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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

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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

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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...

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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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The Heart of the Matter: Leveraging Advances in Cardiac Biology to Innovate Gene-Based Therapies for Heart Failure – Physician’s Weekly

Heart failure (HF) is the most frequent cardiovascular diagnosis and exacts significant health and financial costs around the globe. It is estimated that at least 26 million people worldwide are living with HF, including nearly 6 million in the United States.1, 2 One in nine U.S. deaths in 2009 included heart failure as a contributing cause and about 50 percent of people in the U.S. with HF die within five years of diagnosis.2 The annual cost of HF-related healthcare services, medication and missed days of work is estimated at $40 billion in the United States and $108 billion globally.3, 4 Quality of life in HF patients is frequently worse than many other chronic diseases and comorbidities are common.5-7 The challenges of HF are expected to grow, as it is estimated that more than 8 million people in the United States alone will have HF by 2030.2 Current therapies improve quality of life in the short-term and have improved long-term survival but a significant number of patients have Class 3 HF despite optimal medical and device therapy. These patients have limited treatment options beyond heart transplant and left ventricular assist devices (LVAD). New therapeutic approaches that address the underlying causes of HF are needed to improve patient outcomes.

Heart failure is a complex disease process and multiple pathways contribute to its development and progression. Myocardial ischemia is frequently an issue in both ischemic and non-ischemic cardiomyopathy as well as HF with preserved and/or reduced ejection fraction. Myocardial ischemia results in insufficient oxygen and nutrients and leads to hypoxia, cardiomyocyte and fibrosis, which all contribute to the progression of heart failure. More effective angiogenesis may prevent this progression. Cell homing also plays a critical role, as injured cardiac tissue secretes factors that lead to the recruitment, proliferation, migration and differentiation of progenitor cells that can help repair tissue damage. Stromal cell-derived factor (SDF)-1 has been shown to play an important role in cardiac repair by mediating cell homing.10 Mitochondrial energy generation is also impaired in HF, leading to decreased contractility and adverse changes to cardiac architecture.11 Scar tissue formed in response to cardiomyocyte injury or death can compromise the hearts mechanical strength or electrical signaling results in myocardial infarction. Inflammatory responses to cardiac tissue damage can promote inappropriate and chronic inflammation and the expression of pro-inflammatory molecules that lead to pathologic changes to cardiac architecture.12, 13

These pathways offer a variety of potential new targets for therapeutic intervention to prevent the development and progression of HF. This opens the door to the development of novel therapies that address the underlying molecular and cellular causes of disease rather than treating HF symptoms alone.

After decades of development, gene-based therapies are now validated therapeutic modalities for the treatment of inherited retinal disorders and cancer and are undergoing clinical evaluation in a variety of inherited, acute and chronic diseases. Nearly two dozen single gene-based therapies for HF have been evaluated in clinical trials.14 Genes evaluated as monogenic gene therapy for HF in clinical trials include vascular endothelial growth factor (VEGF) and fibroblast growth factor type 4 (FGF4) to promote angiogenesis; adenylyl cyclase type 6 (AC6) and sarco/endoplasmic reticulum Ca2+-ATPase type 2 (SERCA2) to improve cardiac calcium homeostasis, which plays a critical role in the contraction and relaxation of heart muscle; and stromal cell-derived factor-1 (SDF-1) to improve cell homing and promote cardiac tissue repair. Late-stage trials of single gene therapies have yielded conflicting results, raising the question as to whether positively impacting a single pathway can be sufficient to overcome detrimental activity of other pathways that contribute to the development and progression of HF. Other potential limitations to HF therapies evaluated in clinical trials to date include the method of delivery, dose and the potency of vectors and gene products.

Given the multiple molecular and cellular pathways active in HF, a multi-gene approach to HF gene therapy may be needed. Simultaneously delivering multiple genes that target diverse HF-related pathways has the potential to improve cardiac biology and function. A triple gene therapy approach (INXN-4001, Triple-Gene LLC, a majority-owned subsidiary of Intrexon Corporation) is currently in clinical development, with each of the genes targeting a specific HF-related pathway. The investigational drug candidate INXN4001 vector expresses: the S100A1 gene product, which regulates calcium-controlled networks and modulates contractility, excitability, maintenance of cellular metabolism and survival; SDF-1a which recruits stem cells, inhibits apoptosis and supports new blood vessel formation; and VEGF-165 which initiates new vessel formation, endothelial cell migration/activation, stem cell recruitment and tissue regeneration. The hypothesis is that the simultaneous delivery of multiple genes in a single vector would more effectively improve multiple aspects of cardiac function compared with single gene therapy. It is delivered by retrograde coronary sinus infusion of a triple effector plasmid designed with a self-cleaving linker to constitutively express human S100A1, SDF-1a and VEGF 165. This route is designed to allow for delivery of a dose to the ventricle which may help achieve improved therapeutic effect.

Several preclinical studies have set the foundation on which to advance a triple gene therapy for HF into the clinic.15-17 Using in vitro studies, transfecting cells derived from patients with dilated cardiomyopathy with a triple gene combination demonstrated improvement in contraction rate and duration, to the levels demonstrated by the control cells and did not result in increased cell death compared to controls.15 Studies in an Adriamycin-induced cardiomyopathy rodent model demonstrated triple gene therapy increased fractional shortening and myocardial wall thickness compared to controls.16 In addition, retrograde coronary sinus infusion of INXN-4001 in a porcine model of ischemic HF resulted in a cardiac-specific biodistribution profile.17

A Phase 1 clinical study has been initiated to evaluate the safety of a single dose of triple gene therapy in stable patients implanted with a LVAD for mechanical support of end-stage HF. An independent Data and Safety Monitoring Board agreed to proceeding to the second cohort following review of the data from the first cohort in the multi-site study.18 The study is ongoing and final results will help to inform our understanding of the potential that multi-gene therapy may play in the treatment of HF.

The recent FDA approvals of gene therapies for an inherited retinal disease and cancer are evidence that gene therapy is a valid therapeutic strategy. Realizing the potential of gene therapy in HF will require appropriately designed clinical trials, but several interesting approaches currently in development may prove to be effective. The results of the initial investigational drug INXN-4001 Phase 1 trial should provide insight into the safety of combining S100A1, SDF-1a and VEGF-165. Evaluation of additional multi-gene combinations will also be important for understanding which targeted pathways yield the greatest effects with respect to relevant clinical endpoints. Continued refinement and optimization of vector design and delivery methods will also be important for advancing further HF gene therapies from bench to bedside.

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Genetic study reveals the family secrets of people in the 1800s – New Scientist News

By Michael Le Page

Celebrating the Birth by Jan Steen, 1664. The Wallace Collection, London

In the 19th century, poorer families living in cities in Europe had a higher rate of children who werent biologically related to their legal fathers. This is according to a genetic study that looked at how this rate differs for different socio-economic groups.

It is widely assumed many men arent the biological fathers of their children. The rate of extra-pair paternity, as this is called, has been claimed to be as high as 30 per cent today. They look just like the milkman, goes the popular joke that no parent finds funny.

However, over the past two decades DNA studies in several countries have shown the average rate is low around 1 per cent. Maarten Larmuseau at KU Leuven in Belgium, who authored one of these studies, wondered whether there was a difference between groups.

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He suspected, for example, that the rate was higher among aristocrats in the 17th century, as there was often a large age gap between husband and wife. Extra-pair paternity is depicted in the 1664 painting Celebrating the Birth by Jan Steen, which shows a wealthy Dutch father holding his newborn child. But behind him a man is making the sign of the cuckolds horns, meaning the child was fathered by another.

Larmuseaus team identified 500 pairs of men in Belgium and the Netherlands where, according to genealogical records, each pair descended from the same male ancestor through a male lineage. Half of these ancestors were born before 1840 and the oldest was from 1315.

The men in each pair should have inherited their shared ancestors Y chromosome, as it comes from the father. When DNA testing revealed a mismatch, the team tested other male descendants to narrow down when a son had been fathered by someone other than the husband. All the men were volunteers and the team didnt test close relatives to avoid uncovering recent cases.

What we found was completely the opposite to what we expected, says Larmuseau.

The rate of extra-pair paternity among farmers and more well-to-do craftsmen and merchants was about 1 per cent, rising to 4 per cent among labourers and weavers and nearing 6 per cent among working class people who lived in densely populated cities in the 19th century. This was in comparison to a rate of around 0.5 per cent among the more well-off.

What the study cannot reveal is why people were more likely to be in this situation. We cannot give an explanation, Larmuseau says. We cannot interview them.

One possibility is that poorer women in cities were more vulnerable to male sexual violence and exploitation.

The overall rate was still low, at 1.6 per cent per generation. But that still means a very large number of people alive today may not be aware of their biological parentage. Larmuseau says 30 million people worldwide have done ancestry tests, which suggests up to 500,000 could have made a shocking discovery about their father. Companies offering these tests dont provide any counselling, he says.

Journal reference: Current Biology, DOI: 10.1016/j.cub.2019.09.075

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The Role of Apolipoprotein E on the Age of Ischemic Stroke Onset and Stroke Outcome – Neurology Advisor

Apolipoprotein E (APOE) 4 is associated with younger age at ischemic stroke onset but not with stroke outcomes, according to study results published in Neurology.

Previous studies have shown that APOE genotype is a predictor of outcome after hemorrhagic stroke, but there are conflicting data regarding the effect of this genotype on ischemic stroke. In the current study, researchers investigated the interplay among the 3 common APOE alleles (2, 3, and 4), age at ischemic stroke onset, severity, sex, and outcome.

The study cohort included 6165 cases from the genome-wide association study within the Genetics of Ischemic Stroke Functional Outcome network. Effects of APOE allele 4 and 2 were compared with those of the most common allele, 3.

The study revealed an association between increasing allele count of 4 and younger age at stroke onset (P <.001), which was evident in both sexes and in cases with first-stroke only. However, there was no evidence for direct effect of 4 on outcome after stroke as, following adjustment for age and stroke severity, there was no association between 4 allele count and favorable outcome. In men only, there was a statistically significant association between 2 allele count and poor outcomes following adjustment for ancestry, age, and stroke severity.

