Archive for the ‘Skin Stem Cells’ Category
Scientists find a cell that helps tadpoles tails regrow – Fourways Review
Aristotle already observed in the fourth century B.C. that some animals can regrow their tails after losing them, but the mechanisms that support this kind of regeneration remain difficult to understand.
Using single-cell genomics, scientists at the Wellcome Trust / Cancer Research UK Gurdon Institute at the University of Cambridge developed an innovative strategy to show what happens in different tadpole cells when they regenerate their tails.
Recent advances at Cambridge in next-generation single-cell sequencing mean that scientists can now track which genes are turned on throughout a whole organism or tissue, at the resolution of individual cells. This technique, known as single-cell genomics, makes it possible to distinguish between cell types in more detail based on their characteristic selection of active genes.
These groundbreaking discoveries are beginning to reveal a map of cellular identities and lineages, as well as the factors involved in controlling how cells choose between alternative pathways during embryo development to produce the range of cell types in adults.
Using this technology, Can Aztekin and Dr Tom Hiscock under the direction of Dr Jerome Jullien made a detailed analysis of cell types involved in regeneration after damage in African clawed frog tadpoles (Xenopus laevis). Details were published in the journal Science.
Dr Tom Hiscock said: Tadpoles can regenerate their tails throughout their life; but there is a two-day period at a precise stage in development where they lose this ability. We exploited this natural phenomenon to compare the cell types present in tadpoles capable of regeneration and those no longer capable.
The researchers found that the regenerative response of stem cells is orchestrated by a single sub-population of skin cells, which they named Regeneration-Organizing Cells, or ROCs.
Can Aztekin said: Its an astonishing process to watch unfold. After tail amputation, ROCs migrate from the body to the wound and secrete a cocktail of growth factors that coordinate the response of tissue precursor cells. These cells then work together to regenerate a tail of the right size, pattern and cell composition.
In mammals, many tissues such as the skin epidermis, the intestinal epithelium and the blood system, undergo constant turnover through life. Cells lost through exhaustion or damage are replenished by stem cells. However, these specialised cells are usually dedicated to tissue sub-lineages, while the ability to regenerate whole organs and tissues has been lost in all but a minority of tissues such as liver and skin.
Professor Benjamin Simons, a co-author of the study said: Understanding the mechanisms that enable some animals to regenerate whole organs represents a first step in understanding whether a similar phenomenon could be reawakened and harnessed in mammalian tissues, with implications for clinical applications.
This research was funded by the University of Cambridge, the Cambridge Trust andthe Wellcome Trust;and supported by theEuropean Molecular Biology Organization, the Royal Society,theEuropean Molecular Biology Laboratory, and Cancer Research UK.
Source: University of Cambridge Research
Originally posted here:
Scientists find a cell that helps tadpoles tails regrow - Fourways Review
"I was 18 when I came home and told my mum I was being sexually harassed at work." – Mamamia
Tonight, the ABC will air a three-part documentary series tackling sexual harassment in the workplace.
Among many other brave and formidable women, one of the people featured in the documentary is me.
Except, ironically, you cant actually know what happened to me. What precisely was done to me, which led me to being on your TV screens. You also cant know how my employers handled the situation. You cant know what happened to that perpetrator.
Despite the name of the documentary, Silent No More, I, for a large part, am legally silenced.
This is absolutely through no fault of the incredible documentary makers, who fought so hard for the inclusion of my story. Rather, the non-disclosure agreement (NDA) I signed when I resigned from the workplace after experiencing ongoing sexual harassment from this one employee.
I suppose one of the questions on your mind must be what compelled me to sign an NDA. I had just turned 18 when the perpetrator walked into my life. I was also 18 when I resigned and the settlement, including the NDA, was processed.
Now 21, I dont think Im far enough away from the experience to truly understand how my age impacted the situation. However, I am certain that when youre 18 and your employers, colleagues and perpetrator arent, the imbalance of power between all parties is only tipped further.
At no age is it easy to stare down the barrel of a sexual harassment case, but when youre 18 years old and receiving letters from lawyers, my mind said to get out. Fast.
When I first told my mum what this man was doing to me at work, I just wanted to resign. I didnt want to report. I just so desperately wanted to get out. I had become terrified and physically sick with fear at work, that I wanted the fastest one-way route out of that place: resignation.
With some convincing from my mum and a lawyer, we started some very simple proceedings. Opening up conversations with the employer about my options. To be transparent, I could have escalated my claim to the states Workplace Health and Safety regulator or taken it to court. It was explained that both of those could be quite long and rigorous processes to endure.
And, like many people who dont report allegations of violence, they were simply processes I could not endure. Few people warned me the process of reporting, which I cant talk about, would incur a different type of trauma to the harassment itself. I still had uni to go to the next day, work in my other jobs, and also be an 18-year-old who didnt run home fuelled by bottled panic from the train station.
So, thats how we came to me resigning and settling. Settlement involves a whole bunch of things and agreements, which you cant know about, but the biggest part of the settlement is the NDA inclusion.
I balanced what the settlement gave me; my safety, against what it took away from me; my ability to explain what had been done to me, and I chose my safety.
Despite the way it tears at my heart that people cant know about my experiences, I would choose my safety again. Because, unfortunately, we still do live in a cruel structure that makes many of us choose.
Safety.
Or, your voice.
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"I was 18 when I came home and told my mum I was being sexually harassed at work." - Mamamia
Stem Cell Therapy Market Assessment On Competition 2018 2028 – Space Market Research
TMRR, in its newly published market study, elaborates on the numerous factors that are expected to shape the growth of the Stem Cell Therapy market in the upcoming years. The presented business intelligence report aims to provide readers a thorough understanding of the latest developments and innovations that have taken place in the Stem Cell Therapy market space in recent years. The micro and macro-economic factors that are likely to define the course of the Stem Cell Therapy market in the upcoming years are analyzed in detail.
The study projects that the Stem Cell Therapy market is expected to grow at a CAGR of ~XX% during the forecast period (2019-2029) and attain a value of ~US$XX by the end of 2029. The market analysis touches upon the pricing strategies, revenue growth, and product lines of some of the most prominent players operating in the current Stem Cell Therapy market landscape.
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Critical Data Included in the Report
Regional Analysis
The regional analysis section offers a detailed assessment of the current and future prospects of the Stem Cell Therapy market across various regional markets including:
Application Analysis
The report offers an in-depth understanding of the various applications of the Stem Cell Therapy including:
The consumption volume and pattern of the Stem Cell Therapy across various end-use industries are accurately mapped in the presented report.
Key Trends
The key factors influencing the growth of the global stem cell therapy market are increasing funds in the development of new stem lines, the advent of advanced genomic procedures used in stem cell analysis, and greater emphasis on human embryonic stem cells. As the traditional organ transplantations are associated with limitations such as infection, rejection, and immunosuppression along with high reliance on organ donors, the demand for stem cell therapy is likely to soar. The growing deployment of stem cells in the treatment of wounds and damaged skin, scarring, and grafts is another prominent catalyst of the market.
On the contrary, inadequate infrastructural facilities coupled with ethical issues related to embryonic stem cells might impede the growth of the market. However, the ongoing research for the manipulation of stem cells from cord blood cells, bone marrow, and skin for the treatment of ailments including cardiovascular and diabetes will open up new doors for the advancement of the market.
Global Stem Cell Therapy Market: Market Potential
A number of new studies, research projects, and development of novel therapies have come forth in the global market for stem cell therapy. Several of these treatments are in the pipeline, while many others have received approvals by regulatory bodies.
In March 2017, Belgian biotech company TiGenix announced that its cardiac stem cell therapy, AlloCSC-01 has successfully reached its phase I/II with positive results. Subsequently, it has been approved by the U.S. FDA. If this therapy is well- received by the market, nearly 1.9 million AMI patients could be treated through this stem cell therapy.
Another significant development is the granting of a patent to Israel-based Kadimastem Ltd. for its novel stem-cell based technology to be used in the treatment of multiple sclerosis (MS) and other similar conditions of the nervous system. The companys technology used for producing supporting cells in the central nervous system, taken from human stem cells such as myelin-producing cells is also covered in the patent.
Global Stem Cell Therapy Market: Regional Outlook
The global market for stem cell therapy can be segmented into Asia Pacific, North America, Latin America, Europe, and the Middle East and Africa. North America emerged as the leading regional market, triggered by the rising incidence of chronic health conditions and government support. Europe also displays significant growth potential, as the benefits of this therapy are increasingly acknowledged.
Asia Pacific is slated for maximum growth, thanks to the massive patient pool, bulk of investments in stem cell therapy projects, and the increasing recognition of growth opportunities in countries such as China, Japan, and India by the leading market players.
Global Stem Cell Therapy Market: Competitive Analysis
Several firms are adopting strategies such as mergers and acquisitions, collaborations, and partnerships, apart from product development with a view to attain a strong foothold in the global market for stem cell therapy.
Some of the major companies operating in the global market for stem cell therapy are RTI Surgical, Inc., MEDIPOST Co., Ltd., Osiris Therapeutics, Inc., NuVasive, Inc., Pharmicell Co., Ltd., Anterogen Co., Ltd., JCR Pharmaceuticals Co., Ltd., and Holostem Terapie Avanzate S.r.l.
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Stem Cell Therapy Market Assessment On Competition 2018 2028 - Space Market Research
AI helps cells pull themselves together – Cosmos
By Paul Biegler
US scientists have overcome a major stumbling block in the creation of mini-organs, programming cells to take on the desired shape rather than relying on 3D printing or external scaffolds.
This inside out approach, described in a paper in the journal Cell Systems, could signal a paradigm shift in how mini-hearts, kidneys and brains are grown on the lab bench a technique used to study disease that may one day lead to personalised organ transplants.
The team, led by bioengineer Todd McDevitt at Gladstone Institutes in the US, was driven by an enduring issue with state-of-the-art ways of producing mini-organs such as 3D printing. The cells just wont stay put.
Making a mini-organ or organoid starts when scientists take a persons skin cell and, using the right mix of agents, turn it into an induced pluripotent stem cell. This IPS cell is the blank cheque of biology, capable of becoming almost any cell type.
Grow it into a mini-kidney, say, and you can reproduce kidney diseases and test treatments in a dish sitting on your lab bench. But how faithful that model is depends on the physical organisation of the cells; to mimic a real deal kidney, 3D printing is often used.
But cells, much like unruly teenagers, have a mind of their own and will often wander away from their printed position.
McDevitts team wanted to own those cellular minds and so took control of two genes that together make up something of a joystick that directs how the cells organise.
CDH1 and ROCK1 figure heavily in the complex moves that lead to the final configuration of a group of cells. The pair influences stickiness and repulsion between cells, the surface tension that makes them spherical and their overall speed of migration.
The researchers used the editing tool CRISPR to knock out the two genes at various stages in the evolution of a clump of cells. Their aim was to make a bulls eye pattern, a shape thats common in human development, including in early embryo formation.
To detect that aspirational pattern, they engineered another tweak making the cells fluoresce when CDH1 and ROCK1 were neutralised.
But there was a problem.
Factor in all the potential time points where the genes could be knocked out, the proportion of cells to be targeted, and a host of other variables, and the researchers calculated theyd need to do nearly 9000 trial-and-error experiments.
So they called on AI. They trained a machine learning model to compute the precise pattern of gene knockouts needed to realise their dream shape.
Machine learning can predict what movie you might like based on your viewing history, but it can also generate new insights into biological systems by mimicking them, says co-author Demarcus Briers, from the Boston University Bioinformatics Program.
Our machine-learning model allows us to predict new ways that stem cells can organise themselves, and produces instructions for how to recreate these predictions in the lab.
That model hit a bulls eye, quite literally, allowing the team to produce the concentric pattern of cells they were aiming at.
"We've shown how we can leverage the intrinsic ability of stem cells to organise," says McDevitt. "This gives us a new way of engineering tissues, rather than a printing approach where you try to physically force cells into a specific configuration."
Ultimately, that concrete target shape will give way to a target in the abstract, one with potential to shift the life course.
"We're now on the path to truly engineering multicellular organization, which is the precursor to engineering organs," McDevitt says. "When we can create human organs in the lab, we can use them to study aspects of biology and disease that we wouldn't otherwise be able to."
Decoding the building blocks of life: bit bio races toward a sustainable source of human cells – Proactive Investors UK
The ability to turn human cells into anything we want sounds like the stuff of science fiction. But one Cambridge biotech says it's cracked the code
A sustainable source of human stem cells is one of the holy grails of modern medicine.
With applications as broad as re-growing failed organs, fighting cancer, and stopping animal testing, stem cell therapy is predicted to be worth US$35bn by 2023.
Now, Cambridge startup bit bio, has a new approach to re-coding skin cells from adult humans, and rewinding the clock to give them the power of stem cells, and then turn them into whatever we want them to be all without the controversial involvement of human embryos.
This, says neurosurgeon and founder Dr Mark Kotter, will democratise stem cells, so that anyone can use them, at any time.
The private sector is already placing big bets on the technology, with start-ups in the space raising as much as US$16mln in recent funding rounds.
Kotter says that our inability to produce enough human stem cells to match our need puts troubling limits on research and drug development.
In drug discovery, the biggest bottleneck is the mismatch between animal models and animal cell lines used for drug discovery, and then human setting used in the clinical trial, he explains.
Around 3% of new drugs make it all the way through trials and to market, he says, and the biggest reasons treatments tend to fail in clinical study is that they are either toxic to humans, or they dont work.
The only solution is to bring the human element back to the early stages, says Kotter.
If new therapies were tested on human tissue first, it would reduce or even bypass the need to test on animals, as well as speeding up development.
Kotter founded bit bio, formerly known as Elpis BioMed, in 2016, in addition to startup Meatable, which produces meat by growing cultures in the lab, rather than rearing animals for the table.
The time is now for bit bio, because what it is doing has only been possible since a Nobel Prize-winning discovery twelve years ago, which turned the world of stem cell research upside down.
Kyoto University researcher Shinya Yamanaka proved that it was possible to take a mature human skin cell and reprogram it to be like the stem cell of an embryo.
Until this revelation, stem cell research had been dogged by controversy and expense, as scientists had to use human embryos and umbilical cords as a source of stem cells, and then simulate complex conditions inside the womb in order to make them develop into the cells they desired.
One big problem in early cell reprogramming was that stem cells are incredibly alert to invading DNA and silences any foreign material it detects.
This meant that past attempts run a different program inside a cell often failed, because the cell destroyed it.
What happened next was a moment of "serendipity" in the lab, says Kotter.
Through trial and error, bit bio found they could use certain safe harbours where information is protected within cells, to stop theinterference.
By taking the genetic switch for gene silencing and placing it inside a safe harbour, and then separately running the new cell program inside another safe harbour, scientists found they could override gene silencing in order to change the cell type.
This approach is what Kotter says makes bit bio unique.
The lab can produce up to a kilogram of human cells now, and its tech platform opti-oxhas also proved that it can generate two human cell types with 100% accuracy.
Kotter says that now the range of cells able to be produced matters more than the quantity.
The company is now focused on discovering what separates one type of cell from another, which Kotter says will allow the firm to decode the building blocks of life.
To this end, bit bio is using machine learning to analyse the differences between every type of human cell, from bone marrow cells to liver cells, and create a reference map for all the different types.
Once the research is complete, the company hopes it willbe able to generate any type of human cell, at scale, and with ultimate precision.
Preparations are underway for a Series A funding round, and Kotter says that he is determined not to sell the business, having already rejected offers from would-be buyers.
Bit bio though is in an area hot with competition, which moves quickly.
A US$16mln Series A mega funding round was recently announced in October by another Cambridge start-up, Mogrify, which is hoping to master direct cell reprogramming and turn blood cells straight into brain cells, or any other type.
Mogrify uses big data to identify the small molecules needed to convert, maintain and culture a target cell type.
While both companies were finalists in the 2018 Cambridge Startup of the Year award, bit bio was the one to scoop the prize.
One aspect that separates the two companies is that Mogrify uses its technology to turn cells directly into other cell types, rather than using it to rewindto the stem cell phase, which is when cells can reproduce very quickly,
Kotter says that this stem cell phase focusis whatallows bit bio to havea stable supply of human cells.
If bit bio completes a similar, or even bigger, fundraise, it could advance the fledgling firm from seed to stem, in its attempt to stabilise a production line for essential cell technology.
Calquence approved in the US for adult patients with chronic lymphocytic leukaemia | Small Molecules | News Channels – PipelineReview.com
DetailsCategory: Small MoleculesPublished on Friday, 22 November 2019 14:04Hits: 302
Two Phase III Calquence trials demonstrated superior progression-free survival across multiple settings while maintaining favourable tolerability
Calquence combined with obinutuzumab and as monotherapy reducedthe risk of disease progression or death by 90% and 80%, respectively in ELEVATE-TN
LONDON, UK I November 21, 2019 I AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved Calquence (acalabrutinib) for adult patients with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL).1 The US approval was granted under the FDAs Real-Time Oncology Review and newly established Project Orbis programmes.
The approval is based on positive results from the interim analyses of two Phase III clinical trials, ELEVATE-TN in patients with previously untreated CLL and ASCEND in patients with relapsed or refractory CLL. Together, the trials showed that Calquence in combination with obinutuzumab or as a monotherapy significantly reduced the relative risk of disease progression or death versus the comparator arms in both 1st-line and relapsed or refractory CLL. Across both trials, the safety and tolerability of Calquence were consistent with its established profile.1
Dave Fredrickson, Executive Vice President, Oncology Business Unit said: With over 20,000 new cases anticipated this year in the US alone, todays approval of Calquence provides new hope for patients with one of the most common types of adult leukaemia, offering outstanding efficacy and a favourable tolerability profile. The chronic lymphocytic leukaemia patient population is known to face multiple comorbidities, and tolerability is a critical factor in their treatment.
