Jakobe Kobe Washington is eight years old, loves baseball and is fighting an aggressive form of leukemia.

The Florida boy, who is known to pray for other kids in the hospital, needs life-saving blood stem cells or a bone marrow transplant. So far, his family has been unable to find a match.

On Saturday, Be The Match and the Icla da Silva Foundation will host a drive-through swab event at Irving Mall to try to find a match for Kobe, who has extended family in North Texas.

Its tough to see your kid fighting a fight, and you cant do anything but be there to support him, no control in it at all, Kobes father Jordan Washington, who is from Dallas, told the ABC affiliate in Tampa Bay, Fla.

Every year, more than 12,000 patients turn to Be The Match, a national marrow donation program, to search for blood stem cells or a bone marrow donor to help cure them of blood cancers, such as leukemia and lymphoma, according to a release about the event.

Roughly half of those patients are unable to find a match, with only 23% of Black patients like Kobe finding a match, compared to 77% of white patients, according to the Icla da Silva Foundation, which serves as a recruitment center for Be The Match and focuses on minority populations.

Thats because race and ethnicity play a key role in stem cells and marrow, and of the 22 million potential donors on the registry, only 4% are Black.

Potential donors ages 18 to 44 are encourages to go to the Irving Mall, 3880 Irving Mall, between 10 a.m. and 2 p.m. Saturday.

Participants will then register from their phones and take a swab of their inner cheek.

Those unable to attend can text 4Kobe to 61474 to complete the online registration and have a cheek swab kit sent to their home.

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An 8-year-olds search for bone marrow match in battle with leukemia comes to North Texas - The Dallas Morning News

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PHOENIX, March 4, 2021 /PRNewswire/ --(OTC - CELZ)Creative Medical Technology Holdings announced today a publication in the pre-print server SSRN describing data from its first 15 patients treated in a clinical trial evaluation perispinal injection of bone marrow cells in patients with disc degenerative disease. Evaluation of patients at 30,60 90, 180, and 360 days revealed significant improvement in mobility and reduction in pain score . The mean pain changed from 8.9 at baseline to 4.3 at 30 days and sustained to 1.8 at 6 months and 1.3 at 12 months with a gradual reduction in overall pain medication utilization guided by their healthcare team. No serious adverse effects were noted with some short-term bruising in two patients at the harvest site and no long term adverse events where reported related to the procedure.

"This publication, which is "pre-peer review" describes what to our knowledge is the first demonstration of a signal of clinical efficacy by injecting stem cells in areas surrounding the disc." Said Dr Amit Patel, Board Member and Co-Founder of the Company. "While others have intra-disc injection may help disc pain, the current work regenerates the blood supple to the disc, allowing the disc to heal itself."

The autologous utilization of bone marrow falls under the "minimal manipulation exception" and can be commercialized rapidly, in the same manner that the Company commercialized Caverstem for treatment of erectile dysfunction.

Granted United States Patent #9,598,673 which is owned by the Company covers the use of any mesenchymal stem cells, both from the patient or from donors, for reduction of lower back pain when injected into the major muscles of the lower back.

"Disc degenerative disease represents a multi-billion dollar market for which current medical solutions do not address the underlying cause, while surgery is expensive and not applicable for a significant number of patients." Said Timothy Warbington, President and CEO of the Company. "We are excited to follow the path we did with CaverStem and initiate commercialization of this technology for American patients."

To view our Publication: https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3797402

About Creative Medical Technology HoldingsCreative Medical Technology Holdings, Inc. is a commercial stage biotechnology company specializing in regenerative medicine/stem cell technology in the fields of immunotherapy, urology, neurology and orthopedics and is listed on the OTC under the ticker symbol CELZ. For further information about the company, please visitwww.creativemedicaltechnology.com.

