Application5.2.1 Global Progenitor Cell Product Sales by Application5.2.2 Global Progenitor Cell Product Sales and Market Share by Application (2014-2019)5.3 North America Progenitor Cell Product by Application5.4 Europe Progenitor Cell Product by Application5.5 Asia-Pacific Progenitor Cell Product by Application5.6 South America Progenitor Cell Product by Application5.7 Middle East and Africa Progenitor Cell Product by Application 6 Global Progenitor Cell Product Market Forecast6.1 Global Progenitor Cell Product Sales, Revenue Forecast (2019-2025)6.1.1 Global Progenitor Cell Product Sales and Growth Rate Forecast (2019-2025)6.1.2 Global Progenitor Cell Product Revenue and Growth Rate Forecast (2019-2025)6.2 Global Progenitor Cell Product Forecast by Regions6.2.1 North America Progenitor Cell Product Sales and Revenue Forecast (2019-2025)6.2.2 Europe Progenitor Cell Product Sales and Revenue Forecast (2019-2025)6.2.3 Asia-Pacific Progenitor Cell Product Sales and Revenue Forecast (2019-2025)6.2.4 South America Progenitor Cell Product Sales and Revenue Forecast (2019-2025)6.2.5 Middle East and Africa Progenitor Cell Product Sales and Revenue Forecast (2019-2025)6.3 Progenitor Cell Product Forecast by Type6.3.1 Global Progenitor Cell Product Sales and Revenue Forecast by Type (2019-2025)6.3.2 Pancreatic progenitor cells Growth Forecast6.3.3 Cardiac Progenitor Cells Growth Forecast6.4 Progenitor Cell Product Forecast by Application6.4.1 Global Progenitor Cell Product Sales Forecast by Application (2019-2025)6.4.2 Global Progenitor Cell Product Forecast in Medical care6.4.3 Global Progenitor Cell Product Forecast in Hospital 7 Progenitor Cell Product Upstream Raw Materials7.1 Progenitor Cell Product Key Raw Materials7.1.1 Key Raw Materials7.1.2 Key Raw Materials Price7.1.3 Raw Materials Key Suppliers7.2 Manufacturing Cost Structure7.2.1 Raw Materials7.2.2 Labor Cost7.2.3 Manufacturing Expenses7.3 Progenitor Cell Product Industrial Chain Analysis 8 Marketing Strategy Analysis, Distributors8.1 Sales Channel8.2 Distributors8.3 Downstream Customers 9 Research Findings and Conclusion 10 Appendix10.1 Methodology/Research Approach10.1.1 Research Programs/Design10.1.2 Market Size Estimation10.1.3 Market Breakdown and Data Triangulation10.2 Data Source10.2.1 Secondary Sources10.2.2 Primary Sources10.3 Author List10.4 Disclaimer

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Progenitor Cell Product Market 2020| Worldwide Industry Share, Size, Gross Margin, Trend, Future Demand, Analysis by Top Leading Player and Forecast...

This Autologous Stem Cell and Non-Stem Cell Based Therapies Market research document predicts the size of the market with information on key vendor revenues, development of the industry by upstream & downstream, industry progress, key companies, along with type segment & market application. This market study takes into account a market attractiveness analysis, where each segment is benchmarked based on its market size, growth rate, and general attractiveness. Another major section of this Autologous Stem Cell and Non-Stem Cell Based Therapies Market report is the competitive landscape which provides a clear insight into the market share analysis and actions of key industry players. Quality and transparency is strictly maintained while carrying out research studies to offer an exceptional market research document for your niche.

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All the data of this market report is exceptionally useful to the clients and businesses for making decisions related to revenue, investment, import, export and consumption. To meet the strategic as well as specific needs of the organization or business, a comprehensive market research document such as this Autologous Stem Cell and Non-Stem Cell Based Therapies Market report, has to be in place. Geographical scope of the products is also carried out comprehensively for the major global areas such as Asia, North America, South America, and Africa which helps define strategies for the product distribution in those areas. Competitive landscape is explored in terms of product range, strategies, and future prospects of the key players of the Healthcare industry.

Market AnalysisBesides target market information, DBMR also provides information about your competitor, your customers, products etc. A few techniques we use are: Customer analysis Competitor analysis Risk analysis Product research Advertising research E-mail survey and many more

TheGlobalAutologous Stem Cell and Non-Stem Cell Based Therapies Marketis expected to reach USD113.04 billion by 2025, from USD 87.59 billion in 2017 growing at a CAGR of 3.7% during the forecast period of 2018 to 2025. The upcoming market report contains data for historic years 2015 & 2016, the base year of calculation is 2017 and the forecast period is 2018 to 2025.

Some of the major players operating in the globalautologous stem cell and non-stem cell based therapies marketareAntria (Cro), Bioheart, Brainstorm Cell Therapeutics, Cytori, Dendreon Corporation, Fibrocell, Genesis Biopharma, Georgia Health Sciences University, Neostem, Opexa Therapeutics, Orgenesis, Regenexx, Regeneus, Tengion, Tigenix, Virxsys and many more.

Browse Detailed TOC Herehttps://www.databridgemarketresearch.com/toc/?dbmr=global-autologous-stem-cell-and-non-stem-cell-based-therapies-market

Market Definition:Global Autologous Stem Cell and Non-Stem Cell Based Therapies Market

In autologous stem-cell transplantation persons own undifferentiated cells or stem cells are collected and transplanted back to the person after intensive therapy. These therapies are performed by means of hematopoietic stem cells, in some of the cases cardiac cells are used to fix the damages caused due to heart attacks. The autologous stem cell and non-stem cell based therapies are used in the treatment of various diseases such as neurodegenerative diseases, cardiovascular diseases, cancer and autoimmune diseases, infectious disease.

According to World Health Organization (WHO), cardiovascular disease (CVD) causes more than half of all deaths across the European Region. The disease leads to death or frequently it is caused by AIDS, tuberculosis and malaria combined in Europe. With the prevalence of cancer and diabetes in all age groups globally the need of steam cell based therapies is increasing, according to article published by the US National Library of Medicine National Institutes of Health, it was reported that around 382 million people had diabetes in 2013 and the number is growing at alarming rate which has increased the need to improve treatment and therapies regarding the diseases.

Market Segmentation:Global Autologous Stem Cell and Non-Stem Cell Based Therapies Market

Competitive Analysis:Global Autologous Stem Cell and Non-Stem Cell Based Therapies Market

The global autologous stem cell and non-stem cell based therapies market is highly fragmented and the major players have used various strategies such as new product launches, expansions, agreements, joint ventures, partnerships, acquisitions, and others to increase their footprints in this market. The report includes market shares of autologous stem cell and non-stem cell based therapies market for global, Europe, North America, Asia Pacific and South America.

Major Autologous Stem Cell and Non-Stem Cell Based Therapies Market Drivers and Restraints:

Introduction of novel autologous stem cell based therapies in regenerative medicine

Reduction in transplant associated risks

Prevalence of cancer and diabetes in all age groups

High cost of autologous cellular therapies

Lack of skilled professionals

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Covid-19 impact on Autologous Stem Cell and Non-Stem Cell Based Therapies Market 2020 Industry Research, Share, Trend, Industry Size, Price, Future...

Irvine May 12, 2020 (Thomson StreetEvents) -- Edited Transcript of Chromadex Corp earnings conference call or presentation Monday, May 11, 2020 at 8:30:00pm GMT

* Kevin M. Farr

* Robert N. Fried

H.C. Wainwright & Co, LLC, Research Division - Equity Research Associate

Ladenburg Thalmann & Co. Inc., Research Division - MD of Equity Research

B. Riley FBR, Inc., Research Division - Senior Analyst

Ladies and gentlemen, thank you for standing by, and welcome to ChromaDex Corporation's First Quarter 2020 Earnings Conference Call. My name is Julianne, and I will be the conference operator today. (Operator Instructions) As a reminder, this conference call is being recorded.

This afternoon, ChromaDex issued a news release announcing the company's financial results for the first quarter 2020. If you have not reviewed this information, both are available within the Investor Relations section of ChromaDex's website at http://www.chromadex.com.

I would now like to turn the conference over to Brianna Gerber, Vice President of FP&A and Investor Relations. Please go ahead, Ms. Gerber.

Thank you. Good afternoon, and welcome to ChromaDex Corporation's First Quarter 2020 Results Investor Call.

With us today are ChromaDex's Chief Executive Officer, Rob Fried; Founder and Executive Chairman, Frank Jaksch; and Chief Financial Officer, Kevin Farr.

Today's conference call may include forward-looking statements, including statements related to ChromaDex's research and development and clinical trial plans and the timing and results of such trials; the timing of future regulatory filings, the expansion of the sale of TRU NIAGEN in new markets, future financial results, business development opportunities, future cash needs, ChromaDex's operating performance in the future and future investor interest that are subject to risks and uncertainties relating to ChromaDex's future business prospects and opportunities as well as anticipated results of operations. Forward-looking statements represent only the company's estimates on the date of this conference call and are not intended to give any assurance as to actual future results. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties. Many factors could cause ChromaDex's actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These risk factors include those contained in ChromaDex's quarterly report on Form 10-Q most recently filed with the SEC. Please note that the company assumes no obligation to update any forward-looking statements after the date of this conference call to conform with the forward-looking statements, actual results or to changes in its expectations.

In addition, certain of the financial information presented in this call references non-GAAP financial measures. The company's earnings presentation and earnings press release, which were issued this afternoon and are available on the company's website, present reconciliations to the appropriate GAAP measures.

Finally, this conference call is being recorded via webcast. The webcast will be available at the Investor Relations section of our website at http://www.chromadex.com.

With that, it's now my pleasure to turn the call over to our Chief Executive Officer, Rob Fried. Rob?

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Robert N. Fried, ChromaDex Corporation - CEO & Director [3]

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Thank you, Brianna. Good afternoon, everyone, and thank you for joining our first quarter 2020 investor call. I hope everyone listening is navigating well these troubling times.

ChromaDex had another strong quarter with total net sales of $14.3 million. Overall sales increased 10% sequentially and 43% year-over-year. TRU NIAGEN net sales were $11.1 million, a 10% increase sequentially and a 50% increase year-over-year.

Sales to Watsons were down slightly compared to the prior quarter due to the impact of the coronavirus and the protests on retail traffic in Hong Kong stores.

Importantly, our efforts in reducing costs continued to show positive results as adjusted EBITDA, excluding total legal costs was a net loss of $316,000.

ChromaDex reacted swiftly when the coronavirus hit. We already understood that there is an impact on NAD when viruses are present, but we immediately initiated preclinical research in the area in the first quarter, led by our Chief Scientific Adviser, Dr. Charles Brenner. And as you may have noticed, Dr. Brenner published promising results in the initial preclinical study last month. Further research is required and further research is underway.

Additionally, we adjusted our marketing messaging in the first quarter to include the impact that lifestyle, viral and age-related stressors have on our NAD levels and our cellular health. This, in addition to the existing messages of cellular energy, cellular repair and aging.

And finally, we stepped up our ongoing efforts to streamline costs.

With regard to the overall outlook for the year. It is still not clear if COVID '19 will be positive or negative for our business. We're currently expecting a reduction in our top line growth, but improvement in the bottom line results relative to the outlook presented last quarter. This includes some recent changes to our organization as well as some ongoing initiatives across our supply chain. Kevin will provide additional context when he discusses our financial outlook for the year.

Let's now get to the 3 pillars of our business strategy: build a global brand, to own the science, and to focus on the fundamentals. First, the brand. As mentioned, global TRU NIAGEN net sales were $11.1 million in the quarter, a 10% increase sequentially and a 50% increase year-over-year. TRU NIAGEN represented 78% of the $14.3 million in the quarter.

International sales for TRU NIAGEN represented approximately 29% in the first quarter. This includes sales to Watsons in Hong Kong and Singapore, but also cross-border sales in China, Japan, Europe and sales to our partners in Australia, New Zealand, U.K. and Canada.

Sales to Watsons were $1.8 million in the first quarter, a slight decrease versus the previous quarter. Lower sales in the base business in the first quarter were largely offset by shipments for TRU NIAGEN Beauty, which launched in stores in late April. TRU NIAGEN beauty builds on the success of the TRU NIAGEN brand is an award-winning and best-selling health product among Watsons' Hong Kong loyalty members as well as driver of their health care category. The NIAGEN Beauty will allow us to reach new demographics seeking our science-based solutions for their beauty routines. We're pleased to extend our product portfolio with a strong partner like Watsons.

At this time, there are no plans to extend TRU NIAGEN Beauty beyond the region. E-commerce net sales were $8.2 million, a 4% increase sequentially and a 39% increase year-over-year. Sales from returning customers in the U.S. continue to outpace the new customer sales.

In addition, we have cross-border sales in the U.K., Japan, Korea, Germany, France and China, which grew 179% year-over-year. Currently expanding distribution to include 2 of China's largest online retailers, Kaola and JD.com in the second quarter. These platforms will complement our existing Tmall presence in China.

We also added 2 European cross-border markets in the first quarter following the EFSA approval, France and Germany.

Additionally, we're continuing to build our brand with strong global partnerships. We shipped initial orders to the Australia, U.K. and Persona Nutritions in the first quarter, expanding our partnerships with Matakana Superdrug in the U.K., a division of the A.S. Watson Group and Nestl Health Science, respectively.

In late April, we announced that our U.K. partner is Superdrug, a leading health and beauty retailer with over 800 stores in the U.K. and a member of the A.S. Watson Group. This represents our entry into the European market, and we're proud to expand our partnership with the A.S. Watsons Group. As mentioned last quarter, the initial launch is a small test launch in 200 Superdrug stores across the U.K. as well as superdrug.com. We very much applaud the efforts of Superdrug and Watsons for keeping essential items such as TRU NIAGEN available to customers worldwide during this unprecedented time.

We built upon our relationship with Matakana to include exclusive distribution rights in Australia in online and retail channels. Matakana is an established dietary supplement manufacturer and distributor with more than 90 lines of organic and Superfood products. TRU NIAGEN complements, Matakana's existing portfolio of products and their broad distribution as well as knowledge of our science-based product, this positions the brand for strong growth in Australia. We are partnering with them on a number of influencers, social media and earned media initiatives to drive awareness and sales in the market.

We're very much looking forward to the Nestl Health Science, TRU NIAGEN product later this year, which will emphasize the importance of cellular nutrition. As I previously said, the initial test launch will be in loose powder format, and Nestl plans to begin initial marketing efforts next month.

Persona Nutrition, the division of Nestl Health Science launched TRU NIAGEN in the first quarter. Persona is the leader in the fast-growing area of personalized nutrition. We believe it is a growth opportunity for TRU NIAGEN and one that also helps build the brand.

Our second core objective is to own the science. We are confident in the science behind NIAGEN and are actively tracking the increasing volume of research on the molecule that is currently underway. Several new studies have been registered and published since our last update. Frank will summarize in a moment.

Recently, we announced the first round of results of a combination issue, an in vitro study led by Dr. Charles Brenner, our Chief Scientific Officer; one of the world's foremost experts in NAD research as well as Dr. Stan Perlman, one of the leading experts on coronavirus. Dr. Brenner's preclinical study showed 2 key findings: one, a COVID-19 introduction to the studied cells caused greater than threefold reduction in NAD; and two, these infected cells specifically sought out nicotinamide riboside, NIAGEN in an attempt to replenish NAD levels in the face of the viral infection. We expect additional research from Dr. Brenner to be made public soon.

The next phase of his preclinical research will explore whether introducing nicotinamide riboside, or NIAGEN, may support cells innate immune response to coronaviruses and other viruses. We will publicly share the findings of this research when appropriate. We are also exploring additional preclinical research on nicotinamide riboside, or NIAGEN and COVID-19 through our industry-leading ChromaDex external research program.