Dr Jeff Sharman, Director of Research at Willamette Valley Cancer Institute, Medical Director of Hematology Research for The US Oncology Network, and a lead author of the ELEVATE-TN trial, said: Tolerability remains an issue in the current treatment landscape of chronic lymphocytic leukaemia, which may require ongoing therapy for many years. In the ELEVATE-TN and ASCEND trials comparing Calquence to commonly used treatment regimens, Calquence demonstrated a clinically meaningful improvement in progression-free survival in patients across multiple settings, while maintaining its favourable tolerability and safety profile.
The results of the interim analysis of the ELEVATE-TN trial will be presented at the upcoming American Society of Hematology congress.2
The trial showed a statistically significant and clinically meaningful improvement in progression-free survival (PFS) for patients treated with either Calquence in combination with obinutuzumab or Calquence monotherapy versus chlorambucil chemotherapy plus obinutuzumab, a current standard-of-care combination used in the control arm.1
In the Calquence combination arm, risk of disease progression or death was reduced by 90% (HR 0.10; 95% CI, 0.06-0.17, p<0.0001) and in the monotherapy arm it was reduced by 80% (HR 0.20; 95% CI, 0.13-0.30, p<0.0001).1
The median time to disease progression for patients treated with Calquence in combination with obinutuzumab or as a monotherapy has not yet been reached versus 22.6 months (95% CI, 20-28) for chlorambucil plus obinutuzumab.1
ELEVATE-TN safety overview (most common ARs, 15%):1
Includes multiple ADR terms.
In patients treated with the combination of Calquence plus obinutuzumab, adverse reactions (ARs) led to treatment discontinuation in 11% of patients and a dose reduction of Calquence in 7% of patients. In the monotherapy arm, ARs led to discontinuation in 10% and dose reduction in 4% of patients.1 In the control arm, ARs led to regimen discontinuation in 14% of patients with a dose reduction of chlorambucil in 28% of patients.3 There were no dose reductions for obinutuzumab.1,3
In 1,029 patients with haematologic malignancies who were treated with Calquence 100mg approximately every 12 hours across multiple clinical trials, where 88% received treatment for at least six months and 79% received treatment for at least one year, serious or Grade 3 infections occurred in 19%, and Grade 3 atrial fibrillation and flutter occurred in 1.1% of patients.In the same patient population, major haemorrhage occurred in 3.0% (serious or Grade 3 bleeding or any central nervous system bleeding), with fatal haemorrhage occurring in 0.1% of patients. Second primary malignancies (all grades) including skin cancers occurred in 12% of patients.1
The US approval is among the first to be granted under Project Orbis, an initiative of the US FDA Oncology Center of Excellence, which provides a framework for concurrent submission and review of oncology medicines among international partners. The FDA, the Australian Therapeutic Goods Administration, and Health Canada collaborated on this review. 4
About Calquence
In the US, Calquence (acalabrutinib) is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (CLL)/small lymphocytic lymphoma (SLL). In the US, Canada, Australia, Brazil, Qatar, the United Arab Emirates, Mexico, Argentina, Singapore, Chile, and recently India, Calquence is indicated for adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. Approved under accelerated review in the US, continued approval for previously treated MCL is contingent upon verification and confirmation of clinical benefit in confirmatory trials.
Calquence is a next-generation selective inhibitor of Brutons tyrosine kinase (BTK). Calquence binds covalently to BTK, thereby inhibiting its activity.1,5,6,7 In B-cells, BTK signalling results in activation of pathways necessary for B-cell proliferation, trafficking, chemotaxis, and adhesion.1
As part of an extensive clinical development programme, AstraZeneca and Acerta Pharma are currently evaluating Calquence in 23 company-sponsored clinical trials. Calquence is being developed for the treatment of multiple B-cell blood cancers including CLL, MCL, diffuse large B-cell lymphoma, Waldenstrm macroglobulinaemia and follicular lymphoma and other haematologic malignancies. Several Phase III clinical trials in CLL are ongoing, including ASCEND, ELEVATE-TN, ELEVATE-RR (ACE-CL-006) evaluating Calquence versus ibrutinib in patients with previously treated high-risk CLL, and ACE-CL-311 evaluating Calquence in combination with venetoclax and with/without obinutuzumab versus chemoimmunotherapy in patients with previously untreated CLL without 17p deletion or TP53 mutation.
About ELEVATE-TN
ELEVATE-TN (ACE-CL-007) is a randomised, multicentre, open-label Phase III trial evaluating the safety and efficacy ofCalquence in combination with obinutuzumab, a CD20 monoclonal antibody, or Calquence alone versus chlorambucil, a chemotherapy, in combination with obinutuzumab in previously untreated patients with CLL. In the trial, 535 patients were randomised (1:1:1) into three arms. Patients in the first arm received chlorambucil in combination with obinutuzumab. Patients in the second arm received Calquence (100mg twice daily until disease progression or unacceptable toxicity) in combination with obinutuzumab. Patients in the third arm received Calquence monotherapy (100mg twice daily until disease progression or unacceptable toxicity).1,8
The primary endpoint is PFS in the Calquence and obinutuzumab arm compared to the chlorambucil and obinutuzumab arm, assessed by an independent review committee (IRC), and a key secondary endpoint is IRC-assessed PFS in the Calquence monotherapy arm compared to the chlorambucil and obinutuzumab arm. Other secondary endpoints include objective response rate, time to next treatment and overall survival.1,8
About ASCEND
ASCEND (ACE-CL-309) is a global, randomised, multicentre, open-label Phase III trial evaluating the efficacy of Calquence in previously treated patients with CLL. In the trial, 310 patients were randomised (1:1) into two arms. Patients in the first arm received Calquence monotherapy (100mg twice daily until disease progression or unacceptable toxicity). Patients in the second arm received investigators choice of either rituximab, a CD20 monoclonal antibody, in combination with idelalisib, a PI3K inhibitor, or rituximab in combination with bendamustine, a chemotherapy.1,9
The primary endpoint is PFS assessed by an IRC, and key secondary endpoints include physician-assessed PFS, IRC- and physician-assessed overall response rate and duration of response, as well as overall survival, patient-reported outcomes and time to next treatment.1,9
About CLL
Chronic lymphocytic leukaemia (CLL) is one of the most common types of leukaemia in adults, with an estimated 105,000 new cases globally each year and 20,720 new cases in the US in 2019, and the number of people living with CLL is expected to grow with improved treatment as patients live longer with the disease.10,11,12,13 In CLL, too many blood stem cells in the bone marrow become abnormal lymphocytes and these abnormal cells have difficulty fighting infections.10 As the number of abnormal cells grows there is less room for healthy white blood cells, red blood cells and platelets.10 This could result in anaemia, infection and bleeding.10 B-cell receptor signalling through BTK is one of the essential growth pathways for CLL.
About AstraZeneca in haematology
Leveraging its strength in oncology, AstraZeneca has established haematology as one of four key oncology disease areas of focus. The Companys haematology franchise includes two US FDA-approved medicines and a robust global development programme for a broad portfolio of potential blood cancer treatments. Acerta Pharma serves as AstraZenecas haematology research and development arm. AstraZeneca partners with like-minded science-led companies to advance the discovery and development of therapies to address unmet need.
About AstraZeneca in oncology
AstraZeneca has a deep-rooted heritage in oncology and offers a quickly-growing portfolio of new medicines that has the potential to transform patients lives and the Companys future. With at least six new medicines to be launched between 2014 and 2020, and a broad pipeline of small molecules and biologics in development, the Company is committed to advance oncology as a key growth driver for AstraZeneca focused on lung, ovarian, breast and blood cancers. In addition to AstraZenecas main capabilities, the Company is actively pursuing innovative partnerships and investments that accelerate the delivery of our strategy, as illustrated by the investment in Acerta Pharma in haematology.
By harnessing the power of four scientific platforms Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response and Antibody Drug Conjugates and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and, one day, eliminate cancer as a cause of death.
About AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, Cardiovascular, Renal and Metabolism, and Respiratory. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on Twitter @AstraZeneca.
References
1. CALQUENCE (acalabrutinib) [prescribing information]. Wilmington, DE; AstraZeneca Pharmaceuticals LP; 2019.
2. Sharman JP, et al. ELEVATE TN: Phase 3 Study of Acalabrutinib Combined with Obinutuzumab (O) or Alone Vs O Plus Chlorambucil (Clb) in Patients (Pts) with Treatment-Naive Chronic Lymphocytic Leukemia (CLL). Abstract 31 at: American Society of Hematology 2019 Annual Meeting and Exposition. Available online. Accessed November 2019.
3. Data on File. REF-64711. AstraZeneca Pharmaceuticals LP, Wilmington, DE.
4. US Food and Drug Administration. Project Orbis. Available online. Accessed November 2019.
5. Wu J, Zhang M & Liu D. Acalabrutinib (ACP-196): a selective second-generation BTK inhibitor. J Hematol Oncol. 2016;9(21).
6. Khan Y & OBrien S. Acalabrutinib and its use in treatment of chronic lymphocytic leukemia. Future Oncol. 2018;15(6).
7. Byrd JC, et al. Acalabrutinib (ACP-196) in Relapsed Chronic Lymphocytic Leukemia. N Engl J Med. 2016; 374:323-332.
8. ClinicalTrials.gov. Elevate CLL TN: Study of Obinutuzumab + Chlorambucil, Acalabrutinib (ACP-196) + Obinutuzumab, and Acalabrutinib in Subjects With Previously Untreated CLL. NCT02475681. Available online. Accessed November 2019.
9. ClinicalTrials.gov. A Study of Acalabrutinib vs Investigator's Choice of Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in R/R CLL. NCT02970318. Available online. Accessed November 2019.
10. National Cancer Institute. Chronic Lymphocytic Leukemia Treatment (PDQ)Patient Version. Available online. Accessed November 2019.
11. Global Burden of Disease Cancer Collaboration. Global, Regional, and National Cancer Incidence, Mortality, Years of Life Lost, Years Lived With Disability, and Disability-Adjusted Life-Years for 29 Cancer Groups, 1990 to 2016. JAMA Oncol. 2018;4(11):1553-1568.
12. American Cancer Society. Key Statistics for Chronic Lymphocytic Leukemia. Available online. Accessed November 2019.
13. Jain N, et al. Prevalence and Economic Burden of Chronic Lymphocytic Leukemia (CLL) in the Era of Oral Targeted Therapies. Blood. 2015;126:871.
SOURCE: AstraZeneca
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Calquence approved in the US for adult patients with chronic lymphocytic leukaemia | Small Molecules | News Channels - PipelineReview.com
New Process can 3D Print Living Cells with Precision and Speed – DesignNews
3D bioprinting has come a long way in recent years, with scientists using living tissue to print organs as complex as human skin. Researchers in Austria have unveiled an advancement with a process that can integrate living cells into structures at unprecedented speeds and resolution.
TU Wien developed the new technique using a novel bioink that allows cells to be embedded in a 3D matrix and printed with micrometer precision. The technique performs at a speed of one meter per second, much faster than past methods.
Images show living cells spreading in a 3D scaffold -- from left to right: week 1, week 3 week 5. Top: 3D setup, bottom: one layer only. The process was developed by researchers at TU Wien to create precision bioprinting. (Source: TU Wien)
"Using these 3D scaffolds, it is possible to investigate the behavior of cells with previously unattainable accuracy, said Aleksandr Ovsianikov, head of the 3D Printing and Biofabrication research group at the Institute of Materials Science and Technology at TU Wien. It is possible to study the spread of diseases, and if stem cells are used, it is even possible to produce tailor-made tissue in this way.
Exact Science
To successfully bioprint cells that can turn into living tissue with various characteristics, its key to process the cells in a certain way. While there are many techniques for 3D bioprinting, not all are created equal, said Ovsianikov. Some methods are imprecise or only allow a very short time window in which the cells can be processed without being damaged, while others have material challenges.
He noted that the behavior of a cell behaves depends crucially on the mechanical, chemical and geometric properties of its environment. "The structures in which the cells are embedded must be permeable to nutrients so that the cells can survive and multiply, said Ovsianikov. But it is also important whether the structures are stiff or flexible, whether they are stable or degrade over time.
The team can print 3D objects at microscopically fine resolutions, but using living cells at this size has been challenging. "You need liquids or gels that solidify precisely where you illuminate them with a focused laser beam, Ovsianikov noted. However, these materials must not be harmful to the cells, and the whole process has to happen extremely quickly.
Speeding the Process
To solve this issue, TU Wien researchers have been using what are called two-photon polymerization methods, which use a chemical reaction that is only initiated when a molecule of the material simultaneously absorbs two photons of a laser beam with particularly high intensity. At the point of photon absorption, the substance hardens, while it remains liquid everywhere else, which makes this method best suited to produce extremely fine structures with high precision.
While this allows for high resolution, its a rather slow processtypically in the range of micrometers or a few millimeters per second. This means the cells could die before printing is complete.
Now using the scaffolds, researchers have developed a method that fabricates cell-friendly materials at greater speeds. This means they can print a structure in just a few hours, giving cells a good chance of surviving and developing further. "Our method provides many possibilities to adapt the environment of the cells," said Ovsianikov.. Depending on how the structure is built, it can be made stiffer or softer.
He added that even fine, continuous gradients are possible. In this way, it is possible to define exactly how the structure should look in order to allow the desired kind of cell growth and cell migration. The process can also alter the laser intensity to determine how easily the structure will be degraded over time.
Based on the research, the team has created a company, UPNano, to further develop this technique and create bioprinting innovations. They also published a paper on their work in the journal Advanced Healthcare Materials.
Elizabeth Montalbano is a freelance writer who has written about technology and culture for more than 20 years. She has lived and worked as a professional journalist in Phoenix, San Francisco and New York City. In her free time she enjoys surfing, traveling, music, yoga and cooking. She currently resides in a village on the southwest coast of Portugal.
January 28-30:North America's largest chip, board, and systems event,DesignCon, returns to Silicon Valleyfor its 25th year!The premier educational conference and technology exhibition, this three-day event brings together the brightest minds across the high-speed communications and semiconductor industries, who are looking to engineer the technology of tomorrow. DesignCon is your rocket to the future. Ready to come aboard?Register to attend!
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New Process can 3D Print Living Cells with Precision and Speed - DesignNews
10 promising ways to prevent, diagnose and treat Alzheimer’s – ISRAEL21c
November is Alzheimers Awareness Month. Its a fitting time to look at the latest Israeli advances in preventing, diagnosing and treating the progressive and incurable brain disorder.
Alzheimers disease (AD) is the most common cause of the 9.9 million new cases of dementia diagnosed each year worldwide. The disease primarily strikes the elderly population, affecting 30 percent of those over age of 85.
AD impacts memory, thinking and language skills, and even the ability to carry out simple tasks.
The disease occurs when a protein called amyloid beta aggregates in brain tissues. These protein clumps kill nerve cells, leading to damage in the brain-function mechanisms.
Here are 10 examples of promising Israeli approaches reported within the past two years alone.
PREVENTION
Various genetic, lifestyle and environmental factors can put a person at risk for AD. Among them are diabetes, high blood pressure, obesity, smoking, depression, cognitive inactivity or low education, and physical inactivity.
Preventing the onset of AD is the focus of these approaches:
Eitan Okun, Alzheimers disease researcher at Bar-Ilan University. Photo: courtesy
Most vaccines work by mounting an immune response toward a weakened pathogen to boost the immune systems ability to fight the real pathogen.
Okuns approach primes the body to attack amyloid beta protein clumps in the brain, the signature sign of AD.
Following experiments on mice, Okun is preparing for human trials on people at known risk of developing the disease in their 50s or younger: those genetically inclined toward Alzheimers and people with Down syndrome.
These critical trials will determine whether the vaccine actually works in humans, said Okun. Depending on the success rate and side effects from [human] testing, we will be able to know how much more time is needed to make the vaccine available on a global scale.
Okun also is investigating new ways to diagnose AD earlier and more accurately using advanced MRI (magnetic resonance imaging) technologies to detect initial signs of amyloid protein aggregation in the brain.
BGU Prof. Alon Friedman has invented a new treatment to prevent neurological diseases. Photo courtesy of Dr. Merav Shamir
Introduced by BGN Technologies of Ben-Gurion University of the Negev, the novel therapy hinges on the fact that a malfunctioning BBB allows neurotoxic blood products to enter the brain and cause damage leading to neurological diseases.
The lab of Prof. Alon Friedman discovered that treating the BBB at early stages can protect the brain and prevent disease development.
Their proposed treatment would combine Memantine and Losartan, which have been shown in preclinical studies to protect the integrity of the BBB when administered together. Partners are being sought to continue development.
Prof. Ester Segal of the Technion. Photo: courtesy
They reported on this advance in a recent cover story of the journal Small.
Nanoscale silicon chips invented in Prof. Ester Segals lab allow for the direct insertion of neural growth factor protein into the brain and its gradual release into the target tissue, bypassing the BBB (see above). Afterward delivering all the therapeutic protein loaded onto them, the chips safely dissolve.
In a series of experiments, we showed in mice that the two ways of delivering the platform into the brain led to the desired result, said Technion doctoral student Michal Rosenberg.
Our technology has also been tested in a cellular model of Alzheimers disease and indeed, the protein release has led to rescuing the nerve cells.
DIAGNOSIS
PET scans and spinal taps are now the gold standard for diagnosing AD. Theyre both expensive and carry risks.
Cheaper, noninvasive tests being developed in Israel also could be critical in providing a much earlier diagnosis, when treatment would be most effective.
Thats because the same beta-amyloid proteins that clump in the brain of AD patients appear in the retina of the eyes up to 15 years before the onset of AD symptoms.
RetiSpec developed the retinal scanner at the Ontario Brain Institute in Canada. Clinical studies are ongoing in Israel and Canada.
In October, RetiSpec received the Alzheimers Drug Discovery Foundations Diagnostics Accelerator Award to fund continued development of its hyperspectral imaging technology.