Forward Looking StatementsOTC Markets has not reviewed and does not accept responsibility for the adequacy or accuracy of this release. This news release may contain forward-looking statements including but not limited to comments regarding the timing and content of upcoming clinical trials and laboratory results, marketing efforts, funding, etc. Forward-looking statements address future events and conditions and, therefore, involve inherent risks and uncertainties. Actual results may differ materially from those currently anticipated in such statements. See the periodic and other reports filed by Creative Medical Technology Holdings, Inc. with the Securities and Exchange Commission and available on the Commission's website atwww.sec.gov.

http://www.StemSpine.comwww.CaverStem.comwww.FemCelz.com

SOURCE Creative Medical Technology Holdings, Inc.

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Creative Medical Technology Holdings Publishes Efficacy in Pain Reduction and Mobility in Patients with Disc Degenerative Disc Using StemSpine...

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CAMBRIDGE, Mass.--(BUSINESS WIRE)--Mar 3, 2021--

Magenta Therapeutics (Nasdaq: MGTA), a clinical-stage biotechnology company developing novel medicines to bring the curative power of stem cell transplants to more patients, today reported financial results for the fourth quarter and full-year ended December 31, 2020 and recent program highlights.

Building on our momentum from 2020, we continue to advance our portfolio with now two active Phase 2 clinical trials evaluating MGTA-145 plus plerixafor in patients with blood cancers undergoing autologous and allogeneic stem cell transplant and an additional planned Phase 2 clinical trial evaluating stem cell mobilization and collection in patients with sickle cell disease in partnership with bluebird bio. We have also made additional progress in our preparations for an IND filing for our MGTA-117 targeted conditioning program based on communications with the FDA and the advancement of our IND-enabling studies, said Jason Gardner, D.Phil., President and Chief Executive Officer, Magenta Therapeutics. We very much look forward to generating clinical data during the course of 2021 in these multiple disease settings.

MGTA-145: Stem Cell Mobilization and Collection for Hematopoietic Stem Cell Transplantation and Gene Therapy

Magenta is developing MGTA-145 plus plerixafor to harness these agents complementary mechanisms to mobilize hematopoietic stem cells (HSCs) for collection and transplantation, including for use with gene therapies. The ability to provide rapid, reliable, predictable and safe mobilization and collection of HSCs in stem cell transplantation and gene therapy could position MGTA-145 plus plerixafor to be the preferred mobilization regimen across multiple diseases due to improved patient experience and collection outcomes.

MGTA-145 Current and Planned Activity:

MGTA-145 Recent and Upcoming Scientific Conference Presentations:

MGTA-117: Targeted Conditioning

Magenta is developing a platform of novel antibody-drug conjugates (ADCs) for conditioning, a step in the transplant process that currently relies on the use of systemic chemotherapy agents and radiation. Magentas targeted conditioning programs are designed to selectively eliminate stem cells and/or immune cells from a patient prior to transplant or gene therapy, and to reduce or potentially eliminate the need for high dose or high intensity chemotherapy-based regimens.

MGTA-117, Magentas most advanced conditioning program, is a CD117-targeted antibody conjugated to amanitin and intended for use in patients undergoing transplant. MGTA-117 is designed to deplete hematopoietic stem and progenitor cells to clear space in the bone marrow prior to transplant in support of long-term engraftment and improved disease outcomes in patients. MGTA-117 has shown high selectivity, potent efficacy and tolerability in multiple preclinical studies.

Targeted Conditioning Current and Planned Activity:

Targeted Conditioning Recent and Upcoming Scientific Conference Presentations:

Cash Position: Cash, cash equivalents and marketable securities as of December 31, 2020, were $148.8 million, compared to $145.7 million as of December 31, 2019. Magenta anticipates that its cash, cash equivalents and marketable securities will be sufficient to fund operations and capital expenditures into 2023.