We also continue to build upon and protect our intellectual property, which includes our ongoing litigation against Elysium Health. A May 12 trial date for the California Litigation was postponed due to court closures in the wake of the coronavirus outbreak. We recently submitted a written joint status report, and the court granted our request for a status conference in June.

New York, discovery has been extended by 4 months due to restrictions on taking depositions in the wake of the coronavirus. And in Delaware, regarding patent infringement by Elysium, it has been scheduled for trial on September 27, 2021. Moving forward following the recent Court of Appeals decision that upheld the validity of the Dartmouth patent, which is licensed by ChromaDex.

To remind everyone, Elysium could not appeal the rejection of their challenge to the 807 patent. Now that Elysium lost their appeal of the PTAB decision validating the 086 patent. Elysium cannot raise those same arguments in the patent infringement lawsuit regarding any claims on the 086 patent. We remain confident in the facts of all 3 cases and are eager to get to trial.

In the meantime, we expect lower near-term legal expense with delays attributable to the coronavirus.

Our third strategic pillar is to focus on fundamentals. It is our mission to lead by example of this industry. During the time when the world is looking for new solutions to maintain their health, we strongly encourage consumers to choose trusted brands, supported by published scientific data with regulatory approvals. We continue our basic philosophy of science-based marketing and conservative financial management. We recently announced the $5 million capital raise to provide some further strength to the already strong balance sheet.

In summary, in the wake of the coronavirus, we are successfully driving the business forward. We are leading important research in the field, delivering on incremental growth opportunities and adjusting our cost structure, maintaining a strong balance sheet. I believe ChromaDex will be even stronger once this global macroeconomic crisis is behind us.

And now I will pass the call over to our Chairman, Frank Jaksch, for an update on scientific research. Frank?

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Frank Louis Jaksch, ChromaDex Corporation - Co-Founder & Executive Chairman [4]

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Thank you, Rob. As Rob stated, one of our core objectives is to own the science. We are committed to remaining a global scientific authority on NR and NAD research as well as setting the standard for excellence in the industry with our commitment to science, safety and quality.

Last call, publication of research on NR and NAD has continued to accelerate with the publication of the Ninth Human Trial and multiple preclinical studies.

As Rob mentioned earlier, Dr. Brenner and scientists from the University of Iowa, Oregon Health and Science University and the University of Kansas recently published preliminary preclinical research on the potential impact coronavirus has on NAD levels in cell, animal and human tissue. The findings were published on BioArchive, a preprint server. The researchers characterized the key steps in what happens in a coronavirus infected cell and the impact it has on a innate immunity.

Before moving on, I want to briefly discuss the concept of a innate versus acquired or adaptive immunity. Acquired immunity is where the body's immune cells have developed specific antibodies after being exposed to a virus and they can quickly seek out the virus and destroy it before it can spread infection. This is how vaccines work using the acquired or adaptive immune response to protect us from viruses.

In contrast, innate immunity is where the cells go to work to fight off the infection when it is first introduced to the body. The body mobilizes immune cells to seek out, attack and destroy the virus. What we've learned from these early publications is that NAD is important for the initial innate or nonspecific response. However, further preclinical research is required in those preclinical studies are underway.

There are 40 ongoing, completed and published clinical trials currently registered on clinicaltrials.gov to investigate the pharmacokinetics and the therapeutic effects of NR. This is 1 more than our last update. An additional 9 clinical trials are registered to test NR in combination with other ingredients for a total of 49. We finished the quarter with 195 signed research collaborations, up by approximately 10 compared to last quarter.

I highlighted an interesting recent published study on NR since we last spoke. In April, a preclinical study demonstrating the effects of both niacinamide and our product, nicotinamide riboside. Supplementation on cardiac electrophysiology was published in the Journal of Molecular and Cellular Cardiology. Researchers from the University of Iowa were able to demonstrate that both NR and NAM increased NAD and NADH levels. However, only NR indicated a potential cardiovascular effect. These results reinforce earlier preclinical findings that suggest increased NAD levels may have a beneficial impact on cardiac conditions and arrhythmias. The researchers concluded that the results warrant further investigation into NR as a potential therapy for cardiac arrhythmic disorders.

Finally, I'll briefly touch on the newly registered clinical studies, all of which were registered in April. First, a study was registered by Ko University Hospital in Turkey to establish metabolic improvements in obese patients with nonalcoholic fatty liver disease, or NAFLD. Through dietary supplementation of NR with the combination of serine, L-carnitine and N-cacetylcysteine. Previous studies have suggested that each of these nutrients decrease liver fat. Thus, the researchers hypothesized that supplementation of a combination of these ingredients, including NR, will stimulate pathways to enhance hepatic oxidation, resulting in decreased liver fat.

Additionally, a pilot study was registered by the Cleveland Clinic, a comprehensive cancer care center to investigate the effects of nicotinamide riboside supplementation in allogeneic hematopoietic cell transplantation. The objective is to find a safe and tolerable way to improve engraftment after transplant. Research studies have shown that adding NR to donor cells has the potential to increase blood stem cell numbers and potentially decrease the time to engraftment.

Before turning the call over to Kevin, I'd like to briefly discuss our new framework for categorizing the areas of ongoing research on NR. In the past, I have discussed studies categorized by various health conditions such as heart health or cardiovascular health, brain health or neurological health, liver health as well as many others. At ChromaDex, we've begun to frame the discussion in the context of a new way of looking at health called intrinsic capacity, which is part of the World Health Organization's framework for healthy aging.

According to WHO, intrinsic capacity is the composite of all mental and physical capacities that a person can draw on, including their ability to walk, think, see, hear and remember. It is an indicator of one's ability to cope with physiological stress and still maintain these functions. We categorize these concepts into 5 domains of intrinsic capacity, vitality, cognition, locomotion, sensory and psychological. In other words, intrinsic capacity is defined by the underlying health of our cells. Nutritional solutions such as NR represent an opportunity to help maintain or even improve intrinsic capacity.

We've included a slide in our earnings presentation, illustrating how cellular health supports intrinsic capacity. Going forward, I'll be presenting the summary of ongoing clinical studies in these intrinsic capacity domains consistent with our internal framework.

In summary, ChromaDex is committed to remaining the leader in the NR, NAD and cellular health conversation. As Rob mentioned, Dr. Brenner's preclinical research is ongoing, and we will provide updates when appropriate.

With that, I'll pass the call over to Kevin Farr. Kevin?

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Kevin M. Farr, ChromaDex Corporation - CFO [5]

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Thank you, Frank. Let's look at our financial results for the first quarter of 2020, which reflected continued progress against our key financial objectives and strong underlying business performance. The underlying business is measured by adjusted EBITDA, excluding total legal expense, approached breakeven in the first quarter with a loss of $316,000. This was a $1.8 million improvement sequentially and a $2.4 million improvement year-over-year. Compared to the fourth quarter of 2019, we delivered strong sequential top line growth, higher gross margins, significant lower advertising expense as a percentage of net sales and lower general administrative expenses primarily driven by the absence of Elysium-related debt expense in the current quarter, partially offset by higher severance and restructuring charges, which are related to cost savings initiatives.

In April, we strengthened our balance sheet with a $5 million common stock raise from existing strategic investors. While there was not an immediate need for the additional capital, we believe it's prudent given the current economic uncertainty. We're always opportunistic if an investor wants to invest capital into the company, and it benefits all of our shareholders.

With this additional $5 million, based upon our current outlook, we believe we have enough cash to reach cash flow breakeven and defend our intellectual property, excluding our $7 million committed line of credit. The line of credit provides additional financial flexibility.

Moving to the first quarter results. For the 3 months ended March 31, 2020, ChromaDex reported net sales of $14.3 million up 10% compared to the $13.1 million in the fourth quarter of 2019. Year-over-year net sales were up 43% compared to the first quarter of 2019.

TRU NIAGEN net sales were up 10% sequentially and grew by 50% year-over-year with diversified growth across U.S. e-commerce, Watsons and international cross-border launches year-over-year. Watsons' sales remained solid at $1.8 million in the quarter, but were down slightly versus last quarter. As expected, Watsons' experienced softer consumer takeaway in the first quarter due to store closures in the wake of the coronavirus. As the economy began to reopen in March, these trends improved, but have yet returned to prior levels. As Rob mentioned, we also shipped our new product TRU NIAGEN Beauty in the quarter, which aligned with Watsons' late April launch. We expect continued impact on sales to Watsons in the second quarter due to the coronavirus.

Total NIAGEN-related net sales were up 8% sequentially and 53% year-over-year. We've experienced strong demand for NIAGEN from our customers.

Turning to the rest of the P&L. On a sequential basis, our gross margin was up 90 basis points from 57.0% in the fourth quarter of 2019 to 57.9% in the first quarter of 2020. Year-over-year gross margin increased by 520 basis points to 57.9% compared to 52.8% in the first quarter of 2019.

As a reminder, last year, we recorded a 250 basis point charge related to the wind down of our purple corn ingredient sales. Product cost savings initiative and overall scale in our supply chain drove the improvement in gross margins. We believe both factors as well as favorable mix from growing TRU NIAGEN consumer product sales represent a tailwind to gross margins in 2020.

On a sequential basis, our total operating expenses for the first quarter of 2020 was $14.2 million, down $2.1 million compared to the fourth quarter of 2019. As a reminder, the fourth quarter of 2019 included a onetime bad debt charge of $2.2 million related to the full write-off of our Elysium receivable.

Our selling and marketing expenses were down $0.7 million to $4.4 million in the first quarter of 2020 compared to $5.1 million in the fourth quarter of 2019. As a percentage of net sales, this expenditure was down 800 basis points in the first quarter of 2020 versus the fourth quarter of 2019.

We made continued progress, improving marketing efficiency in our TRU NIAGEN business driven by strong returning customer growth while investing in initiatives to drive new customer growth, both in the U.S. and internationally. We continue to monitor daily e-commerce metrics such as customer acquisition costs to adjust messaging and spending, which is increasingly important in this fluid environment.

As reported, G&A expense was down $1.3 million to $8.8 million in the first quarter of 2020 versus $10.1 million in the fourth quarter of 2019. This included $2.4 million of legal fees and $1.0 million of severance and restructuring expenses in the current quarter. Excluding legal fees, severance, restructuring and equity compensation expense, first quarter 2020 G&A expense was lowered by $0.1 million versus the fourth quarter of 2019 comparable G&A expense, which also excluded Elysium-related bad debt expense.

Legal expense was up slightly compared to the fourth quarter of 2019. Motions for summary judgment when we decided following hearings in the California matter during the first quarter, and discovery accelerated in the New York litigation.

Sequentially, the trial was delayed in California case due to the suspension of all jury trials caused by the coronavirus. For the same reason, deposition discovery was delayed in New York.

As a result, we expect legal expense to be lower in the second quarter of 2020 despite ongoing investments in the Delaware patent infringement case in preparation for the Markman Hearing in December 2020, and the trial in September 2021.

For the first quarter of 2020, our operating loss was $5.9 million versus $8.9 million in the fourth quarter of 2019, which included the $2.2 million bad debt write-off. The net loss attributable to common shareholders for the first quarter of 2020 was $5.9 million or a loss of $0.10 per share as compared to the net loss of $8.9 million or a loss of $0.15 per share for the fourth quarter of 2019. The fourth quarter of 2019 net loss per share included the $0.04 per share bad debt expense.

As we said, we believe it's important to focus on sequential trends in our business to demonstrate progress towards cash flow breakeven. To help investors better engage the underlying performance of our business in the second quarter of 2019, we introduced a new non-GAAP measure adjusted EBITDA, excluding total legal expense. ChromaDex defines adjusted EBITDA, excluding total legal expense as net income or loss, which is adjusted for income tax, interest, depreciation, amortization, noncash stock compensation costs, bad debt expense related to Elysium, severance and restructuring expenses and total legal spending. We have included a reconciliation to the appropriate GAAP measures in our earnings release slide.

Litigation expenses represents the majority of our legal spend today. We are excluding total legal spending from adjusted EBITDA since we expect to decline significantly after the matters are concluded.

In the fourth quarter of 2019, we began excluding severance and restructuring expenses that we expect to deliver measurable, sustainable net cost savings in late 2020 and beyond. We made changes to the organization in the first quarter and completed negotiations as part of our end-to-end supply chain evaluation.

On an annualized basis, we identified at least $2 million of gross savings, with the majority of the savings delivered to be realized in 2021. We incurred $1.2 million of severance and restructuring expenses related to these cost savings initiatives. As is prudent in this uncertain economic environment, we'll continue to evaluate our cost structure and see additional opportunities in our supply chain.

As I previously highlighted, adjusted EBITDA, excluding total legal expense improved by $1.8 million to a loss of $0.3 million in the first quarter of 2020 compared to a loss of $2.1 million in the fourth quarter of 2019.

Year-over-year, we delivered a $2.4 million improvement in the first quarter of 2020 versus a loss of $2.7 million in the first quarter of 2019. The improvement in the first quarter of 2020 was primarily driven by higher sales and gross margins and marketing efficiency.

Moving to the balance sheet and cash flow. We ended the first quarter of 2020 with cash of $13.6 million, down $5.2 million versus the fourth quarter of 2019.

In the first quarter of 2020, our net cash used in operation was a negative $5.2 million versus a negative $0.6 million in the fourth quarter of 2019.

Consistent with our expectation, the higher cash outflows from operations this quarter was driven by working capital, which is a $1.6 million use of cash in the first quarter of 2020 compared to a $3.9 million source of cash in the fourth quarter of 2019. The use of cash in the first quarter was related to an increase in accounts receivable and a decrease in accounts payable, largely due to lower NIAGEN ingredient purchases.

Today, we've successfully navigated the business during the coronavirus pandemic. At this time, we do not expect any supply to change disruptions from coronavirus and have implemented risk assessment strategies to manage this going forward.

As it relates to revenues, the COVID-19 situation remains fluid and difficult to predict. Against this backdrop, we are managing our expenses to mitigate the bottom line impact to the company.

As Rob said, we took a hard look at our 2020 financial plan to ensure we're prioritizing investments with the highest return in the current environment.

For full year 2020, we expect continued top line growth driven by our U.S. e-commerce business, launches in new international markets such as the U.K. and Australia, and launches on new platforms such as Persona Nutrition. As we have said, we anticipate a lower growth rate than the 47% in 2019 due to: a larger revenue base, the impact of the coronavirus and the impact to divesting our Spherix regulatory consulting business, which accounted for roughly $700,000 of 2019 net sales.

As Rob mentioned, we see the coronavirus having impact on Watsons in the second quarter. There has also been a modest impact in our HCP business where some sales are tied to trade shows, which have been canceled.

COVID-19 may also impact our international market launches at retail, but these are incremental opportunities relative to 2019. It's too early to determine the impact of the coronavirus on our e-commerce sales. Consumers are likely to balance concerns about employment, overall macroeconomic weakness with their desire to invest in their health with supplements like TRU NIAGEN.

Based on the trends to date, we're planning for continued growth in this business in 2020. We continue to expect gross margin expansion due to the favorable mix from our growing e-commerce business, the product design changes implemented in late 2019 and additional supply chain cost savings initiatives.

We continue to expect an increase in selling and marketing expense of $3 million to $5 million, including investments in brand awareness and investments in new market launches. We expect continued improvement in selling and marketing expense as a percentage of net sales driven by strong sales growth from returning customers.