This could allow doctors to compare brain scans taken over time from the same patient, and to differentiate between healthy and diseased brain tissue, without resorting to invasive or dangerous procedures such as brain tissue biopsies, explained lead researcher Dr. Aviv Mezer.
Clara is based on a relatively recent understanding that AD affects the brains orientation system before it affects memory.
The overlap between how the self is oriented to the world and the brain mechanisms that are disturbed by Alzheimers disease is astonishing, Arzy told ISRAEL21c.
Clara asks patients questions about themselves and their relationships to people, places and events. It then compares that information to a baseline and generates a computer-based test tailored for the individual that can diagnose very early Alzheimers.
The team from Dr. Shahar Arzys computational neuropsychiatry lab at Hadassah Hebrew University Medical Center in Jerusalem. Photo: courtesy
According to a study Arzys team published in the Proceedings of the National Academy of Sciences and in the American Psychological Associations journal Neuropsychology, Clara is 95 percent accurate.
Clara is now in the midst of a five-year test at Harvard to compare data generated by the system with data from AD markers taken via amyloid PET scan, quantitative and functional MRI and other neuropsychological tests.
Jaul and Oded Meiron (a cognitive neuroscientist who heads the Electrophysiology and Neuro-cognition Lab in Herzogs Clinical Research Center for Brain Sciences) published an articlein the Journal of Alzheimers Disease outlining their discovery of the link between the two conditions.
The reason is that the abnormal changes in the brain that lead to dementia are happening in other parts of the body, including the skin. Skin tissue and brain tissue derive from the same embryonic stem cells.
Jaul and Meiron are working with an American company to develop a test to identify a biomarker for abnormal cell density in the skin of dementia patients. They hope that this skin test could pinpoint an individuals type and stage of dementia. The biomarkers show the most promise in identifying AD, they say.
TREATMENT
A variety of approved medications for AD including Exelon, developed in Israel cannot cure or stop the progression of the disease. They only relieve or delay AD symptoms, such as memory loss and confusion.
A few Israeli pharmaceuticals under development aim to improve Alzheimer treatment options.
Breathing in pure oxygen in a pressurized room or chamber stimulates the release of growth factors and stem cells, which promote healing.
This revolutionary treatment for Alzheimers disease uses a hyperbaric oxygen chamber, which has been shown in the past to be extremely effective in treating wounds that were slow to heal, said lead researcher Prof. Uri Ashery.
Asherys group tested the therapy on a mouse model of Alzheimers disease. The treatment was found to reduce behavioral deficiencies compared to control mice.
Remarkably, the treatment also reduced plaque pathology and neuroinflammation in the test mice by about 40 percent.
Further research will investigate the underlying mechanisms of the therapy and evaluate its beneficial effects in Alzheimer patients.
Yotam Nisemblat, CEO of ProteKt Therapeutics. Photo: courtesy
Incubated at FutuRx in Ness Ziona, ProteKt was spun out of PKR kinase inhibitor research by University of Haifa Prof. Kobi Rosenblum. Inhibition of the enzyme PKR is a unique idea for improving memory consolidation.
Protein aggregation tends to increase with age and can lead to neurodegeneration because proteins can adopt an erroneous configuration, where theyre misfolded, explains Prof. Martin Kupiec.
The paper he and his colleagues published in Molecular Cell describes how removing glucose from a particular aggregated protein made the blob dissolve.
If the results can be replicated in more complex proteins, scientists will have a new research avenue toward treatments that could reverse the neurodegenerative effect of protein aggregates, Kupiec says.
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10 promising ways to prevent, diagnose and treat Alzheimer's - ISRAEL21c
India Knight on the facial serum that transformed her skin – The Times
This product gave our columnist her best-ever skin. Read on
The Sunday Times,November 17 2019, 12:01am
This is one of those ding-ding-ding with a knife on a glass occasions. Obviously I review products I love and recommend from the heart every week, but equally obviously, not every single one is necessarily a life-changer. My personal list of the skincare products I would never again be without is not especially long. However, I currently have the best skin I have ever had in my entire life, including during periods when I paid much more attention to it and had regular facials, microdermabrasions, peels and so on. Hence the glass dinging.
Decree is another line by a doctor, in this case a Dr AJ Sturnham, who is a GP with a special interest in dermatology and aesthetics. The idea is that the line
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India Knight on the facial serum that transformed her skin - The Times
Shark Tank Season 11 Episode 8 Everything About Gallant Stem Cell Bank For Dogs As Seen on Shark Tank! Unknown Facts – TheNewsCrunch
Gallant Stem Cell Therapy For Dogs is one of the product companies to be featured on Shark Tank Season 11 Episode 8. The story behind the birth of Gallant Stem Cell Therapy For Dogs is pretty interesting. Here are some of the unknown facts about Gallant and its founders, Aaron Hirschhorn.
Aaron Hirschhorn is the founder and former-CEO of the popular dog-sitting marketplace DogVacay. Aaron is a noted entrepreneur with more than 20 years of experience in building companies and investing in them. DogVacay app was launched in 2013 and Aaron managed to raise $47 million from his erstwhile investors.
Aaron was the finalist in the Ernst & Young Entrepreneur of the Year Award 2016. In April 2017, Aarons DogVacay app merged with Rover.com and eventually went on to become a $1 billion pet services marketplace.
Trouble struck Aarons life when he suffered a massive back injury and was forced to undergo stem cell treatment which yielded amazing results to his surprise. Aaron, being an ardent dog lover wondered why this cutting-edge medical technology of stem cell transplants cannot be applied to dogs.
As a result, Gallant was born in the middle of 2018. According to Gallant, Your pups stem cells haveincredible healing power. Extract and store these powerful cells during your pets spay/neuter, so that you can unleash their potential when your best friend needs it most.
Ever since its inception, the mission of Gallant stem cell therapy is to help pets live a healthier life and make use of the epic technology of stem cell therapy in saving the lives of tons of dogs.
Dogs enter their senior years around 7 and begin feeling the effects of aging as early as 4! Traditional methods of treatment for injury and age-related conditions are expensive and can have harmful side effects. Stem cells are incredible natural healers. However, up to 99% of stem cells are lost over time due to aging. This forms the bottomline of Gallants business problem.
Gallant raised $7 million investment in August 2019.
From the moment you entrust Gallant with your dogs stem cells, were actively invested in their long-term health and well-being. Working in tandem with you and your veterinarian, we will collect and store these powerful cells now, so down the road we can help to treat the most common health problems your dog may face. We will also update you on new and potentially life-changing treatments as they become available.
Pick your pups stem cell storage plan you dont have to have a spay/neuter procedure scheduled yet! You can always add that in later. Our proprietary process requires no additional training, so any veterinarian you trust to alter your dog is qualified. Ahead of your dogs spay/neuter, we will connect with your vet and send our collection kit directly to their office.
2. Collect
On the big day, we align with your vet before the procedure and arrange for a courier. During your dogs spay/neuter procedure, your veterinarian will take out the stem cell-rich reproductive tissue they would normally discard into the collection kit.
3. Preserve
Once the tissue is received by our scientists, we send confirmation to both you and your veterinarian. Your dogs tissue is first inspected for quality before isolating the stem cells. The stem cells are then counted and frozen in liquid nitrogen to preserve their potency in our secure, state-of-the-art laboratory. Once this process is complete, you and your veterinarian will be notified that your pets stem cells are safely stored. The cells are then monitored by our team to ensure they stay perfectly preserved.
4. Treat
Your pets stem cells are at the ready to be sent to your veterinarian if/when treatment is needed. Treatments are out-patient procedures and cost about $300. A stem cell procedure is not painful to your pet and does not require anesthesia to administer.
Gallants stem cell therapy is receiving a lot of exciting reviews online. The therapy has been successful in saving scores of dogs with conditions like osteoarthritis, skin conditions, chronic dry eye.
Gallant is offering a $395 off discount for using the code SHARKTANK
How did Gallant fare in Shark Tank Season 11? What did the Sharks have to tell about it? Did Gallant Get a Deal on Shark Tank? More information to be updated soon in this post.
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Shark Tank Season 11 Episode 8 Everything About Gallant Stem Cell Bank For Dogs As Seen on Shark Tank! Unknown Facts - TheNewsCrunch
Everything you need to know about Victoria Beckhams first skincare product launching tomorrow – Evening Standard
The latest lifestyle, fashion and travel trends
He is one of the most googled names in beauty, and she, one of the most prominent figures in fashion.
It was therefore a fitting match for Victoria Beckham to join forces with Augustinus Bader the notoriously publicity-shy director of stem cell biology and cell technology at the University of Leipzig for her first foray in to skincare.
Bader became a household beauty name in February 2018, after the launch of his cult-product The Cream caused convulsions of desire to ripple throughout the beauty industry thanks to its ultra-hydrating and restorative qualities.
And so when looking for a scientific collaborator to join her on her endeavour in to skincare, it seemed a natural fit for the two to merge theircomplementingareas of expertise.
The Cell Rejuvenating Priming Moisturizer (Victoria Beckham Beauty)
Cue the result of the pairing: Victoria Beckham Beautys Cell Rejuvenating Priming Moisturizer.
The moisturiser is the new-and-improved iteration of the Morning Aura Primer Beckham launched as part of her collaboration with Este Lauder in 2016.
The product, which Beckham has re-developed with the help of 59-year-old Bader, is a multifunctional cream thatclaims to prime, impart a glow and also to repair.
Commenting on the collaborative beauty effort, Beckham took to her Instagram page to note: It has been a dream to develop, with Augustinus, a priming moisturizer that works to improve the health of my skin and gives that fresh, natural glow that I love.
Meanwhile Bader said: "It was an honour to collaborate with Victoria for her first Skin launch. I'm excited to share some of our skincare benefits in this product. It's the first product of its kind to care for your skin cells while also preparing your skin for makeup application."
A celebrity facialist has revealed VB's 9-step daily skincare routine
This marks the first skincare product 45-year-old Beckham has launched under her beauty line, which she debuted to critical-acclaim in September, alongside the brands co-founder, Sarah Creal.
Victoria Beckham Beauty has the tagline Luxury Performance, Clean Beauty, and is refusing to pigeonhole itself as just a beauty brand, instead referring to itself as clean beauty movement.
Cell Rejuvenating Priming Moisturizer costs 92 for 30ml and launches tomorrow exclusively at victoriabeckhambeauty.com and augustinusbader.com.
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Everything you need to know about Victoria Beckhams first skincare product launching tomorrow - Evening Standard
Circulating Tumor Cells And Cancer Stem Cells Market Revenue To Witness Steady Growth Through 2017-2025 – Statsflash
The tumor cells which have shed into lymphatic system and circulated over the body through blood circulation are called as circulating tumor cells. Circulating tumor cells may comprise seeds for metastasis. Stem cells are the type of cells that can differentiate into specialized cells and have the capacity of self-renewal.
Cancer stem cells are the cancer cells that possess the characteristics of normal stem cells. Cancer stem cells are said to be responsible for relapse of cancers in patients. There is a growing interest in these two cell types due to their fundamental biological and clinical implications. Circulating tumor cells and cancer stem cells are an important element in order to understand cancer related mechanism and to find a cure from all type of cancers. These cells can be used for detecting of metastasis and the patients who are at a higher risk of cancer relapse.
The global circulating tumor cells and cancer stem cells market is anticipated to grow at a rapid rate owing to development in biotechnology and biomedical engineering. According to WHO, Cancer is the leading cause of mortality and morbidity globally impacting about 14 million people annually, leading to rapid increase in research activities worldwide. Circulating tumor cells and cancer stem cells are under research for various types of cancer such as breast cancer, lung cancer, colorectal cancer, skin cancer. Government and various government bodies are taking interest and initiative to boost funds and activities which is one of the major factor driving the growth of the global circulating tumor cells and cancer stem cells market.
Increase in demand of oncology screening, diagnosis and treatment monitoring the patients disease progression is one of the factor likely to propel the growth of the market through 2024. Furthermore, application of the circulating tumor cell for the drug discovery, use of cells in development of tumor specific biomarkers for targeted therapies are driving the growth of the global market. However, the ethical issues involved in research and regulation to perform human trials are some of the major factor that are retraining the growth of the global market.
Based on technology type, the global circulating tumor cells and cancer stem cells market is divided into following
Based on Application types, the global circulating tumor cells and cancer stem cells market is divided into following
The global circulating tumor cells and cancer stem cells market is segmented on the basis of technology type, application type and geographical region. On the basis of technology type the global market is divided into cell enrichment, Detection and CTC Analysis. Enrichment is further divided into positive selection, negative selection, Microchips and others. Detection is further divided into Immunocytochemicals technology, Molecular based technology, EPISPOT functional invitro assay.
Cell Enrichment accounted for the largest market share globally owing to higher usage in oncology research and highly accurate technology. Microchip technology is expected to register high growth in the global market due to introduction of cluster chip technology which enables to capture the clusters of circulating tumor cells. On the basis of application type, the global market is divided into Biomarkers, tumorigenesis, stem cell research and others.
Geographically the global circulating tumor cells and cancer stem cells market is divided into North America, Europe, Asia Pacific, Latin America, Middle East and Africa. North America is the dominating region in the global market attributing to the factors like developed economy, developed healthcare domain, strong funding for oncology research, rise in prevalence rate of cancer, favorable initiatives by government bodies. Asia Pacific region is expected to register high growth during the forecast period as a result of awareness, development of research and healthcare domains and prevalence of cancer.
Some of the major player operating in the global circulating tumor cells and cancer stem cells market are QIAGEN Hannover, AVIVA Biosciences, Epic Sciences, ApoCell, Cynvenio Biosystems, Fluxion Biosciences, Rarecells, Janssen Diagnostics, LLC, CellTraffix Inc., Silicon Biosystems, Advanced Cell Diagnostics, Inc. among others worldwide.
To maintain a significant position in the global market key players are involved in collaboration with the cancer research universities and hospitals, for example in November 2015 Epic Sciences announced collaboration Abramson cancer Centre of University Pennsylvania. This collaboration is expected to explore the field of biomarkers which are identified by circulating tumor cells. The key participants are expanding the market by developing the facilities in different regions. For example, in September 2014 advanced cell diagnostic Inc. established a subsidiary in Europe to serve the European market.
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Victoria Beckham on testing products on David and Harper’s concerns for sustainability as she launches new skincare – The Times
Victoria Beckham has called on scientist Augustinus Bader, who created a 205 face cream that celebrities rave about, to develop a hi-tech skincare product that claims to supercharge your complexion
The Sunday Times,November 17 2019, 12:01am
Do you remember when Victoria Beckham launched a product called Morning Aura? It was part of her first make-up collection for Este Lauder in 2016 and sent fans into a frenzy, selling out in record time.
In September, VB launched her own beauty brand, Victoria Beckham Beauty, with the help of Sarah Creal the former head of global make-up marketing and product development at Este Lauder, and the woman who worked closely with her on that first beauty collection. And now they are returning to Morning Aura, but better, Beckham says, when we speak on the phone.
But this isnt the usual new-bottle-same-formula reboot: she has teamed up with Professor Skincare himself, Augustinus Bader, one of the most googled names in beauty. Bader shot
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Victoria Beckham on testing products on David and Harper's concerns for sustainability as she launches new skincare - The Times
Global Regenerative Medicine Market to Grow Over $81 Billion by 2023 and Market Driven by Stem Cells – PharmiWeb.com
PUNE, India, Nov. 13, 2019 /PRNewswire/ -- This report provides a comprehensive overview of the size of the regenerative medicine market, segmentation of the market (stem cells, tissue engineering and CAR-T therapy), key players and the vast potential of therapies that are in clinical trials.The analysis indicates that the global Regenerative Medicine Market was worth $28 billion in 2018 and will grow to over $81 billion by 2023, with a CAGR of 23.3% between this time frame. Within this market, the stem cell industry will grow significantly. This report describes the evolution of such a huge market in 15 chapters supported by over 350 tables and figures in 700 pages report at https://www.reportsnreports.com/reports/974420-global-regenerative-medicine-market-analysis-forecast-to-2021-stem-cells-tissue-engineering-biobanking-car-t-industries.html
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Executive Summary
Regenerative medicine's main objective is to heal and replace organs/cells that have been damaged by age, trauma or disease. Congenital defects can also be addressed with regenerative medicine. Therefore, it's market encompasses dermal wounds, cardiovascular disease, specific cancer types and organ replacement. To that end, regenerative medicine is a broader field and manipulates the body's immune system and regeneration potential to achieve its requirement. Financially speaking, investment into this space is dominated by grants, private investors and publicly traded stocks. Looking forward, the regenerative medicine market is promising for a number of robust reasons including:
Of course restrictions to this market include strict regulations in certain geographies, and also the level of investment required to support R&D, clinical research, trials and commercialization. Reimbursement strategies are also paramount to success of the overall space.
There are over 700 regenerative medicine companies globally at present. At present, the total regenerative medicine market has more than 500 products commercialized. The Regenerative Medicine Marketencompasses a number of key technology submarkets including:
Reconstructive surgeries for bones and joints is the mainstay of the regenerative medicine market. Geographically speaking, due to the dominance of the bone and joint reconstruction market, the US has the biggest space. This is followed by Europe. However, due to recent positive legislation in Japan and Europe, the stem cell arena will grow more substantially in these regions over the next five years. By 2023, it is possible that Europe will surpass the US market with respect to stem cell applications, and this will become more likely if the Trump Administration restricts legislation and funding.
Market Applications & Opportunities for Regenerative Therapies
Regenerative medicine, including cellular and gene therapies will have a significant impact on the expenditure of payers once reimbursement schemes are optimized. To that end, a number of conditions that regenerative medicine tackles is synonymous with an aging population such as:
Global Financial Landscape
The last few years have been busy for regeneration medicine, cellular therapeutics and the gene therapy industry, with high investment from pharma giants such as Eli Lilly, BMS, Astra Zeneca and Sanofi. Company partnerships were also in motion that included Kite Pharma and Bluebird/Five Prime, Juno and Fate Therapeutics/ Editas Medicine.