The researchers acknowledged several study limitations, including those of Genetics of Ischemic Stroke Functional Outcome study that were previously reported, as well as the relatively small sample size for the sex-stratified analyses and use of imputed values from single nucleotide polymorphism arrays to establish common APOE alleles.

This study shows that APOE 4 carriers have a younger age at ischemic stroke onset. We also detected worse functional outcome in male 2 carriers, a result needing replication, concluded the researchers.

Reference

Lagging C, Lorentzen E, Stanne TM, et al. APOE 4 is associated with younger age at ischemic stroke onset but not with stroke outcome. Neurology. 2019;93:849-853

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Ankylosing Spondylitis Not Linked to Axial Psoriatic Arthritis – Pharmacy Times

Psoriasis in ankylosing spondylitis (AS) is not related to axial psoriatic arthritis (PsA), a type of psoriasis that causes lower back inflammation and pain similar to AS, according to a study published in Rheumatology.

The study included approximately 1303 patients with PsA and 766 patients with AS from 2 Canadian clinics. Of the patients with PsA, 477 had axial PsA and 826 had peripheral PsA. In the AS group, 91 participants had psoriasis and 675 did not.

Patients at both clinics were followed and assessed using a variety of diagnostic tools, with visits every 6 to 12 months for an average of 12.6 years for patients with axial PsA and 6.7 years for the patients with peripheral PsA. The average follow-up for AS with psoriasis was 5.4 years and 3.5 years for those without psoriasis.

The analysis showed that overall, patients with AS were younger at diagnosis, with an average age of 21.3 years in patients with psoriasis and 22.9 years in those without psoriasis compared with axial patients with PsA who had an average age at diagnosis of 34.4 years. There were also more males in both AS groups compared with the axial PsA group.

Spondyloarthritis is a family of inflammatory diseases causing arthritis and involves areas where ligaments and tendons attach to bones. AS is the most common form of spondyloarthritis and mainly affects the joints at the base of the spine where it meets the pelvis.

More patients in both AS groups tested positive for HLA-B27, a genetic marker for inflammatory arthritis of the spine and joints. Of the AS patients with psoriasis, 82% tested positive, while 75% of those without psoriasis tested positive. In the axial PsA group, only 19% tested positive.

Approximately 90% of patients with AS with psoriasis and 92% without psoriasis reported back pain compared with only 21% of patients with axial PsA. Furthermore, compared with patients with axial PsA, patients with AS and with and without psoriasis had a higher grade of sacroiliitis, or inflammation of the joints connecting the lower spine to the pelvis.

When the data were analyzed over time, there was also an increase in joint swelling in both patients with axial PsA and patients with peripheral PsA, whereas patients with AS with or without psoriasis were more likely to have back pain and a higher BASMI, or Bath Ankylosing Spondylitis Metrology Index, a measure of AS disease severity.

The study reveals that axial PsA and AS with psoriasis are 2 different diseases with different genetics, demographics, and disease expression, according to the study authors.

Reference

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Ankylosing Spondylitis Not Linked to Axial Psoriatic Arthritis - Pharmacy Times

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Tips on finding female ancestors – The County

Nancy Battick, Special to The County November 14, 2019

Finding the maiden name of a female ancestor can be a challenge. Mens names were recorded in town vital records but the wife was usually listed by her given name only.

Finding the maiden name of a female ancestor can be a challenge. Mens names were recorded in town vital records but the wife was usually listed by her given name only.

Heres the definition of terms Im using: Given name is the first name; maiden name was usually the womans fathers last or surname; the womans married surname was that of the husband. When searching for an ancestors maiden name your success often depends on the time period involved. The census may help but unless a woman was a widow or head of a household, her name didnt appear in our censuses until 1850. Widows were usually listed as Widow Carter. So, how do you go about locating these ladies hidden by history? In this and the following column Ill try to give you some pointers.

In the U.S. Census youll find a wifes name enumerated beneath her husbands, showing her first name and usually an initial, such as Mary C. While C. could be a middle initial it is more often a clue to her maiden name. Assuming the couple didnt move into the town already married, start your search by combing the neighborhood for surnames beginning with C. Check earlier censuses to see if there is a daughter Mary of the correct age.

Also, note all living in the couples household is there a mother, brother, or sister-in-law listed. Note their surname because its most likely the wifes family.

Youre fortunate if the lady youre seeking has a less common first name such as Sophronia. Lets suppose youve found a possible Sophronia and her family. Now check to see if you can find a will or a deed settling her fathers estate. You may find an entry that states the name of the daughter and her husband among the heirs.

Another familiar situation in remote areas was that brothers often married women who came from the same family. If youve exhausted conventional sources, try searching the family tree. Check the marriages of your male ancestors brothers and trace their marriages. Chances are you might find connections. Im researching a line where two brothers married two sisters and another brother married a first cousin of the sisters. This happened more often than realized and unless there was a genetic disposition to certain diseases caused no problems. We all know the jokes about shopping for a wife at family reunions, but it happened, and rare is the tree without a cousin marriage of one degree or the other.

Should your ancestor have moved to your town complete with a family, dont despair. Here in Maine until the late 19th century, most immigrants came from our sister New England states. These states kept detailed records from their earliest settlements so dont be daunted if you learn your ancestor came from Duxbury, Massachusetts. The Massachusetts records are really good. Odds are youll find information on your ancestors marriage.

In my next column Ill have a few more tips in seeking the unknown maiden names of female ancestors.

Columnist Nancy Battick of Dover-Foxcroft has researched genealogy for over 30 years. She is past president of the Maine Genealogical Society, author of several genealogical articles and co-transcribed the Vital Records of Dover-Foxcroft. Nancy holds an MA in History from UM and lives in DF with her husband, Jack, another avid genealogist. Reader emails are welcome at nbattick@roadrunner.com.

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After half a century, Salem soccer referee still can’t take his eyes off the game – Salem Reporter

John Plechl survived World War II, moving to Salem and becoming a referee in 1964. At 86, he stays active to keep up with the kids running up and down the field.

John Plechl makes a call during a recent soccer match in Salem.(Ron Cooper/Special to Salem Reporter)

John Plechl watched as the girls junior varsity soccer team from North Salem High School warmed up for their match.

The 5-foot-tall referee with glasses and white hair, standing in a yellow shirt and black shorts, finally gave a sharp whistle and called for the team captains.

After the coin toss, Plechl tells the girls with his German accent, Okay, have a good game.

And Oregons oldest referee goes to work, jogging back and forth on the field, keeping up with the teenage athletes.

For more than 55 years, Plechl has been a fixture on the soccer field, blowing his whistle and doling out advice.

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Plechl was born in former Yugoslavia, before his parents and siblings moved to Germany in 1944 to escape being killed or put in a concentration camp under the reign of Josep Broz, commonly known as Tito.

Plechl started playing goalkeeper in an Austrian league as a teen after his family had moved to Austria a year before World War II ended. Back then, soccer balls were made of leather and heavy.

When it was raining when the ball was coming towards you, the coach said, Dont head the ball when it comes like that, but dont chest it because itll kill you. Plechl said.

They practiced barefoot and when the shoemaker made them leather soccer shoes, Plechl got blisters breaking them in.

In 1955, Plechls family immigrated to the U.S., following Plechls sister, who had married an American soldier.

Plechl remembers his first job, picking up rocks at the future site of the Lebanon High School football field.

He went on to become a tailor, working at Meier and Frank for most of his life, retiring at 67 as the demand for tailoring dwindled.

But he continued with soccer, becoming one of the pioneers of the sport in Salem.

John Plechl has been refereeing in Salem since 1964. (Ron Cooper/Special to Salem Reporter)

At 86, he is one of the oldest soccer referees in the nation, maybe even the world. Plechl is the same age as the Guinness World Record holder, who was the worlds oldest soccer referee at age 83 in 2016.

During peak soccer season, Plechl will referee a game, which typically last an hour and 20 minutes, each day.

He also works out regularly, going to the Courthouse Club Fitness in west Salem several times a week.

Plechl doesnt have a distinct answer as to why he stays involved with the sport, but its clear his passion for the game is the culprit.

What has changed is my immense, immense respect for this man, said Jose Maciel, the commissioner of the Salem Soccer Referee Association Knowing I can give him a call hey I have this game up in Molalla.

And Plechl will typically respond, Oh yeah Jose, no worries.

Over the 15 years Maciel has known Plechl, hes grown to appreciate the referees dependability and willingness to help.

Everybody whos been in the presence of Johnnie in the officiating world has positively been effected by it and it motivates whats going on, Maciel said.

Harry Garabedia got involved in the Salem soccer scene in the mid-1970s when there was only one amateur team the Salem Kickers.

Plechl helped found the Salem Kickers in the 1960s and started refereeing in 1964 at the recommendation of a friend.

In those days, Garabedia said, Plechl was the only referee in town.

He did anything and everything, he said. Anytime you would call John, he was there.

John Plechl referees a recent soccer game in Salem. (Ron Cooper/Special to Salem Reporter)

Dick Horner met Plechl when he played on Salems second mens soccer team, the Hot Spurs.

Horner put down the soccer ball and donned a whistle more than 40 years ago.

Horner said a successful referee must be fit, decisive, knowledgeable about the rules and have the ability to manage people in a stressful situation.

Referees have just over a second to make a call before players and coaches start saying hey, Horner said.

For Plechl, The most important thing for a referee is to be honest. You see something, you have to call the same on them as on everybody else. Most of the people who watch, they recognize that.

He knows almost everyone in Salems soccer community, and if someone doesnt know Plechl then their grandparents probably do, Horner said.

John Plechl makes a call during a recent soccer match in Salem. (Ron Cooper/Special to Salem Reporter)

Most all Plechls family members have played soccer at some point.

Plechls son Kevin coaches the Sprague High School girls soccer team for which his granddaughter plays.

It might be just part genetic, Kevin said.

Kevin Plechl would go out with his dad when he was 11 and be whats now called the assistant referee, raising a flag when a player was offsides or out of bounds.

Kevin said he was young, but he understood the laws of the game well.

There were a few times that he was cussed out as a young guy, he said, but I always felt dad was there to protect me.

The Plechls had season tickets for Portland Timbers games in the 1970s and Kevin remembers piling into a Volkswagen bus with his dads soccer buddies to go to games.