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Edited Transcript of CDXC earnings conference call or presentation 11-May-20 8:30pm GMT - Yahoo Finance

According to the World Health Organization (WHO), cardiovascular disease, specifically ischemic heart disease, is one of the leading causes of death worldwide. Cardiovascular diseases result in an estimated 17.9 million deaths each year. This is about 31% of all deaths worldwide (1). Medical researchers are continually working on ways to reduce those numbers, including the development of new technologies to combat premature deaths from cardiovascular diseases. This article will focus, in particular, on the value of induced pluripotent stem cells (iPSCs) in cardiac research.

iPSCs are a type of pluripotent stem cell. These are master cells that can differentiate into any cell or tissue the body needs. They are generated directly from somatic cells through ectopic expression of various transcription factors, such as

Theyve become key tools to model biological processes, particularly in cell types that are difficult to access from living donors. Many research laboratories are working to enhance reprogramming efficiency by testing different cocktails of transcription factors.

iPSCs have become essential in a number of different research fields, including cardiac research.

They are a valuable and advantageous technologic development for two main reasons:

Most people have heard of embryonic stem cells, which are one variation of pluripotent cells. Like iPSCs, they can be used to replace or restore tissues that have been damaged.

The problem is that embryonic stem cells are only found in preimplantation stage embryos (3). Whereas iPSCs are adult cells that have been genetically modified to work like embryonic stem cells. Thus, the term, inducedpluripotent stem cells.

The development of iPSCs was helpful because embryos are not needed. This reduces the controversy surrounding the creation and use of stem cells. Further, iPSCs from human donors are also more compatible with patients than animal iPSCs, making them even closer to their embryonic cousins.

The Japanese inventor of iPSCs, Professor Shinya Yamanaka earned a Nobel Prize in 2012 for the discovery that mature cells can be reprogrammed to become pluripotent. (4) The Prize was awarded to Dr. Yamanaka because of the significant medical and research implications this technology holds.

iPSCs hold a lot of promise for transplantation medicine. Further, they are highly useful in drug development and modeling of diseases.

iPSCs may become important in transplantation medicine because the tissues developed from them are a nearly identical match to the cell donors. This can potentially reduce the chances of rejection by the immune system (5).

In the future, and with enough research, it is highly possible that researchers may be able to perfect the iPSC technology so that it can efficiently reprogram cells and repair damaged tissues throughout the body.

iPSCs forgo the need for embryos and can be made to match specific patients. This makes them extremely useful in both research and medicine.

Every individual with damaged or diseased tissues could have their own pluripotent stem cells created to replace or repair them. Of course, more research is needed before that becomes a reality. To date, the use of iPSCs in therapeutic transplants has been very limited.

One of the most significant areas where iPSCs are currently being used is in cardiac research. With appropriate nutrients and inducers, iPSC can be programmed to differentiate into any cell type of the body, including cardiomyocyte. This heart-specific cell can then serve as a great model for therapeutic drug screening or assay development.

Another notable application of iPSCs in cardiac research is optical mapping technology. Optical mapping technology employs high-speed cameras and fluorescence microscopy to examines the etiology and therapy of cardiac arrhythmias in a patient-like environment. This is typically done by looking into electrical properties of multicellular cardiac preparations., e.g. action potential or calcium transient, at high spatiotemporal resolution (6).

Optical mapping technology can correctly record or acquire data from iPSCs. iPSCs are also useful in mimicking a patients cardiomyocytes with their specific behaviors, resulting in more reliable and quality data of cardiac diseases.

iPSCs are vital tools in cardiac research for the following reasons:

iPSCs are patient-specific because they are 100% genetically identical with their donors. This genomic make-up allows researchers to study patients pathology further and develop therapeutic agents for treating their cardiac diseases.

Induced pluripotent stem cell-derived cardiomyocytes (iPSC-CMs), help researchers predict the cardiotoxicity of drugs like with widely used chemotherapy reagents (10). Predictions like this were close to impossible before iPSC technology entered the research game.

iPSCs really come into play with their ability to model diseases. Because iPSCs are genetic matches to their living donors, they are uniquely useful for the study of genetic cardiac diseases like monogenic disorders. iPSCs help researchers understand how disease genotypes at the genetic level manifest as phenotypes at the cellular level (5).

Long QT syndrome, a condition that affects the repolarization of a patients heart after a heartbeat, is a notable example of iPSC-based disease modeling (7). This syndrome has been successfully modeled using iPSCs and is an excellent model for other promising target diseases (7).

Long QT syndrome is not the only disease that has been modeled by iPSCs. Other cardiac diseases like Barth syndrome-associated cardiomyopathy and drug-induced kidney glomerular injuries have been modeled as well (8).

The advent of iPSC technology has created a wealth of new opportunities and applications in cardiovascular research and treatments. In the near future, researchers hope that iPSC-derived therapies will be an option for thousands, if not millions of patients worldwide.

More from this author: The Promising Future of Nanomedicine and Nanoparticles

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The U.S. Food and Drug Administration (FDA) announced on Tuesday that it has approved dapagliflozin, also known under the brand name Farxiga, for the treatment of heart failure in adults with reduced ejection fraction. The drug can potentially reduce the risk of cardiovascular death and hospitalization for heart failure.

AstraZenecas Farxiga is now the first in its drug class of sodium-glucose co-transporter 2 (SGLT2) inhibitors to be approved to treat adults with the New York Heart Associations functional class II-IV heart failure with reduced ejection fraction. AstraZeneca was granted with the approval of Farxiga related to heart failure by the FDA.

In a clinical trial, Farxiga appeared to improve survival and reduce the need for hospitalization in adults with heart failure and reduced ejection fraction.

To determine the efficacy of the drug, researchers looked at the number of instances of cardiovascular death, hospitalization for heart failure and urgent heart failure visits. Some trial participants were given a once-daily dose of 10mg of Farxiga, while others were given a placebo. After approximately 18 months, those who were given Farxiga had fewer cardiovascular deaths, hospitalizations for heart failure and urgent heart failure visits compared to their counterparts.

Heart failure is a serious health condition that contributes to one in eight deaths in the U.S. and impacts nearly 6.5 million Americans, said Norman Stockbridge, M.D., Ph.D., director of the Division of Cardiology and Nephrology in the FDAs Center for Drug Evaluation and Research. This approval provides patients with heart failure with reduced ejection fraction an additional treatment option that can improve survival and reduce the need for hospitalization.

Farxiga can cause side effects including dehydration, urinary tract infections and genetical yeast infections. It can also potentially result in serious cases of necrotizing fasciitis of the perineum in people with diabetes and low blood sugar when combined with insulin.

On Tuesday, BioCardia, Inc. also announced positive preclinical data supporting its new drug application for anti-inflammatory cell therapy for heart failure. BioCardias allogenic neurokinin 1 receptor positive mesenchymal stem cell (NK1R+ MSC) therapy appeared to improve heart function in a study. NK1R+ MSC is being marketed under the name CardiALLO.

Researchers looked at 26 animals treated with both low dose and high dose CardiALLO in their study. Echocardiographic measures of cardiac ejection fraction, fractional shortening and cardiac outflow all notably improved in the animals.

In light of these positive data on our allogenic NK1R+ MSC therapy, we expect to meet our internal timeline to complete our submission to the FDA for our first indication for CardiALLO, and potentially receive IND acceptance by the end of the second quarter, said BioCardia Chief Scientific Officer Ian McNiece, PhD. The MSCs that were studied are subtypes of MSC that we have delivered previously in our co-sponsored trials, which we believe have enhanced potency over MSC generated from unselected bone marrow cells. We look forward to seeing additional data from this animal study that are currently being analyzed, including histology and pathology of the heart and lungs.

BioCardia also intends to submit an IND for the use of NK1R+ MSC delivered via intravenous infusion for the treatment of Acute Respiratory Distress Syndrome caused by COVID-19.

Approximately 6.5 million adults in the U.S. are living with heart failure, according to the Centers for Disease Control and Protection. In 2017, it was a contributing cause of death in one out of eight people.

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FDA Approves AstraZeneca's Farxiga for Heart Failure in Adults with Reduced Ejection Fraction - BioSpace

(MENAFN - iCrowdNewsWire) May 8, 2020

According to the new market research report " Cell Therapy Technologies Market by Product (Consumables, Equipment, Software), Cell Type (Human Stem & Differentiated, Animal), Process Stages (Cell Processing, Distribution, Handling, QC), End User, and Region - Global Forecast to 2023, , published by MarketsandMarkets, The global cell therapy technologies market is projected to reach USD 19.9 billion by 2023 from USD 10.2 billion in 2018, at a CAGR of 14.4% during the forecast period.

Browse in-depth TOC on 'Cell Therapy Technologies Market" 75 - Table30 Figures116 Pages

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Rising government investments for cell-based research, the increasing number of GMP-certified production facilities, and the large number of oncology-oriented cell-based therapy clinical trials are the key factors driving the growth of this market. China, India, Japan, Korea, and Brazil are emerging markets for cell therapy instruments. These markets boast comparatively lenient standards and government regulations as opposed to developed markets in North America and the EU, and thus offer significant growth potential for providers. However, the high cost of cell-based research and the low success rate is expected to restrain market growth to some extent during the forecast period.

Consumables are expected to account for the largest cell therapy technologies market share in 2018 : By product, the cell therapy technologies market is segmented into consumables, equipment, and systems & software. The consumables segment is expected to account for the largest share of the market in 2018. Factors such as increasing investments by companies to develop advanced products as well as government initiatives for enhancing cell-based research are contributing to the growth of the cell therapy consumables market.

Cell processing segment to witness the highest growth during the forecast period :

Based on process, the cell therapy technologies market is segmented into cell processing; cell preservation, distribution, and handling; and process monitoring and quality control. The cell processing segment is expected to account for the largest market share in 2018 and is projected to witness the highest CAGR during the forecasted period.

Human cells segment accounts for the large share of the cell therapy instruments market, by cell type :

Based on cell type, the market is segmented into human cells and animal cells. In 2018, the human cells segment is expected to account for the largest share of the cell therapy technologies market. The rising adoption of human cells over animal cells for cell therapeutics research, technological advancements, and the rising incidence of diseases such as cancer and cardiac abnormalities are the key factors driving the growth of this segment.

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North America to dominate the cell therapy technologies market during the forecast period : The market is segmented into four major regions, namely, North America, Europe, Asia Pacific, and the Rest of the World (RoW). North America is expected to dominate the market in 2018 owing to the high burden of chronic diseases and increasing R & D activities in the pharmaceutical and biotechnology industries. The Asia Pacific region is expected to register the highest CAGR during the forecast period.

The major players in the western blotting market are Beckman Coulter (US), Becton, Dickinson and Company (US), GE Healthcare (US), Lonza (Switzerland), Merck KGaA (Germany), Miltenyi Biotec (Germany), STEMCELL Technologies, Inc. (Canada), Terumo BCT (US), and Thermo Fisher Scientific (US).

MENAFN0805202000703403ID1100139731

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Cell Therapy Technologies Market to Receive Overwhelming Hike in Revenues by 2023 - MENAFN.COM

TEL AVIV, Israel & PARSIPPANY, N.J. & INCHEON, South Korea--(BUSINESS WIRE)-- Teva Pharmaceuticals USA, Inc., a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), and Celltrion Healthcare, Co., Ltd. (KRX KOSDAQ:091990), today announced that TRUXIMA (rituximab-abbs) injection is now available in the United States for the treatment of:

TRUXIMA is the only biosimilar to the reference product Rituxan1 (rituximab) available to treat rheumatoid arthritis in the United States. See important safety information below including Boxed Warning regarding fatal infusion-related reactions, severe mucocutaneous reactions, hepatitis B virus reactivation and progressive multifocal leukoencephalopathy.

We are proud to make TRUXIMA available to patients and providers as a treatment option for these indications, especially as this is the only rituximab biosimilar indicated for rheumatoid arthritis, said Brendan OGrady, Executive Vice President, North America Commercial, Teva. Following the launch of our other biosimilar earlier this year, we remain focused on our commitment to lower healthcare costs and increase price competition through the availability of biosimilars.

Celltrion Healthcare and Teva Pharmaceutical Industries Ltd. entered into an exclusive partnership in October 2016 for Teva to commercialize TRUXIMA in the U.S. and Canada. In May 2019, TRUXIMA was approved by the U.S. Food and Drug Administration (FDA) to match all of the reference products oncology indications described below.

We are pleased that patients in the United States can now have access to TRUXIMA for these new indications, said Mr. Hyoung-Ki Kim, Vice Chairman at Celltrion Healthcare. We believe that the continued use of biosimilars in the U.S. market will contribute to addressing unmet needs for patients and providers.

Earlier this year, the Centers for Medicare and Medicaid Services (CMS) granted pass-through status for TRUXIMA in the hospital outpatient setting. The Wholesale Acquisition Cost (WAC or list price) for TRUXIMA will be 10 percent lower than the reference product. TRUXIMA is expected to be available through primary wholesalers at a WAC of $845.55 per 100mg vial and $4,227.75 per 500mg vial. Actual costs to individual patients and providers for TRUXIMA are anticipated to be lower than WAC because WAC does not account for additional rebates and discounts that may apply. Savings on out-of-pocket costs may vary depending on the patients insurance payer and eligibility for participation in the assistance program.

Teva also offers dedicated patient support services through the CORE program. CORE is available to help eligible patients, caregivers and healthcare professionals navigate the reimbursement process. CORE offers a range of services, including benefits verification and coverage determination, support for precertification and prior authorization, assistance with coverage guidelines and claims investigation, and support through the claims and appeals process. A savings program is also available for eligible commercially insured patients. To learn more, please visit TevaCORE.com.

Please see the Important Safety Information below including the Boxed Warning regarding fatal infusion-related reactions, severe mucocutaneous reactions, hepatitis B virus reactivation and progressive multifocal leukoencephalopathy. For more information, please see the full prescribing information.

Indications TRUXIMA (rituximab-abbs) is indicated for the treatment of adult patients with:

Non-Hodgkins Lymphoma (NHL)

Chronic Lymphocytic Leukemia (CLL)

Rheumatoid Arthritis (RA)

Granulomatosis with Polyangiitis (GPA) (Wegeners Granulomatosis) and Microscopic Polyangiitis (MPA)

Important Safety Information

WARNING: FATAL INFUSION-RELATED REACTIONS, SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY

Infusion-Related Reactions: Administration of rituximab products, including TRUXIMA, can result in serious, including fatal, infusion-related reactions. Deaths within 24 hours of rituximab infusion have occurred. Approximately 80% of fatal infusion-related reactions occurred in association with the first infusion. Monitor patients closely. Discontinue TRUXIMA infusion for severe reactions and provide medical treatment for Grade 3 or 4 infusion-related reactions

Severe Mucocutaneous Reactions: Severe, including fatal, mucocutaneous reactions can occur in patients receiving rituximab products

Hepatitis B Virus (HBV) Reactivation: HBV reactivation can occur in patients treated with rituximab products, in some cases resulting in fulminant hepatitis, hepatic failure, and death. Screen all patients for HBV infection before treatment initiation, and monitor patients during and after treatment with TRUXIMA. Discontinue TRUXIMA and concomitant medications in the event of HBV reactivation

Progressive Multifocal Leukoencephalopathy (PML), including fatal PML, can occur in patients receiving rituximab products

WARNINGS AND PRECAUTIONS

Infusion-Related Reactions - Rituximab products can cause severe, including fatal, infusion-related reactions. Severe reactions typically occurred during the first infusion with time to onset of 30-120 minutes. Rituximab product-induced infusion-related reactions and sequelae include urticaria, hypotension, angioedema, hypoxia, bronchospasm, pulmonary infiltrates, acute respiratory distress syndrome, myocardial infarction, ventricular fibrillation, cardiogenic shock, anaphylactoid events, or death

Premedicate patients with an antihistamine and acetaminophen prior to dosing. For RA, GPA, and MPA patients, methylprednisolone 100 mg intravenously or its equivalent is recommended 30 minutes prior to each infusion. Institute medical management (e.g. glucocorticoids, epinephrine, bronchodilators, or oxygen) for infusion-related reactions as needed. Depending on the severity of the infusion-related reaction and the required interventions, temporarily or permanently discontinue TRUXIMA. Resume infusion at a minimum 50% reduction in rate after symptoms have resolved. Closely monitor the following patients: those with pre-existing cardiac or pulmonary conditions, those who experienced prior cardiopulmonary adverse reactions, and those with high numbers of circulating malignant cells (25,000/mm3)