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Stem Cell Market Analysis & Forecast to 2023
Today the stem cell and regenerative medicine industries are interlinked and over the last number of years have grown substantially. Regenerative medicine replaces or regenerates cells, tissues or organs and in order to achieve this, uses produces from the pharmaceutical, biologics, medical device and cell therapy spaces. Therefore, cell therapy and stem cells come under the umbrella market of regenerative medicine. Cell therapy is a platform by which regenerative medicine can achieve its aim and concentrates on using cells as therapeutics to treat disease.
Tissue Engineering Market Analysis and Forecast to 2023
Tissue engineering was the forerunner of the present regenerative medicine market. The area of biomaterials was developed to use cells and biological material and incorporate them into scaffolds and functional tissues. Some of the main applications of tissue engineered products include artificial skin and cartilage and so this area dominates the dermatology, bone and joint submarket. Wound repair is also a significant area for tissue engineering, with products such as Dermagraft in the market.
Tissue engineering is being driven by the increase in technology of biomaterials, bioscaffolds and bio 3D printing. The rise in the amount of orthopedic transplantations is demanding the market to produce more innovative solutions such as 3D printed organs. In the long term future, Kelly Scientific forecasts the advance of cutting edge 3D bioprinters in this market place.
Biobanking Market Analysis
The biobanking industry is made up of over 500 public and private blood banks globally. These companies and institutions collect, store and distribute adipose tissue, cord blood and birth tissues, musculoskeletal tissues, pericardium, skin, bone, vascular tissue, autologous and allogeneic cells and other biological samples. They operate by charging a collection fee and then a storage fee, which is usually operational for 20 years. Private banking costs between $1,350 to $2,300 as an initial fee, and then between $100 to $175 per annum for storage. Public banking is free, and a number of hybrid models have been introduced in Europe and Asia to date.
CAR-T Industry
The CAR-T industry is addressing unmet needs in specific relapsed cancers, however does early clinical trial data support a blockbuster status for this upcoming therapy? Some patients do indeed show long term activity and high remission rates, but there is a large proportion of patients with toxicities such as cytokine release syndrome and neurotoxicity. The main players within the CAR-T market are Juno Therapeutics, Kite Pharma, Novartis and Cellectis. The market is moving ahead, backed by years of R&D, from both academia and industry, investors capital and small clinical studies. From 2017, Kelly Scientific forecasts that CAR-T therapy will become more streamlined, with faster manufacturing times as advances in technologies take hold and clinical trials provide more robust evidence that this immunotherapy is robust. These factors, plus strategies to reduce adverse reactions and toxicities and larger players like Novartis taking stage will push CAR-T therapy ahead. However, recent deaths in the Juno ROCKET trial are creating questions amongst investors. How will the CAR-T space influence the total immunotherapy industry going forward? This comprehensive report scrutinizes the total market and provides cutting-edge insights and analysis.
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Key Questions Answered
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4th Annual MarketsandMarkets Bioprocessing of Advanced Cellular Therapies & Regenerative Medicine Congress
Date: 10th 11th March 2020Location: London UK
In the 4th edition of MarketsandMarkets Bioprocessing of Advanced Cellular Therapies & Regenerative Medicine we would be focusing on the pre-clinical, manufacturing, clinical and regulatory aspects of cell therapies and regenerative medicine. This Congress event will be held on 10th and 11th March 2020 in London -UK
Regenerative therapies are proving its acceptance in potential of cell-based therapies for chronic disorders. Since our past three editions, our aim through this conference is to provide illustrative approach to recent developments in technologies of bioprocessing of cellular therapies, to process development and addressing qualitative and regulatory hurdles.
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Global Regenerative Medicine Market to Grow Over $81 Billion by 2023 and Market Driven by Stem Cells - PharmiWeb.com
10 Times 2000s Sci-Fi Movies Predicted The Future | ScreenRant – Screen Rant
If you're a science fiction enthusiast, then chances are, you already have a clear picture of what the future holds for humanity. Be it space travel, robots, or some weird means of extradimensional communication, sci-fi films have given us a glimpse of future technologies and events one way or another. In fact, each decade, sci-fi movies' futuristic predictions keep growing more accurate.
RELATED:Ranked: 10 Scariest '90s Sci-Fi Movie Monsters
By the 2000s, some of them have already gotten a little too prophetic and hauntingly precise. Needless to say, they are definitely worth watching for their predictions alone. So, we present you with 10 sci-fi films from the 2000s that got the future right in one or more aspects. These masterpieces have not only entertained us but also prepared us for the coming years.
Crime is one of the favorite subject matters of sci-fi media because it allows for creative twists in the otherwise exhaustive genre.Minority Report(2002)and its Pre-crime system is a good example. It's basically a prediction of who will commit crimes or become criminals based on their psychological background and allows authorities to stop crim before they even happen.
As it turns out, Pre-crime is not entirely far-fetched as a law-enforcement system. Japan (who'd have thought?) has something quite similar but less advanced, from A.I. cameras that can detect shoplifters before they do the deed to a "crime analytics" system which predicts where crime will happen. Their police force only began using such tech during this decade.
A.I. Artificial Intelligenceis one of the most philosophical sci-fi films of all time and doesn't shy away from questioning the nature of humanity and what makes us human. In that regard, it paints a rather familiar scene of the future where humans are using robots for prostitution.
RELATED:10 Sci-Fi Movies That Will Make You Think As Much As Inception
In the film, this becomes apparent as soon as Jude Law's robot character, Gigolo Joe, gets introduced. You can probably guess what he does for a living. You'll either be pleased or weirded out to know that bots like Gigolo Joe exist today. There are now official sex dolls who can talk and even give compliments, there's even a brothel full of dolls. Who knows what a few more years of robotics and primal human urges can bring?
Many things inWall-Efrom 2008 are now starting to become true today. Well, perhaps they were already true back then, but they're definitely becoming a lot more apparent today. We're talking about the Earth becoming a giant landfill, advertisements everywhere there's a breathing human being, drivable chairs, and of course, rising obesity rates.
Oh, there's also the fact that certain Governments and even corporations are most likely already looking for a way out of Earth (andto Mars) before things get too messy. In a way,Wall-Eis already happening and we really should be more alarmed now, shouldn't we?
You've probably never heard ofThe Islandbefore and that's due to the film not having the best marketing. In any case,The Islandis about a man who struggles to fit in at an isolated compound he lives in. He soon discovers that everyone was a clone of someone else and that they were merely being harvested for their organs to treat the social elite.
RELATED:10 Best Sci-Fi Movies of the '90s, According to IMDb
Surprise, surprise, there have been scientific and medical breakthroughs about the exact same thing. Scientists have been able to use human cloning to create stem cells that were used to regenerate the skin cells of a 75-year-old man. Further studies and developments are needed and we're still stuck with experimenting on pigs at the moment.
I, Robot was a cinematic flop but was still impressive enough to get its own meme culture more than a decade later. Critics often hailed it as a rip-off ofBlade Runner but in hindsight,I, Robot was a little more radical in how it gave us a picture of future societies. In the film, corporations ruled everything, with automation and A.I. replacing many jobs, making lots of humans unemployed.
Sadly, robots might actually soon take our jobs. We're not just referring to blue-collar work being replaced by heavy machinery; A.I. is learning fast and might take over some administrative jobs and basically everything that requires routine and repetition. It's time to re-evaluate your career options.
It's more romance than sci-fi butEternal Sunshine of the Spotless Mindhas that one plot device (metaphorical or not) which makes quality as science fiction. That would be the memory deletion procedure which a mad neuro-surgeon in the film invented. It allows him to delete people's memories of other people, basically selective amnesia with consent; the first application the filmmakers thought for that technology was moving on from a heartbreak.
RELATED:10 Worst Sci-Fi Movies, According To IMDb
Turns out, there are more practical uses for such a procedure in the real world. Scientists have successfully erased some traumatic memories for mice back in 2013 by locating a gene. They do hope to apply the same procedure to ease the mental pain of patients with post-traumatic stress disorders (PTSD), rather than just for couples with breakup difficulties.
Unfortunately,The Matrixwas released back in 1999, which makes it a year short of qualifying as a 2000s movie. Still, it had sequels and an animated anthology spin-off calledThe Animatrixthat basically explored the same ideas. One notable technology thatThe Matrixfranchiseprophesized (see what we did there?) is virtual reality.
The protagonists ofThe Matrixfranchise basically plug themselves into computers to sort of act as viruses that can bring down their machine enemies. To an extent, we do have this tech today in the form of VR headsets. It's not as immersive as sticking a huge needle into your spine, of course.
Marvel'sIron Manback in 2008 kicked off many great and influential things that we enjoy today and among those is a rekindled interest in robotics and military engineering. Apart from Robert Downey Jr. as Tony Stark, the biggest star inIron Manwas his self-sustaining and relatively compact armor; it's basically the equivalent of a whole country's army controlled by one man.
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We don't have anything that advanced today; it's practically impossible at the moment with our limited resources and lack of further frontal lobe development but the U.S. Army is trying nonetheless with its exo-suit. These allow soldiers a better physical edge on the battlefield. They did try to re-create something more similar to the Iron Man suit but failed and ended up wasting millions of dollars.
The idea of visiting, recording, and manipulating dreams was popularized in Hollywood by films likeInception; however,Inception's primary inspiration was a Japanese anime film calledPaprika(2006), which also explored the same concept of entering, viewing, and interfering with dreams.
These days, such a feat is no longer limited to daydreaming; in 2011, a team of scientists at UC Berkeley was able to view someone else's dream. The scientists recordedthe subjects'brain activity and then translated the whole thing into a video. There were also scientists in Kyoto, Japan who managed to predict another person's dream into a picture which was 60 percent accurate. No more forgetting your dreams sooner or later.
You're probably tired of seeingChildren of Menin movie lists over and over again but it can't be helped, it's such a revelatory masterpiece that we can learn a lot from it. It's more modern dystopia than sci-fi, meaning most of what the film foresaw are political and socio-economic struggles similar to what we're experiencing today.
Apart from the rapidly declining birth rate which is happening to a certain country today,Children of Menalso painted a picture of a disturbing immigration crisis where people of wartorn countries are rushing like animals to the only countries with functioning governments left in the world. Oh, and resources are also in decline and everyone's out for themselves.Sounds eerily familiar.
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10 Times 2000s Sci-Fi Movies Predicted The Future | ScreenRant - Screen Rant
International Stem Cell Corporation Announces Financial Results for the Three and Nine-Months ended September 30, 2019 – Associated Press
Press release content from ACCESSWIRE. The AP news staff was not involved in its creation.
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CARLSBAD, CA / ACCESSWIRE / November 15, 2019 / International Stem Cell Corporation (OTCQB:ISCO) ( http://www.internationalstemcell.com ) (ISCO or the Company), a California-based clinical stage biotechnology company developing novel stem cell-based therapies and biomedical products, today announced operating results for the three and nine months ended September 30, 2019.
As we mentioned before we completed the enrollment of the Phase I Parkinsons disease clinical trial and currently involved in reorganizing our revenue-generating subsidiaries. We expect that we will see positive results of this reorganization next year. - commented Andrey Semechkin, PhD., CEO and Co-Chairman of ISCO.
Year-to-Date Financial Highlights
About International Stem Cell Corporation
International Stem Cell Corporation is focused on the therapeutic applications of human parthenogenetic stem cells (hpSCs) and the development and commercialization of cell-based research and cosmetic products. ISCOs core technology, parthenogenesis, results in the creation of pluripotent human stem cells from unfertilized oocytes (eggs). hpSCs avoid ethical issues associated with the use or destruction of viable human embryos. ISCO scientists have created the first parthenogenetic, homozygous stem cell line that can be a source of therapeutic cells for hundreds of millions of individuals of differing genders, ages and racial background with minimal immune rejection after transplantation. hpSCs offer the potential to create the first true stem cell bank, UniStemCell. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology ( http://www.lifelinecelltech.com ), and stem cell-based skin care products through its subsidiary Lifeline Skin Care (www.lifelineskincare.com). More information is available at http://www.internationalstemcell.com.
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Safe Harbor Statement
Statements pertaining to anticipated developments, expected results of clinical studies, progress of research and development, and other opportunities for the company and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as will, believes, plans, anticipates, expects, estimates,) should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, regulatory approvals, need and ability to obtain future capital, application of capital resources among competing uses, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the companys business, particularly those mentioned in the cautionary statements found in the companys Securities and Exchange Commission filings. The company disclaims any intent or obligation to update forward-looking statements.
International Stem Cell Corporation and Subsidiaries Condensed Consolidated Balance Sheets (in thousands, except share data and par value) (Unaudited)
Assets
Cash
Accounts receivable, net
Inventory, net
Prepaid expenses and other current assets
Total current assets
Non-current inventory
Property and equipment, net
Intangible assets, net
Right-of-use assets
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Total assets
Liabilities, Redeemable Convertible Preferred Stock, and Stockholders' Equity (Deficit)
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Series D Redeemable Convertible Preferred stock, $0.001 par value, 50 shares authorized, 43 issued and
outstanding, with liquidation preference of $4,300 at September 30, 2019
Stockholders' Equity (Deficit)
Series B Convertible Preferred stock, $0.001 par value, 5,000,000 shares authorized, 250,000
issued and outstanding, with liquidation preferences of $423 and $411 at September 30, 2019 and
December 31, 2018
Series D Convertible Preferred stock, $0.001 par value, 50 shares authorized, 43 issued and
outstanding, with liquidation preference of $4,300 at December 31, 2018
Series G Convertible Preferred stock, $0.001 par value, 5,000,000 shares authorized, issued and
outstanding, with liquidation preference of $5,000 at September 30, 2019 and December 31, 2018
Series I-1 Convertible Preferred stock, $0.001 par value, 2,000 shares authorized, 814 issued and
outstanding, with liquidation preferences of $814 at September 30, 2019 and December 31, 2018
Series I-2 Convertible Preferred stock, $0.001 par value, 4,310 shares authorized,
issued and outstanding with liquidation preference of $4,310 at September 30, 2019 and December 31, 2018
Common stock, $0.001 par value, 120,000,000 shares authorized, 7,533,083 and 6,933,861 shares
issued and outstanding at September 30, 2019 and December 31, 2018
Additional paid-in capital
Accumulated deficit
Total stockholders' equity (deficit)
Total liabilities, redeemable convertible preferred stock and stockholders' equity (deficit)
International Stem Cell Corporation and Subsidiaries Condensed Consolidated Statements of Operations (in thousands, except per share data) (Unaudited)
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Weighted average shares-diluted
Contacts:
International Stem Cell Corporation
Russell A. Kern, PhD
Phone: 760-940-6383
Email:
SOURCE: International Stem Cell CORP
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International Stem Cell Corporation Announces Financial Results for the Three and Nine-Months ended September 30, 2019 - Associated Press
Defensins and the dermis – Dermatology Times
Wound healing is complex. Injured tissues undergo a multi-phase process from hemostasis to tissue remodeling. And defensin plays a role.
Basically, it's your natural mechanism for healing a wound, and it stimulates a specific stem cell, the LGR6+ stem cell, according to Greg Keller, M.D., who presented Clinical Data with Defensins at the Global Aesthetic Conference in Miami earlier this month.
After activation, LGR6+ stem cells physically migrate into the basal layer of the skin and create a new epidermis, and eventually, new, younger-acting skin, says Dr. Keller.
In her Cosmeceutical Critique of The role of defensins in treating skin aging, Leslie Baumann, M.D., writes, LGR6+ stem cells, which are dormant until they are activated to respond to damage, are stimulated by defensins.1
She effectively summarizes their role in anti-aging as:
Old fibroblast and keratinocytes are sluggish and lazy. Old cells do not hear signals as well as younger cells. LGR6+ stem cells repopulate the epidermis with new, young keratinocytes. Defensin stimulates LGR6+ stem cells. The defensin/LGR6+ pathway plays a role in keratinization. Using topical defensin can improve the skins appearance.
Theoretically, says Dr. Keller, hair follicles provide a way for defensins to enter the skin to activate the LGR6+ pathway, but We wanted to actually measure wrinkles and quantify how much better the skin was in terms of pore size, oiliness, wrinkles, and the like.
So he, Amy Taub, M.D., Vivian Bucay, M.D., Jay Williams, Ph.D, and Darius Mehregan, M.D., conducted a participant- and investigator-blinded, placebo-controlled, multi-center study with the defensin-containing DefenAge 3-step system (Progenitor Biologics) that includes the 2-Minute Reveal Masque, 24/7 Barrier Balance Cream and 8-in-1 BioSerum, on 44 women, 41-71 years of age with skin types I to V.2
References:
1. Taub A, Bucay V, Keller G, Williams J, Mehregan D. Multi-Center, Double-Blind, Vehicle-Controlled Clinical Trial of an Alpha and Beta Defensin-Containing Anti-Aging Skin Care Regimen With Clinical, Histopathologic, Immunohistochemical, Photographic, and Ultrasound Evaluation. J Drugs Dermatol. 2018;17(4):426-441.2. Bauman L. The role of defensins in treating skin aging. Cosmeceutical Critique. MDedge Dermatology. April 1, 2018. Accessed November 13, 2019. Available at: https://www.mdedge.com/dermatology/article/161149/aesthetic-dermatology/...
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Defensins and the dermis - Dermatology Times
BREAKTHROUGH: Her vision was getting worse, then animal research made things clear – Speaking of Research
By Justin A. Varholick, Ph.D.