Research and Development Expenses: Research and development expenses were $12.3 million in the fourth quarter of 2020, compared to $18.7 million in the fourth quarter of 2019. The decrease was driven primarily by decreased preclinical costs for manufacturing related to the conditioning programs, lower manufacturing and clinical trial costs due to the discontinuance of enrollment in the Phase 2 clinical trial of MGTA-456 in inherited metabolic diseases in June 2020 and lower clinical trial costs for the MGTA-145 Phase 1 clinical trial which was completed in the first quarter of 2020.

General and Administrative Expenses: General and administrative expenses were $6.8 million for the fourth quarter of 2020, compared to $5.9 million for the fourth quarter of 2019. The increase was primarily due to an increase in personnel costs, professional services and insurance costs associated with Magentas expanded clinical trial preparations.

Net Loss: Net loss was $18.2 million for the fourth quarter of 2020, compared to net loss of $23.2 million for the fourth quarter of 2019.

About Magenta Therapeutics

Magenta Therapeutics is a clinical-stage biotechnology company developing medicines to bring the curative power of immune system reset through stem cell transplant to more patients with blood cancers, genetic diseases and autoimmune diseases. Magenta is combining leadership in stem cell biology and biotherapeutics development with clinical and regulatory expertise, a unique business model and broad networks in the stem cell transplant community to revolutionize immune reset for more patients.

Magenta is based in Cambridge, Mass. For more information, please visit http://www.magentatx.com.

Follow Magenta on Twitter: @magentatx.

Forward-Looking Statement

This press release may contain forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995 and other federal securities laws, including express or implied statements regarding Magentas future expectations, plans and prospects, including, without limitation, statements regarding expectations and plans for presenting pre-clinical and clinical data, projections regarding future revenues and financing performance, our long-term growth, cash, cash equivalents and marketable securities, the anticipated timing of our clinical trials and regulatory filings, the development of our product candidates and advancement of our preclinical programs, the timing, progress and success of our collaborations, as well as other statements containing the words anticipate, believe, continue, could, endeavor, estimate, expect, anticipate, intend, may, might, plan, potential, predict, project, seek, should, target, will or would and similar expressions that constitute forward-looking statements under the Private Securities Litigation Reform Act of 1995. The express or implied forward-looking statements included in this press release are only predictions and are subject to a number of risks, uncertainties and assumptions, including, without limitation: uncertainties inherent in clinical studies and in the availability and timing of data from ongoing clinical studies; whether interim results from a clinical trial will be predictive of the final results of the trial; whether results from preclinical studies or earlier clinical studies will be predictive of the results of future trials; the expected timing of submissions for regulatory approval or review by governmental authorities; regulatory approvals to conduct trials or to market products; whether Magenta's cash resources will be sufficient to fund Magenta's foreseeable and unforeseeable operating expenses and capital expenditure requirements; risks, uncertainties and assumptions regarding the impact of the continuing COVID-19 pandemic on Magentas business, operations, strategy, goals and anticipated timelines, Magentas ongoing and planned preclinical activities, Magentas ability to initiate, enroll, conduct or complete ongoing and planned clinical trials, Magentas timelines for regulatory submissions and Magentas financial position; and other risks concerning Magenta's programs and operations are described in additional detail in its Annual Report on Form 10-K expected to be filed on or about March 3, 2021, its Quarterly Reports on Form 10-Q and its other filings made with the Securities and Exchange Commission from time to time. Although Magenta's forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Magenta. As a result, you are cautioned not to rely on these forward-looking statements. Any forward-looking statement made in this press release speaks only as of the date on which it is made. Magenta undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future developments or otherwise.

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Magenta Therapeutics Reports Fourth Quarter and Full-Year 2020 Financial Results and Recent Program Highlights - Tullahoma News and Guardian

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COSELA is the first myeloprotection therapy indicated to reduce the incidence of chemotherapy-induced myelosuppression in adult patients. Credit: G1 Therapeutics. Small cell lung cancer represents nearly 10% to 15% of all lung cancer cases. Credit: BonD80 / Shutterstock. Trilaciclib is a competitive inhibitor of cyclin dependent kinases 4 and 6 (CDK4/6). Credit: StudioMolekuul / Shutterstock.