Sometimes its hard to get a word in, his friends will say, but they always see him with a positive attitude.

Honestly if you were to see my dad and hang out with him, you really never see him with any sort of negative attitude or in a bad mood. You dont see him grumpy, Kevin said. He just enjoys being around the game and being around people.

Hes an institution to say the least, Garabedia, the soccer referee, said.

Have a tip? Contact reporter Saphara Harrell at 503-549-6250,saphara@salemreporter.comor @daisysaphara.

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What’s Driving the Growth of Global Male Hypogonadism Market – TMR Research Blog

Male hypogonadism is a condition where the body doesnt create enough of the testosterone hormone; the hormone that assumes a key job in manly development and advancement during adolescence. There is an unmistakable need to expand the attention to hypogonadism all through the medicinal calling, particularly in essential consideration doctors who are typically the main port of require the patient. Hypogonadism can altogether decrease the personal satisfaction and has brought about the loss of employment and division of couples, prompting divorce. It is additionally significant for specialists to perceive that testosterone isnt only a sex hormone. There is a significant research being distributed to exhibit that testosterone may have key activities on digestion, on the vasculature, and on mind work, notwithstanding its notable impacts on bone and body structure. Hence the global male hypogonadism market is gaining momentum these days.

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Trending Treatments of Global Male Hypogonadism Market:

Transdermal Patches: Transdermaltestosterone patches are accessible in India under the brand name Androderm.Transdermal patches convey consistent levels of testosterone over a 24-hourtime frame. Application site responses represent most of unfriendly impactsrelated with transdermal patches, with old men demonstrating especiallyinclined to skin bothering. Neighborhood responses incorporate pruritus,rankling under the fix, erythema, vesicle arrangement, indurations, andunfavorably susceptible contact dermatitis. Roughly 10% of the patients suspendfix treatment because of skin responses.

Buccal Tablets: Buccal testosterone tablets, promoted as Striant, discharge testosterone in a pulsatile way, are like endogenous emission. With this course, the pinnacle testosterone levels are quickly accomplished and an unfaltering state is come to constantly portion following twice-day by day dosing. Like gel and transdermal items, buccal organization maintains a strategic distance from first-pass digestion. Nourishment and drink dont change medicate ingestion. Albeit well-endured, transient gum aggravation and a severe taste are the boss antagonistic impacts related with this course. And hence are one of the most effective treatmemt of male hypogonadism market.

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Testosterone therapy prescription linked to increased VTE risk in JAMA study – Specialty Medical Dialogues

The researchers conducted the study to evaluate whether the clinical prescription of testosterone therapy was associated with short-term risk of venous thromboembolism in men with and without hypogonadism or not. They found that Testosterone therapy is associated with increased risk for venous thromboembolism (VTE) in men. The case-crossover study has been published in JAMA Internal Medicine.

According to the American Heart Association, Venous thromboembolism (VTE) refers to a blood clot that starts in a vein. It is the third leading vascular diagnosis after a heart attack and stroke and includes Deep vein thrombosis andPulmonary embolism .

The researchers used insurance claims databases, researchers identified roughly 40,000 men without cancer whod experienced a VTE. Out of them, nearly 8% were diagnosed with hypogonadism. Each patient served as his own control. The immediate 6 months before the VTE was the case period, and the 6 months before that was the control period.

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A claim for testosterone therapy was more common in the 6 months before VTE, compared with the control period, both for men without hypogonadism (0.8% for case period vs. 0.5% for control period) and for those with (34% vs. 22%).

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It was found that the use of testosterone therapy in the 6-month case period was associated with an increased risk of venous thromboembolism among men with and without hypogonadism. The testosterone prescription during the case period was associated with roughly double the risk for VTE. The risk was highest in the first 3 months of starting testosterone.

The authors concluded that testosterone therapy was associated with an increase in short-term risk for VTE among men with and without hypogonadism, with some evidence that the association was more pronounced among younger men. These findings suggest that caution should be used when prescribing testosterone therapy.

For further reference log on to:

JAMA Intern Med.Published online November 11, 2019. doi:https://doi.org/10.1001/jamainternmed.2019.5135

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Testosterone therapy prescription linked to increased VTE risk in JAMA study - Specialty Medical Dialogues

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bluebird bio and Forty Seven Announce a Research Collaboration to Study an All Antibody Conditioning Regimen for Use in Combination with Autologous…

CAMBRIDGE, Mass. & MENLO PARK, Calif.--(BUSINESS WIRE)--bluebird bio, Inc. (Nasdaq: BLUE) and Forty Seven, Inc. (Nasdaq:FTSV) announced today that they have entered into a research collaboration to pursue clinical proof-of-concept for Forty Sevens novel antibody-based conditioning regimen, FSI-174 (anti-cKIT antibody) plus magrolimab (anti-CD47 antibody), with bluebirds ex vivo lentiviral vector hematopoietic stem cell (LVV HSC) gene therapy platform. This collaboration will focus on a conditioning approach aimed to deliver reduced toxicity and will initially target diseases that have the potential to be corrected with transplantation of autologous gene-modified blood-forming stem cells. If successful, the new conditioning regimen could allow for more patients to undergo gene therapy.

Autologous hematopoietic stem cell transplantation (HSCT) and most ex vivo LVV HSC gene therapies require that a patients own stem cells first be depleted from the bone marrow to facilitate the engraftment of the new (or gene-modified) HSCs through a process called conditioning. Conditioning is performed using chemotherapy or radiation, which can place patients at risk for infection and require hospitalization until bone marrow cells have recovered. In addition, conventional conditioning can place patients at risk for secondary malignancy and infertility. As a result, the overall toxicity profile of current conditioning regimens limits the types of patients who are eligible for gene therapy. It is hoped that novel antibody based conditioning regimens could avoid these toxicities.

We are excited about this collaboration, combining our industry-leading LVV HSC gene therapy platform with Forty Sevens novel antibody-based conditioning regimen, said Philip Gregory, chief scientific officer, bluebird bio. We believe that, if successful, this novel conditioning modality could not only increase the number of patients and physicians who may consider gene therapy but also improve the overall risk benefit profile for stem cell-based gene therapy, as well as potentially reduce time and costs associated with hospital visits.

Forty Seven is advancing the pioneering work on CD47 and cKIT from our scientific founder, Irv Weissmans lab. We have shown that antibody blockade of CD47 can synergize with other antibodies targeting cancer to promote tumor engulfment. Based on this experience, coupled with the results of preclinical studies, we are eager to explore this dual-antibody approach for the potential treatment of non-malignant diseases, says Jens Peter Volkmer, M.D., Founder and Vice President of Research and Development at Forty Seven.

Forty Sevens President and Chief Executive Officer, Mark McCamish, M.D., Ph.D., commented, bluebird is a leading gene therapy company and we are excited to collaborate with them. Stem cell transplantation is potentially curative for a variety of blood diseases, including genetic blood disorders like sickle cell disease and beta-thalassemia. If successful, we believe our chemo- and radiation-free, all-antibody approach could expand transplantation beyond genetic blood disorders to a range of indications for which current transplantation approaches are suboptimal. In 2020, we plan to evaluate FSI-174 in healthy volunteers, before initiating a combination study of Forty Sevens novel all-antibody conditioning regimen and bluebirds gene therapy product.

Under the terms of the agreement, bluebird bio will provide its ex vivo LVV HSC gene therapy platform and Forty Seven will contribute its innovative antibody-based conditioning regimen for the collaboration.

About FSI-174 and MagrolimabFSI-174 is a humanized monoclonal antibody targeting cKIT, which is a receptor that is highly expressed on hematopoietic stem cells. Magrolimab is a humanized monoclonal antibody targeting CD47, which is a dont eat me signal to macrophages and is expressed on all cells. Magrolimab is currently being investigated in Phase 2 clinical trials to treat cancer and has established clinical efficacy in four indications, including myelodysplastic syndrome, acute myeloid leukemia, diffuse large B cell lymphoma and follicular lymphoma, with a favorable safety profile in over 350 patients treated, including some patients treated continuously for over two years. When combined, FSI-174 sends a positive signal to macrophages to target blood forming stem cells for removal and magrolimab disengages inhibitory signals that block phagocytosis. Combination of these antibodies has shown efficient removal of blood forming stem cells, allowing for transplantation in pre-clinical models.

About bluebird bio, Inc.bluebird bio is pioneering gene therapy with purpose. From our Cambridge, Mass., headquarters, were developing gene therapies for severe genetic diseases and cancer, with the goal that people facing potentially fatal conditions with limited treatment options can live their lives fully. Beyond our labs, were working to positively disrupt the healthcare system to create access, transparency and education so that gene therapy can become available to all those who can benefit.

bluebird bio is a human company powered by human stories. Were putting our care and expertise to work across a spectrum of disorders by researching cerebral adrenoleukodystrophy, sickle cell disease, transfusion-dependent -thalassemia and multiple myeloma using three gene therapy technologies: gene addition, cell therapy and (megaTAL-enabled) gene editing.

bluebird bio has additional nests in Seattle, Wash.; Durham, N.C.; and Zug, Switzerland. For more information, visit bluebirdbio.com.

Follow bluebird bio on social media: @bluebirdbio, LinkedIn, Instagram and YouTube.

bluebird bio is a trademark of bluebird bio, Inc.

About Forty Seven Inc.Forty Seven, Inc. is a clinical-stage immuno-oncology company that is developing therapies targeting cancer immune evasion pathways based on technology licensed from Stanford University. Forty Sevens lead program, magrolimab, is a monoclonal antibody against the CD47 receptor, a dont eat me signal that cancer cells commandeer to avoid being ingested by macrophages. This antibody is currently being evaluated in multiple clinical studies in patients with myelodysplastic syndrome, acute myeloid leukemia, non-Hodgkins lymphoma, ovarian cancer and colorectal carcinoma.

For more information, please visit http://www.fortyseveninc.com or contact info@fortyseveninc.com.