Severe Mucocutaneous Reactions - Mucocutaneous reactions, some with fatal outcome, can occur in patients treated with rituximab products. These reactions include paraneoplastic pemphigus, Stevens-Johnson syndrome, lichenoid dermatitis, vesiculobullous dermatitis, and toxic epidermal necrolysis. The onset of these reactions has been variable and includes reports with onset on the first day of rituximab exposure. Discontinue TRUXIMA in patients who experience a severe mucocutaneous reaction. The safety of re-administration of rituximab products to patients with severe mucocutaneous reactions has not been determined

Hepatitis B Virus Reactivation - Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure and death, can occur in patients treated with drugs classified as CD20-directed cytolytic antibodies, including rituximab products. Cases have been reported in patients who are hepatitis B surface antigen (HBsAg) positive and also in patients who are HBsAg negative but are hepatitis B core antibody (anti-HBc) positive. Reactivation also has occurred in patients who appear to have resolved hepatitis B infection (i.e., HBsAg negative, anti-HBc positive and hepatitis B surface antibody [anti-HBs] positive)

HBV reactivation is defined as an abrupt increase in HBV replication manifesting as a rapid increase in serum HBV DNA levels or detection of HBsAg in a person who was previously HBsAg negative and anti-HBc positive. Reactivation of HBV replication is often followed by hepatitis, i.e., increase in transaminase levels. In severe cases increase in bilirubin levels, liver failure, and death can occur

Screen all patients for HBV infection by measuring HBsAg and anti-HBc before initiating treatment with TRUXIMA. For patients who show evidence of prior hepatitis B infection (HBsAg positive [regardless of antibody status] or HBsAg negative but anti-HBc positive), consult with physicians with expertise in managing hepatitis B regarding monitoring and consideration for HBV antiviral therapy before and/or during TRUXIMA treatment

Monitor patients with evidence of current or prior HBV infection for clinical and laboratory signs of hepatitis or HBV reactivation during and for several months following TRUXIMA therapy. HBV reactivation has been reported up to 24 months following completion of rituximab therapy

In patients who develop reactivation of HBV while on TRUXIMA, immediately discontinue TRUXIMA and any concomitant chemotherapy, and institute appropriate treatment. Insufficient data exist regarding the safety of resuming TRUXIMA treatment in patients who develop HBV reactivation. Resumption of TRUXIMA treatment in patients whose HBV reactivation resolves should be discussed with physicians with expertise in managing HBV

Progressive Multifocal Leukoencephalopathy (PML) - JC virus infection resulting in PML and death can occur in rituximab product-treated patients with hematologic malignancies. The majority of patients with hematologic malignancies diagnosed with PML received rituximab in combination with chemotherapy or as part of a hematopoietic stem cell transplant. Most cases of PML were diagnosed within 12 months of their last infusion of rituximab

Consider the diagnosis of PML in any patient presenting with new-onset neurologic manifestations. Evaluation of PML includes, but is not limited to, consultation with a neurologist, brain MRI, and lumbar puncture

Discontinue TRUXIMA and consider discontinuation or reduction of any concomitant chemotherapy or immunosuppressive therapy in patients who develop PML

Tumor Lysis Syndrome (TLS) - Acute renal failure, hyperkalemia, hypocalcemia, hyperuricemia, or hyperphosphatemia from tumor lysis, sometimes fatal, can occur within 12-24 hours after the first infusion of rituximab products in patients with NHL. A high number of circulating malignant cells ( 25,000/mm3) or high tumor burden, confers a greater risk of TLS

Administer aggressive intravenous hydration and anti-hyperuricemic therapy in patients at high risk for TLS. Correct electrolyte abnormalities, monitor renal function and fluid balance, and administer supportive care, including dialysis as indicated

Infections - Serious, including fatal, bacterial, fungal, and new or reactivated viral infections can occur during and following the completion of rituximab product-based therapy. Infections have been reported in some patients with prolonged hypogammaglobulinemia (defined as hypogammaglobulinemia >11 months after rituximab exposure). New or reactivated viral infections included cytomegalovirus, herpes simplex virus, parvovirus B19, varicella zoster virus, West Nile virus, and hepatitis B and C. Discontinue TRUXIMA for serious infections and institute appropriate anti-infective therapy. TRUXIMA is not recommended for use in patients with severe, active infections

Cardiovascular Adverse Reactions - Cardiac adverse reactions, including ventricular fibrillation, myocardial infarction, and cardiogenic shock may occur in patients receiving rituximab products. Discontinue infusions for serious or life-threatening cardiac arrhythmias. Perform cardiac monitoring during and after all infusions of TRUXIMA for patients who develop clinically significant arrhythmias, or who have a history of arrhythmia or angina

Renal Toxicity - Severe, including fatal, renal toxicity can occur after rituximab product administration in patients with NHL. Renal toxicity has occurred in patients who experience tumor lysis syndrome and in patients with NHL administered concomitant cisplatin therapy during clinical trials. The combination of cisplatin and TRUXIMA is not an approved treatment regimen. Monitor closely for signs of renal failure and discontinue TRUXIMA in patients with a rising serum creatinine or oliguria

Bowel Obstruction and Perforation - Abdominal pain, bowel obstruction and perforation, in some cases leading to death, can occur in patients receiving rituximab in combination with chemotherapy. In postmarketing reports, the mean time to documented gastrointestinal perforation was 6 (range 1-77) days in patients with NHL. Evaluate if symptoms of obstruction such as abdominal pain or repeated vomiting occur

Immunization - The safety of immunization with live viral vaccines following rituximab product therapy has not been studied and vaccination with live virus vaccines is not recommended before or during treatment

Prior to initiating TRUXIMA physicians should ensure patients vaccinations and immunizations are up-to-date with guidelines. Administration of any non-live vaccines should occur at least 4 weeks prior to a course of TRUXIMA

Embryo-Fetal Toxicity - Based on human data, rituximab products can cause fetal harm due to B-cell lymphocytopenia in infants exposed to rituximab in-utero. Advise pregnant women of the risk to a fetus. Females of childbearing potential should use effective contraception while receiving TRUXIMA and for 12 months following the last dose of TRUXIMA

Concomitant Use With Other Biologic Agents and DMARDS Other Than Methotrexate

Observe patients closely for signs of infection if biologic agents and/or DMARDs are used concomitantly as limited safety data is available.

Use of concomitant immunosuppressants other than corticosteroids has not been studied in GPA or MPA patients exhibiting peripheral B-cell depletion following treatment with rituximab products

Use in RA Patients Who Have Not Had Prior Inadequate Response to TNF Antagonists

TRUXIMA should only be used in patients who have had a prior inadequate response to one or more TNF antagonist

Most common adverse reactions in clinical trials of NHL (25%) were: infusion-related reactions, fever, lymphopenia, chills, infection, and asthenia

Most common adverse reactions in clinical trials of CLL (25%) were: infusion-related reactions and neutropenia

Most common adverse reactions in clinical trials of RA (10%) were: upper respiratory tract infection, nasopharyngitis, urinary tract infection, and bronchitis (other important adverse reactions include infusion-related reactions, serious infections, and cardiovascular events)

Most common adverse reactions in clinical trials of GPA and MPA (15%) were: infections, nausea, diarrhea, headache, muscle spasms, anemia, peripheral edema, and infusion-related reactions

Nursing Mothers - There are no data on the presence of rituximab in human milk, the effect on the breastfed child, or the effect on milk production. Since many drugs including antibodies are present in human milk, advise a lactating woman not to breastfeed during treatment and for at least 6 months after the last dose of TRUXIMA due to the potential for serious adverse reactions in breastfed infants

About TRUXIMA TRUXIMA (rituximab-abbs) is a U.S. Food and Drug Administration (FDA)-approved biosimilar to RITUXAN (rituximab) for the treatment of: adult patients with CD20-positive, B-cell NHL to be used as a single agent or in combination with chemotherapy or CLL in combination with fludarabine and cyclophosphamide (FC); for rheumatoid arthritis (RA) in combination with methotrexate in adult patients with moderately-to severely-active RA who have inadequate response to one or more TNF antagonist therapies; and granulomatosis with polyangiitis (GPA) (Wegeners Granulomatosis) and microscopic polyangiitis (MPA) in adult patients in combination with glucocorticoids

TRUXIMA has the same mechanism of action as Rituxan and has demonstrated biosimilarity to Rituxan through a totality of evidence.

About Celltrion Healthcare, Co. Ltd. Celltrion Healthcare conducts the worldwide marketing, sales and distribution of biological medicines developed by Celltrion, Inc. through an extensive global network that spans more than 120 different countries. Celltrion Healthcares products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with the US Food and Drug Administration (FDA) cGMP guidelines and the EU GMP guidelines.

About Teva Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has been developing and producing medicines to improve peoples lives for more than a century. We are a global leader in generic and specialty medicines with a portfolio consisting of over 3,500 products in nearly every therapeutic area. Around 200 million people around the world take a Teva medicine every day, and are served by one of the largest and most complex supply chains in the pharmaceutical industry. Along with our established presence in generics, we have significant innovative research and operations supporting our growing portfolio of specialty and biopharmaceutical products. Learn more at http://www.tevapharm.com.

Teva's Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 regarding the launch of TRUXIMA Injection for Rheumatoid Arthritis in the United States, which are based on managements current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to:

and other factors discussed in our Annual Report on Form 10-K for the year ended December 31, 2019, including in the sections captioned "Risk Factors and Forward Looking Statements. Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.

1 RITUXAN is a registered trademark of Genentech and Biogen.

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Teva and Celltrion Healthcare Announce the Launch of TRUXIMA (rituximab-abbs) Injection for Rheumatoid Arthritis, the Only Biosimilar to Rituxan...

What is the impact of Covid-19 crisis on the Indian pharma industry?India has an important position in the global pharmaceutical sector as it is the largest provider of generic drugs globally. In the first 9 months of FY20, India exported pharma products worth US$15.6 bn and imported pharma products (mainly bulk drugs and intermediates) worth US$5.0 bn.

2 With the Lockdown imposed in India, what were the operational issues faced by pharma companies?There are numerous operational issues faced due to lockdown restrictions. Firstly, there is limited availability for cargo flights for finished goods export due to which air freight have gone up by ~4x. This has also affected the supply of non-essential drugs to customers. Secondly, raw materials and intermediaries cargo which are imported via shipping lines are kept quarantined at seaports for 14 days before being allowed for further inland movement. As on April 6, 2020, pharma raw materials and finished goods worth over USD 1bn were stuck at the ports on account of these constraints. Thirdly and more specific to manufacturing, transportation of ancillary supplies like packaging materials has been affected. Further non-availability of contractual workers has led to a shortage of manpower in other ancillary activities related to production.

Most of these challenges are likely to see resolution with the lifting of lockdown restrictions in the coming days and weeks.

4. How will the new guidelines on Lockdown exemption from Ministry of Home Affairs (MHA) help the industry?Lockdown exemption after April 20, 2020 provided by latest MHA guidelines will allow manufacturing units to remain operational and help in addressing some of these issues as pharmaceutical industry and its ancillary industries have been notified in essential category. In the initial days, the ports will have to handle higher cargo which may lead to temporary congestion, but the situation is expected to ease with time. 5.What are the immediate focus areas for pharma companies today?After relaxation in lockdown measures, the immediate focus would be to ramp up production levels, exports and resume supplies to domestic market so that the temporary shortfall caused by reduction in supplies could be compensated. An evaluation of near-term liquidity requirements and possible sources as further clarity emerges is a task that is likely to continue. Also, it is very important that companies continue to ensure proper preventive measures for safety of their employees working in manufacturing units.

6.How can these companies improve their near-term liquidity requirements during these times?The export-oriented units should actively follow up for liquidation of Merchandise Exports from India Scheme (MEIS) scrips for payment of duty or sale in open market and GST refunds, which are expected to get processed faster based on governments direction to Central Board of Indirect Taxes and Customs (CBIC). Also, depending on their liquidity requirements, the companies can avail moratorium on loans and reassessment of their working capital limits.7

7.How are pharma companies ensuring safety and well-being of the employees and other workers in manufacturing facilities?The pharma companies need to comply with regulatory requirements of (United States Foods and Drug Administration) USFDA, UK Medicines and Healthcare products Regulatory Agency (UKMHRA) and other regulatory agencies and therefore, maintain high standards of workplace hygiene and safety. The manufacturing units have been equipped with necessary temperature monitoring devices for early identification of symptoms for COVID-19 in employees, with social distancing and sanitization are being strictly implemented by companies for the workforce within the plant, in canteens and transit buses. Also, Indian Pharmaceutical Alliance and its member companies have come together and developed Best Practices document to safeguard employee safety in pharmaceutical manufacturing.

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Post relaxation in lockdown, the focus for Pharma would be to ramp up production : Ramkumar SV - ETHealthworld.com

The lungs are ground zero, but COVID-19 also tears through organ systems from brain to blood vessels.

Science's COVID-19 coverage is supported by the Pulitzer Center.

The coronavirus wreaked extensive damage (yellow) on the lungs of a 59-year-old man who died at George Washington University Hospital, as seen in a 3D model based on computed tomography scans.

On rounds in a 20-bed intensive care unit one recent day, physician Joshua Denson assessed two patients with seizures, many with respiratory failure, and others whose kidneys were on a dangerous downhill slide. Days earlier, his rounds had been interrupted as his team tried, and failed, to resuscitate a young woman whose heart had stopped. All of the patients shared one thing, says Denson, a pulmonary and critical care physician at the Tulane University School of Medicine. They are all COVID positive.

As the number of confirmed cases of COVID-19 approaches 2.5 million globally and deaths surpass 166,000, clinicians and pathologists are struggling to understand the damage wrought by the coronavirus as it tears through the body. They are realizing that although the lungs are ground zero, the virus' reach can extend to many organs including the heart and blood vessels, kidneys, gut, and brain.

[The disease] can attack almost anything in the body with devastating consequences, says cardiologist Harlan Krumholz of Yale University and Yale-New Haven Hospital, who is leading multiple efforts to gather clinical data on COVID-19. Its ferocity is breathtaking and humbling.

Understanding the rampage could help doctors on the front lines treat the roughly 5% of infected people who become desperately and sometimes mysteriously ill. Does a dangerous, newly observed tendency to blood clotting transform some mild cases into life-threatening emergencies? Is an overzealous immune response behind the worst cases, suggesting treatment with immune-suppressing drugs could help? And what explains the startlingly low blood oxygen that some physicians are reporting in patients who nonetheless are not gasping for breath? Taking a systems approach may be beneficial as we start thinking about therapies, says Nilam Mangalmurti, a pulmonary intensivist at the Hospital of the University of Pennsylvania (HUP).

What follows is a snapshot of the fast-evolving understanding of how the virus attacks cells around the body. Despite the more than 1500 papers now spilling into journals and onto preprint servers every week, a clear picture is elusive, as the virus acts like no pathogen humanity has ever seen. Without larger, controlled studies that are only now being launched, scientists must pull information from small studies and case reports, often published at warp speed and not yet peer reviewed. We need to keep a very open mind as this phenomenon goes forward, says Nancy Reau, a liver transplant physician who has been treating COVID-19 patients at Rush University Medical Center. We are still learning.

WHEN AN INFECTED PERSON expels virus-laden droplets and someone else inhales them, the novel coronavirus, called SARS-CoV-2, enters the nose and throat. It finds a welcome home in the lining of the nose, according to a recent arXiv preprint, because cells there are rich in a cell-surface receptor called angiotensin-converting enzyme 2 (ACE2). Throughout the body, the presence of ACE2, which normally helps regulate blood pressure, marks tissues potentially vulnerable to infection, because the virus requires that receptor to enter a cell. Once inside, the virus hijacks the cell's machinery, making myriad copies of itself and invading new cells.