COSELA (trilaciclib) is the first approved myeloprotection therapy indicated to reduce the occurrence of chemotherapy-induced bone marrow suppression in adult patients.

Developed by G1 Therapeutics (GTHX), a US-based clinical-stage biopharmaceutical company, the drug is available in a single-dose vial as a sterile, preservative-free, yellow lyophilised cake in a 300mg dosage strength for intravenous administration.

In June 2020, G1 Therapeutics signed a three-year co-promotion agreement with German pharmaceutical firm Boehringer Ingelheim (BI) to jointly promote trilaciclib for the treatment of small cell lung cancer in the US and Puerto Rico.

Under the agreement, G1 Therapeutics will lead marketing, market access and medical engagement initiatives for COSELA while Boehringer Ingelheim will undertake salesforce engagements.

In August 2020, China-based Simcere Pharmaceutical Group was granted the development and commercialisation rights of the drug in all indications for Greater China.

The New Drug Application (NDA) for trilaciclib was submitted to the US Food and Drug Administration (FDA) in June 2020 and granted priority review in August 2020.

In February 2021, the FDA approved trilaciclib to reduce chemotherapy-induced myelosuppression in extensive-stage small cell lung cancer (ES-SCLC) patients, prior to chemotherapy treatments involving platinum-etoposide or topotecan options. The FDA also bestowed breakthrough therapy designation to trilaciclib in August 2019.

Myelosuppression, also known as bone marrow suppression, is a chemotherapy-induced bone marrow damage condition that lowers blood cell production.

Although chemotherapy drugs are used to destroy cancer cells, they can also cause damage to healthy cells in the bone marrow such as hematopoietic stem and progenitor cells (HSPCs), which produce white blood cells, red blood cells and platelets.

Myelosuppression is a side effect of chemotherapy and occurs when the hematopoietic stem and progenitor cells are damaged by chemotherapy treatment, thereby suppressing the ability of bone marrow to produce blood cells.

The common symptoms associated with myelosuppression include fatigue, shortness of breath, and dizziness. Myelosuppression can also lead to serious blood cell diseases such as anaemia, neutropenia and thrombocytopenia.

Trilaciclib is a transient and competitive inhibitor of cyclin-dependent kinases 4 and 6 (CDK4/6). The drug delivers a myeloprotective therapy against chemotherapy-induced bone marrow suppression by inhibiting CDK4/6 that regulates cell cycle.

By inhibiting CDK4/6, trilaciclib temporarily and reversibly induces G1 cell cycle arrest in hematopoietic stem and progenitor cells (HSPCs) and prevents transition to the synthesis phase (S phase) of cell cycle, thus protecting the HSPCs from the damaging effects of chemotherapy and maintaining the normal function of the bone marrow.

COSELAs FDA approval was based on the outcome of three randomised, double-blind, placebo-controlled clinical trials in patients with extensive-stage small cell lung cancer. The effectiveness of drug was evaluated in combination with carboplatin-etoposide, with or without atezolizumab and topotecan chemotherapy.

The studies randomly enrolled 245 patients to receive either intravenous (IV) trilaciclib or placebo prior to the start of chemotherapy.

The primary endpoints of the studies were the percentage of patients with severe neutropenia and its duration during the first chemotherapy cycle.

The trials demonstrated clinical reduction in the duration and severity of neutropenia among ES-SCLC patients who received trilaciclib before chemotherapy.

A positive impact on red blood cell transfusions and other myeloprotective measures was also observed.

The most frequent side effects observed in the patients during the clinical trials were fatigue, hypophosphatemia, hypocalcaemia, hypokalaemia, headache, high aspartate aminotransferase levels and pneumonia. More than 3% of the patients who received COSELA experienced serious adverse reactions, including respiratory failure, haemorrhage and thrombosis.