As we grow older theres an impending fear that we will slowly, but surely, begin to lose our vision. This slow loss of vision is clinically dubbed low vision and impacts more than 39 million Americans, costs $68 billion annually in direct health care costs, and is only growing in our population as baby boomers enter the at-risk age of 65 and older. Magnifiers can often be used to help people with acute issues of low vision, but are often inconvenient and frustrating. More serious issues of low vision such as cataracts, age-related macular degeneration, glaucoma, and diabetic retinopathy require advanced treatment and surgery. For example, cataracts can be improved or reversed by removing the cloudy lens and replacing it with an artificial one. Such surgeries are not always ideal, or convenient, and further contribute to the already hefty direct health care costs. But, a recent breakthrough by Japanese scientists, in correcting blurry vision, might reverse this bleak future.
Old cells can become new againOur story begins around the mid-20th century, in 1958. A young and aspiring scientist, named John Gurdon, was studying frogs at the University of Oxford in England. Not everyone thought Gurdon would end up actually becoming a scientist. In his early days his school master thought such a career was far-fetched for Gurdon. Indeed, he ranked last in his Biology class out of 250 students. Yet despite such poor grades, Gurdon found himself studying frogs at Oxford and earning a doctoral degree in Biology. And his studies would surprisingly lead to a breakthrough in vision, and likely many other issues in human health, like Parkinsons Disease, heart disease, and spinal cord injury.
At the time Gurdon was trying to test an age-old theory on cell development. Many scientists before him discovered that cells the smallest unit of life begin without a clear fate in the early stages of an embryo. Then as the cell develops, their fate becomes more clear. They become cells of the heart, of the brain, the kidneys, the stomach, the spinal cord, or the eyes. But they cannot go back to a time when they had no fate, or specialization. The cells can only develop in one direction, from no destiny, to a clear path, then to a mature adult cell; like one found in the heart. But you just cant take a heart cell and start the process over, maybe turning it into a brain cell.
In disagreement with this theory, Gurdon did a simple experiment. He knew that a tadpole has more adult cells than a frog egg. A tadpole has gills, a heart, eyes, etc., while a frog egg simply does not. So, he cut open the tadpole and removed a single cell from the intestine; an intestinal cell. He then cut open the intestinal cell and removed its nucleus; the seed of the cell carrying all the DNA. Very carefully, he did the same with the frog egg, and finally replaced the nucleus of the frog egg with the nucleus of the intestinal cell. According to the age-old theory, the intestinal nucleus should stop normal development of the frog egg. But thats not what happened.
Instead, the new frog egg continued to develop normally, becoming a tadpole that later became an adult frog. Gurdon thought this was unbelievably odd, and so did everyone else in science. After many more experiments doing the exact same procedure (i.e., replication), it seemed that what he saw was a real, replicable fact. For some reason the nucleus of the intestinal cell was able to reverse itself to have no fate and slowly develop into any other adult cell. The seed from the intestine somehow could become the seed of a heart, brain, kidney, or even an eye cell and of course, an intestinal cell too.
After many more experiments testing the same theory, on many more animals, it seemed the theory was true, but it just didnt work for mammals. Given that the same effect could not be repeated in a mammal, some believed this discovery did not apply to humans. But they were wrong.
The discovery of induced pluripotent stem cellsAlmost 45 years later, around the start of the millennium, Shinya Yamanaka and Kazutoshi Takahashi began running experiments that would translate Gurdons findings to humans. Born after Gurdons findings were already published and well known, Yamanaka and Takahashi grew up in a world in which the fact that old cells can become new again was widely knowna solid foundation for further hypotheses, experiments, and discovery. So, the scientists set out to do what no one had before: turn adult skin cells of mice into new cells without a clear fate.
Yamanaka, the lead investigator of the study, shared a similar early history with Gurdon. He first became a medical doctor in Japan but was frustrated by his inability to quickly remove small human tumors taking over an hour rather than the typical 10 minutes. Senior doctors gave him the nickname Jamanaka, a Japanese pun for the word jama meaning obstacle. He then found himself earning a PhD in pharmacology and becoming a post-doctoral scientist, but spent more time caring for mice than doing actual research. Frustrated again, his wife suggested he just become a practicing physician. Despite her advice, Yamanaka applied to become an Assistant Professor at Nara Institute of Science and Technology, in Japan, and won everyone over with his fantastical ideas of investigating embryonic stem cells; the cells without a clear fate.
Then the persistence paid off when Yamanaka with his assistant, Takahashi discovered how to induce adult skin cells from mice to return to an embryonic, or stem cell, state without a clear fate. They began their experiments knowing that gene transcription factors proteins that turn genes on and off were responsible for keeping embryonic cells in a state without a clear fate. They thought that by turning specific genes on and off with these factors, they could turn back time and make an adult cell embryonic again. So, they tried many different combinations of gene transcription factors and ultimately discovered that 4 specific ones were enough to induce an adult skin cell to a mouse to become an embryonic cell. Because these re-newed embryonic cells, or stem cells, originally came from adult cells they came up with a new name, induced pluripotent stem cell. Broken down, induced pluripotent stem cells means that the cell was induced to become pluripotent pluri meaning several, like plural, and potent meaning very powerful (and stem meaning to have the ability to turn into any cell in the body).
These induced pluripotent cells were thought to be very powerful indeed and scientists across the globe were excited by this great discovery. They had visions of taking a persons skin or blood, forming them into induced pluripotent cells, and then using them to grow a new liver or new parts of the brain. Laboratories across the world confirmed the results by repeating the experiment.
Human stem cells Just repeating the experiments in mice, or frogs, was not enough. They needed to begin making induced pluripotent stem cells from humans. Enter scientists from the University of Wisconsin-Madison. The lead scientist, James Thomson was already well known for deriving primate embryonic cells from rhesus monkeys in 1995 and the first human embryonic cell line in 1998. In fact, Thomsons accomplishment of isolating embryonic cells from monkeys was the first sound evidence that it was possible to do the same for humans. Such discoveries placed him on the forefront in ethical considerations for research using human embryos and the most obvious scientist to lead the path toward making induced pluripotent stem cells from humans.
Thomsons team made the first human derived induced pluripotent stem cells from adult skin, with Yamanaka as a co-scientist. They followed the same general principles set by Yamanaka, who did the procedure with mouse skin cells. Importantly to Thomson, this discovery helped to relieve some ethical controversy with using human embryos to make human stem cells. By being able to induce adult human skin to become pluripotent stem cells, much research on human stem cells could be done without human embryos albeit research with human embryos remains necessary.
Yet more important to the discussion at hand, the ability to induce human skin to become pluripotent stem cells placed us on the edge of a breakthrough. With some clinical trials in humans, the fantasy of growing a new liver, heart, or eye was more a reality than ever before.
The start of human trials In 2012, around the time both Gurdon and Yamanaka were presented with the Nobel Prize in Physiology and Medicine for their work leading to induced pluripotent stem cells, human clinical trials were beginning in Japan. The first clinical trial was for age-related macular degeneration, an eye condition leading to blindness. Unfortunately, this trial was quickly terminated when Yamanaka and his team identified small gene mutations in the transplanted induced pluripotent stem cells from the first patient. Although the procedure did cure the patient of macular degeneration, these small gene mutations worried the scientists because they could lead to tumor development.
But recently with the introduction of an inducible suicide gene that can signal cells with abnormal growth to die, human trials are starting up again. In October of 2018, Japanese scientists began trials with Parkinsons disease, a brain disease related to a shortage of neurons producing dopamine. Scientists took cells from the patients, made them into induced pluripotent stem cells, guided them to develop into dopamine producing cells, and then deposited them in the dopamine centers of the brain through surgery. The outcome is promising since similar procedures in monkeys have been successful.
Other trials in Japan have also started, including spinal cord injury and one for replacing the cornea of the eye. Early results replacing damaged corneas with induced pluripotent stem cells, thereby correcting blurry vision, were just announced at the end of August. Although it will take more patients and safety checks before all humans can get induced pluripotent cells to correct their damaged eyes, malfunctioning brains, or broken spinal cords, Takahashi the post-doctoral scientist working with Yamanaka thinks it might happen as early as 2023. So, it looks like that in our lifetime we just might be able to stay young and enjoy retirement because of great breakthroughs in animal research.Note, EuroStemCell is a great resource for learning more about the ethics and research currently being done with stem cells derived from human embryos.
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BREAKTHROUGH: Her vision was getting worse, then animal research made things clear - Speaking of Research
How 3D Printing Is Turning Each And Every Industry On Its Head – SafeHaven.com
Calling all carnivores: ever thought about getting a meat printer? Of hand-crafting delectable beef steaks at home from plant proteins, that have the same texture, appearance, and flavor as real meat, only without the distasteful killing part?
3D-printed steaks and chicken could be on the menu in European restaurants as early as 2020, with home-spun meat printers available to the consumer within a few more years. Israel-based Redefine Meat is already using advanced food formulations along with proprietary 3D printing technology to make what it calls the holy grail of alt-meat,reports Tech Radar Pro.
The idea sounds absurd, but its not so far-fetched, as three-dimensional printing technology goes in directions no-one could dream of, prior to the launch of 3D printing in the 1980s.
Uses
Put simply, 3D printing is a progression of 2D printing, where a third dimension is added to the printing of images on a flat surface (a regular ink-jet printer), adding depth and allowing the printer cartridge to move in all directions. A digital file is first created using modeling software, then sent to the printer, depositing layers of the chosen material - often plastic or wax - to build up the final product. Other printing materials include plastics, powders, filaments, paper, and even human or animal cells - used in the cutting-edge new field of bioprinting.
3D printing is also referred to as additive manufacturing because objects are made by injection-molding them to the desired size and shape, versus traditional manufacturing which invariably entails loading material into a machine to be cut to the required dimensions. With additive manufacturing, material is added, layer upon layer, without creating waste/ scrap.
3D Printer employs agood analogy for 3D printing, describing the process as similar to baking a multi-layered cake:
3D printers use a variety of very different types of additive manufacturing technologies, but they all share one core thing in common: they create athree dimensionalobject by building it layer by successive layer, until the entire object is complete. Its much like printing in two dimensions on a sheet of paper, but with an added third dimension: UP. The Z-axis.
Each of these printed layers is athinly-sliced, horizontal cross-section of the eventual object. Imagine a multi-layer cake, with the baker laying down each layer one at a time until the entire cake is formed. 3D printing is somewhat similar, but just a bit more precise than 3D baking.
Formerly known as stereolithography, 3D printing was invented in 1983 by Chuck Hull, co-founder of 3D Systems. Frustrated by how long it took to make small, custom parts, Hull suggested using his furniture companys UV lamps to create parts by curing photosensitive resin, layer by layer. Calling the technology stereolithography, Hull applied for a patent and was issued one in 1986.
Two years later, start-up 3D Systems manufactured the first 3D printer, the SLA-1.
It took over 30 years for the technology to become mainstream, but now 3D printing can be done by anyone with access to a base-model 3D printer, which can be purchased for under $500.
Among the more interesting items that have been 3D-printed are prosthetic limbs, fabricated firearms, electrical vehicles, steel parts (Caterpillar introduced thefirst 3D-printed excavatorin 2017), quick-build homes, parts for combat aircraft, spacecraft, and even decorative chocolates.
Relativity Space is 3D-printing rockets at its Los Angeles headquarters.
According to Wired,youll find four of the largest metal 3D printers in the world, churning out rocket parts day and night. The latest model of the companys proprietary printer, dubbed Stargate, stands 30 feet tall and has two massive robotic arms that protrude like tentacles from the machine. The Stargate printers will manufacture about 95 percent, by mass, of Relativitys first rocket, named Terran-1. The only parts that wont be printed are the electronics, cables, and a handful of moving parts and rubber gaskets.
Z-Morph Bloglists five more really cool, recently-printed 3D-printed objects:
Methods
From its mid-80s beginning, a number of 3D printing technologies have emerged.
The first, known asStereolithography (SLA), concentrates a beam of ultraviolet light onto the surface of a vat filled with liquid photocurable resin. The laser beam draws out the 3D model one layer at a time, with each slice hardening as the light hits the resin. The solidified structure is gradually dragged up by a lifting platform, while the laser continues to form a different pattern for each layer to create the desired shape of the object.
Digital Light Processing (DLP)is similar toStereolithography, butuses more conventional light sources. A liquid crystal display allows for a large amount of light to be projected onto the surface of the object being printed, and for the resin to harden quickly.
Fused Deposition Modeling (FDM)was invented in the late 1980s. The object is made by extruding a stream of melted thermoplastic material to form layers. The layers harden and fuse together almost immediately after leaving the extrusion nozzle.
InSelective Layer Sintering (SLS), powdered materials instead of liquid photopolymer is drawn from the vat, including polystyrene, ceramics, glass, nylon and metals such as steel, titanium, aluminum and silver. A layer of powdered material is placed on top of the previous layer using a roller and then the powdered material is fused or sintered according to a certain pattern.
PolyJetphotopolymershoots out a photopolymer liquid, similarly to an ink-jet printer, which is hardened with a UV light. This technology acquired by Stratasys allows for various materials and colors to be incorporated into single prints, and at high resolutions.
WithSyringe Extrusion, virtually any material with a creamy viscosity such as clay, cement or silicone, can be 3D-printed using syringe extruders. The syringe is heated or not heated, depending on the material.
Other variants of these technologies includeSelective Laser Melting (SLM),Electron Beam Melting (EBM)which uses an electron beam instead of a laser, andLaminated Object Manufacturing (LOM), where layers of paper, plastic or metal, coated with adhesive, are successively glued together and cut to shape.
Market
Sales related to 3D printing, including printers, materials and services, will move past $US2.7 billion in 2019 and hit $3 billion in 2020according to Deloitte Global, with a CAGR of 12.5%. Comparing that to the $12 trillion in global manufacturing revenues indicates the amount of growth potential in 3D printing and bioprinting.
The consulting firm explains that companies across multiple industries are increasingly using 3D printing for more than just rapid prototyping:
3D printers todayare capable of printinga greater variety of materials (which mainly means more metal printing and less plastic printing, although plastic will likely still predominate); they print objects faster than they used to, and they can print larger objects (build volume). A steady stream of new entrants is expanding the market. 3D printing is considered an essential ingredient in Industry 4.0, the marriage of advanced production and operations techniques with smart digital technologies that is being heralded as the Fourth Industrial Revolution.
Deloitte notes the number of materials used in 3D printing has more than doubled from five years ago, with mixed-material printers becoming more common. 3D printers are also about twice as fast in 2019 as they were in 2014.
It says the biggest shift is from plastic to metal printing: Plastic is fine for prototypes and certain final parts, but the trillion-dollar metal-parts fabrication market is the more important market for 3D printers to address. Plastics share of the 3D printing industry fell from 88 to 65% in 2017-18, and metal rose from 28 to 36%.
A recent technology called binder jet metal printing could halve the time required to produce each part, compared to the relatively slow and expensive selective laser sintering (SLS) method, states Deloitte.
Size capabilities are improving too. A few yearsagoa high-end metal printer could only build an object 10x10x10 cm or one cubic liter. In 2019 metal printers with the capacity to print 30x30x30 cm are available.
Companies
As 3D printing technology continues to advance, more and more companies are forming, eager to get in on the action. Three of the largest are Stratasys, 3D Systems and Proto Labs; these companies offer 3D printers and services to help manufacturers move prototypes into production.
Based in Minnesota,Stratasyshas over 600 granted or pending additive manufacturing patents, including for the FDM,Polyjetand WDM 3D printing technologies. Among the sectors Stratasys serves are healthcare, aerospace, automotive and education. The companyssubsidiaries include MakerBot,GrabCAD,RedEyeOnDemand and Solid Concepts.
Asmentioned3D Systemswas first out of the gate with a 3D printer, back in 1988. Along with pioneering stereolithography, 3D Systems has also developed selective laser sintering, multi-jet printing, film-transfer imaging, color jet printing, direct metal printing, and plastic jet printing. Divided into three business units - products, materials and services - 3D Systems offers small desk-top printers, metal printers and commercial printers that print in plastics and other materials.
Also headquartered in Minnesota isProto Labs, established in 1999. Building on automated solutions to develop plastic and metal parts used in manufacturing, in 2014 Proto Labs launched an industrial-grade 3D printing service, enabling software developers and engineers to quickly move prototypes into production. The company acquired Rapid Manufacturing in 2017 to further its efforts in sheet metal fabrication. It currently has 2,300 employees in 12 manufacturing hubs.
3D bioprinting - the next big thing in medical investing
According to the United Network for Organ Sharing, every day 21 people in the United States die waiting for an organ, and over 120,000 people are on organ transplant waiting lists.
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The situation is worse in Canada. While Spain has 43 donors per million people, the US has 26, Britain has 21, and Canada has just 20. Out of 4,500 Canadians waiting for an organ, about 260 will die each year, according toThe Organ Project. Thats five deaths per week.
Imagine if, instead of waiting for an organ from another person - possibly a relative but likely a stranger - you could walk into a doctors office and have one manufactured, with your cells. It sounds far-fetched, but the technology now exists for the tailor-made transplantation of organs through brand-new medicine called 3D bioprinting.
What is 3D bioprinting?
3D printing is a progression of 2D printing, where a third dimension is added to the printing of images on a flat surface (a regular ink-jet printer), adding depth and allowing the printer cartridge to move in all directions. A digital file is first created using modeling software, then sent to the printer, depositing layers of the chosen material - often plastic or wax - to build up the final product.
Among the more interesting items that have been 3D-printed are prosthetic limbs, fabricated firearms, electrical vehicles, steel parts (Caterpillar introduced thefirst 3D-printed excavatorin 2017), quick-build homes, parts for combat aircraft and spacecraft, and even decorative chocolates.
Bioprinting operates on the same principle as regular 3D printing but instead of plastic, wax or other matter, bioprinters deposit layers of living cells to build structures like blood vessels or skin tissue. The cells are taken from an animal or a human being and cultivated until there are enough to create bio-ink which is then loaded into the printer using mechanical syringes. Adult stem cells can also be utilized.