As the virus multiplies, an infected person may shed copious amounts of it, especially during the first week or so. Symptoms may be absent at this point. Or the virus' new victim may develop a fever, dry cough, sore throat, loss of smell and taste, or head and body aches.

If the immune system doesn't beat back SARS-CoV-2 during this initial phase, the virus then marches down the windpipe to attack the lungs, where it can turn deadly. The thinner, distant branches of the lung's respiratory tree end in tiny air sacs called alveoli, each lined by a single layer of cells that are also rich in ACE2 receptors.

Normally, oxygen crosses the alveoli into the capillaries, tiny blood vessels that lie beside the air sacs; the oxygen is then carried to the rest of the body. But as the immune system wars with the invader, the battle itself disrupts healthy oxygen transfer. Frontline white blood cells release inflammatory molecules called chemokines, which in turn summon more immune cells that target and kill virus-infected cells, leaving a stew of fluid and dead cellspusbehind (see graphic, below). This is the underlying pathology of pneumonia, with its corresponding symptoms: coughing; fever; and rapid, shallow respiration. Some COVID-19 patients recover, sometimes with no more support than oxygen breathed in through nasal prongs.

But others deteriorate, often suddenly, developing a condition called acute respiratory distress syndrome. Oxygen levels in their blood plummet, and they struggle ever harder to breathe. On x-rays and computed tomography scans, their lungs are riddled with white opacities where black spaceairshould be. Commonly, these patients end up on ventilators. Many die, and survivors may face long-term complications (see sidebar, p. 359). Autopsies show their alveoli became stuffed with fluid, white blood cells, mucus, and the detritus of destroyed lung cells.

Some clinicians suspect the driving force in many gravely ill patients' downhill trajectories is a disastrous overreaction of the immune system known as a cytokine storm, which other viral infections are known to trigger. Cytokines are chemical signaling molecules that guide a healthy immune response; but in a cytokine storm, levels of certain cytokines soar far beyond what's needed, and immune cells start to attack healthy tissues. Blood vessels leak, blood pressure drops, clots form, and catastrophic organ failure can ensue.

Some studies have shown elevated levels of these inflammation-inducing cytokines in the blood of hospitalized COVID-19 patients. The real morbidity and mortality of this disease is probably driven by this out of proportion inflammatory response to the virus, says Jamie Garfield, a pulmonologist who cares for COVID-19 patients at Temple University Hospital.

But others aren't convinced. There seems to have been a quick move to associate COVID-19 with these hyperinflammatory states. I haven't really seen convincing data that that is the case, says Joseph Levitt, a pulmonary critical care physician at the Stanford University School of Medicine.

He's also worried that efforts to dampen a cytokine response could backfire. Several drugs targeting specific cytokines are in clinical trials in COVID-19 patients. But Levitt fears those drugs may suppress the immune response that the body needs to fight off the virus. There's a real risk that we allow more viral replication, Levitt says.

Meanwhile, other scientists are zeroing in on an entirely different organ system that they say is driving some patients' rapid deterioration: the heart and blood vessels.

IN BRESCIA, ITALY, a 53-year-old woman walked into the emergency room of her local hospital with all the classic symptoms of a heart attack, including telltale signs in her electrocardiogram and high levels of a blood marker suggesting damaged cardiac muscles. Further tests showed cardiac swelling and scarring, and a left ventriclenormally the powerhouse chamber of the heartso weak that it could only pump one-third its normal amount of blood. But when doctors injected dye in her coronary arteries, looking for the blockage that signifies a heart attack, they found none. Another test revealed the real cause: COVID-19.

How the virus attacks the heart and blood vessels is a mystery, but dozens of preprints and papers attest that such damage is common. A 25 March paper in JAMA Cardiology found heart damage in nearly 20% of patients out of 416 hospitalized for COVID-19 in Wuhan, China. In another Wuhan study, 44% of 36 patients admitted to the intensive care unit (ICU) had arrhythmias.

The disruption seems to extend to the blood itself. Among 184 COVID-19 patients in a Dutch ICU, 38% had blood that clotted abnormally, and almost one-third already had clots, according to a 10 April paper in Thrombosis Research. Blood clots can break apart and land in the lungs, blocking vital arteriesa condition known as pulmonary embolism, which has reportedly killed COVID-19 patients. Clots from arteries can also lodge in the brain, causing stroke. Many patients have dramatically high levels of D-dimer, a byproduct of blood clots, says Behnood Bikdeli, a cardiovascular medicine fellow at Columbia University Medical Center.

The more we look, the more likely it becomes that blood clots are a major player in the disease severity and mortality from COVID-19, Bikdeli says.

Infection may also lead to blood vessel constriction. Reports are emerging of ischemia in the fingers and toesa reduction in blood flow that can lead to swollen, painful digits and tissue death.

In the lungs, blood vessel constriction might help explain anecdotal reports of a perplexing phenomenon seen in pneumonia caused by COVID-19: Some patients have extremely low blood-oxygen levels and yet are not gasping for breath. In this scenario, oxygen uptake is impeded by constricted blood vessels rather than by clogged alveoli. One theory is that the virus affects the vascular biology and that's why we see these really low oxygen levels, Levitt says.

If COVID-19 targets blood vessels, that could also help explain why patients with pre-existing damage to those vessels, for example from diabetes and high blood pressure, face higher risk of serious disease. Recent Centers for Disease Control and Prevention (CDC) data on hospitalized patients in 14 U.S. states found that about one-third had chronic lung diseasebut nearly as many had diabetes, and fully half had pre-existing high blood pressure.

Mangalmurti says she has been shocked by the fact that we don't have a huge number of asthmatics or patients with other respiratory diseases in her hospital's ICU. It's very striking to us that risk factors seem to be vascular: diabetes, obesity, age, hypertension.

Scientists are struggling to understand exactly what causes the cardiovascular damage. The virus may directly attack the lining of the heart and blood vessels, which, like the nose and alveoli, are rich in ACE2 receptors. By altering the delicate balance of hormones that help regulate blood pressure, the virus might constrict blood vessels going to the lungs. Another possibility is that lack of oxygen, due to the chaos in the lungs, damages blood vessels. Or a cytokine storm could ravage the heart as it does other organs.

We're still at the beginning, Krumholz says. We really don't understand who is vulnerable, why some people are affected so severely, why it comes on so rapidly and why it is so hard [for some] to recover.

THE WORLDWIDE FEARS of ventilator shortages for failing lungs have received plenty of attention. Not so a scramble for another type of equipment: kidney dialysis machines. If these folks are not dying of lung failure, they're dying of renal failure, says neurologist Jennifer Frontera of New York University's Langone Medical Center, which has treated thousands of COVID-19 patients. Her hospital is developing a dialysis protocol with a different kind of machine to support more patients. What she and her colleagues are seeing suggests the virus may target the kidneys, which are abundantly endowed with ACE2 receptors.

According to one preprint, 27% of 85 hospitalized patients in Wuhan had kidney failure. Another preprint reported that 59% of nearly 200 hospitalized COVID-19 patients in China's Hubei and Sichuan provinces had protein in their urine, and 44% had blood; both suggest kidney damage. Those with acute kidney injury were more than five times as likely to die as COVID-19 patients without it, that preprint reported.

The lung is the primary battle zone. But a fraction of the virus possibly attacks the kidney. And as on the real battlefield, if two places are being attacked at the same time, each place gets worse, says co-author Hongbo Jia, a neuroscientist at the Chinese Academy of Sciences's Suzhou Institute of Biomedical Engineering and Technology.

One study identified viral particles in electron micrographs of kidneys from autopsies, suggesting a direct viral attack. But kidney injury may also be collateral damage. Ventilators boost the risk of kidney damage, as do antiviral compounds including remdesivir, which is being deployed experimentally in COVID-19 patients. Cytokine storms can also dramatically reduce blood flow to the kidney, causing often-fatal damage. And pre-existing diseases like diabetes can increase the chances of kidney injury. There is a whole bucket of people who already have some chronic kidney disease who are at higher risk for acute kidney injury, says Suzanne Watnick, chief medical officer at Northwest Kidney Centers.

ANOTHER STRIKING SET of symptoms in COVID-19 patients centers on the brain and nervous system. Frontera says 5% to 10% of coronavirus patients at her hospital have neurological symptoms. But she says that is probably a gross underestimate of the number whose brains are struggling, especially because many are sedated and on ventilators.

Frontera has seen patients with the brain inflammation encephalitis, seizures, and a sympathetic storm, a hyperreaction of the sympathetic nervous system that causes seizurelike symptoms and is most common after a traumatic brain injury. Some people with COVID-19 briefly lose consciousness. Others have strokes. Many report losing their sense of smell and taste. And Frontera and others wonder whether, in some cases, infection depresses the brain stem reflex that senses oxygen starvationanother explanation for anecdotal observations that some patients aren't gasping for air, despite dangerously low blood oxygen levels.

ACE2 receptors are present in the neural cortex and brain stem, says Robert Stevens, an intensive care physician at Johns Hopkins Medicine. And the coronavirus behind the 2003 severe acute respiratory syndrome (SARS) epidemica close cousin of today's culpritwas able to infiltrate neurons and sometimes caused encephalitis. On 3 April, a case study in the International Journal of Infectious Diseases, from a team in Japan, reported traces of new coronavirus in the cerebrospinal fluid of a COVID-19 patient who developed meningitis and encephalitis, suggesting it, too, can penetrate the central nervous system.

But other factors could be damaging the brain. For example, a cytokine storm could cause brain swelling. The blood's exaggerated tendency to clot could trigger strokes. The challenge now is to shift from conjecture to confidence, at a time when staff are focused on saving lives, and even neurologic assessments like inducing the gag reflex or transporting patients for brain scans risk spreading the virus.

Last month, Sherry Chou, a neurologist at the University of Pittsburgh Medical Center, began to organize a worldwide consortium that now includes 50 centers to draw neurological data from care patients already receive. Early goals are simple: Identify the prevalence of neurologic complications in hospitalized patients and document how they fare. Longer term, Chou and her colleagues hope to gather scans and data from lab tests to better understand the virus' impact on the nervous system, including the brain.

No one knows when or how the virus might penetrate the brain. But Chou speculates about a possible invasion route: through the nose, then upward and through the olfactory bulbexplaining reports of a loss of smellwhich connects to the brain. It's a nice sounding theory, she says. We really have to go and prove that.

A 58-year-old woman with COVID-19 developed encephalitis, with tissue damage in the brain (arrows).

Most neurological symptoms are reported from colleague to colleague by word of mouth, Chou adds. I don't think anybody, and certainly not me, can say we're experts.

IN EARLY MARCH, a 71-year-old Michigan woman returned from a Nile River cruise with bloody diarrhea, vomiting, and abdominal pain. Initially doctors suspected she had a common stomach bug, such as Salmonella. But after she developed a cough, doctors took a nasal swab and found her positive for the novel coronavirus. A stool sample positive for viral RNA, as well as signs of colon injury seen in an endoscopy, pointed to a gastrointestinal (GI) infection with the coronavirus, according to a paper posted online in The American Journal of Gastroenterology (AJG).

Her case adds to a growing body of evidence suggesting the new coronavirus, like its cousin SARS, can infect the lining of the lower digestive tract, where ACE2 receptors are abundant. Viral RNA has been found in as many as 53% of sampled patients' stool samples. And in a paper in press at Gastroenterology, a Chinese team reported finding the virus' protein shell in gastric, duodenal, and rectal cells in biopsies from a COVID-19 patient. I think it probably does replicate in the gastrointestinal tract, says Mary Estes, a virologist at Baylor College of Medicine.

Recent reports suggest up to half of patients, averaging about 20% across studies, experience diarrhea, says Brennan Spiegel of Cedars-Sinai Medical Center in Los Angeles, coeditor-in-chief of AJG. GI symptoms aren't on CDC's list of COVID-19 symptoms, which could cause some COVID-19 cases to go undetected, Spiegel and others say. If you mainly have fever and diarrhea, you won't be tested for COVID, says Douglas Corley of Kaiser Permanente, Northern California, co-editor of Gastroenterology.

The presence of virus in the GI tract raises the unsettling possibility that it could be passed on through feces. But it's not yet clear whether stool contains intact, infectious virus, or only RNA and proteins. To date, We have no evidence that fecal transmission is important, says coronavirus expert Stanley Perlman of the University of Iowa. CDC says that, based on experiences with SARS and with the coronavirus that causes Middle East respiratory syndrome, the risk from fecal transmission is probably low.

The intestines are not the end of the disease's march through the body. For example, up to one-third of hospitalized patients develop conjunctivitispink, watery eyesalthough it's not clear that the virus directly invades the eye.

Other reports suggest liver damage: More than half of COVID-19 patients hospitalized in two Chinese centers had elevated levels of enzymes indicating injury to the liver or bile ducts. But several experts told Science that direct viral invasion isn't likely the culprit. They say other events in a failing body, like drugs or an immune system in overdrive, are more likely causes of the liver damage.

This map of the devastation that COVID-19 can inflict on the body is still just a sketch. It will take years of painstaking research to sharpen the picture of its reach, and the cascade of effects in the body's complex and interconnected systems that it might set in motion. As science races ahead, from probing tissues under microscopes to testing drugs on patients, the hope is for treatments more wily than the virus that has stopped the world in its tracks.

Excerpt from:
A rampage through the body - Science Magazine

Detailed market survey on the Global Autologous Stem Cell Based Therapies Market Research Report 2020-2026. It analyses the vital factors of the Autologous Stem Cell Based Therapies market supported present business Strategy, Autologous Stem Cell Based Therapies market demands, business methods utilised by Autologous Stem Cell Based Therapies market players and therefore the future prospects from numerous angles well. Business associatealysis could be a market assessment tool utilized by business and analysts to grasp the quality of an business. Autologous Stem Cell Based Therapies Market report It helps them get a sense of what is happening in an industry, i.e., demand-supply statistics, Autologous Stem Cell Based Therapies Market degree of competition within the industry, Autologous Stem Cell Based Therapies Market competition of the business with different rising industries, future prospects of the business.

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The Global Autologous Stem Cell Based Therapies market worth about xx billion USD in 2020 and it is expected to reach xx billion USD in 2026 with an average growth rate of x%. United States is the largest production of Autologous Stem Cell Based Therapies Market and consumption region in the world, Europe also play important roles in global Autologous Stem Cell Based Therapies market while China is fastest growing region.

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Geographically, Autologous Stem Cell Based Therapies market report is segmented into several key Regions, with production, consumption, revenue. The major regions involved in Autologous Stem Cell Based Therapies Market are (United States, EU, China, and Japan).

Leading companies reviewed in the Autologous Stem Cell Based Therapies report are:

RegeneusMesoblastPluristem Therapeutics IncU.S. STEM CELL, INC.Brainstorm Cell TherapeuticsTigenixMed cell Europe

Autologous Stem Cell Based Therapies Market Product Type Segmentation As Provided Below:The Autologous Stem Cell Based Therapies Market report is segmented into following categories:

The product segment of the report offers product market information such as demand, supply and market value of the product.

The application of product in terms of USD value is represented in numerical and graphical format for all the major regional markets.The Autologous Stem Cell Based Therapies market report is segmented into Type by following categories;Embryonic Stem CellResident Cardiac Stem CellsUmbilical Cord Blood Stem Cells

The Autologous Stem Cell Based Therapies market report is segmented into Application by following categories;Neurodegenerative DisordersAutoimmune DiseasesCardiovascular Diseases

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Industry analysis, for an entrepreneur or a company, is a method that helps it to understand its position relative to other participants in the Autologous Stem Cell Based Therapies Market. It helps them to identify both the opportunities and threats coming their way and gives them a strong idea of the present and future scenario of the Autologous Stem Cell Based Therapies industry. The key to extant during this changing business setting is to know the variations between yourself and your competitors within the Autologous Stem Cell Based Therapies Market. The deep research study of Autologous Stem Cell Based Therapies market based on development opportunities, growth limiting factors and feasibility of investment will forecast the Autologous Stem Cell Based Therapies market growth.