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COSELA (trilaciclib) for the Treatment of Chemotherapy-Induced Myelosuppression - Clinical Trials Arena

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Eight labs who were recipients of the University Cancer Centers funding in December for projects advancing cancer research will use the funds to delve into cancer biology, cancer therapeutics and population science.

Four of the eight projects are investigating immunotherapy for gastrointestinal cancers, the tumor environments impact on cancer cell growth, the potential application of an FDA-approved Parkinsons drug to treat glioma brain tumors and the ability of a novel drug to target cancer cells that exhibit heightened aggressiveness following immunotherapy, The Herald previously reported.

The Herald spoke with three of the four other principal investigators that received grants.

Assistant Professor of Medicine Hina Khans pilot project will study the effects of blocking the antibody for chitinase 3-like-1, or CHI3L1, in advanced non-small cell lung cancer. CHI3L1 is a protein that plays an important role in tissue repair, and elevated levels of the protein indicate poor outcomes in advanced stage cancer patients. The researchers will test whether blocking the antibody a molecule that binds CHI3L1 will prevent cell resistance to immune checkpoint inhibitors in this type of lung cancer.

Assistant Professor of Medicine Olin Liang is interested in exploring womens ability to fight off leukemia and other blood diseases later in life relative to men. While the effect of aging on blood cancer development has been well-studied, not much research has gone into studying sex differences, Liang said.

Past work from the Liang lab has shown that the bone marrow environment remains healthier longer in women, leading to better blood cell production and immune response. By transplanting bone marrow stem cells from young male mice into middle-aged male and female mice, the researchers were able to compare the expression of these cells amongst the two sexes. They found higher expression in female middle-aged mice, which is indicative of a healthier bone marrow environment. This observation was due to receptors molecules that can interact with hormones to produce a response in a cell on the surface of bone marrow stem cells that were uniquely responsive to sex hormones predominantly found in women.

We have narrowed it down to two sex hormone receptors that may play a role, Liang said, referring to the receptors for follicle-timulating hormone and androgen hormone. The lab plans to use the Cancer Center pilot project funds to further study the importance of these receptors.

Using gene editing technology, the researchers plan on removing genes that code for these hormone receptors from model organisms. This step will allow them to test the effect that the loss of one or both of the receptors has on female stem cell expression levels. If the elimination of the sex hormone receptor diminishes stem cell expression, that may indicate that the receptor plays a regulatory role.

The Liang lab believes that results from these experiments will not only offer greater insight to the development of blood cancers, but also help in the formulation of sex-specific treatments. Liang hopes this research leads to treatments that enhance the male (blood cell producing) system to reduce risk of age-related blood cancer, or even other diseases.

Assistant Professor of Molecular Biology, Cell Biology and Biochemistry Mamiko Yajima studies the expression of germline molecules, which are normally only expressed during development, and how they contribute to plasticity, or the cells adaptability. Her pilot project will focus on the specific germline factor DEAD-Box Helicase 4 (DDX4), which has been found to be abnormally expressed in the tumors of certain cancers, such as small cell lung cancer and melanoma.

Yajimas lab has previously studied the expression of DDX4 in cells and organisms like sea urchins and mice. She plans to test if (DDX4) actually contributes to plasticity in the context of cancer. Yajima believes that as a germline factor, DDX4 may increase cancer cells adaptability, allowing them to develop drug resistance and migrate throughout the body more frequently.

The Yajima lab plans on using the Cancer Center funding to partner with Director of Thoracic Oncology at Rhode Island Hospital Christopher G. Azzoli and Associate Professor of Pathology and Laboratory Medicine Maria L. Garcia-Moliner to analyze DDX4 expression in cancer patient samples.

I applied for this funding with the specific goal to have access to clinical samples, Yajima said. This next stage of the project will facilitate collaboration between me, a basic biologist, and physician scientists that have the expertise to help me answer the question I want to study in a clinical setting.