Key to the process is a dissolvable gel which acts as a kind of incubator for the cells to multiply - like an embryo growing in a womb. Researchers may also plant cells around 3D scaffolds made of biodegradable polymers or collagen, allowing them to develop into functional tissue. The cells use their inherent properties to seek out similar cells to join with. Researchersare able tocontrol the shape into which the cells form, and the printer builds the final structure.
After the tissues are fully grown and shaped, they are placed into a recipients body. The hope is that the 3D-printed object becomes as much a part of the patients body as the cells he or she was born with.
There are currently five common methods of 3D bioprinting:
- Inkjet bioprinting: Droplets of bio-ink are deposited, layer by layer, onto a culture plate. Cells that can help fight breast cancer have been successful printed using inkjet bioprinting.
- Extrusion bioprinting: Polymer or hydrogel is loaded in syringes and dispensed via pneumatic- or screw-driven force, onto a building platform. The motion is controlled by a computer. Extrusion bioprinting offers lower resolution than inkjet bioprinting but the fabrication speed is considerably higher, allowinganatomically-shapedobjects to be generated.
- Laser-assisted bioprinting: A laser is used to deposit the biomaterials into a receptor via a tape covered with biological material. The laser irradiates the tape, causing the biological material to evaporate and reach the receptor in the form of droplets. The droplets contain a biopolymer that acts as an adhesive to help the cells to grow. This high-resolution bioprinting method is being used in a partnership between French bioprinting companyPoietisand LOral to recreate a hair follicle that could lead to a cure for baldness.
- Stereolithography: Stereolithographic bioprinting uses a digital micro-mirror to direct ultraviolet light onto the printing surface. Light directed by the micro-mirrors triggers the formation of molecular bonds, which cause light-sensitive hydrogels to form into solid material.
- Bioprinting with acoustic waves: Using a device that allows cells to be manipulated with acoustic waves, researchers can manipulate where the waves will meet along three axes. The waves then form a trap that captures the cells, which are collected to create 3D patterns.
How far has it progressed?
Some of the most advanced work on bioprinting has been done at the Wake Forest Institute for Regenerative Medicine in California. One of the first major structures that Wake Forestbioprintedwas a human bladder. Made from cells extracted from a patient with a poor-functioning bladder, the 3D-printed bladder was successfully transplanted. The project built on custom-grown bladders that had previously been transplanted into seven patients suffering from spina bifida, a birth defect that affects the spinal cord.
Wake Forest staffers have also created an outer human ear, and implantedbioprintedskin, bone and muscle on laboratory animals that successfully grew into surrounding tissue.
The institutes director, AnthonyAtala, sees bioprinting astotalytransforming the relationship between the transplant patient and doctor, in much the same way that Dell changed the way consumers interacted with the computer company that sold PCs tailored to each customers unique needs. Patients could order replacement parts in much the same way they might order a new clutch for their Mazda.
Youd have companies that exist to process cells, create constructs, tissue. Your surgeon might take a CT scan and a tissue sample and ship it to that company,Atalasaid in afeature article on bioprinting in Smithsonian Magazine.
The company would then ship the organ back a week or so later, ready for implantation. Welcome to the new world of regenerative medicine: the plug and play human body.
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Atalasaid the technology is developing to the point where researchers are almost able to replicate simple organs like the outer ear and the trachea (windpipe). Importantly, there are no real surgical challenges, he told Smithsonian.
Challenges
The holy grail of 3D bioprinting would be to come up with a viable kidney for transplant. ProfessorAtala, of the Wake Forest Institute, created the first small-scalebioprintedkidney in 2002. However,Atalais the first to admit that his machine-produced kidney is nowhere near at the level it needs to be for a human transplant. A TED TalkAtalagave in 2011 about bioprinting, which culminated with a dramatic display of an object - really an over-sized bean - became controversial when the press gotaholdof it and printed enthusiastic, but wrong, stories about the technology eliminating the need for a kidney transplant.
Another potential roadblock is the cost. No-one yet knows what it would cost tobioprintand transplant a human organ on demand, and how accessible the procedure would be to the masses of patients requiring a transplant. And while there have been successful bioprinted organ transplants, there havent been enough to determine how well the human body will accept the new tissue or artificial organ.
Finally, one shouldnt underestimate the complexity and level of difficulty involved. Aspharmaforumpoints out, A complex network of cells, tissues, nerves and structures in a human organ need to be correctly positioned with a highest precision for it to function properly. From arranging the thousands of tiny capillaries in a liver, to printing a heart that beats, it is a long, difficult process.
Skin
Wake Forest is working on a skin-cell printer capable of printing live skin cells directly onto a burn wound. The procedure could replace skin-grafting, a procedure where healthy skin is harvested from an unburnt part of a patients body. Skin grafting can be hard to heal from, and in severe burn cases, there isnt enough healthy skin left to use.
This new printing technique only needs a patch of skin 10% the size of the burn, that is used to grow enough cells for 3D printing. The wound is then scanned for size and depth, information which the printer uses to print skin cells at the proper depths to cover the wound.
In 2017 scientists in Madrid created a prototype of a 3D bioprinter that can create functional human skin. The printer is adequate for transplanting skin and for testing cosmetic, chemical and pharmaceutical products,ScienceDaily reported.
Hearts
At the Texas Heart Institute in Houston, researchers are working with decelluarized pig hearts. The organs have been stripped of muscle and other living tissue, but the original architecture is intact. The idea is to use decelluarized pig hearts, repopulated with bioprinted human cells, for implantation into humans. Sofarthe institute has succeeded in injecting pig hearts with living bovine cells, then inserted them into cows where they worked successfully next to a cows heart.
Already, patients with a defective heart valve can have a pigs valve or a mechanical valve implanted. Doris Taylor, director of the institutes regenerative medicine research program, says thedecelluarizedmethod gets around the tricky process of printing at the extremely high resolution required for highly vascularized (containing many blood vessels) organs like the heart.
The tech is going to have to improve a great deal before were able tobioprinta kidney or a heart, and get blood to it, and keep it alive, Taylor told Smithsonian.
More recent developments though are moving in that direction. In 2016 Harvard researchers 3D-printed the first heart-on-a-chip. The tiny device contains living human heart cells that mimic the hearts functions.
In 2018, 3D printingstartupBioLife4D successfully produced human tissue in the form of a cardiac patch - derived from a patients white blood cells with multiple cell types contained in the human heart.According to pharmaforum, its another step towards bioprinting major organs for transplant.
Scientists at the American Friends of Tel Aviv University havereportedly 3D-printed a fully-vascularized heartusing fat cells from a donor. The fat cells were partially cultured and re-programmed into heart cells. This early-stage technology has only been able to print a heart the size of a rabbits, but researchers hope to test the printed hearts in other animals.
Ovaries
Northwestern University in Illinois debuted a 3D-printed ovary using the acoustic waves method described above, and in Sweden, researchers have successfully created human cartilage tissue, also using acoustic waves.
Thyroids
Russian scientists aboard the International Space Stationsuccessful bioprinted the first organ in space: a mouses thyroid. Spaces zero-gravity environment enables organs and tissues to mature faster than on Earth.
Bones/ cartilage
A team from the UKs Swansea University has apparently developed a bioprinting process that uses regenerative material to create an artificial bone matrix. The technology could replace bone grafting, a surgical procedure that replaces missing or damaged bones with synthetic materials. Unlike bone grafting, which doesnt allow new bone tissues to form, thus limiting mechanical integrity, 3D-printed bones are capable of fusing with, and even replacing over time, a patients natural bones.
Cartilage printing could revolutionize joint care through a hand-held cartilage printing device calledBioPen. Built by Australian researchers, theBioPencontains stem cells derived from a patients fat, which create custom scaffolds of living material into failing joints much like 3D-printed bones. So farBioPenhas only been tested on sheep but developers plan to accelerate it to regenerate functional human cartilage.
Corneas
Finally, a group of researchers in South Korea has 3D-printed prototype corneas fromdecelluarizedcorneal stroma and stem cells. Unlike artificial corneas currently available, made of substances like synthetic polymer which resist incorporation into the eye, printed corneas are made to mimic the material within natural corneas. The invention could replace the need for donors and synthetic corneas in cataract surgery and other sight complications.
Investment opportunity
3D bioprinting has come a long way since ProfessorAtalasfirst artificial bladder in 2002. At Ahead of the Herd, we think it is the next big thing in regenerative medicine. Science always starts out with experimentation, sometimes many years of it, before the technologies are commercialized. We want our subscribers to bewell awareof 3D bioprintings potential, putting them in a position to get in early to companies that are offeringbioprintedproducts.
While there are currently a handful of bioprinting firms, we see an entire ecosystem of small firms developing, with each focusing on a different aspect, technology or part of the body. It will not take 10 years for start-up pub-cos to IPO, seeking money to develop their technologies.
Currently valued at USD$685 million, within the next six years,the global bioprinting market is expected to expand by a CAGR of 26.2%, reaching $4.4 billion by 2026. The United States and Canada are the industry leaders, making bioprinting an ideal new sector for North America-focused investors.
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How 3D Printing Is Turning Each And Every Industry On Its Head - SafeHaven.com
Brand story: Our top stories on the biggest beauty brands in APAC – CosmeticsDesign-Asia.com
1 Shiseido believes Drunk Elephant has only just scratched the surface of its potential
Japanese beauty conglomerate Shiseido is looking to accelerate US-based Drunk Elephants global footprint to maximise the brands opportunities for growth and development.
Shiseido reportedly beat out competitors such as the Estee Lauder Companies and Unilever to buy the clean beauty for $845m. This deal is expected to close by the end of this year.
Drunk Elephant founder Tiffany Masterson will continue in her role as Chief Creative Officer and assume the additional role of President, reporting directly to Marc Rey, CEO of Shiseido Americas and Chief Growth Officer of Shiseido.
This deal marks another large skin care acquisition this year, including LOccitane Groups $900m purchase of ELEMIS and Unilevers $500m deal for Tatcha.
Shiseido sees great value in Drunk Elephant and is well placed to continue to cultivate the brand growth under the Shiseido umbrella. The potential [of the brand] has only just been scratched, a spokesperson from Shiseido told CosmeticsDesign-Asia.
The head of Natura International has revealed the company plans to begin its international expansion with South East Asia as its starting point.
In September, the Brazilian company announced plans to form a new subsidiary in Singapore to manage its brands Aesop and The Body Shop.
This region is very important for us, not just for growth but also to help us learn more about consumers that are becoming more and more sophisticated. Singapore is a very important hub for this region. Not only does it connect nearby countries, it also is a place to create brand awareness for the region, said Daniel Silveira, head of Natura International.
Silveira told CosmeticsDesign-Asia that the company had ambitious goal of expanding into around 70 markets worldwide in the next 10 years and SEA was crucial to its plans.
This month, the firm launched its Natura brand in Malaysia, further strengthening its ties to the region.
The research arm of LVMH is collaborating with the Centre for iPS Cell Research and Application of Kyoto University (CiRA) to study the mechanism of skin metabolism for Parfums Christian Dior.
The aim of the joint project is to explore how oxidative metabolism affects skin keratinocyte self-renewal or differentiation capabilities.
The effects of age on mitochondrial status, skin regeneration and differentiation will be investigated with the hope of contributing to major therapeutic discoveries in the skin and cutaneous rejuvenation, said CiRA in a press statement.
Under the direction of Nobel Prize laureate Shinya Yamanaka, CiRA is a leading centre for induced pluripotent stem cell research.
According to CiRA, iPS cells are cells generated by introducing a small number of factors into body cells such as skin cells and blood cells.
Shiseido has found that yeast extract has the potential to keep skin capillaries healthy, which in turn boost collagen production and maintains skin elasticity.
The firms research team discovered this through its study of capillaries and its relation to skin elasticity.
This research was first presented at the International Federation of Societies of Cosmetic Chemists Conference 2019 in Milan where it won the top award in the Podium Presentation category.
Using the companys original 3D visualisation technology, researchers studied subjects aged around 20 and 60.
Subjects in the 20s with high elasticity in their skin were found to have thick and dense structure of capillaries as compared to older subjects.
Japanese cosmetics company Kao Corporation is looking to strengthen its global brand presence with the launch of the Curl skin care range in the UK and US.
The brand is part of the groups 11 strategic global brands of its G11 cosmetics portfolio. As such, it is crucial to the companys strategy to strengthen its presence in the global cosmetics market.
Hiwako Yoshino, a spokesperson for the company, told CosmeticsDesign-Asia that Curls entry into the UK is a starting point for a European expansion.
Kao plans to accelerate the growth of G11 in Asia and the European market, which continues to grow and have high cosmetic sensitivity. Curl, one of the G11, is following the strategy and starting the business in the UK as the beginning for Europe, said Yoshino.
Back in July, the firms cosmetics business reported mid-single digit growth in the first half of the year, largely due to the popularity of the prestige brand, Sensai.
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Brand story: Our top stories on the biggest beauty brands in APAC - CosmeticsDesign-Asia.com
BIORESTORATIVE THERAPIES, INC. (OTCMKTS:BRTX) Files An 8-K Submission of Matters to a Vote of Security Holders – Market Exclusive
BIORESTORATIVE THERAPIES, INC. (OTCMKTS:BRTX) Files An 8-K Submission of Matters to a Vote of Security HoldersItem 5.07 Submission of Matters to a Vote of Security Holders.
On November 13, 2019, BioRestorative Therapies, Inc. (the Company) held a Special Meeting of Stockholders (the Special Meeting). The following is a listing of the votes cast for and against, as well as abstentions, with respect to the matters voted upon at the Special Meeting. At the Special Meeting, the Companys stockholders (i) approved an amendment to the Companys Certificate of Incorporation to increase the number of shares of common stock authorized to be issued by the Company from 150,000,000 to 300,000,000, (ii) approved amendments to the Certificate of Incorporation of the Company, and authorized the Board of Directors of the Company to select and file one such amendment, to effect a reverse stock split of the Companys common stock at a ratio of not less than 1-for-2 and not more than 1-for-100, with the Board of Directors of the Company having the discretion as to whether or not the reverse stock split is to be effected, and with the exact ratio of any reverse stock split to be set at a whole number within the above range as determined by the Companys Board of Directors in its discretion (the Reverse Stock Split Proposal), which Reverse Stock Split Proposal revises the reverse stock split ratio approved by the Companys stockholders on May 30, 2019 and (iii) authorized the Board of Directors of the Company, in its discretion, to reduce the number of shares of common stock authorized to be issued by the Company in proportion to the percentage decrease in the number of outstanding shares of common stock resulting from the reverse split (or a lesser decrease in authorized shares of common stock as determined by the Companys Board of Directors in its discretion).
(d) Exhibits.
3.1 Certificate of Amendment of Certificate of Incorporation of the Company
About BIORESTORATIVE THERAPIES, INC. (OTCMKTS:BRTX)
BioRestorative Therapies, Inc. develops therapeutic products and medical therapies using cell and tissue protocols, involving adult (non-embryonic) stem cells. The Company offers human and plant stem cell derived cosmetic and skin care products. Its programs relate to the treatment of disc/spine disease and metabolic disorders and include Disc/Spine Program (brtxDISC) and Metabolic Program (ThermoStem). Its curved needle device (CND) is a needle system with a curved inner cannula to allow access to difficult-to-locate regions for the delivery or removal of fluids and other substances. The CND is intended to deliver stem cells and/or other therapeutic products or material to the interior of a human intervertebral disc, the spine region, or other areas of the body. The device relies on the use of pre-curved nested cannulae that allows the cells or material to be deposited in the posterior and lateral aspects of the disc to which direct access is not possible due to outlying structures.
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BIORESTORATIVE THERAPIES, INC. (OTCMKTS:BRTX) Files An 8-K Submission of Matters to a Vote of Security Holders - Market Exclusive
New Weill Neurohub will unite UCSF, UC Berkeley, UW in race to find new treatments for brain diseases – UW Today
Engineering | Health and medicine | News releases | Population Health | Research | Science | Technology
November 12, 2019
Microscopy image showing the cytoskeleton within neurons, which are differentiating from induced pluripotent stem cells.UC San Francisco
With a $106 million gift from the Weill Family Foundation, UC Berkeley, UC San Francisco and the University of Washington have launched the Weill Neurohub, an innovative research network that will forge and nurture new collaborations between neuroscientists and researchers working in an array of other disciplines including engineering, computer science, physics, chemistry and mathematics to speed the development of new therapies for diseases and disorders that affect the brain and nervous system.
A 2016 study by the Information Technology & Innovation Foundation estimated that, in the U.S. alone, neurological and psychiatric disorders and diseases including Alzheimers; Parkinsons; anxiety and depression; traumatic brain injury and spinal cord injury; multiple sclerosis; ALS; and schizophrenia carry an economic cost of more than $1.5 trillion per year, nearly 9 percent of GDP.
The gains in knowledge amassed by neuroscientists over the past few decades can now be brought to the next level with supercomputers, electronic braincomputer interfaces, nanotechnology, robotics and powerful imaging tools, said philanthropist Sanford I. Sandy Weill, chairman of the Weill Family Foundation. The Neurohub will seize this opportunity by building bridges between people with diverse talents and training and bringing them together in a common cause: discovering new treatments to help the millions of patients with such conditions as Alzheimers disease and mental illness.
Complementing the strengths of UCSF, Berkeley and the UW, the Weill Neurohub will draw on the expertise and resources of the 17 National Laboratories overseen by the Department of Energy, which excel in bioengineering, imaging, and data science. In August 2019, the Weill Family Foundation and the DOE signed a Memorandum of Understanding creating a new publicprivate partnership. The partnership is exploring the use of the Departments artificial intelligence and supercomputing capabilities, in conjunction with Bay Area universities and the private sector, to advance the study of traumatic brain injury, or TBI, and neurodegenerative diseases.