Finally, The global research document on the Autologous Stem Cell Based Therapies Market discovers a large set of information regarding the competitive business environment and other substantial components. The prime aim of these major competitors is to focus on improved technologies and newer innovations.

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Study on Autologous Stem Cell Based Therapies Market (impact of COVID-19) 2020-2026 Brainstorm Cell Therapeutics, Tigenix, Med cell Europe - Bandera...

Many in the medical community view an experimental antiviral drug called remdesivir, manufactured by Gilead Sciences, as the best chance for a treatment. In tests in academic labs, in work sponsored by the federal government, it has been shown to block viral replication. A clutch of clinical trials are underway worldwide to test it in patients, and Gilead is distributing it to thousands of people on a "compassionate use" basis. Remdesivir is considered a broad-spectrum antiviral, meaning it is believed to work against multiple types of virus. But it failed in a test against Ebola last year. Also, it has a big drawback: It is a liquid that must be given intravenously, which means people must go to a hospital or clinic on 10 consecutive days to be treated. Gilead, the National Institutes of Health and the World Health Organization are among those sponsoring multiple clinical trials, and preliminary results are expected within weeks.

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Here are the drugs that could treat coronavirus. But don't expect a silver bullet. - The Philadelphia Inquirer

In this Autologous Stem Cell And Non Stem Cell Based Therapies Market report, industry trends have been explained on the macro level which makes it possible to summarize the market landscape and probable future issues. The report analyses and estimates general market drivers in the form of consumer demand, government policy and demand which are related to consumer buying pattern and thereby market growth and development. This market research report contains thorough analysis of market and numerous related factors that range from market drivers, market restraints, market segmentation, opportunities, challenges, and market revenues to competitive analysis. This report is also useful when launching a new product or expanding the business regionally or globally.

Key Market Competitors:

Few of the major market competitors currently working in the europe autologous stem cell and non-stem cell based therapies market are Takeda Pharmaceutical Company Limited, Cytori Therapeutics Inc., General Electric Spiegelberg GmbH & Co. KG ., Medtronic, Natus Medical Incorporated., Integra LifeSciences Corporation, RAUMEDIC AG, Abbott., Endotronix, Inc. among others.

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Market Analysis: EuropeAutologous Stem Cell and Non-Stem Cell Based Therapies Market

Europe autologous stem cell and non-stem cell based therapies market is registering a substantial CAGR in the forecast period of 2019-2026. The report contains data from the base year of 2018 and the historic year of 2017. The rise in the market can be attributed growing awareness of the therapeutic potential of stem cells in effective disease management and increased public-private investment in the development of stem cell therapies.

Market Definition: EuropeAutologous Stem Cell and Non-Stem Cell Based Therapies Market

Autologous stem cell transplantation, the individuals own undivided cells or stem cells are collected and transplanted back to the person after intensive therapy. These therapies are performed using hematopoietic stem cells, in some cases, cardiac cells are used to correct the damage caused by heart attacks. Autologous and non-systemic stem cell therapies are used to treat different diseases, for example neurodegenerative diseases, cardiovascular diseases, cancer and autoimmune diseases, parasitic diseases.

Market Drivers

Market Restraints

Segmentation:EuropeAutologous Stem Cell and Non-Stem Cell Based Therapies Market

By Product Type

By Application

By End-User

By Country

Key Developments in the Market:

Competitive Analysis:

Europe Autologous Stem Cell and Non-Stem Cell Based therapies market is highly fragmented and the major players have used various strategies such as new product launches, expansions, agreements, joint ventures, partnerships, acquisitions, and others to increase their footprints in this market. The report includes market shares of autologous stem cell and non-stem cell based therapies market for Europe.

Autologous Stem Cell And Non Stem Cell Based Therapies reports includes the following deliverable

This report scope includes a holistic study of the current dynamics of the market, industry growth and restraints of the Global Autologous Stem Cell And Non Stem Cell Based Therapies Market. It provides the market forecast to 2025, recent developments in the market and pipeline analysis of the major players. The report also includes a review of micro and macro forecasts, new entrant strategies, and market penetration strategies with a comprehensive value chain analysis.

Table Of Contents: Global Autologous Stem Cell And Non Stem Cell Based Therapies MarketPart 01: Executive Summary

Part 02: Scope Of The Report

Part 03: Research Methodology

Part 04: Market Landscape

Part 05: Pipeline Analysis

Part 06: Market Sizing

Part 07: Five Forces Analysis

Part 08: Market Segmentation

Part 09: Customer Landscape

Part 10: Regional Landscape

Part 11: Decision Framework

Part 12: Drivers And Challenges

Part 13: Market Trends

Part 14: Vendor Landscape

Part 15: Vendor Analysis

Part 16: Appendix

Browse TOC with selected illustrations and example pages of Global Autologous Stem Cell And Non Stem Cell Based Therapies Market @https://www.databridgemarketresearch.com/toc/?dbmr=europe-autologous-stem-cell-and-non-stem-cell-based-therapies-market&skp

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Autologous Stem Cell And Non Stem Cell Based Therapies Market Insight, Present Scenario & Growth Prospect 2020-2026 - Science In Me

Advance Market Analyticsreleased the research report ofGlobal Liver CirrhosisMarket, offers a detailed overview of the factors influencing the global business scope.Global Liver Cirrhosis Market research report shows the latest market insights with upcoming trends and breakdown of the products and services.The report provides key statistics on the market status, size, share, growth factors of the Global Liver Cirrhosis.This Report covers the emerging players data, including: competitive situation, sales, revenue and global market share of top manufacturers are F. Hoffmann-La Roche AG (Switzerland), Merck & Co., Inc (United States), Abbott Laboratories (United States), Novartis International AG (Switzerland), Bristol Myers Squibb Company (United States), Gilead Sciences, Inc (United States), Conatus Pharmaceuticals (United States), GlaxoSmithKline plc (United Kingdom), Grifols, S.A. (Spain), GWOXI Stem Cell Applied Technology Co., Ltd (China), Hepion Pharmaceuticals (United States), Intercept Pharmaceuticals, Inc. (United States) and Lepu Medical Technology (Beijing) Co., Ltd. (China).

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The liver cirrhosis means the condition that causes scar tissue of the liver to replace healthy liver tissue cells, it happens over the period due to the chronic infection or alcohol addiction. It is diagnosed by various radiology tests such as computed tomography (CT), ultrasound, magnetic resonance imaging (MRI), needle biopsy of the liver. A new imaging technique called elastography, which can be performed with ultrasound or MRI, can also diagnosis cirrhosis.

Market Trend

Market Drivers

Opportunities

Restraints

Challenges

The Global Liver Cirrhosisis segmented by following Product Types:

Type (Alcoholic Cirrhosis, Atrophic Cirrhosis, Biliary Cirrhosis, Cardiac Cirrhosis, Cryptogenic Cirrhosis), Application (Hospitals, Specialty Clinics, Others), Treatment (Self-care, Medications {Diuretic, Ammonia Reducer, Beta Blocker, Antibiotics, Antiviral Drug}, Medical procedure {Rubber Band Ligation, Therapeutic Endoscopy, and Transjugular Intrahepatic Portosystemic Shunt}, Surgery {Liver transplantation}), Stages (Stage 1, Stage 2, Stage 3, Stage 4), Tests (Computed Tomography (CT), Ultrasound, Magnetic Resonance Imaging (MRI), Needle Biopsy)

Region Included are: North America, Europe, Asia Pacific, Oceania, South America, Middle East & Africa

Country Level Break-Up: United States, Canada, Mexico, Brazil, Argentina, Colombia, Chile, South Africa, Nigeria, Tunisia, Morocco, Germany, United Kingdom (UK), the Netherlands, Spain, Italy, Belgium, Austria, Turkey, Russia, France, Poland, Israel, United Arab Emirates, Qatar, Saudi Arabia, China, Japan, Taiwan, South Korea, Singapore, India, Australia and New Zealand etc.Enquire for customization in Report @:https://www.advancemarketanalytics.com/enquiry-before-buy/63193-global-liver-cirrhosis-market

Strategic Points Covered in Table of Content of Global Liver Cirrhosis Market:

Chapter 1: Introduction, market driving force product Objective of Study and Research Scope the Global Liver Cirrhosis market

Chapter 2: Exclusive Summary the basic information of the Global Liver Cirrhosis Market.

Chapter 3: Displayingthe Market Dynamics- Drivers, Trends and Challenges of the Global Liver Cirrhosis

Chapter 4: Presenting the Global Liver Cirrhosis Market Factor Analysis Porters Five Forces, Supply/Value Chain, PESTEL analysis, Market Entropy, Patent/Trademark Analysis.

Chapter 5: Displaying the by Type, End User and Region 2013-2018

Chapter 6: Evaluating the leading manufacturers of the Global Liver Cirrhosis market which consists of its Competitive Landscape, Peer Group Analysis, BCG Matrix & Company Profile

Chapter 7: To evaluate the market by segments, by countries and by manufacturers with revenue share and sales by key countries in these various regions.

Chapter 8 & 9: Displaying the Appendix, Methodology and Data Source

Finally, Global Liver Cirrhosis Market is a valuable source of guidance for individuals and companies.

Data Sources & Methodology

The primary sources involves the industry experts from the Global Liver Cirrhosis Market including the management organizations, processing organizations, analytics service providers of the industrys value chain. All primary sources were interviewed to gather and authenticate qualitative & quantitative information and determine the future prospects.

In the extensive primary research process undertaken for this study, the primary sources Postal Surveys, telephone, Online & Face-to-Face Survey were considered to obtain and verify both qualitative and quantitative aspects of this research study. When it comes to secondary sources Companys Annual reports, press Releases, Websites, Investor Presentation, Conference Call transcripts, Webinar, Journals, Regulators, National Customs and Industry Associations were given primary weight-age.

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Liver Cirrhosis Market Projected to Gain Significant Value by 2024 - Science In Me

CAMBRIDGE, England--(BUSINESS WIRE)--Metrion Biosciences Limited (Metrion), the specialist ion channel CRO and drug discovery company, today announced it has contributed to two new peer-reviewed papers under the U.S. Food and Drug Administrations (FDA) CiPA (Comprehensive in vitro Proarrhythmia Assay) initiative. The papers, in Nature Scientific Reports1 and Toxicology and Applied Pharmacology2, focus on application of improved cardiac safety testing protocols and recommendations for best practice for the drug discovery industry.

The CiPA Initiative (www.cipaproject.org), which began in July 2013 following a workshop at the US FDA, has the objective to revise and enhance the regulatory framework assessing cardiac safety of new chemical entities. Under current guidelines, new therapeutics undergo initial assessment of proarrhythmic risk by measuring activity against the hERG cardiac ion channel, before progressing to studies in preclinical animal models and ultimately, a Thorough QT interval study in the clinic. The CiPA initiative aims to extend the use of advances in early electrophysiology-based cardiac ion channel screening, in silico predictive modelling, and human induced pluripotent stem cell derived cardiomyocytes to improve the accuracy and reduce the cost of predicting the cardiac liability of new drug candidates. Metrions research forms part of the first stage of the proposed harmonisation work, to provide clarity on how to standardise cardiac ion channel assays to ensure they deliver consistent data for in silico models of clinical cardiac arrythmia risk.

The first paper1, published in Nature Scientific Reports on 27th March 2020 by an international group of authors drawn from 20 different commercial and academic laboratories, including Metrion Biosciences, was coordinated by the Health and Environmental Sciences Institute (HESI). It reviews data from a multi-year, multi-site collaboration across industry, academia and the FDA regulatory agency to optimize experimental protocols and reduce experimental variability and bias. The goal of the study was to guide the development of best practices for the use of automated patch clamp technologies in early cardiac safety screening. High quality in vitro cardiac ion channel data is required for accurate and reliable characterisation of the risk of delayed repolarisation and proarrhythmia in the human heart and to guide subsequent clinical studies and regulatory submissions.

The second paper2, to be published formally in Toxicology and Applied Pharmacology paper on 1st May 2020 but currently available online, uses automated patch clamp data from the CiPA consortium to address the lack of statistical quantification of variability, which hinders the use of primary hERG potency data to predict cardiac arrhythmia. The consortium establishes a more systematic approach to estimate hERG block potency and safety margins.

Dr Marc Rogers, CSO, Metrion Biosciences, said: The Metrion team has been a participant in the international CiPA Initiative since inception and we are now pleased to be able to announce the publication of our data from this global collaborative scientific effort. We believe these projects will make a significant contribution to the eventual revision of cardiac safety testing guidelines by the FDA and other international regulatory agencies. They also contribute to deepening our knowledge of the underlying causes of proarrhythmia, which will help prevent early attrition of potentially promising drugs.

Contributing organisations to the Nature Scientific Reports CiPA study include: Charles River Laboratories; Bayer AG; Sophion Bioscience A/S; Nanion Technologies; GlaxoSmithKline PLC; Pfizer; Sanofi R&D; Astra Zeneca; BSYS GmbH; Bristol-Myers Squibb Company; Eurofins Discovery; Merck; Metrion Biosciences Ltd.; Natural and Medical Science Institute at the University of Tbingen; Northwestern Feinberg School of Medicine, Chicago; Roche Innovation Center Basel; Novoheart; Health and Environmental Sciences Institute, Washington, DC; AbbVie.

Contributing organisations to the Toxicology and Applied Pharmacology hERG study include: Center for Drug Evaluation and Research, Food and Drug Administration; Eli Lilly and Company; AstraZeneca; CiPA LAB; NMI-TT GmbH; Sophion Bioscience A/S; B'SYS GmbH; The Ion Channel Company; F. Hoffmann-La Roche AG; Eurofins Discovery; Bristol-Myers Squibb; Merck & Co., Inc; Metrion Biosciences Ltd.; Nanion Technologies; Charles River Laboratories; Bayer AG; University of Nottingham; Universit de Lille.

For more information on Metrions fully integrated Cardiac Safety Screening / CiPA Screening service, please visit: https://www.metrionbiosciences.com/services/cardiac-safety-screening/

Merion Biosciences comprehensive cardiac safety testing White Paper The changing landscape of cardiac safety will also be available on the Companys website from 13th April 2020.

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Metrion Biosciences and International Scientific Consortium Publish Data and New Recommendations for in Vitro Risk Assessment of the Cardiac Safety of...

, which were found to produce high levels of Interleukin-6 (IL-6), was abated in the presence of anti-IL-6 monoclonal antibodies, according to study results intended to be presented at the annual meeting of the American College of Cardiology (ACC.20).

In a diseased state, cardiacmesenchymal stromal cells (cMSCs) remodel and secrete inflammatory cytokines,including IL-6. IL-6 has been shown to be a potent inducer of Ca2+-mediatedarrhythmia substrates in human myocytes. While anti-IL-6 monoclonal antibodies havean established role in the treatment of autoimmune diseases and malignancies, theiruse in the treatment of cardiac disease has not been well studied.

Using extracted device leads and explanted hearts from patients with and without heart failure, investigators isolated cMSCs (failing and non-failing cMSCs, respectively), and quantified IL-6 using an enzyme-linked immunosorbent assay. Myocytes were derived from induced pluripotent stem cells (iPSCs) from individuals without heart failure and cultured in monolayers. Myocytes were treated with exogenous IL-6 or cocultured with failing cMSCs with and without anti-IL-6 monoclonal antibody. Fluorescent indicators were used to detect the presence of Ca2+ alternans during steady state pacing.