Follow Forty Seven on social media: @FortySevenInc, LinkedIn

Forward-Looking StatementsThis release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," potentially, and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. These statements include those related to the research and development plans for bluebird bios and Forty Sevens respective platforms and product candidates, the timing and success of Forty Sevens collaboration with bluebird bio, Forty Sevens plans to pursue clinical proof-of-concept for FSI-174 plus magrolimab with the LVV HSC gene therapy platform, the focus on diseases that have the potential to be corrected with transplantation of autologous gene-modified blood-forming stem cells, the tolerability and efficacy of FSI-174 and magrolimab, Forty Sevens plans to continue development of FSI-174 plus magrolimab, as well as related timing for clinical trials of the same.

Any forward-looking statements are based on the companies managements current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risks that the exploratory antibody-based conditioning platform will not be successful or will not be safe or effective in clinical trials, the risks that the collaboration between bluebird bio and Forty Seven will not continue or be successful, and the risk that the parties will not be successful in advancing the collaboration in development, the risk that potential product candidates that bluebird bio and Forty Seven develop may not progress through clinical development or receive required regulatory approvals within expected timelines or at all, the risk that clinical trials may not confirm any safety, potency or other product characteristics described or assumed in this press release and the risk that such product candidates may not be beneficial to patients or successfully commercialized. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the companies actual results to differ from those contained in the forward-looking statements, see the section entitled Risk Factors in each companys most recent Form 10-K as well as discussions of potential risks, uncertainties and other important factors in subsequent filings with the Securities and Exchange Commission at http://www.sec.gov. All information contained in this press release are not guarantees of future performance and speak only as of the date hereof, and each of bluebird bio and Forty Seven disclaims any obligation to update this information to reflect future events or circumstances unless required by law.

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The Value and Versatility of Clinical Flow Cytometry – Technology Networks

What is flow cytometry and how does it work?Flow cytometry(FCM) is a scientific technique used to measure the physical and biochemical characteristics of cells.1The sample is injected into the flow cytometer instrument, where it is typically focused to flow one cell at a time past light sources and detectors. Tens of thousands of cells can be examined in seconds to determine their morphology, granularity, scattering and transmission of light, or fluorescence of biomarkers, depending on the variation of FCM used.

The first conventional fluorescence-based flow cytometer was developed and commercialized in the late 60s/early 70s in Germany.2 Over the last five decades, FCM has developed rapidly in terms of the number of its applications and the quantity and dimensionality of the data it generates.1,3 Dr. Minh Doan, formerly of the Imaging Platform of the Broad Institute (USA) and now head of Bioimaging Analytics at GlaxoSmithKline in the USA, states, There have been significant advances in all three Vs of flow cytometry data: velocity (throughput/speed of data acquisition), volume (data content), and variety (sample types and signal acquisition technology).

Michael Parsons, manager of the Flow Cytometry Core of the Lunenfeld-Tanenbaum Research Institute in Toronto, Canada, agrees. The two biggest trends in flow cytometry are high content data and the merging of technologies from separate disciplines. For example, the last five years or so have seen the emergence of mass cytometry, which merges the disciplines of flow cytometry and mass spectrometry. In its latest iteration, an image cytometry module has been incorporated to generate unprecedented amounts of content (number of measured parameters) from relatively small amounts of patient tissue. Spectral flow cytometry has also established itself as an important emerging technology. Indeed, mass cytometry can now measure up to 50 features on a single cell simultaneously using antibodies tagged with rare earth metals,4 and imaging flow cytometry allows for 1000s of morphological features and multiple fluorescence markers to be analyzed per cell.3Flow cytometry, therefore, has inarguable potential as a clinical tool for disease diagnosis, prognosis, and therapeutic monitoring. However, some challenges remain in translating the full promise of FCM into clinical practice. Here, some of the current clinical applications of FCM will be discussed, as well as some of the compelling new applications being researched.

Similarly, FCM of liquid biopsies could be used to detect circulating tumor cells in the bloodstream.3 These cells are extremely rare, and with its high sensitivity, FCM is perfectly poised to make a significant impact in this area. This approach has potential for the clinical detection of early-stage cancer as well as the detection of circulating metastatic or drug-resistant cancer cells. For example, a study published earlier this year described label-free liquid biopsy with very high throughput (> 1 million cells/second) for drug-susceptibility testing during leukemia treatment.8

Prior to an organ transplant, FCM can be used to crossmatch the patient's serum with donor lymphocytes to detect antibodies that could result in organ rejection.1 Postoperatively, the analysis of various cell markers on the peripheral blood lymphocytes can indicate early transplant rejection, detect bone marrow toxicity arising from immunosuppressive therapies, and help differentiate infections from organ rejection. For blood transfusions, FCM can be used to detect contamination of blood with residual white blood cells, which can have adverse effects such as pulmonary edema.9Groups such as Dr. Roshini Abrahams at Nationwide Childrens Hospital in Ohio, USA, are using FCM to diagnose primary immunodeficiency disorders with the use of immunophenotyping and functional assays.10 These disorders are caused by genetic mutations that result in defects in the immune system, such as X-linked (Brutons) agammaglobulinemia and X-linked hyper-IgM syndrome. Over 300 of these disorders have been identified thus far, and the causative mutations lower immune defense against the attack of infections.

HIV is, of course, an example of a secondary (acquired) immunodeficiency disorder. FCM analysis of CD4 and other markers on lymphocytes in the peripheral blood is used to monitor the treatment of HIV patients, and a CD4 count <200 cells/mL together with a positive antibody test for HIV is used as a diagnostic for AIDS.1 Secondary immunodeficiencies can also be caused by e.g., substance abuse, malnutrition, other medical conditions, and certain medical treatments. FCM of a panel of markers can be used to confirm suspected cases.1In pregnancy, when a Rhesus blood group D-negative mother carries a D-positive fetus, fetal-maternal bleeding can sensitize the mother to the D-positive blood cells from the fetus and this can be fatal to subsequent D-positive newborns.11 FCM is used to measure the degree of fetal-maternal hemorrhage to determine the correct dose of prophylactics to be administered shortly after delivery.

In addition to oncology and immunology applications, FCM is also used to diagnose a variety of rare hematologic disorders12 as well as autoimmune/autoinflammatory disorders such as spondylarthritis (arthritis of the spine).13 Another area of research that is likely to give rise to increasing clinical applications in the future is that of platelet activity, which is important in many clinical conditions.1,14

Experts suggest that it may be possible to overcome this data analysis hurdle by applying machine learning approaches coupled with further standardization of FCM workflows.3,15 The most exciting applications of high content data revolve around the use of machine learning, in particular, deep learning, to extract relevant meaning from large data sets. Machine learning, coupled with big data, has the potential for driving diagnosis and treatment options tailored to the patients disease in a timely manner, says Dr. Parsons. In addition, Prof. Sadao Ota of RCAST at the University of Tokyo, Japan, points out, We still need to figure out how to design a workflow that convincingly validates diagnostic results, especially if the diagnosis employs the power of machine learning. Such developments are necessary before the rich information content of advanced FCM technology can be fully applied in the clinic.

In terms of other future advances in the field, Prof. Ota specifically makes mention of the potential of cell sorters combined with FCM.16 There are exciting and unique applications of sorters in fields such as cell therapy and regenerative medicine. Also, creating key applications of imaging cell sorters in pharmaceutical fields may accelerate global drug discovery. Dr. Doan concurs, Disease heterogeneity makes it hard to validate findings. Perhaps the use of flow cytometry with sorting capability can help such validation, where events-of-interest collected by flow cytometry can be validated with other downstream assays. Finally, as Dr. Doan notes, With multiple layers of data(types) incorporated altogether, there are now possibilities to do more with less, i.e., label-free sample measurement, which could lead to more direct, faster, and smarter diagnoses. Rare events (e.g., metastatic cancer cells) may soon be detected better than before.References1.Bakke A.C. Clinical Applications of Flow Cytometry. Laboratory Medicine. 2000; 31(2): 97104. doi: 10.1309/FC96-DDY4-2CRA-71FK.2.Herzenberg L.A., Parks D., Sahaf B., Perez O., Roederer M., Herzenberg L.A. The history and future of the fluorescence activated cell sorter and flow cytometry: a view from Stanford. Clinical Chemistry. 2002;48(10):181918273.Doan M., Vorobjev I., Rees P., Filby A., Wolkenhauer O., Goldfeld A.E., Lieberman J., Barteneva N., Carpenter A.E., Hennig H. Diagnostic potential of imaging flow cytometry. Trends in Biotechnology. 2018;36(7):649652. doi: 10.1016/j.tibtech.2017.12.008.4.Olsen L.R, Leipold M.D., Pedersen C.B., Maecker H.T. The anatomy of single cell mass cytometry data. Cytometry Part A. 2019;95(2):156172. doi: 10.1002/cyto.a.23621.5.Laerum O.D., Farsund T. Clinical application of flow cytometry: a review. Cytometry. 1981;2(1):113. doi: 10.1002/cyto.990020102.6.Li J., Wertheim G., Paessler M., Pillai V. Flow cytometry in pediatric hematopoietic malignancies. Clinics in Laboratory Medicine. 2017;37(4):879893. doi: 10.1016/j.cll.2017.07.009.7.Gupta S., Devidas M., Loh M.L., Raetz E.A., Chen S., Wang C., Brown P., Carroll A.J., Heerema N.A., Gastier-Foster J.M., Dunsmore K.P., Larsen E.C., Maloney K.W., Mattano L.A. Jr., Winter S.S., Winick N.J., Carroll W.L., Hunger S.P., Borowitz M.J., Wood B.L. Flow-cytometric vs. -morphologic assessment of remission in childhood acute lymphoblastic leukemia: a report from the Childrens Oncology Group (COG). Leukemia. 2018;32(6):13701379. doi: 10.1038/s41375-018-0039-7.8.Kobayashi H., Lei C., Wu Y., Huang C-J., Yasumoto A., Jona M., Li W., Wu Y., Yalikun Y., Jiang Y., Guo B., Sun C-W., Tanaka Y., Yamada M., Yatomi Y., Goda K. Intelligent whole-blood imaging flow cytometry for simple, rapid, and cost-effective drug-susceptibility testing of leukemia. Lab on a Chip. 2019;19(16):26882698. doi: 10.1039/c8lc01370e.9.Castegnaro S., Dragone P., Chieregato K., Alghisi A., Rodeghiero F., Astori G. Enumeration of residual white blood cells in leukoreduced blood products: Comparing flow cytometry with a portable microscopic cell counter. Transfusion and Apheresis Science. 2016;54(2):266270. doi: 10.1016/j.transci.2015.10.001.10.Abraham R.S., Aubert G. Flow cytometry, a versatile tool for diagnosis and monitoring of primary immunodeficiencies. Clinical and Vaccine Immunology. 2016;23(4):254271. doi: 10.1128/CVI.00001-16.11.Kim Y.A., Makar R.S. Detection of fetomaternal hemorrhage. American Journal of Hematology. 2012;87(4):417423. doi: 10.1002/ajh.22255.12.Bn M.C., Le Bris Y., Robillard N., Wuillme S., Fouassier M., Eveillard M. Flow cytometry in hematological nonmalignant disorders. International Journal of Laboratory Hematology. 2016;38(1):516. doi: 10.1111/ijlh.12438.13.Duan Z., Gui Y., Li C., Lin J., Gober H.J., Qin J., Li D., Wang L. The immune dysfunction in ankylosing spondylitis patients. Bioscience Trends. 2017;11(1):6976. doi: 10.5582/bst.2016.01171.14.Pasalic L. Assessment of platelet function in whole blood by flow cytometry. Methods in Molecular Biology. 2017;1646:349367. doi: 10.1007/978-1-4939-7196-1_27.15.Doan M., Carpenter A.E. Leveraging machine vision in cell-based diagnostics to do more with less. Nature Materials. 2019;18(5):414418. doi: 10.1038/s41563-019-0339-y.16.Ota S., Horisaki R., Kawamura Y., Ugawa M., Sato I., Hashimoto K., Kamesawa R., Setoyama K., Yamaguchi S., Fujiu K., Waki K., Noji H. Ghost cytometry. Science. 2018;360(6394):12461251. doi: 10.1126/science.aan0096.