Secretary of Energy Rick Perry, who has spearheaded the creation of an AI and Technology Office during his tenure at DOE, said that the vision for the Weill Neurohub dovetails with his own mission to make publicly funded AI and supercomputing resources more widely accessible to advance scientific discovery. We are on the cusp of great discoveries that could transform our approach to TBI, Alzheimers disease and other neurological and psychiatric disorders, and easing access to the world-class computational power of our National Laboratories to initiatives like the Weill Neurohub is a win-win for science and the public sector and, eventually, for patients.
As many neurological disorders, such as dementia, are associated with aging, the costs of these unmet medical needs are expected to increase significantly in the coming years. California, with the largest aging population in the U.S., with one in five residents reaching age 65 or older in the next decade, faces particularly formidable challenges, said Gov. Gavin Newsom.
Every day, millions of people in California, the nation, and the world are facing the uncertainty of neuro-related diseases, mental illness and brain injuries, and collaboration between different disciplines in science, academia, government and philanthropy is critical to meet this challenge. Together, we must accelerate the development and use cutting-edge technology, innovation and tools that will advance research and practical application that will benefit people across the world and for generations to come, said Newsom. I want to thank Sandy Weill and his wife, Joan, for their amazing work, kindness, dedication and commitment to philanthropic causes, especially when they open doors, bridge gaps, and make innovation and collaboration possible to advance causes that can truly have an impact on peoples quality of life.
Sanford and Joan Weill.UC San Francisco
The Weill Neurohub will enable the three universities to work together on these pressing problems. For example, the UW and UCSF, renowned research universities with long traditions of excellence in basic neuroscience research, also have federally sponsored Alzheimers Disease Research Centers, or ADRCs. Through the Weill Neurohub, members of the UWs ARDC, part of the UW Medicine Memory and Brain Wellness Center, and UCSFs ADRC, led by the UCSF Memory and Aging Center, will collaborate with top neurodegeneration researchers at Berkeley.
The Weill Neurohub will provide funding for faculty, postdoctoral fellows, and graduate students at the UW, Berkeley and UCSF working on cross-disciplinary projects, including funding for high-risk/high-reward proposals that are particularly innovative and less likely to find support through conventional funding sources. But the bulk of the Weill Neurohubs funding will support highly novel cross-institutional projects built on one or more of four scientific pillars that Weill Neurohub leaders have deemed priority areas for answering the toughest questions about the brain and discovering new approaches to disease: imaging; engineering; genomics and molecular therapeutics; and computation and data analytics.
The Weill Neurohub may seek additional academic, corporate and philanthropic partners to harness resources collaboratively, better scale research and development efforts, share information and data and create partnerships to make breakthroughs faster and at a lower cost than the current paradigm allows.
Relevant examples of interdisciplinary or cross-institutional neuroscience projects now underway at UCSF, Berkeley and/or the UW include:
This gift expands on the unique vision and mission of the UCSF Weill Institute for Neurosciences, established in 2016 with a $185 million gift from the Weill Family Foundation and Joan and Sandy Weill whose giving to the neuroscience community now exceeds $300 million said UCSFs Dr. Stephen Hauser, the Robert A. Fishman Distinguished Professor of Neurology and Weill Institute director.
The UCSF Weill Institute set out to break down walls between the clinical disciplines of neurology, neurosurgery and psychiatry, and also bring these clinical specialties together with the basic neurosciences, said Hauser. Now, with the Weill Neurohub, were going even further: eliminating institutional boundaries between three great public research universities, and also other disciplinary walls between traditional neuroscience and non-traditional approaches to understanding the brain. By embracing engineering, data analysis and imaging science at this dramatically higher level areas in which both Berkeley and the UW are among the best in the world neuroscientists on all three campuses will gain crucial tools and insights that will bring us closer to our shared goal of reducing suffering from brain diseases.
Hauser will serve as one of two co-directors of the new Weill Neurohub along with Berkeleys Ehud Udi Isacoff, the Evan Rauch Chair of Neuroscience. Together with Tom Daniel, the Joan and Richard Komen Endowed Chair and professor of biology at the UW, they will serve on the Weill Neurohubs Leadership Committee.
In the Weill Neurohub, the emphasis will be on technology to enable discovery of disease mechanisms, and thus development of novel treatments and early detection of neurologic diseases, to allow intervention before conditions become severe, said Isacoff, who heads Berkeleys Helen Wills Neuroscience Institute. The technologies include next-generation neuroimaging and therapeutic manipulations ranging from brain implants to CRISPR gene editing, with major efforts in machine learning and high-speed computation. I think these three campuses can succeed in this joint mission in a way that no others can the combined expertise this group brings to the table, especially when you bring in the National Labs, really is unparalleled.
Tom Daniel, the Joan and Richard Komen Endowed Chair and professor of biology at the University of Washington.University of Washington
The UWs Daniel added, The Weill Neurohub brings together three outstanding public institutions, each with a deep commitment to bridge boundaries between science, engineering, computer science and data science to address fundamental problems in neuroscience and neural disorders. To my knowledge, this is a nationally unique enterprise drawing on diverse approaches to accomplish goals no single institution could reach alone, as well as seeding and accelerating research and discovery.
Neuroscientists have made huge strides in understanding the brain in the 30 years since President George H. W. Bush designated the 1990s as the Decade of the Brain, and subsequently through the National Institute of Healths ongoing BRAIN Initiative, first announced by President Obama in 2013. But treatments for neurological and psychiatric diseases have lagged far behind those for other common afflictions, such as cardiovascular disease and cancer.
Much of the lack of progress on neurological and psychiatric disease is due to the unparalleled complexity of the nervous system, in which hundreds of billions of nerve cells and support cells form as many as 100 trillion connections in intricate three-dimensional networks throughout the brain and spinal cord. The Weill Neurohubs leaders believe reaching beyond conventional approaches is essential to grappling with this complexity.
Despite amazing advances in neuroscience, new therapies are not reaching patients with mental illness and neurological disorders nearly as quickly as they have for heart disease and cancer. And in addition to the terrible personal toll these illnesses exact on patients and their families, they also have a massive impact on our healthcare system and on the global economy, said Joan Weill, president of the Weill Family Foundation. Our goal, through the broad and multifaceted approach of the Weill Neurohub, is to begin to change that.
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New Weill Neurohub will unite UCSF, UC Berkeley, UW in race to find new treatments for brain diseases - UW Today
Celgene Receives CHMP Positive Opinion for REVLIMID (lenalidomide) in Combination With Rituximab for the Treatment of Adult Patients With Previously…
SUMMIT, N.J.--(BUSINESS WIRE)--Celgene Corporation (NASDAQ:CELG) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the approval of REVLIMID (lenalidomide) in combination with rituximab (anti-CD20 antibody) (R) for the treatment of adult patients with previously treated follicular lymphoma (FL) (Grade 1-3a). If approved by the European Commission (EC), R2 will be the first combination treatment regimen for patients with FL that does not include chemotherapy.
Since its initial approval in 2007, REVLIMID has continued to demonstrate its benefits across a range of serious blood disorders in Europe and a CHMP positive opinion for this combination with rituximab is very good news for patients with follicular lymphoma. We look forward to the European Commission decision, said Tuomo Ptsi, President of Hematology/Oncology for Celgene Worldwide Markets.
In FL, a subtype of indolent NHL, the immune system is not functioning optimally.1,2 When this dysfunction occurs, the immune system either fails to detect or attack cancerous cells.1,2 Rituximab is a monoclonal antibody that targets the CD 20 antigen on the surface of pre-B and mature B-lymphocytes. Upon binding to CD20, rituximab causes B-cell lysis. Lenalidomide is an immunomodulator that increases the number and activation of T and natural killer (NK) cells, resulting in the lysis of tumor cells. The R2 combination regimen acts by complementary mechanisms to help the patients immune system to find and destroy the cancer cells.3
Given the incurable nature of FL2, a high unmet medical need exists for the development of novel treatment options with new mechanisms of action and a tolerable safety profile to help improve progression-free survival (PFS) especially in the setting of previously treated FL.
The estimated incidence of NHL in Europe was 100,055 cases in 2018; FL accounts for approximately 25% of all NHL cases and is the most common form of indolent NHL.3,4,5
Chemotherapy is a standard of care for indolent forms of NHL, but most patients will relapse or become refractory to their current treatment, said Prof. John Gribben, President of EHA and Centre for Haemato-Oncology, Barts Cancer Institute, in England The combination of REVLIMID and rituximab could represent a new, chemotherapy-free treatment option for patients with previously treated follicular lymphoma.
The CHMP positive opinion is based primarily on results from the randomized, multi-center, double-blind, Phase 3 AUGMENT study, which evaluated the efficacy and safety of the R combination versus rituximab plus placebo in patients with previously treated FL (n=295).6,7 Additionally, findings from the MAGNIFY study were included as support for the safety and the efficacy of lenalidomide plus rituximab in patients with relapsed or refractory FL, including rituximab refractory FL patients.8
The CHMP reviews applications for all member states of the European Union (EU), as well as Norway, Liechtenstein, and Iceland. The European Commission, which generally follows the recommendation of the CHMP, is expected to make its final decision in approximately two months. If approval is granted, detailed conditions for the use of this product will be described in the REVLIMID Summary of Product Characteristics (SmPC), which will be published in the revised European Public Assessment Report (EPAR).
About Follicular Lymphoma
Lymphoma is a blood cancer that develops in lymphocytes, a type of white blood cell in the immune system that helps protect the body from infection.9 There are two classes of lymphoma Hodgkins lymphoma and non-Hodgkins lymphoma (NHL) each with specific subtypes that determine how the cancer behaves, spreads and should be treated.3,10,11 Other differentiating factors of lymphomas are what type of lymphocyte is affected (T cell or B cell) and how mature the cells are when they become cancerous.11
Follicular lymphoma is the most common indolent (slow-growing) form of NHL, accounting for approximately 25% of all Non-Hodgkin lymphoma (NHL) patients.5,12 Most patients present with advanced disease usually when lymphoma-related symptoms appear (e.g., nodal disease, B symptoms, cytopenia) and receive systemic chemoimmunotherapy.5 While follicular lymphoma patients are generally responsive to initial treatment, the disease course is characterized by recurrent relapses over time with shorter remission periods.13
About AUGMENT
AUGMENT is a Phase 3, randomized, double-blind clinical trial evaluating the efficacy and safety of REVLIMID (lenalidomide) in combination with rituximab (R) versus rituximab plus placebo in patients with previously treated follicular lymphoma (FL). AUGMENT included patients diagnosed with Grade 1, 2 or 3a FL, who were previously treated with at least 1 prior systemic therapy and two previous doses of rituximab. Patients were documented relapsed, refractory or progressive disease following systemic therapy, but were not rituximab-refractory.6,7
The primary endpoint was progression-free survival, defined as the time from date of randomization to the first observation of disease progression or death due to any cause. Secondary and exploratory endpoints included overall response rate, durable complete response rate, complete response rate, duration of response, duration of complete response, overall survival, event-free survival and time to next anti-lymphoma therapy.6,7
About REVLIMID
REVLIMID is approved in Europe and the United States as monotherapy, indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma (MM) who have undergone autologous stem cell transplantation. REVLIMID as combination therapy is approved in Europe, in the United States, in Japan and in around 25 other countries for the treatment of adult patients with previously untreated MM who are not eligible for transplant. REVLIMID is also approved in combination with dexamethasone for the treatment of patients with MM who have received at least one prior therapy in nearly 70 countries, encompassing Europe, the Americas, the Middle-East and Asia, and in combination with dexamethasone for the treatment of patients whose disease has progressed after one therapy in Australia and New Zealand.
REVLIMID is also approved in the United States, Canada, Switzerland, Australia, New Zealand and several Latin American countries, as well as Malaysia and Israel, for transfusion-dependent anaemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities and in Europe for the treatment of patients with transfusion-dependent anemia due to low- or intermediate-1-risk MDS associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate.
In addition, REVLIMID is approved in Europe for the treatment of patients with mantle cell lymphoma (MCL) and in the United States for the treatment of patients with MCL whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib. In Switzerland, REVLIMID is indicated for the treatment of patients with relapsed or refractory MCL after prior therapy that included bortezomib and chemotherapy/rituximab.
REVLIMID is not indicated and is not recommended for the treatment of patients with chronic lymphocytic leukemia (CLL) outside of controlled clinical trials.
Important Safety Information
WARNING: EMBRYO-FETAL TOXICITY, HEMATOLOGIC TOXICITY, and VENOUS and ARTERIAL THROMBOEMBOLISM
Embryo-Fetal Toxicity
Do not use REVLIMID during pregnancy. Lenalidomide, a thalidomide analogue, caused limb abnormalities in a developmental monkey study. Thalidomide is a known human teratogen that causes severe life-threatening human birth defects. If lenalidomide is used during pregnancy, it may cause birth defects or embryo-fetal death. In females of reproductive potential, obtain 2 negative pregnancy tests before starting REVLIMID treatment. Females of reproductive potential must use 2 forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after REVLIMID treatment. To avoid embryo-fetal exposure to lenalidomide, REVLIMID is only available through a restricted distribution program, the REVLIMID REMS program.
Information about the REVLIMID REMS program is available at http://www.celgeneriskmanagement.com or by calling the manufacturers toll-free number 1-888-423-5436.
Hematologic Toxicity (Neutropenia and Thrombocytopenia)
REVLIMID can cause significant neutropenia and thrombocytopenia. Eighty percent of patients with del 5q MDS had to have a dose delay/reduction during the major study. Thirty-four percent of patients had to have a second dose delay/reduction. Grade 3 or 4 hematologic toxicity was seen in 80% of patients enrolled in the study. Patients on therapy for del 5q MDS should have their complete blood counts monitored weekly for the first 8 weeks of therapy and at least monthly thereafter. Patients may require dose interruption and/or reduction. Patients may require use of blood product support and/or growth factors.
Venous and Arterial Thromboembolism
REVLIMID has demonstrated a significantly increased risk of deep vein thrombosis (DVT) and pulmonary embolism (PE), as well as risk of myocardial infarction and stroke in patients with MM who were treated with REVLIMID and dexamethasone therapy. Monitor for and advise patients about signs and symptoms of thromboembolism. Advise patients to seek immediate medical care if they develop symptoms such as shortness of breath, chest pain, or arm or leg swelling. Thromboprophylaxis is recommended and the choice of regimen should be based on an assessment of the patients underlying risks.
CONTRAINDICATIONS
Pregnancy: REVLIMID can cause fetal harm when administered to a pregnant female and is contraindicated in females who are pregnant. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential risk to the fetus
Severe Hypersensitivity Reactions: REVLIMID is contraindicated in patients who have demonstrated severe hypersensitivity (e.g., angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis) to lenalidomide
WARNINGS AND PRECAUTIONS
Embryo-Fetal Toxicity: See Boxed WARNINGS
REVLIMID REMS Program: See Boxed WARNINGS: Prescribers and pharmacies must be certified with the REVLIMID REMS program by enrolling and complying with the REMS requirements; pharmacies must only dispense to patients who are authorized to receive REVLIMID. Patients must sign a Patient-Physician Agreement Form and comply with REMS requirements; female patients of reproductive potential who are not pregnant must comply with the pregnancy testing and contraception requirements and males must comply with contraception requirements
Hematologic Toxicity: REVLIMID can cause significant neutropenia and thrombocytopenia. Monitor patients with neutropenia for signs of infection. Advise patients to observe for bleeding or bruising, especially with use of concomitant medications that may increase risk of bleeding. MM: Patients taking REVLIMID/dex or REVLIMID as maintenance therapy should have their complete blood counts (CBC) assessed every 7 days for the first 2 cycles, on days 1 and 15 of cycle 3, and every 28 days thereafter. MDS: Patients on therapy for del 5q MDS should have their complete blood counts monitored weekly for the first 8 weeks of therapy and at least monthly thereafter. Patients may require dose interruption and/or dose reduction. Please see the Black Box WARNINGS for further information. MCL: Patients taking REVLIMID for MCL should have their CBCs monitored weekly for the first cycle (28 days), every 2 weeks during cycles 2-4, and then monthly thereafter. Patients may require dose interruption and/or dose reduction
Venous and Arterial Thromboembolism: See Boxed WARNINGS: Venous thromboembolic events (DVT and PE) and arterial thromboses (MI and CVA) are increased in patients treated with REVLIMID. Patients with known risk factors, including prior thrombosis, may be at greater risk and actions should be taken to try to minimize all modifiable factors (e.g., hyperlipidemia, hypertension, smoking). Thromboprophylaxis is recommended and the regimen should be based on patients underlying risks. ESAs and estrogens may further increase the risk of thrombosis and their use should be based on a benefit-risk decision
Increased Mortality in Patients with CLL: In a clinical trial in the first-line treatment of patients with CLL, single agent REVLIMID therapy increased the risk of death as compared to single agent chlorambucil. Serious adverse cardiovascular reactions, including atrial fibrillation, myocardial infarction, and cardiac failure, occurred more frequently in the REVLIMID arm. REVLIMID is not indicated and not recommended for use in CLL outside of controlled clinical trials
Second Primary Malignancies (SPM): In clinical trials in patients with MM receiving REVLIMID, an increase of hematologic plus solid tumor SPM, notably AML and MDS, have been observed. Monitor patients for the development of SPM. Take into account both the potential benefit of REVLIMID and risk of SPM when considering treatment
Increased Mortality with Pembrolizumab: In clinical trials in patients with multiple myeloma, the addition of pembrolizumab to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of patients with multiple myeloma with a PD-1 or PD-L1 blocking antibody in combination with a thalidomide analogue plus dexamethasone is not recommended outside of controlled clinical trials
Hepatotoxicity: Hepatic failure, including fatal cases, has occurred in patients treated with REVLIMID/dex. Pre-existing viral liver disease, elevated baseline liver enzymes, and concomitant medications may be risk factors. Monitor liver enzymes periodically. Stop REVLIMID upon elevation of liver enzymes. After return to baseline values, treatment at a lower dose may be considered
Severe Cutaneous Reactions: Severe cutaneous reactions including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported. These events can be fatal. Patients with a prior history of Grade 4 rash associated with thalidomide treatment should not receive REVLIMID. Consider REVLIMID interruption or discontinuation for Grade 2-3 skin rash. Permanently discontinue REVLIMID for Grade 4 rash, exfoliative or bullous rash, or for other severe cutaneous reactions such as SJS, TEN, or DRESS.