The secretion of IL-6 was found tobe 5.6 times higher in failing vs nonfailing cMSCs (n=4; P <.005) and 66 times higher in cMSCs vs iPSC-derived humanmyocytes (n=5; P <.002). Myocytes thatwere cocultured with failing cMSCs or were exposed to exogenous IL-6 had largeincreases in Ca2+ alternans compared with myocytes cultured alone (343%,n=12, P <.001 and 300%, n=5, P <.002, respectively). These Ca2+alternans were reduced to baseline levels in myocyte/cMSC cocultures treated vsnot treated with IL-6 (reduction, 400%; n=18, P <.001).

These results suggest anovel anti-arrhythmic therapeutic strategy in heart failure using anti-IL-6drugs such as tocilizumab, sarilumab, or siltuximab, concluded theresearchers.

Reference

Vasireddi S, Sattayaprasert P,Moravec C, et al. Targeted anti-inflammatory treatment with anti-Il-6monoclonal antibody for calcium-mediated arrhythmia substrates in heartfailure. Intended to be presented at: American College of Cardiologys 69thAnnual Scientific Session; March 28-30, 2020; Chicago, IL. Presentation 915-09.

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Anti-IL-6 Monoclonal Antibodies as Antiarrhythmic Treatment for HF - The Cardiology Advisor

Dallas-based American Heart Association (AHA) awarded more than $14 million in scientific research grants for health technology solutions focused on heart and brain health, including special projects related to COVID-19, last week. The grants went to four multidisciplinary teams around the country to create the AHAs 10th Strategically Focused Research Network. The newest network centers on Health Technologies and Innovation.

Consumer adoption of healthcare technology on digital mediums like tablets, smartphones, and wearable devices offer a unique outlet to find new solutions to improve health outcomes, American Heart Association president Robert A. Harrington said in a statement.

The AHA peer review team moved forward with its selection of the centers for its latest strategically focused research network when the COVID-19 pandemic in the U.S. broke. The nonprofit science-based organization knows the times are challenging as it works towards its mission of a culture of health.

It felt this was an incredible opportunity for us to provide additional support in harnessing new innovations to tackle the challenges that are crippling the nation, and frankly the globe, Harrington said.

Grantees that will create the 10th network are research teams at Cincinnati Childrens Hospital, The Johns Hopkins University, Stanford University School of Medicine and the University of Michigan. Each team will receive $2.5 million each for their individual projects aimed at reducing health care disparities, empowering people to better manage their health and wellness, and enhancing patient/provider connectivity, the AHA said.

Collectively the teams will also receive $4 million to work on at least one highly impactful project and form a national Health Technology Research Collaborative, it said. The Collaborative may ultimately serve as an American Heart Association research think tank to assist with identifying, creating, testing and bringing to scale future innovative health technologies.

In addition, each research team also can apply for supplemental research grants of up to $200,000 for rapid action projects to develop technology solutions to address the COVID-19 pandemic, the AHA said. Those projects might provide aid for health care systems, doctors or care providers, first responders, patients or consumers.

These supplemental grants are part of the AHAs $2.5 million commitment to research efforts to better understand this unique coronavirus and its interaction with the bodys cardiovascular and cerebrovascular systems.

The peer review committee has assembled an exceptional network to move this work forward and I want to recognize the dedication and commitment of that panel of many renowned experts, Harrington said. The Association uses an intense, multi-stage review process in selecting the centers for our focused research networks and were very appreciative of the committee members who lend their time and expertise to this critical process.

The AHA program brings together basic, clinical, and population researchers with engineers, IT developers, policy leaders, health care clinicians and patients. That lets the teams improve existing technology, and also identify new and innovative ways to put technology to work in addressing heart and brain health, American Heart Association volunteer James A. Weyhenmeyer, Ph.D. said.

Weyhenmeyer is vice president for research and economic development at Auburn University and chair of the Associations peer review team for the selection of the new grant recipients. Its especially important that all of these projects be focused with an equity-first lens to ensure our most vulnerable populations are being served, he noted.

The AHA is currently funding seven Strategically Focused Research Networks (SFRN) with focuses on Go Red For Women, Heart Failure, Obesity, Children, Vascular Disease, Atrial Fibrillation, and Arrhythmias & Sudden Cardiac Death. Three of AHAs networksPrevention, Hypertension, and Disparitieshave been completed. Locally, the University of Texas Southwestern was a grantee in the completed Prevention SFRN.

With the launch of its newest network, the American Heart Association has invested more than $190 million to establish 12 SFRNs since the program was launched in 2010-2011. The idea behind the science networks is the collaboration of scientists to focus research to address key strategic issues that were identified by the AHAs Board of Directors, in areas such as hypertension, womens health, heart failure, obesity, children, vascular disease, atrial fibrillation, sudden cardiac death, and type 2 diabetes. Each established network centers around the understanding, prevention, diagnosis and treatment of a key research topic. Four to six research centers make up each network, AHA said, which brings together investigators with expertise.

More networks can be expected in 2020 and beyond, AHA said.

The latest projects funded by the $14.5 million in grants commenced on April 1. Here they are, per the AHA:

Active Detection and Decentralized Dynamic Registry to Improve Uptake of Rheumatic Heart Disease Secondary Prevention (ADD-RHD) at Cincinnati Childrens HospitalLed by Andrea Beaton, M.D., a pediatric cardiologist at Cincinnati Childrens Hospital, this team will address the global health issue of rheumatic heart disease which affects more than 40 million people, most living in poor countries or poor areas in wealthier countries. The team will concentrate on getting more people living with rheumatic heart disease into guideline-based care using technology to find more people with rheumatic heart disease, keep them in care and generate the investment case to scale up national rheumatic heart disease action plans in low-income countries. Additionally, theyll be looking for early career doctors and scientists who want to help people get better care using technology and educate this next generation in solutions developed to improve global health in the future. The team consists of a collaborative with the Rheumatic Heart Disease Research Collaborative in Uganda (RRCU) including the Uganda Heart Institute, Childrens National Medical Center and the University of Washington in Seattle; the Cincinnati Childrens Digital Experience and Bioinformatics Centers; Northern Kentucky Universitys Biostatistics Department, Health Innovation Center and Health Sciences Institute; REACH (a global technical organization in rheumatic heart disease) and an industry partnership with Caption Health. While the project and solutions will be made for people living in developing countries, the team hopes to learn a lot about how to help people have better health in the United States.

Center for Mobile Technologies to Achieve Equity in Cardiovascular Health at The Johns Hopkins University in BaltimoreLed by cardiologist Seth Martin, M.D., M.H.S., and neurologist David Newman-Toker, M.D., Ph.D., this teams mission is to leverage mobile and wearable technologies to empower patients and clinicians, enhance the quality of care, increase value and improve the diagnosis and management of heart diseases and stroke. Early and accurate diagnoses are essential to ensure the appropriate delivery of guideline-recommended management to engage patients and their caregivers to achieve the best patient outcomes possible. The collaborative project will span the patient experience from diagnosis to management to improve patient care throughout the patient journey. Specifically, the team will develop and test a smartphone application for stroke diagnosis, following their experience with a goggle-based eye-tracking technology in the Armstrong Institute Center for Diagnostic Excellence. On the management side, the team will work on a virtual cardiovascular rehab that builds on their Corrie Health platform to empower patients in guideline-based prevention. Patients and their families from demographically diverse backgrounds will join as partners in the technology advancement process.

Center for Heart Health Technology (H2T): Innovation to Implementation at Stanford University Led by Mintu Turakhia, M.D. M.A.S., Executive Director of Stanfords Center for Digital Health, associate professor of medicine and a cardiac electrophysiologist at the VA Palo Alto Health Care System, the H2T Centers mission is to rapidly develop technologies that address unmet needs for heart health, evaluate them quickly and then implement these solutions at scale. The team will address the issue of high blood pressure, which affects more than 115 million Americans and costs the U.S. health care system more than $22 billion each year. The team will develop a clinician- and patient-facing digital health system for semi-automated management and evidence-based titration of blood pressure medications. The app will be tested in a randomized trial conducted in Northern California and New Jersey in people of different races, educations, and backgrounds and in a population of gig economy workers (rideshare drivers), who can be at increased risk of heart disease.

Wearables In Reducing Risk and Enhancing Daily Lifestyle (WIRED-L) at the University of MichiganLed by Brahmajee Nallamothu, M.D., M.P.H., a professor in the Division of Cardiovascular Diseases at the University of Michigan, this team plans to establish the Wearables In Reducing risk and Enhancing Daily Lifestyle (WIRED-L) Center dedicated to building and testing mobile health (mHealth) apps that leverage wearables like smartwatches to improve physical activity and nutrition in hypertensive patients. The apps will use just-in-time-adaptive digital interventions to deliver notifications to participants when they are most likely to be responsive using contextual information obtained from their devices. WIRED-L will enroll diverse communities that include African Americans and older adults rarely included in mHealth studies, to better close the digital divide between rich and poor. Additionally, WIRED-L will train a diverse and inclusive set of future leaders in mHealth through a highly integrated program that focuses on the key and complementary areas of clinical trials, data science, and health equity research.

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Hubert Zajicek wants to tap the strong innovation community in North Texas to share know-how, combat shortages, and come up with new solutions during the COVID-19 pandemic.

The Plano-based remote patient monitoring startup is now offering providers a no-cost solution for low-risk patients or those with mild symptoms simply by answering a series of questions.

The collaboration will allow physicians to virtually diagnose medical conditions, heightening safety for everyone.

A professor at the University of North Texas Health Science Center is collaborating with an international team to test whether stem cells can combat COVID-19 pneumonia.

Due to the effects of COVID-19, Southlake-based SmartCounseling is working to reduce costs for mental health services. The company's new platform also allows licensed professionals to expand their services online quickly.

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Health Tech: Dallas-based American Heart Association Awards $14M in Research Grants for Heart, Brain, and COVID-19 Innovation - dallasinnovates.com

LONDON--(BUSINESS WIRE)--The global autologous cell therapy market is poised to grow by USD 1.97 billion during 2020-2024, progressing at a CAGR of almost 22% during the forecast period. Request free sample pages

Read the 120-page report with TOC on "Autologous Cell Therapy Market Analysis Report by Therapy (Autologous stem cell therapy and Autologous cellular immunotherapies), Application (Oncology, Musculoskeletal disorders, and Dermatology), Geography (North America, APAC, Europe, South America, and MEA), and the Segment Forecasts, 2020-2024".

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The market is driven by the increasing demand for effective drugs for cardiac and degenerative disorders. In addition, the limitations in traditional organ transplantations are fueling the demand for stem cell therapies. All these factors are anticipated to boost the growth of the autologous cell therapy market.

The demand for effective drugs for cardiac and degenerative disorders has been increasing across the world. In addition, the discovery of possible cardiac autologous cells has enabled vendors to develop novel drugs for the treatment of various cardiac diseases. For instance, Mesoblast is developing MPC-150-IM. It is a Phase III candidate for the treatment of advanced and end-stage chronic heart failure. Similarly, Shire has been developing autologous stem cell therapies for chronic myocardial ischemia. These products are expected to be launched during the forecast period and will have a positive impact on the growth of the global autologous cell therapy market.

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Major Five Autologous Cell Therapy Market Companies:

Bayer AG

Bayer AG operates its business through segments such as Pharmaceuticals, Crop Science, Consumer Health, and Animal Health. The company offers induced pluripotent stem cells. They are developed by reprogramming mature body cells to behave like embryonic stem cells that are injected to restore diseased tissue in patients.

Brainstorm Cell Therapeutics Inc.

Brainstorm Cell Therapeutics Inc. operates its business through an unified business segment. NurOwn is the key offering of the company. It is a cell therapy platform, which develops mesenchymal stem cells for the treatment of human diseases such as immune and inflammatory diseases.

Daiichi Sankyo Co. Ltd.

Daiichi Sankyo Co. Ltd. operates its business through segments such as Innovative Pharmaceuticals, Generic, Vaccine, and OTC Related. Heartcel is the key offering of the company. It is an immune-modulatory progenitor cell therapeutic agent, which is used for ischemic heart failure.

FUJIFILM Holdings Corp.

FUJIFILM Holdings Corp. operates its business through segments such as Imaging solutions, Healthcare and material solutions, and Document solutions. The company uses induced pluripotent stem cells to derive differentiated cells, which are used in researching various diseases and conditions.

Holostem Terapie Avanzate Srl

Holostem Terapie Avanzate Srl operates its business through an unified business segment. Holoclar is the key offering of the company. It is an advanced therapy medicinal product containing stem cells indicated to repair the cornea after injury.

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Global Cancer Stem Cell Therapeutics Market Global cancer stem cell therapy market by type (allogeneic stem cell transplant and autologous stem cell transplant) and geography (Asia, Europe, North America, and ROW).

Global Mantle Cell Lymphoma Therapeutics Market Global mantle cell lymphoma therapeutics market by product (combination therapy and monotherapy) and geography (Asia, Europe, North America, and ROW).

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While many of us are practicing social distancing, working from home or living in quarantine-like and isolated situations, life goes on as normal for the space station-dwelling astronauts.

They're aware of the pandemic and have been sharing their support for people across the globe through their Twitter accounts. NASA astronaut Jessica Meir shared her perspective: "From up here, it is easy to see that we are truly all in this together. #EarthStrong."

But the astronauts aren't just floating around and taking cool pictures of Earth. Each week, hundreds of science experiments are in progress on the station. In addition to working on these experiments, the astronauts study themselves to better understand the human body in space.

Here's a look at the cool science they've been doing 254 miles from Earth.

Space pants

Living in space is an adjustment for the human body as it adapts to the lack of gravity.

Over the years, astronauts have noticed changes in their vision as a response to the headward fluid shift they experience. This also increases pressure in the head.

Last week, NASA astronauts Jessica Meir and Andrew Morgan, as well as Russian cosmonaut Oleg Skripochka, tested out the Russian Chibis hardware, also known as the Russian Space Agency's Lower Body Negative Pressure experiment.

It's basically a pair of pants housed in the Russian Orbital Segment of the space station.

The rubber pants use suction to draw fluids back down towards the legs and feet, just like we experience walking on Earth.

Researchers hope that hardware to reverse the fluid shift astronauts experience in space could also help with their vision changes.

While Morgan was wearing the Chibis pants, Meir used a tonometer to measure his eye pressure, with doctors on Earth watching in real time. Morgan's head and chest were also scanned to monitor blood flow.

The astronauts also tested their hearing as part of the European Space Agency's Acoustic Diagnostics experiment to monitor if the astronauts' hearing changes in response to noise and lack of gravity on the station.

Heart, muscle and bone

Multiple experiments are currently occurring on the station that could not only benefit the health of astronauts, but human life on Earth as well.

These cells could treat astronauts who experience heart abnormalities and be used to treat people and children with cardiac diseases and disorders on Earth. The cells can also be used to investigate the development of new pharmaceuticals.

One experiment, called Engineered Heart Tissues, allows the astronauts to watch heart cell muscle contractions in real time.

Meir and Morgan have been taking care of the heart cells, watching how they react to the lack of gravity. When the heart cells return to Earth, the results of the space experiment will be compared with a similar control experiment on Earth.

The astronauts have also been studying bone samples to understand and develop bone treatments for astronauts who suffer bone loss in space, as well as people diagnosed with osteoporosis on Earth. The goal is to determine new treatments for both.

Mice are also sharing space on the station with the astronauts in a mouse habitat so they can study how the mice and their gene expression reacts to zero gravity.

Understanding how their gene expression is altered can help NASA better prepare for long-term human spaceflight. The study also serves a secondary purpose of allowing them to determine countermeasures for muscle atrophy, which can occur in space or for patients on bed rest.

It's all in your gut

Astronauts don't get much of a chance to vary their diets in space. That means they could also be missing out on vital nutrients and other added benefits of the fresh food we consume on Earth.