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The Value and Versatility of Clinical Flow Cytometry - Technology Networks

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Sodium Selenite Improves The Therapeutic Effect Of BMSCs Via Promoting | OTT – Dove Medical Press

Dongmei Yan,1,* Botao Tang,2,* Lixin Yan,3 Lei Zhang,1 Meijuan Miao,1 Xi Chen,4 Guangyi Sui,5 Qi Zhang,1 Daoyuan Liu,1 Hui Wang1

1Department of Blood Transfusion, The Second Affiliated Hospital of Harbin Medical University, Harbin, Peoples Republic of China; 2Department of Cardiology, Heilongjiang Red Cross Hospital, Harbin, Peoples Republic of China; 3Department of Laboratory Medicine, The Second Affiliated Hospital of Harbin Medical University, Harbin, Peoples Republic of China; 4Department of Hematology, The Second Affiliated Hospital of Harbin Medical University, Harbin, Peoples Republic of China; 5Ethics Committee, The Tumor Hospital Affiliated to Harbin Medical University, Harbin, Peoples Republic of China

*These authors contributed equally to this work

Correspondence: Hui WangDepartment of Blood Transfusion, The Second Affiliated Hospital, Harbin Medical University, Xuefu Road No. 246, Nangang District, Harbin, Heilongjiang Province, Peoples Republic of ChinaTel +86-451-86605134Email wanghui@hrbmu.edu.cn

Purpose: Sodium selenite (Na2SeO3) has been known to restore the antioxidant capacity of bone marrow mesenchymal stem cells (BMSCs), reduce the production of reactive oxygen species (ROS) in the cells, and promote cell proliferation and inhibit cell apoptosis. However, it is still not clear whether selenium can mediate the differentiation and inhibit the induced hemagglutination of BMSCs. In this study, we attempted to explore the effect of Na2SeO3 on these aspects of BMSCs.Methods: We evaluated the fate of the MSCs isolated from the bone marrow of mice by studying their differentiation and proliferation after treatment with Na2SeO3. We also simultaneously evaluated the coagulation reaction induced by Na2SeO3-treated BMSCs in vitro.Results: While the mice-derived BMSCs expressed CD44, CD73, CD90, and CD105, they did not express CD45. The morphology of the derived cells was homogeneously elongated. These results showed that the isolated cells are indeed BMSCs. We found that 0.1 M and 1 M of Na2SeO3 promoted the proliferation and apoptosis of BMSCs, respectively. This showed that Na2SeO3 can be toxic and exert certain side effects on the BMSCs. The results of the osteogenic and adipogenic assay showed that 0.1 M Na2SeO3 could significantly promote the osteogenic and adipogenic differentiation of BMSCs by upregulating the lipid factors (LPL and PPRAG) and osteogenic factors, RUNX2, COL1, and BGP, in a concentration-dependent manner. Coagulation experiments in animals (mice and rats) revealed that Na2SeO3 can reduce the coagulation time of BMSCs in a concentration-dependent manner, which is related to the high expression of hematopoietic factors (SDF-1, GM-CSF, IL-7, IL-8, IL-11, and SCF).Conclusion: Na2SeO3 promotes the proliferation and differentiation as well as reduces the coagulation time of BMSCs, and this effect might enhance the therapeutic effect of BMSCs.

Keywords: sodium selenite, BMSCs, proliferation, differentiation, coagulation factors, clotting time

This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution - Non Commercial (unported, v3.0) License.By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms.

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Sodium Selenite Improves The Therapeutic Effect Of BMSCs Via Promoting | OTT - Dove Medical Press

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BrainStorm Cell Therapeutics Announces Research Grant Award From the National Multiple Sclerosis Society – Yahoo Finance

NEW YORK, Nov. 14, 2019 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics, Inc. (NASDAQ:BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, announced today that the Company has received a $495,330 grant from the National Multiple Sclerosis Society, through its Fast Forward program, to advance BrainStorms Phase 2 open-label, multicenter clinical trial of repeated intrathecal administration of NurOwn (autologous MSC-NTF cells) in participants with progressive Multiple Sclerosis (NCT03799718).

Chaim Lebovits, President and CEO of BrainStorm stated, We are very pleased to receive this generous grant from the National MS Society. Currently, we are conducting our Phase 2 study in three leading US medical centers: The Keck School of Medicine of USC, The Stanford School of Medicine, and Cleveland Clinic. This research funding will help advance our investigational therapy NurOwn as a potential unmet need for patients with progressive MS. MS continues to devastate the lives of patients and their families and we thank the National MS Society for helping us advance our innovative research program.

Currently, progressive MS treatment options are limited and NurOwn is a promising new autologous cellular treatment modality that has the potential to directly address MS disease pathways, said Ralph Kern MD MHSc, COO and CMO of BrainStorm. He added, This funding from the National MS Society will help us explore key neuroinflammation and neural repair biomarkers in progressive MS to confirm NurOwns unique mechanism of action and guide the design of future clinical trials to address this important unmet patient need.

Leveraging resources in this Phase 2 clinical study of a cell-based therapy for progressive MS exemplifies our work to accelerate research to improve clinical care for people living with MS. said Mark Allegretta, PhD, Vice President of Research at the National MS Society. Were pleased to work with BrainStorm to test a broad panel of biomarkers of neuroinflammation and repair as correlates of the effect of treatment with NurOwn.

About Multiple SclerosisMultiple sclerosis is an unpredictable, often disabling disease of the central nervous system. There is currently no cure for MS. Symptoms vary from person to person and range from numbness and tingling, to mobility challenges, blindness and paralysis. An estimated 1 million people live with MS in the United States. Most people are diagnosed between the ages of 20 and 50 and it affects women three times more than men.

About The National Multiple Sclerosis Society:The National MS Society, founded in 1946, funds cutting-edge research, drives change through advocacy, and provides programs and services to help people affected by MS live their best lives. Connect to learn more and get involved: nationalMSsociety.org, Facebook, Twitter, Instagram, YouTube or 1-800-344-4867.

About NurOwnNurOwn (autologous MSC-NTF) cells represent a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors. Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression. BrainStorm has fully enrolled a Phase 3 pivotal trial of autologous MSC-NTF cells for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm also recently received U.S. FDA acceptance to initiate a Phase 2 open-label multicenter trial in progressive MS and enrollment began in March 2019.

About BrainStorm Cell Therapeutics Inc.BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm has fully enrolled a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six U.S. sites supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm also recently received U.S. FDA clearance to initiate a Phase 2 open-label multicenter trial in progressive Multiple Sclerosis. The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) started enrollment in March 2019. For more information, visit the company's website at http://www.brainstorm-cell.com.

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Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could causeBrainStorm Cell Therapeutics Inc.'sactual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorms need to raise additional capital, BrainStorms ability to continue as a going concern, regulatory approval of BrainStorms NurOwn treatment candidate, the success of BrainStorms product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorms NurOwn treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorms ability to manufacture and commercialize the NurOwn treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorms ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation,; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available athttp://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

CONTACTS

Corporate:Uri YablonkaChief Business OfficerBrainStorm Cell Therapeutics Inc.Phone: 646-666-3188uri@brainstorm-cell.com

Media:Sean LeousWestwicke/ICR PRPhone: +1.646.677.1839sean.leous@icrinc.com

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BrainStorm Cell Therapeutics Announces Research Grant Award From the National Multiple Sclerosis Society - Yahoo Finance

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At 27 with a new baby, she thought she had the flu. It was blood cancer. – IndyStar

New mom, 27, wife of IndyCar mechanic battling cancer Dana Hunsinger Benbow, dana.benbow@indystar.com

The chemotherapy coursing through her veins is brutal. One anti-nausea medication a day doesn'ttouch it so Caitlyn Goslee takes two. On a good day, theymight getrid of her gnawing sickness. Often, they don't.

Her 11-month-old daughter traipsingall over the house makes being sick right now both awful and wonderful.

Awful because her daughter has lived more than a third of her life with a mom battling cancer. She has spent days in a hospital bed, with her chubby cheeks and sweet smile and no clue of the fight her mom is in.

Wonderful because when Goslee gets throughall of this, her daughter will have been too young to remember any of it.

Caitlyn Goslee with her daughter, now 11 months old.(Photo: Provided by Caitlyn Goslee)

The 104.9 degree fever in July.

The diagnosis of sepsis. Ofinfluenza type A and influenza type B.