Tumor Lysis Syndrome (TLS): Fatal instances of TLS have been reported during treatment with lenalidomide. The patients at risk of TLS are those with high tumor burden prior to treatment. These patients should be monitored closely and appropriate precautions taken
Tumor Flare Reaction (TFR): TFR has occurred during investigational use of lenalidomide for CLL and lymphoma. Monitoring and evaluation for TFR is recommended in patients with MCL. Tumor flare may mimic the progression of disease (PD). In patients with Grade 3 or 4 TFR, it is recommended to withhold treatment with REVLIMID until TFR resolves to Grade 1. REVLIMID may be continued in patients with Grade 1 and 2 TFR without interruption or modification, at the physicians discretion
Impaired Stem Cell Mobilization: A decrease in the number of CD34+ cells collected after treatment (>4 cycles) with REVLIMID has been reported. Consider early referral to transplant center to optimize timing of the stem cell collection
Thyroid Disorders: Both hypothyroidism and hyperthyroidism have been reported. Measure thyroid function before start of REVLIMID treatment and during therapy
Early Mortality in Patients with MCL: In another MCL study, there was an increase in early deaths (within 20 weeks), 12.9% in the REVLIMID arm versus 7.1% in the control arm. Risk factors for early deaths include high tumor burden, MIPI score at diagnosis, and high WBC at baseline (10 x 109/L)
Hypersensitivity: Hypersensitivity, including angioedema, anaphylaxis, and anaphylactic reactions to REVLIMID has been reported. Permanently discontinue REVLIMID for angioedema and anaphylaxis.
ADVERSE REACTIONS
Multiple Myeloma
Myelodysplastic Syndromes
Mantle Cell Lymphoma
DRUG INTERACTIONS
Periodic monitoring of digoxin plasma levels is recommended due to increased Cmax and AUC with concomitant REVLIMID therapy. Patients taking concomitant therapies such as erythropoietin stimulating agents or estrogen containing therapies may have an increased risk of thrombosis. It is not known whether there is an interaction between dex and warfarin. Close monitoring of PT and INR is recommended in patients with MM taking concomitant warfarin
USE IN SPECIFIC POPULATIONS
Please see full Prescribing Information, including Boxed WARNINGS.
Please see full SmPC for further information.
About Celgene
Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through next-generation solutions in protein homeostasis, immuno-oncology, epigenetics, immunology and neuro-inflammation. For more information, please visit http://www.celgene.com. Follow Celgene on Social Media: @Celgene, Pinterest, LinkedIn, Facebook and YouTube.
Forward-Looking Statements
This press release contains forward-looking statements, which are generally statements that are not historical facts. Forward-looking statements can be identified by the words "expects," "anticipates," "believes," "intends," "estimates," "plans," "will," "outlook" and similar expressions. Forward-looking statements are based on management's current plans, estimates, assumptions and projections, and speak only as of the date they are made. Celgene undertakes no obligation to update any forward-looking statement in light of new information or future events, except as otherwise required by law. Forward-looking statements involve inherent risks and uncertainties, most of which are difficult to predict and are generally beyond each company's control. Actual results or outcomes may differ materially from those implied by the forward-looking statements as a result of the impact of a number of factors, many of which are discussed in more detail in the Annual Report on Form 10-K and other reports of each company filed with the Securities and Exchange Commission, including factors related to the proposed transaction between Bristol-Myers Squibb and Celgene, such as, but not limited to, the risks that: managements time and attention is diverted on transaction related issues; disruption from the transaction make it more difficult to maintain business, contractual and operational relationships; legal proceedings are instituted against Bristol-Myers Squibb, Celgene or the combined company could delay or prevent the proposed transaction; and Bristol-Myers Squibb, Celgene or the combined company is unable to retain key personnel.
1 Scott DW, Gascoyne RD. The tumour microenvironment in B cell lymphomas. Nat Rev Cancer. 2014;14(8):517-534.2 Kridel R, Sehn LH, Gascoyne RD. Pathogenesis of follicular lymphoma. J Clin Invest. 2012;122(10):3424-3431.3 Chiu H, Trisal P, Bjorklund C, et al. Combination lenalidomide-rituximab immunotherapy activates anti-tumour immunity and induces tumour cell death by complementary mechanisms of action in follicular lymphoma. Br J Haematol. 2019;185(2):240-253.4 European Cancer Information System. Estimates of cancer incidence and mortality in 2018, for all countries. Available at: https://ecis.jrc.ec.europa.eu/explorer.php. Accessed August 2019.5 European Society for Medical Oncology. Follicular Lymphoma: A Guide for Patients. 2014. Available at: https://www.esmo.org/content/download/52236/963497/file/EN-Follicular-Lymphoma-Guide-for-Patients.pdf . Accessed September 2019.6 Leonard JP, Trneny M, Izutsu K, et al. AUGMENT: A Phase III Study of Lenalidomide Plus Rituximab Versus Placebo Plus Rituximab in Relapsed or Refractory Indolent Lymphoma. J Clin Oncol. 2019;10;37(14):1188-1199.7 ClinicalTrials.gov Rituximab Plus Lenalidomide for Patients With Relapsed / Refractory Indolent Non-Hodgkin's Lymphoma (Follicular Lymphoma and Marginal Zone Lymphoma) (AUGMENT). Available at: https://clinicaltrials.gov/ct2/show/NCT01938001 Accessed September 2019.8 ClinicalTrials.gov Lenalidomide Plus Rituximab Followed by Lenalidomide Versus Rituximab Maintenance for Relapsed/Refractory Follicular, Marginal Zone or Mantle Cell Lymphoma (MAGNIFY). Available at: https://clinicaltrials.gov/ct2/show/NCT01996865 Accessed August 2019.9 American Cancer Society. Lymphoma. Available at: https://www.cancer.org/cancer/lymphoma.html. Accessed August 2019.10 American Cancer Society. What is Hodgkin Lymphoma? Available at: https://www.cancer.org/cancer/hodgkin-lymphoma/about/what-is-hodgkin-disease.html. Accessed August 2019.11 American Cancer Society. What is Non-Hodgkin Lymphoma? Available at: https://www.cancer.org/cancer/non-hodgkin-lymphoma/about/what-is-non-hodgkin-lymphoma.html. Accessed August 2019.12 Lymphoma Action. Follicular lymphoma. Available at: https://lymphoma-action.org.uk/types-lymphoma-non-hodgkin-lymphoma/follicular-lymphoma. Accessed November 2019.13 Montoto S, Lopez-Guillermo A, Ferrer A, et al. Survival after progression in patients with follicular lymphoma: analysis of prognostic factors. Ann Oncol. 2002;13(4):523-30.
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Celgene Receives CHMP Positive Opinion for REVLIMID (lenalidomide) in Combination With Rituximab for the Treatment of Adult Patients With Previously...
What to do in Macau: The 66th Grand Prix, $28888 wine dinners and more – Lifestyle Asia
Macau is the ultimate setting for some high octane fun this weekend with the return of the annual Macau Grand Prix, now heading into its 66th year. As the city is pulsing with adrenaline, there are plenty of gastronomic highlights as well as the creme de la creme of lifestyle experiences to keep on your radar. Here are all the best events to check out in Macau this month.
When: 16 November
Price: MOP501,000 from Macau Grand Prix
The annual mecca for motorsports is back: Macau opens its venerated 6.2km Guia Circuit as the annual Macau Grand Prix edges into its 66th edition. Veteran and young drivers alike are descending on the SAR for the ultimate glory across three headlining races the Formula 3 Macau Grand Prix, the FIA GT World Cup, and the FIA WTCR, also known as the Macau Guia Race. Sundays Grand Prix finale will have all eyes on some of the worlds best racers such as F3 world champion Dan Ticktum as he returns to the spotlight to vie for his third consecutive win at Macau; alongside newcomers such as David Schumacher, nephew of seven-time Formula 1 winner Michael.
If youre not watching from the Grand Stand or the thrilling Lisboa Bend Stand, for a vantage point to catch all the action in comfort, youll want to head to the Grand Lapa for its annual Grand Prix Live BBQ Buffet all weekend from 1617 November, which will also be broadcasting live on mega screens.
More info here.
When: 30 November1 December
Price: HK$5881,688 from MGM
Actor-turned-chef Nicholas Tse is lending both sides of his talents to this unique food and music festival held for the very first time in Macau. MGM is hosting two nights of unmissable concerts by Tse and fellow Canto-pop stars JW, Joey Yung, rock group Mr., Angela Hui, Chinese singer Liu Junge, Singaporean songstress Joanna Dong, and Macanese band MFM. Alongside two nights of performances, Chef Nic has also partnered with MGMs most eminent chefs to deliver mouthwatering menus of local delicacies, as well as live demonstrations featuring popular chef collaborations from his TV show brought to life. Dont miss this rare chance for dinner and a show.
MGM COTAI, 1/F Roof Terrace, Avenida Da Nave Desportiva, Cotai, Macau, +853 8806 8888
When: Through 29 February, 2020
Theres nothing better than a steamy hot pot dinner during the cooler months: Head to Broadway Macau for a foodie extravaganza of Macanese delicacies for its fourth Hot Pot Street promotion for an eclectic taste of the Cantonese winter tradition. The hotels flagship food street introduces 20 authentic varieties of hot pots showcasing a full spectrum of broths, casseroles and winter warmers from an array of international cuisines, paired with spreads of fresh seafood, organic produce, and premium beef from all over the world.
Broadway Macau, Avenida Marginal Flor de Lotus, Cotai, Macau, +853 8883 3338
The latest hot opening adding to the epicurean haven that is Taipa Village is none other than Barcelona, an innovative new Spanish restaurant and bar by chef Hector Costa Fernandez. Dishing up modern tapas and refreshed Spanish classics, Barcelona is a three-storey venue with a stylish ground floor bar and chefs table overlooking an open kitchen, a first-floor dining room inspired by its eponymous city, and an exotic rooftop bar offering views over the vibrant entertainment area below.
Barcelona, 47 Rua dos Clerigos, Taipa, Macau, +853 2845 5168
Facialist to the stars Margie Lombard, founder of Margys of Monte-Carlo brings an exclusive spa experience to Morpheus this autumn. Famed for her gold mask facial, Margys upgrades her ultimate skin rejuvenating treatment with a new platinum mask treatment that is solely available at Morpheus Spa. Book into one of only six suites for an exalted 110-minute session of pampering with the Prestige Facial with Platinum Mask (MOP3,980), and watch as the chainmail-like platinum mask does its work to retexturise skin for an unbeatable lasting radiance. The Platinum mask is also available as a 20-minute add-on (MOP2,500) together with Margys prized bespoke Stem Cell Illuminating Facial (MOP3,800), which uses a new serum featuring the regenerating power of Swiss Apple stem cells.
Morpheus Spa, 35/F, Morpheus, City of Dreams, Estrada do Istmo, Macau, +853 8868 3098
When: 16 November and 25 January, 2020
Price: MOP28,888 + 10 percent service charge
City of Dreams two-Michelin-starred Alain Ducasse by the eponymous legend is home to some of the most exclusive French haute cuisine menus in this part of the world as it is, but this autumn the restaurant is presenting two unprecedented wine-pairing dinners, billed as featuring some of the greatest vintages of all time. On 16 November, guests can look forward to five rare vintages from Domaine de la Romane-Conti, as well as a prize draw to win a bottle of 1997 Grands-chzeaux. On 25 January next year, guests can also book in as they celebrate Bordeauxs landmark 1982 vintage with a horizontal tasting of Chteau Pichon Longueville Comtesse de Lalande, Chteau Mouton Rothschild, Chteau Margaux, Chteau Cheval Blanc and Chteau Lafite Rothschild and have the opportunity to win a bottle of 1982 Chteau Margaux. Priced at MOP28,888 per person, these exclusive wine dinners will feature a tailor-made seven course menu and kick off with a glass of Dom Prignon 2009, followed by five rare vintages and Grand Crus. Make your reservation by email to adam@cod-macau.com or call +853 8868 3432.
Alain Ducasse, Level 3, Morpheus, City of Dreams, Estrada do Istmo, Macau, +853 8868 3432
Price: MOP7801,280
The St. Regis Macaos Iridium Spa has unveiled its newest treatment, a session that combines both mindful and physical therapy by allowing guests to create their own blended diffuser scents and body scrubs. After spending time learning more about the healing powers of aromatherapy, the guest is given a 45-minute massage and body treatment thats sure to melt away all the tensions of the mind and body.
Iridium Spa, 38/F, St. Regis Macao, S/N, Estrada do Istmo, Macau, +853 8113 4949
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What to do in Macau: The 66th Grand Prix, $28888 wine dinners and more - Lifestyle Asia
Serving those who serve – The Hub at Johns Hopkins
ByKristin Hanson
This article was originally published on Nov. 8 on giving.jhu.edu
Between 2001 and the beginning of 2018, more than 1,500 U.S. military service members lost limbs in the line of duty. Although technology has improved the prosthetic devices these people can use, a stubborn obstacle remains: the fragility of human skin.
"Skin was never meant to hold this kind of pressure," says Lee Childers, the senior scientist for the Extremity Trauma and Amputation Center of Excellence at Brooke Army Medical Center in San Antonio, Texas.
"Think about it like a blister on your foot. It's painful, but you can still get by," he continues. "In an amputation, it's a blister on your residual limb. You can't use your prosthesis until the blister is completely healed. If it's your leg [that is affected], you can't walk for two or three weeks. Think about how that would impact your life."
What if there were a way to make the skin at an amputation site tougher, like the palm of your hand or the sole of your foot? Luis Garza, an associate professor of dermatology at Johns Hopkins and leader of the Veteran Amputee Skin Regeneration Program, is developing a cell therapy that could enable prosthetics wearers to use their devices longer.
"This is an example of personalized medicine," Garza says. "We're taking each person's own cells, growing them up, and inserting them back in."
Garza's postdoctoral research focused on skin stem cells. In 2009, he and his department chair, Sewon Kang, began having conversations about how that work could help the increasing numbers of veterans coming back from war with amputations. Garza and his team received grants from the U.S. Department of Defense, National Institutes of Health, and Maryland Stem Cell Fund that have moved the program forward in the past decade.
Garza's team spent the summer of 2019 testing "normal" subjectsthose without amputationsto perfect the procedure, including the dose, content, method, and frequency of the injections. During one appointment, members of Garza's team took biopsies of skin from a subject's scalp and sole. The cells went to a lab where they were grown under an FDA-approved protocol and passed through quality control tests.
In a second appointment, subjects completed a questionnaire and underwent baseline measurements of their skin's thickness and strength. Garza's team then injected a site on the subjects' skin with the stem cells grown from their cells in the lab.
Image caption: Luis Garza, associate professor of dermatology at Johns Hopkins, leads the Veteran Amputee Skin Regeneration Program.
"We're hoping that these stem cell populations will engraft in the new skin," Garza says.
The subjects returned to Hopkins several months later to go through the questionnaire and measurements once more, and Garza's team documented changes.
Confident in the results they gleaned from the normal subjects, Garza's team enrolled its first subject with an amputation in August. Moving from the normal population to the amputation-affected population quickly unearthed some aspects of the therapy Garza didn't anticipate.
"When we talked with him, he said 'I don't want to mess with my one remaining footdo you have to take skin from there?' And we said, 'Actually, no, we could do your palm,'" Garza says.
His team then tested the biopsy and growth of palm cells from subjects in the normal population. "We're moving away from having our product informed purely by biology to letting our therapy development be shaped by the user."
Although federal grants have supported much of the program's progress, private philanthropy has played a role, too. Corporations like Northrop Grumman, foundations like the Alliance for Veteran Support, and grateful patients with and without ties to the armed forces have contributed nearly $300,000. Those gifts have enabled the program to persevere through gaps between federal grants.
Private funds will be increasingly important as the project enters its next phase: extension to military medical centers around the country. Garza's team must prove that the safeguards to protect cells on their round-trip voyage from a test site to Hopkins are effective. They also must secure approval by local institutional review boards for clinical studies.
"Soldiers are used to getting orders, but you can't order someone to be part of a [medical] study," Garza says. "There are hard medical ethics questions around how to make this open to them but ensure they don't feel obligated. We've been working on that for a year, and we probably have another six months or so to go."
Childers stands ready for whenever the program's extension is a go. He will lead the study at Brooke Army Medical Center and feels motivated by the prospect of helping many of the veterans he works with every day.
"We do everything we can to serve those who serve us. This can enable people to return to duty and be redeployed if they choose," he says. "This is game-changing technology that will have an impact for our service members, but also others who live with amputation."
That population includes the hundreds of thousands of Americans who've undergone amputations for complications of diabetes, who must use a wheelchair, or who wear ankle or foot orthoses for help with walking, among others.
"Having the ability to transform skin anywhere you want to target on the body will have gigantic implications across the entire spectrum of our society in many ways," Childers says.
There's a lot of work to be done before such benefits reach the public, Garza cautions. With continued support from donors and the military community, though, he's optimistic about the program's future.
"The challenges are pretty big, but I think within five years, it could happen," he says. "That's the hope."
Disclaimer: The view(s) expressed herein are those of the author(s) and do not reflect the official policy or position of the Brooke Army Medical Center, the U.S. Army Medical Department, the U.S. Army Office of the Surgeon General, the Department of the Army, the Department of the Air Force and Department of Defense or the U.S. Government.
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Serving those who serve - The Hub at Johns Hopkins