The Japanese space agency's Probiotics investigation is studying how good gut bacteria could improve the human microbiome on long-term missions.

Meanwhile, the astronauts are also participating in an experiment called Food Acceptability, looking at the "menu fatigue" that happens when they eat based on limited options over months on the station. This usually causes them to lose weight by the time they return to Earth.

Continued here:
While we were stockpiling, here's what astronauts were up to in space last week - CNN

Regenerative Medicine Market: Snapshot

Regenerative medicine is a part of translational research in the fields of molecular biology and tissue engineering. This type of medicine involves replacing and regenerating human cells, organs, and tissues with the help of specific processes. Doing this may involve a partial or complete reengineering of human cells so that they start to function normally.

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Regenerative medicine also involves the attempts to grow tissues and organs in a laboratory environment, wherein they can be put in a body that cannot heal a particular part. Such implants are mainly preferred to be derived from the patients own tissues and cells, particularly stem cells. Looking at the promising nature of stem cells to heal and regenerative various parts of the body, this field is certainly expected to see a bright future. Doing this can help avoid opting for organ donation, thus saving costs. Some healthcare centers might showcase a shortage of organ donations, and this is where tissues regenerated using patients own cells are highly helpful.

There are several source materials from which regeneration can be facilitated. Extracellular matrix materials are commonly used source substances all over the globe. They are mainly used for reconstructive surgery, chronic wound healing, and orthopedic surgeries. In recent times, these materials have also been used in heart surgeries, specifically aimed at repairing damaged portions.

Cells derived from the umbilical cord also have the potential to be used as source material for bringing about regeneration in a patient. A vast research has also been conducted in this context. Treatment of diabetes, organ failure, and other chronic diseases is highly possible by using cord blood cells. Apart from these cells, Whartons jelly and cord lining have also been shortlisted as possible sources for mesenchymal stem cells. Extensive research has conducted to study how these cells can be used to treat lung diseases, lung injury, leukemia, liver diseases, diabetes, and immunity-based disorders, among others.

Global Regenerative Medicine Market: Overview

The global market for regenerative medicine market is expected to grow at a significant pace throughout the forecast period. The rising preference of patients for personalized medicines and the advancements in technology are estimated to accelerate the growth of the global regenerative medicine market in the next few years. As a result, this market is likely to witness a healthy growth and attract a large number of players in the next few years. The development of novel regenerative medicine is estimated to benefit the key players and supplement the markets growth in the near future.

Global Regenerative Medicine Market: Key Trends

The rising prevalence of chronic diseases and the rising focus on cell therapy products are the key factors that are estimated to fuel the growth of the global regenerative medicine market in the next few years. In addition, the increasing funding by government bodies and development of new and innovative products are anticipated to supplement the growth of the overall market in the next few years.

On the flip side, the ethical challenges in the stem cell research are likely to restrict the growth of the global regenerative medicine market throughout the forecast period. In addition, the stringent regulatory rules and regulations are predicted to impact the approvals of new products, thus hampering the growth of the overall market in the near future.

Global Regenerative Medicine Market: Market Potential

The growing demand for organ transplantation across the globe is anticipated to boost the demand for regenerative medicines in the next few years. In addition, the rapid growth in the geriatric population and the significant rise in the global healthcare expenditure is predicted to encourage the growth of the market. The presence of a strong pipeline is likely to contribute towards the markets growth in the near future.

Global Regenerative Medicine Market: Regional Outlook

In the past few years, North America led the global regenerative medicine market and is likely to remain in the topmost position throughout the forecast period. This region is expected to account for a massive share of the global market, owing to the rising prevalence of cancer, cardiac diseases, and autoimmunity. In addition, the rising demand for regenerative medicines from the U.S. and the rising government funding are some of the other key aspects that are likely to fuel the growth of the North America market in the near future.

Furthermore, Asia Pacific is expected to register a substantial growth rate in the next few years. The high growth of this region can be attributed to the availability of funding for research and the development of research centers. In addition, the increasing contribution from India, China, and Japan is likely to supplement the growth of the market in the near future.

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Global Regenerative Medicine Market: Competitive Analysis

The global market for regenerative medicines is extremely fragmented and competitive in nature, thanks to the presence of a large number of players operating in it. In order to gain a competitive edge in the global market, the key players in the market are focusing on technological developments and research and development activities. In addition, the rising number of mergers and acquisitions and collaborations is likely to benefit the prominent players in the market and encourage the overall growth in the next few years.

Some of the key players operating in the regenerative medicine market across the globe areVericel Corporation, Japan Tissue Engineering Co., Ltd., Stryker Corporation, Acelity L.P. Inc. (KCI Licensing), Organogenesis Inc., Medtronic PLC, Cook Biotech Incorporated, Osiris Therapeutics, Inc., Integra Lifesciences Corporation, and Nuvasive, Inc.A large number of players are anticipated to enter the global market throughout the forecast period.

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Regenerative Medicine Market Demand, Growth, Opportunities and Analysis Of Top Key Player Forecast To 2025 - Daily Science

In the recently published 3D bioprinting and its potential impact on cardiac failure treatment: An industry perspective, authors Ravi K. Birla and Stuart K. Williams explore the potential for tissue engineering in cardiac medicine, and the eventual assembly of a bioprinted heart.

While heart failure usually requires a transplant, it can be challenging to find a suitable donor. Once a transplant is completed, there is a long road ahead too via a permanent need for immune suppression therapytreatment that is hard on patients. The usual survival rate for patients is typically under 13 years.

There are currently more than 6.2 million patients in the US with heart failure, and heart failure accounted for 78,356 mortalities in 2016, stated the authors.

In this study, the researchers review the challenges of bioprinting for the creation of heart tissue, as well as the logical and systematic process to bioprint human heart.

While medical science is full of progressive tools, treatments, and devicesespecially for heart patientsno technology has been more promising for the eventual fabrication of organs than tissue engineering. With the potential to yield a biofabricated heart, made up of both biologic and artificial construct, a total heart could feasibly emerge with modular parts for easy replacing.

Definition of tissue engineeringthe building blocks of tissue engineering are cells, biomaterials, and bioreactors. Cells are the functional elements of all tissue and organs, while biomaterials are designed to simulate the mammalian extracellular matrix and provide structural support. Bioreactors are custom devices to deliver physiological cues for 3D tissue/organ development and maturation. Electrical stimulation is delivered by parallel electrodes, while uniaxial stretch, illustrated by the single arrow, is designed to apply cyclic movement of the bioengineered tissue.

Cardiac tissue engineering encompasses:

The ability to bioengineer components of the heart or the entire bioartificial heart, both have applications in changing the standard of care for patients with heart disorders, explained the authors. Depending on the severity of the patient, a cardiac patch may be sufficient to augment lost contractile function, while in cases of chronic heart failure, a total bioartificial heart may be required.

In addition to spatial regulation of the cells, bioprinting also allows accurate placement of the biomaterials. This is where 3D bioprinting provides a powerful tool that allows us to accurately position different cell types in a very specific pattern, thereby allowing tight control over the heart bioengineering process.

Overview of cardiac tissue engineeringthe field of cardiac tissue engineering includes methods to bioengineer contractile 3D heart muscle, biological pulsating pumps, bioengineered left ventricles, bioartificial valves and vascular grafts, and biofabricated hearts. Contractile 3D heart muscle is designed to replicate the properties of mammalian heart muscle tissue and can be used as a patch to augment left ventricle pressure after myocardial infarction. Pulsating pumps are designed to generate intra-luminal pressure and can be used as biological pumps. Left ventricles can be used as a component of the heart or to replace under-performing ventricles in pediatric cases of hypoplastic left heart syndrome. Valves and vascular grafts can be used to replaced mammalian valves and blood vessels or as components of the bioengineered heart.

Major components of the human heartthe human heart consists of four chambers, four valves, the cardiac conduction system, contractile cardiomyocytes, and a complex vasculature. The four chambers are the left and right ventricle and aorta, while the four valves are the aortic and mitral valves and pulmonary and tricuspid valves. The cardiac conduction system consists of the SAN, AVN, bundle of His, and the Purkinje fibers. Cardiac vasculature consists of the greater vessels as well as the smaller micro-circulation. Cardiomyocytes are the cells responsible for heart muscle contraction.

So far, most research involving bioprinting of cardiac tissue has shown the initial feasibility of bioprinting hearts. With the amount of research and tools available today, such progress is inevitable.

Based on the current state of the art in whole heart bioengineering, we can safely say that human hearts will be available for clinical transplantation though we cannot assign a specific timeframe for this fate to be accomplished, state the authors.

Bioprinting of the human heart has its beginnings in the initial history of tissue engineering in 2003, and then further in research a few years later.

The 3D bioprinting processisolated cells are suspended in a custom formulated bioink and loaded into a syringe. Examples of cells required to bioprint hearts include contractile cardiomyocytes, conducting pacemaker and Purkinje cells, structural fibroblast cells and vascular smooth muscle cells, and endothelial cells. Pneumatic pressure is used to extrude the cell-loaded bioink through the printing tip, and a layer by layer approach is used to build tissue and/or organ

Scientific breakthroughs for 3D bioprinting human hearts.

There has continued to be rapidly growing success in bioprinting and the subsequent fabrication of heart tissue, allowing scientists to realize less of fantasy in such exercisesand more of a reality.

Process for bioprinting human heartspatient MRI images are used to model the heart. Dermal fibroblasts are isolated from patient skin biopsies and converted to iPS cells and then to cardiomyocytes. Cardiomyocytes are combined with bioinks and used to bioprint patient-specific human hearts. Bioprinted hearts are conditioned in bioreactors and used for transplantation.

The roadmap for bioprinting a heart includes:

The single most important challenge that needs to be overcome in the field, and one that in general staggers the field of cardiac stem cell therapy, is the immaturity of reprogrammed cardiomyocytes, conclude the researchers. Conversion of iPS cells to cardiomyocytes is now standard and reproducible, the differentiated cells resemble an embryonic phenotype, and driving these cells to an adult phenotype remains a critical challenge in the field of cardiac stem cell therapy.

Once reproduced by independent research labs, coupled with the availability of commercial bioreactors for electromechanical stimulation, the availability of mature cardiomyocytes will provide a clear pathway to 3D bioprint human hearts for clinical transplantation.

Bioprinting is used in a wide variety of applications today, from cardiac patches and cellularized hearts to the creation of heart valves, and more, ultimately shaping an overall transformation of cell culture. What do you think of this news? Let us know your thoughts! Join the discussion of this and other 3D printing topics at 3DPrintBoard.com.

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The Progress & Ongoing Challenge of 3D Bioprinting Cardiac Tissue - 3DPrint.com

How many sufferers are currently on the Covid 19 Charit stations, and what is the treatment of the patients who come to you?

We have on our Covid 19 ward currently has nine patients, including some who are doing reasonably well but cannot be well cared for at home, and those who are a little more serious and who need support from one to two liters of oxygen per minute. Some of them also have to be checked repeatedly to determine whether they need to be transferred to the intensive care unit and mechanically ventilated. And finally there are eleven ventilated patients in our Covid intensive care unit today.

When should ventilation be?

What is important is the respiratory rate, i.e. the frequency with which the patient breathes and the saturation of his blood with oxygen . We observe: How much oxygen do I give, how much is received? This is a good parameter for the extent of lung damage. The patient experiences exhaustion at a certain point, then we have to ventilate. Covid 19 has something very destructive to the lung cells.

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If everything goes well, the situation will improve within three days, so that we can weave the patient, ie wean from the ventilator, but it can also take a week or two last. This type of ventilation is not enough for a subgroup, here we use a kind of replacement lung outside the body. All of this is not new territory for intensive care medicine, but it is very complex and personnel-intensive.

Sick every year 750. 000 People with pneumonia, 290. 000 from them to the hospital. So there is plenty of experience with pneumonia. What is special about the current situation?

If you look at the classic bacterial pneumonia, then come against the bacteria use antibiotics. In these cases, you can often see a black-and-white effect: seriously ill people quickly get well with medication. That is now different in the treatment of the Covid virus infection 19 Antibiotics play no role at first, they may come into play later with complications caused by bacteria. What we have so far against Covid 19 is insufficient.

Which drugs are used?

First there is an old preparation from HIV treatment, Kaletra, which contains the active substances against retroviruses lopinavir and retonavir contains. However, the effect and possible side effects have to be weighed here, because the agent can, for example, increase liver values. In the New England Journal of Medicine (NEJM), a paper from China has just appeared in which its use made no difference. However, there was only very late, namely twelve to 13 days after Beginning of the disease, therapy started.

Then there is a candidate from Ebola research, the active ingredient Remdesivir. According to the first findings, it seems to be rather effective, but of course the experiences are not endless. Studies are ongoing and you can use it as part of an individual healing attempt. However, it is currently difficult to get hold of the drug, it is not supplied in large quantities. It is very important that you can only have it within the framework of a formalized process. There is a narrow treatment window: the patient must be intubated, but he must not have circulatory failure.

What about the malaria drug hydroxychloroquine, about which a violent dispute has arisen between the virologists in France after a small, uncontrolled study?

Hydroxycloroquine appears with every new virus infection because it has a certain effectiveness. However, this active ingredient also has side effects, especially on the cardiac conduction system. It is therefore important to monitor the patient's ECG. A large randomized clinical trial of hydroxychloroquine is currently underway under the direction of the University Hospital in Tbingen.

What about clinical studies, science comes In view of the tense situation in everyday clinical practice, rightly so?

Yes, we will do better than a few years ago at EHEC! In the end, there were no really new insights. This is changing this time, we are closely networked, randomized clinical studies are being carried out that span several centers, and the procedures are being coordinated. Not everyone can do what they want. We have come together in competence networks. Physicians, large clinics and scientists from basic research have been working well together for years in the CAP network for pneumonia acquired outside the hospital, which was funded by the Federal Ministry of Research and is now working as a foundation. Large international clinical trials are now underway.

The French national research institution Inserm announced yesterday that its Aegis the substances Kaletra, Remedesvir and Hydrochloroquine, which we have just spoken about to be compared in a large international study called Discovery, the WHO launched the large-scale study Solidarity. Agents that are already being used against other diseases are being tested. How about the ACE2 inhibitor, of which there is currently a lot of talk ?

We have Access to the inhibitor that attaches to ACE2 and its associated protease and can thus block virus uptake into the cell, and we will also test it in a study. However, this ACE2 inhibitor has so far only proven its effectiveness in cell culture. The question remains whether and in what dose it works in humans. I know of a dozen other drug candidates whose investigation is planned as part of studies in our clinic. This also includes some experimental approaches that are used to block signaling pathways in the cell so that the virus cannot replicate, or in which stem cells are used. Another approach is to restore the tightness of the vessels. With severe pneumonia, there is water in the lungs where there used to be air. The lungs look white on the x-ray.

What about the idea , use blood plasma from people who have survived the disease to heal the sick?

This is obvious and is currently being pursued. If you think about it further, you could use antibody-based therapy. The cells that made the antibody in a previous patient are isolated beforehand and ultimately let them produce large amounts of antibody.

In addition to this search for new therapies Research on other questions is also important: In the BMBF-funded project PROGRESS-net, we have been dealing with the genetic differences between patients with severe pneumonia for some time. We want to understand why some of them have to go to intensive care later because they develop lung failure and possibly sepsis. And we want to be able to predict it.

What situation are we in now and how will it go on? Currently the therapeutic instruments are very modestly equipped. It is now the phase of science and clinical trials. However, unlike Italy at the moment, we have the chance not from Covid 19 to be overwhelmed if we test sensibly and know where we stand.

We are in a different situation from the plague in the Middle Ages, where people are were smart enough to use contact blocks, but the epidemic only came to a halt after there were no longer enough victims. We can hope that in the end a new therapeutic or a new vaccine will put an end to the spook.

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The therapeutic options are still insufficient - Bandera County Courier