The day when what Goslee thought was astrain of the flu morphed into the diagnosis of aviciousblood cancer.

"I'm 27," she said Monday. "Things didn't add up."

The scary, unknown health issues started in July ata time in her life when Gosleeleast expected it.

She was young,healthy and had just had a baby girlin December. Goslee and IndyCar mechanic Brian Goslee who has worked for the series 18 years and is now with driver Jack Harvey were proud parents. In March, the couple was married.

By that summer, Goslee was a new mom, buttoning up onesies and changing diapers. She was a new wife andstarting a life as a stepmom to Brian Goslee's three children, a 9-year-old and 7-year-old twins.

Caitlyn Goslee is surrounded by her husband, Brian, baby girl and three stepchildren.(Photo: Provided by Caitlyn Goslee)

Goslee was busy and wrung out and she thought every bit of it was fabulous.

Then that bout with the "flu" hit. For six weeks between July and August, Goslee said doctors gave her different diagnoses. During thatsix-week period she was in and out of the hospital three times, 17 days in all.

The flu swab in her nose tested positive. Then she was told she was septic and, on top of that, had respiratory syncytial virus or RSV.

"All of that happened before they figured it out," she said. But then they studied her blood counts and it was those counts that gave the final, devastating clue.

Goslee had myelodysplastic syndromes, a group of cancers in which immature blood cells in the bone marrow do not mature or become healthy blood cells.

For apatient with MDS, the blood stem cells (immature cells) do not become mature red blood cells, white blood cells, or platelets in the bone marrow, according to the National Cancer Institute. Theimmature blood cells, calledblasts, don'twork the way they should and either die in the bone marrow or soon after they go into the blood. Thatmeans less room for healthy white blood cells, red blood cells, and platelets to form in the bone marrow.

"The only way to get a full remission is with a bone marrow transplant," Goslee said.

But first, Goslee has to get healthy enough for the transplant. Healthy enough means four rounds of chemotherapy. She has completed two and will start her third round next week.

Along the way, the Goslees have kept apositive attitude.

"For me, this is just a bump in the road," she said. "With the chemo and this transplant, it will be a memory; in five years we are going to look back on this. Of course, this isntthe bump anybody wants, but we stay positive for the kids."

Goslee will never forget the night she met her husband-to-be.In addition to working as a mechanic, he has a business turning old IndyCar gears into clocks.

Caitlyn Goslee wasputting on a fundraiser for Riley Hospital for Children at IU Health and had been texting Brian about donating one of his pieces to help. He said yes.

That night at the fundraiser attended by tons of people in the racing community ittook place during the Performance Racing Industry trade show she looked over and saw Brian.

Caitlyn and Brian Goslee with their four children.(Photo: Provided by Caitlyn Goslee)

"Who is that guy?" she asked a friend. Come to find out, it was the guy she'd been texting about donating his clocks.

"I think I kind of like him," Caitlyn Goslee remembers telling her friend. Thatlike turned into life. And now the two are fighting for hers together.

Goslee will have a biopsy in December to see if her cells are healthy enough the leukemic cells in her bone marrow need to be down to a certain level for a transplant. If so, the Goslees will have plenty of reason to celebrate both that and the first birthday of their baby girl.

The racing community, friends and family are helping Goslee in her fight with cancer. Gosleesays the insurance company will not pay for her chemotherapy, which is $38,000 a week.

To help, the public is invited to attend a fundraising event Monday, Nov. 11 from 5 p.m. to 10 p.m. at Speedway Indoor Karting,1067 N Main St, Speedway -- 50% of all money raised from karting will be donated, there will be live and silent auction items and a 50/50 raffle.

Several big-ticket items will be raffled off live at the event. For those who cannot attend, raffle tickets can be purchased online. The raffle will take place at 8:30 p.m. Tickets can be purchased online or in person until 8 p.m. Questions, contact Chris Wheeler at info@tntatsik.com.

Donate online toGoslee benefit: fundly.com/caitlyn-goslee-benefit

Follow IndyStar sports reporter Dana Benbow on Twitter:@DanaBenbow. Reach her via e-mail: dbenbow@indystar.com.

See original here:
At 27 with a new baby, she thought she had the flu. It was blood cancer. - IndyStar

Recommendation and review posted by Bethany Smith

BrainStorm Cell Therapeutics Announces Ralph Kern MD MHSc to Present at the 7th International Stem Cell Meeting – Yahoo Finance

NEW YORK, Nov. 12, 2019 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics, Inc. (NASDAQ:BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, today announced that the Companys Chief Operating and Chief Medical Officer Ralph Kern MD MHSc will present at the 7th International Stem Cell Meeting, which is hosted by the Israel Stem Cell Society. The Conference will be held November 12-13, in Tel Aviv, Israel.

Ralph Kern, MD, MHSc, said: I welcome the opportunity to participate in the 7th International Stem Cell Meeting where I will share the advances BrainStorm has made with NurOwn. It is a privilege to participate and to exchange ideas with many of the international scientific leaders in stem cell research.

About NurOwn

NurOwn (autologous MSC-NTF) cells represent a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors. Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression. BrainStorm has fully enrolled a Phase 3 pivotal trial of autologous MSC-NTF cells for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm also recently received U.S. FDA acceptance to initiate a Phase 2 open-label multicenter trial in progressive MS and enrollment began in March 2019.

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm has fully enrolled a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six U.S. sites supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm also recently received U.S. FDA clearance to initiate a Phase 2 open-label multicenter trial in progressive Multiple Sclerosis. The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) started enrollment in March 2019. For more information, visit the company's website at http://www.brainstorm-cell.com

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could causeBrainStorm Cell Therapeutics Inc.'sactual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorms need to raise additional capital, BrainStorms ability to continue as a going concern, regulatory approval of BrainStorms NurOwn treatment candidate, the success of BrainStorms product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorms NurOwn treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorms ability to manufacture and commercialize the NurOwn treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorms ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation,; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available athttp://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

Story continues

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BrainStorm Cell Therapeutics Announces Ralph Kern MD MHSc to Present at the 7th International Stem Cell Meeting - Yahoo Finance

Recommendation and review posted by Bethany Smith

From inspiration to innovation | UDaily – UDaily

Article by Karen B. Roberts Photos by Evan Krape November 11, 2019

The Merriam-Webster Dictionary defines an inventor as one who creates or introduces something new.

Thomas Edison is one. So is Emily Day.

Edison created the incandescent light bulb and the typewriter, among dozens of other things.

Day, an assistant professor in biomedical engineering at the University of Delaware, is working on technology that may one day replace bone marrow transplants by enabling nanoparticle carrier systems to deliver medication and cargo directly to stem cells without the need to remove them from the body.

The University recognized more than 225 inventors, including Day, on Tuesday, Oct. 29, for their remarkable contributions to UD and to society at large.

The event, held at the Roselle Center for the Arts and coordinated by the UDResearch Office, celebrated researchers with discoveries in engineering, health care, energy, agriculture and many other fields.

You, our inventors, have taken nuggets of ideas, of discoveries that youve made and developed them through hard work, trial and error, failure and success. Youve shown tenacity and drive, patience and persistence, and the results are what were celebrating today, said UD Provost Robin Morgan.

Enriching the environment for entrepreneurship

Since 2008, UD researchers have generated more than 500 inventions.

Working in collaboration with its partners, the University has made a concerted effort to enrich the environment for these types of efforts in Delaware, contributing to the states economic prosperity and positively impacting the greater good.

UD research expenditures for fiscal year 2019 totaled $161 million, a record-setting 10% increase over 2018, to explore pressing topics across the sciences, engineering, humanities and social sciences.

During this same time frame, UD researchers generated 33 patent applications and secured 11 patents, with the support of the Universitys Office of Economic Innovation and Partnerships (OEIP). OEIP has licensed six UD-developed technologies to outside companies and evaluated numerous other potential inventions currently under development.

Several UD-developed technologies are now featured in the Association of University Technology Managers Better World Project, which highlights successful examples where academic research and technology transfer combine to benefit the broader world. One of these is the UD-patented microbe UD10-22, a unique strain of Bacillus subtilis that helps plants grow stronger, developed by Harsh Bais, associate professor of plant and soil sciences, and Janine Sherrier, a former UD faculty member. UD licensed the technology to BASF, a global chemical company, in 2013. After completing successful trials and regulatory clearances, the technology is now available in the market as a key component of BASFs Velondis and Nodulator Duo product lines in Canada and the United States. Trials are ongoing for the product to be available in four additional product lines and for a range of crops to be sold in several countries in South America, Europe and Asia.

We are building a dynamic and rich ecosystem to support this type of activity, now and in the future, said Charles G. Riordan, UD vice president for research, scholarship and innovation.

Continued growth of UDs Science, Technology and Advanced Research (STAR) Campus through strategic partnerships and infrastructure development is one example that firmly positions the University as an innovation powerhouse for the community, state and region. The Delaware Innovation Space, the business incubator that is a public-private partnership between the state of Delaware, DuPont and UD, is another.

Riordan reported that Delaware Innovation Space, with its 130,000 square feet of lab-based tech space for startups, already is 90% occupied, hosting 13 companies including UD startups W7energy and MCET along with serving an additional dozen companies through its virtual program. The result more than 240 jobs created or retained.

Other resources available on campus to support innovators and entrepreneurs include, but are not limited to, OEIP, competitive funding opportunities, seed funding and training programs at UDs Horn Entrepreneurship,and new and existing core research facilities.

Other UD technologies that have had success in the marketplace during the past year include Avkin, a leading manufacturer of sensor-enabled, high-fidelity, wearable technology for health care simulation education founded byAmy Cowperthwait, director of Healthcare Theatre for the College of Health Sciences.The patented devices are used for training health care workers and caregivers to perform clinical procedures, such asdrawing blood, tracheostomy care or catheter insertion. Designed to be worn by a live actor, Avkin products provide a realistic, patient-centered simulation.

Today, the UD-developed products can be found in select medical and nursing schools and health systems.The company now has five products in the market, and recently launched a new package aimed at equipping todays practitioners with the knowledge and skills necessary to prevent hospital acquired infections and to improve patient outcomes.

Isao Noda, UD affiliated professor in materials science and engineering, said it is particularly important to foster innovation and invention among students. An inventor himself, Noda is named on more than 60grantedU.S. patents.

One of Nodas inventions is abio-basedplasticmade from vegetable oilsknown asNodax, which can be used to make eco-friendlyproductsranging from biodegradable plastic straws topiezoelectricnanofibers forsensors and other electronics. Nodainventedthe material while a research fellow atProcterand Gamble. Today, UDscientistsare part of theexploratorywork onNodax, collaboratingon fundamental research to see just what elsethisnovelmaterialcan do.

In industry, invention is required. If you dont invent, you will be fired. But many graduates get jobs in industry without any of the training on how to invent, so this is amazingly important, said Noda.

Day agreed and said her approach to innovation shifted in recent years, particularly when speaking with students.

In the beginning of my academic career I was more focused on publishing papers, Day said. As my group has become more established, I now tell my students, Hey, before you go present this or publish, its important for you to submit your invention disclosure to protect your ideas.

Excerpt from:
From inspiration to innovation | UDaily - UDaily

Recommendation and review posted by Bethany Smith

Heartbreaking moment dad meets the woman who saved his life – he feared his son would grow up without a father – Manchester Evening News

This is the tear-jerking moment a dad shares a hug with the woman who saved his life.

James O'Donnell, from Burnage, feared the worst after being diagnosed with a blood disorder similar to leukaemia in 2016.

Usual treatments were failing and James was undergoing a blood transfusion every week while battling constant infections, the Liverpool Echo reports.

James was running out of options and despaired at the pain his death could cause his eight-year-old son, Harrison.

But in a stunning stroke of fortune, his saviour was only the other side of the M62 - LiverpoolCouncil admin worker Leah McDougall.

The 29-year-old mum, from Bootle, had taken the time to sign up to the register of potential stem cell donors on her lunch break at a pop-up stall, organised by blood cancer charity DKSM, the previous year.

James, who despite his Manc heritage is an avid Liverpool FC fan, told staff at the charity that he would be up for meeting his donor, who could have been anyone from a number of European countries using the register.

James, along with his wife Andrea and young Harrison, got the chance to meet Leah for the first time at a DKSM charity gala in London on Wednesday last week (November 6).

James, who says he finally feels like himself after a long period of illness, told the ECHO: "I was just getting chest infections and water infections all the time.

"I am quite a healthy person, and I was in good shape and I knew I should not be getting ill all the time."

He said after a few weeks of tests his was invited to take a bone marrow biopsy and was told the devastating news on his 40th birthday.

The disease meant James' bone marrow was not producing enough white blood cells, but doctors told him a treatment called anti-thymocite globulin (ATG) had a "75% chance" of success.

However, when that failed, fear and doubt began to creep in.

He said: "We are always saying I would get through this, we were thinking I would get better. But I started to think it's not happening, it's not going to be for me, this.

"I thought, I have been good in life, I need some luck. We were having a really hard time.

"My son was four or five then, and it was hard for him having a dad going from playing football with him to being in hospital."

Eventually doctors revealed the only option was for James to have a bone marrow transplant.

The O'Donnell's went through further disappointment when tests on his three siblings revealed none were a match, so the waiting game to find a suitable donor began.

But on a March day in 2017, he got a call to say: "We have got a perfect match, a 10 out of 10."

The operation was a success and after four weeks doctors told James the new bone marrow cells were taking effect.

He said: "We were so lucky to find a donor only about 25 miles away. Some people never find one and we had one on our doorstep."

The powerful emotion of meeting Leah last week is summed up by James: "It was the second best moment of my life after my son being born.

"What she has done means that I can see my son growing up and that he has a father."

Leah did not hesitate to agree to help a total stranger when she was asked by DKSM.

Describing the moment she met James and his family, she told the ECHO: "We were both speechless. When I walked on stage we were just hugging each other for ages.

"It is weird, we felt like we had known each other for years, I felt like I had known him my whole life.

"It just takes five minutes out of your time to sign up to the register; that's like going to the kitchen to make a drink.

"You just think about the impact it is going to have on someone, it is saving someone's life. I feel lucky to have been able to give something back."

James says his family and Leah are planning to meet up again, possibly at a Liverpool FC game.

He said: "Without her, I wouldn't have a future."

DKSM has urged anyone aged 17-55, and in general good health, to sign up to the register here.

Dr Manos Niklolousis, Haematologist at University Hospital Birmingham NHS Foundation Trust, said:"Blood stem cells can be used to treat a wide range of blood cancers and blood disorders and we urgently need more people to come forward as donors.

"Currently, only 2% of the UK population are registered so matching donors with patients isnt easy within a growing multicultural population.

"Many of those in need are unable to find a sibling match and so rely on the generosity of strangers, and a blood stem cell transplant can be some patients only hope of survival.

"As a doctor who treats people with blood cancer or disorders, it is upsetting to know that some patients could have been saved if only more potential donors were registered and available to donate.

"I look forward to the day when there will be a donor for every patient in need."

Continued here:
Heartbreaking moment dad meets the woman who saved his life - he feared his son would grow up without a father - Manchester Evening News

Recommendation and review posted by Bethany Smith

Discover the Global Cord Stem Cell banking Market gain impetus due to the growing demand over 2026 – Markets Gazette 24

Global Cord Stem Cell Banking Market By Storage Type (Private Banking, Public Banking), Product Type (Cord Blood, Cord Blood & Cord Tissue), Service Type (Collection & Transportation, Processing, Analysis, Storage), Source (Umbilical Cord Blood, Bone Marrow, Peripheral Blood Stem, Menstrual Blood), Indication (Cerebral Palsy, Thalassemia, Leukemia, Diabetes, Autism), Geography (North America, South America, Europe, Asia-Pacific, Middle East and Africa) Industry Trends and Forecast to 2026

Market Analysis: Global Cord Stem Cell Banking Market

Global Cord stem cell banking market is estimated to reach USD 13.8 billion by 2026 registering a healthy CAGR of 22.4%. The increasing number of parents storing their childs cord blood, acceptance of stem cell therapeutics, high applicability of stem cells are key driver to the market.

Market Definition: Global Cord Stem Cell Banking Market

Cord stem cells banking is nothing but the storing of the cord blood cell contained in the umbilical cord and placenta of a newborn child. This cord blood contains the stem cells which can be used in future to treat disease such as leukemia, thalassemia, autoimmune diseases, and inherited metabolic disorders, and few others.

Market Drivers

Market Restraint

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Segmentation: Global Cord Stem Cell Banking Market

By Storage Type

By Product Type

By Service Type

By Indication

By Source

By Geography

Key Developments in the Market:

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Competitive Analysis: Global Cord Stem Cell Banking Market

Global cord stem cell banking market is highly fragmented and the major players have used various strategies such as new product launches, expansions, agreements, joint ventures, partnerships, acquisitions and others to increase their footprints in this market. The report includes market shares of cord stem cell banking market for Global, Europe, North America, Asia Pacific, South America and Middle East & Africa.

Key Market Competitors: Global Cord Stem Cell Banking Market

Few of the major market competitors currently working in the global cord stem cell banking market are CBR Systems, Inc., Cordlife, Cells4Life Group LLP, Cryo-Cell International, Inc., Cryo-Save AG, Lifecell, StemCyte India Therapeutics Pvt. Ltd, Viacord, SMART CELLS PLUS., Cryoviva India, Global Cord Blood Corporation, National Cord Blood Program, Vita 34, ReeLabs Pvt. Ltd., Regrow Biosciences Pvt. Ltd. , ACROBiosystems., Americord Registry LLC., New York Blood Center, Maze Cord Blood, GoodCell., AABB, Stem Cell Cryobank, New England Cryogenic Center, Inc. among others

Research Methodology:Global Cord Stem Cell Banking Market

Data collection and base year analysis is done using data collection modules with large sample sizes. The market data is analysed and forecasted using market statistical and coherent models. Also market share analysis and key trend analysis are the major success factors in the market report. To know more pleaseRequest an Analyst Callor can drop down your inquiry.

The key research methodology used byDBMR Researchteam is data triangulation which involves data mining, analysis of the impact of data variables on the market, and primary (industry expert) validation. Apart from this, other data models include Vendor Positioning Grid, Market Time Line Analysis, Market Overview and Guide, Company Positioning Grid, Company Market Share Analysis, Standards of Measurement, Top to Bottom Analysis and Vendor Share Analysis. To know more about the research methodology, drop in an inquiry to speak to our industry experts.

Primary Respondents

Demand Side: Doctors, Surgeons, Medical Consultants, Nurses, Hospital Buyers, Group Purchasing Organizations, Associations, Insurers, Medical Payers, Healthcare Authorities, Universities, Technological Writers, Scientists, Promoters, and Investors among others.

Supply Side: Product Managers, Marketing Managers, C-Level Executives, Distributors, Market Intelligence, and Regulatory Affairs Managers among others.

Reasons to Purchase this Report

Customization of the Report:

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Originally posted here:
Discover the Global Cord Stem Cell banking Market gain impetus due to the growing demand over 2026 - Markets Gazette 24

Recommendation and review posted by Bethany Smith

Cocker Spaniel Coco goes to US to try and save her puppy’s life – Lancaster and Morecambe Citizen

ONE man and his dog are travelling to North Carolina this week, to provide a puppy with a pioneering stem cell transplant that could save her life.

Robert Alcock and his cocker spaniel, Coco, are making the journey so Coco, 7, can donate her stem cells to one of her own puppies, Millie, 6, who has cancer.

The experimental procedure is not yet available in the UK and can only be performed at one US hospital, the NC State Veterinary Hospital.

It involves using stem cells from the bone marrow of one dog and injecting them into the other.

Even if the operation is a success, there is only a 50 percent chance that Millie will be cured.

Millie was taken to the USA when her owners, Serena and Andrew Lodge, emigrated for work. After moving across the pond, Millie contracted cancer.

Millie the dog last week and (inset) before she became ill

Mr Alcock, who lives in Darwen, said the only way to help her is the transplant.

The 52-year-old catering manager said: Serena and Andrew started chemo on Millie three months ago but theyve been told the only chance theyll have of curing her is if they find a positive donor so she can have a transplant.

They contacted us, and we sent some blood samples for testing, along with samples from one of Cocos other pups.

They both came back positive but because Coco is Millies mother the vet said she would be a better match.

Mr and Mrs Lodge then asked Mr Alcock if he would fly to the USA with Coco so she could help save Millies life.

On Wednesday, Mr Alcock made the journey to North Carolina, to the only animal hospital in the States that can perform that kind of transplant on dogs.

Mr Alcock added: The Lodges have paid for everything, and I didnt like to ask how much the operation is costing but I think it will be in the thousands.

We will be in America for about a week.

Coco will go into hospital on Sunday for the procedure and then the cells will be donated on Monday.

Coco is expected to make a full recovery from the operation, but there is only a 50 per cent chance that Millie could be cured once the transplant has been completed.

Robert and Coco

Mr Alcock added: If it was a human then the chances of survival would be really good.

But this is a pioneering procedure, they havent done very many of these transplants before, so well have to wait and see what happens.

See the original post:
Cocker Spaniel Coco goes to US to try and save her puppy's life - Lancaster and Morecambe Citizen

Recommendation and review posted by Bethany Smith

Global PNH and aHUS Industry: Sales, Revenue, Market Share and Competition by Manufacturer Covered in a Latest Research – Exchange 99

PNH and aHUS, both are extremely rare and genetic diseases. Due to PNH, destruction of red blood cells of a person occurs quite sooner than it should. It is an acquired hematopoietic stem cell disorder. Hematopoietic stem cells are developed in bone marrow and eventually turn into red blood cells, white blood cells and platelets. A person with PNH has some defected hematopoietic cells which create defective red blood cells. These defective cells are highly susceptible to premature destruction by the complement system. aHUS is a disorders in which blood clots are formed in small blood vessels throughout the body. TMA can lead to heart stroke, attack, kidney failure and death. Soliris is the only drug treatment available in the market for treating these diseases.

Access Report Details at: https://www.themarketreports.com/report/global-pnh-and-ahus-market-by-manufacturers-countries-type-and-application-forecast

Market share of global PNH and aHUS industry is dominate by companies like Alexion Pharmaceuticals, Alnylam Pharmaceuticals, Omeros Corporation, RA Pharmaceuticals and others which are profiled in this report as well in terms of Sales, Price, Revenue, Gross Margin and Market Share (2018-2019).

There are 15 Chapters to deeply display the global PNH and aHUS market.

Chapter 1, to describe PNH and aHUS Introduction, product scope, market overview, market opportunities, market risk, market driving force;

Chapter 2, to analyze the top manufacturers of PNH and aHUS, with sales, revenue, and price of PNH and aHUS, in 2017 and 2019;

Chapter 3, to display the competitive situation among the top manufacturers, with sales, revenue and market share in 2017 and 2019;

Chapter 4, to show the global market by regions, with sales, revenue and market share of PNH and aHUS, for each region, from 2013 to 2019;

Chapter 5, 6, 7, 8 and 9, to analyze the key regions, with sales, revenue and market share by key countries in these regions;

Chapter 10 and 11, to show the market by type and application, with sales market share and growth rate by type, application, from 2013 to 2019;

Chapter 12, PNH and aHUS market forecast, by regions, type and application, with sales and revenue, from 2019 to 2024;

Chapter 13, 14 and 15, to describe PNH and aHUS sales channel, distributors, traders, dealers, Research Findings and Conclusion, appendix and data source

Purchase this premium research report at: https://www.themarketreports.com/report/buy-now/1502309

Market Segment by Regions, regional analysis covers:

North America (USA, Canada and Mexico)

Europe (Germany, France, UK, Russia and Italy)

Asia-Pacific (China, Japan, Korea, India and Southeast Asia)

South America (Brazil, Argentina, Columbia, etc.)

Middle East and Africa (Saudi Arabia, UAE, Egypt, Nigeria and South Africa)

Market Segment by Type, covers:

PNH

aHUS

Market Segment by Applications, can be divided into

Hospitals

Ambulatory Surgical Centers

Diagnostic Centers

Others

Ask your report related queries at: https://www.themarketreports.com/report/ask-your-query/1502309

Read more:
Global PNH and aHUS Industry: Sales, Revenue, Market Share and Competition by Manufacturer Covered in a Latest Research - Exchange 99

Recommendation and review posted by Bethany Smith

Tearful dad meets woman who saved his life and gave him future with his son – Liverpool Echo

This is the poignant moment a dad and his young family broke down as they met the woman who saved his life.

James O'Donnell, 43, was running out of options after being diagnosed with aplastic anemia, a blood disorder similar to leukaemia, in 2016.

Usual treatments were failing and James was undergoing a blood transfusion every week while battling constant infections.

James, from Burnage in Manchester, feared his luck was out and despaired at the pain his death could cause his eight-year-old son Harrison.

But in a stunning stroke of fortune, his saviour was only the other side of the M62; Liverpool Council admin worker Leah McDougall.

The 29-year-old mum, from Bootle , had taken the time to sign up to the register of potential stem cell donors on her lunch break at a pop-up stall, organised by blood cancer charity DKMS, the previous year.

James, who despite his Manc heritage is an avid Liverpool FC fan, told staff at he charity that he would be up for meeting his donor, who could have been anyone from a number of European countries using the register.

James, along with his wife Andrea and young Harrison, got the chance to meet Leah for the first time at a DKMS charity gala in London on Wednesday last week (November 6).

James, who says he finally feels like himself after a long period of illness, told the ECHO: "I was just getting chest infections and water infections all the time.

"I am quite a healthy person, and I was in good shape and I knew I should not be getting ill all the time."

He said after a few weeks of tests his was invited to take a bone marrow biopsy and was told the devastating news on his 40th birthday.

The disease meant James's bone marrow was not producing enough white blood cells, but doctors told him a treatment called anti-thymocite globulin (ATG) had "75% chance" of success.

However when that failed, fear and doubt began to creep in for James.

He said: "We are always saying I would get through this, we were thinking I would get better. But I started to think it's not happening, it's not going to be for me, this.

"I thought, I have been good in life, I need some luck. We were having a really hard time. My son was four or five then, and it was hard for him having a dad going from playing football with him to being in hospital."

Eventually doctors revealed the only option was for James to have a bone marrow transplant.

The O'Donnells went through further disappointment when tests on his three siblings revealed none were a match, so the waiting game to find a suitable donor began.

But on a March day in 2017, he got a call to say: "We have got a perfect match, a 10 out of 10."

The operation was a success and after four weeks doctors told James the new bone marrow cells were taking effect.

He said: "We were so lucky to find a donor only about 25 miles away. Some people never find one and we had one on our doorstep."

The powerful emotion of meeting Leah last week is summed up by James: "It was the second best moment of my life after my son being born.

"What she has done means that I can see my son growing up and that he has a father."

Leah did not hesitate to agree to help a total stranger when she was asked by DKMS.

Describing the moment she met James and his family, she told the ECHO: "We were both speechless. When I walked on stage we were just hugging each other for ages.

"It is weird, we felt like we had known each other for years, I felt like I had known him my whole life.

"It just takes five minutes out of your time to sign up to the register; that's like going to the kitchen to make a drink.

"You just think about the impact it is going to have on someone, it is saving someone's life. I feel lucky to have been able to give something back."

James says his family and Leah are planning to meet up again, possibly at a Liverpool FC game.

He said: "Without her, I wouldn't have a future."

DKMS has urged anyone aged 17-55, and in general good health, to sign up to the register here .

Dr Manos Niklolousis, Haematologist at University Hospital Birmingham NHS Foundation Trust, said:"Blood stem cells can be used to treat a wide range of blood cancers and blood disorders and we urgently need more people to come forward as donors.

"Currently, only 2% of the UK population are registered so matching donors with patients isnt easy within a growing multicultural population.

"Many of those in need are unable to find a sibling match and so rely on the generosity of strangers, and a blood stem cell transplant can be some patients only hope of survival.

"As a doctor who treats people with blood cancer or disorders, it is upsetting to know that some patients could have been saved if only more potential donors were registered and available to donate. I look forward to the day when there will be a donor for every patient in need."

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Tearful dad meets woman who saved his life and gave him future with his son - Liverpool Echo

Recommendation and review posted by Bethany Smith

Secret Shopper: What supplements are best to boost immunity? – New Hope Network

NFM Secret Shopper: Im confused about whats best to boost my immunity. Is it zinc, vitamin C, vitamin D, elderberry or something else?

Retailer: Any of those can help with immunity, but it depends on when you take them. Vitamin C is good for when you already have a cold, but if you eat your fruits and veggies, you probably dont need to take a vitamin C supplement all the time. Same with zinc and elderberry. But vitamin D is a supplement you might need every day, depending on your levels.

NFM: That makes sense. Any other supplements youd recommend, especially for cold and flu season?

Retailer: Garlic is popular and seems to work pretty well for immunity.

Our expert educator: Yufang Lin, M.D., of the Cleveland Clinics Center for Integrative and Lifestyle Medicine

Immunity is very complex. As an integrative practitioner, I look at the whole picture, so the first things I suggest are getting enough sleep, hydrating well and eating healthy. As for specific foods that boost immunity, garlic and ginger are both antimicrobial, antifungal and antiviral. You can use them in your day-to-day cooking, but if you are getting sick, definitely step up your intake, whether through food or supplements. Ginger, which is also anti-inflammatory, can also be made into tea.

There is data showing that both vitamin C and zinc support the immune system when you are sick. They are particularly useful in the first few days of illness, as they can reduce the duration and severity. But use these supplements only as needed, not on a long-term basis.

Elderberry is a diuretic, so if you are running a fever, it can help you sweat it out. Another supplement, echinacea, revs up the immune system, so it is great for fighting off a cold or even for the early stages of the flu. The problem with echinacea is it can stimulate the immune system too much, which is bad if you have an autoimmune disease. But for most people, it can be very helpful, but take it only for three to five days.

Vitamin D is a hormone so it generally has many benefitsfor mood, bone health and immune support. But it is more for day-to-day care, not to start taking once you get sick.

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Secret Shopper: What supplements are best to boost immunity? - New Hope Network

Recommendation and review posted by Bethany Smith


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