To identify whether DDX4 expression correlates with patient survival, the lab will also use the funds to conduct clinical data mining of patient gene expression using the Universitys supercomputer.

Associate Professor of Dermatology and Epidemiology Eunyoung Cho studies the role of dietary factors in the development of chronic diseases. Previous work from Chos lab found that eating foods containing high levels of citrus, such as grapefruits, oranges and figs, is associated with an increased risk of skin cancer. The Cho lab plans to use the Cancer Center pilot project funds to determine the component of citrus fruit responsible for the increased risk of melanoma, the most fatal type of skin cancer.

Cho believes that furanocoumarins, a class of compounds present in high levels in citrus fruits, are what lead to the higher rates of skin cancer. These compounds can absorb ultraviolet radiation from sunlight and become activated, damaging DNA and causing mutations that can result in cancer.

To test this hypothesis, Cho has partnered with Associate Professor of Medical Science Elena Oancea, who specializes in melanoma research at the molecular level. They plan on measuring whether melanin-forming skin cells show increased levels of DNA damage when exposed to furanocoumarins and UV light.

If their data supports that furanocoumarins increase risk of cancer, this could open the door to population-based studies. Cho described one potential future direction as assessing whether furanocoumarin levels in human urine samples are indicative of melanoma risk.

Its very interesting to think about citrus fruit is something you eat all the time, Cho said. People dont understand that when you eat grapefruit (and) then go into the sunlight, you may actually increase your chance of (getting) skin cancer.

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U. Cancer Center pilot projects: investigating cancer connections - The Brown Daily Herald

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EDMONTON -- Thirteen months old with her health deteriorating in an orphanage in China, Hosanna Crowell was introduced to a Canadian couple, Greg and Cathy Crowell, who would prove to be game changers in her life.

"I remember when they first handed her to us in the orphanage and we looked at her and she had such determination and this frail, little body," remembers Cathy Crowell. "She was sucking her two little fingers, looking around and taking it all in. I said to my husband, she's a fighter."

Now 14, Hosanna has never stopped fighting. Born with a heredity condition called Beta Thalissemia Major, her bone marrow produces deformed blood cells, preventing oxygen from sticking to them. Without the blood of donors, her organs would be starved of oxygen. Every two weeks she visits the Stollery Children's Hospital where she receives her transfusions. To date, she's had 286. But with other people's blood, comes complications. Each night she's given intravenous drugs over 11 hours to keep her body working.

"Right now it's becoming a burden to me," says Hosanna Crowell. "I have to get poked so much my veins are becoming really scar tissued and it's starting to be really hard to find spots."

The only cure is a stem cell transplant. "In terms of any individual, a sibling will have a one-in-four chance of being a match for any individual," says pediatric hematologist Dr. Catherine Corriveau-Borque.

The journey to find a match has been years in the making. "It's like finding a needle on the bottom of the ocean. It's way harder than in a haystack," according to Crowell.

A post on the Chinese version of Facebook garnered a lot of attention, viewed more than 27 million times. "The process was quite something and then seeing the response from China with so many people and it going viral... wow," recounts Crowell from her Stony Plain home. "The kindness of strangers just so impacted us."

The posts reached Hosanna's biological family. Her mother and father as well as two siblings came forward, did the DNA testing and underwent a procedure to see if there was a match. "Yes," says Hosanna Crowell, "one of my siblings is a perfect match."

A stem cell transplant is now scheduled for late 2021. The cost to make this happen sits around $80,000 to cover incidentals such as travel visas, transportation, accommodation and COVID-19 testing. A GoFundMe campaign is a quarter of the way there.

"Really we're just trying to jump through all the little hoops to get them here," Crowell adds. "This is an amazing thing that's happened, we've been given a gift for our daughter and we're very grateful. I also feel for people who are waiting for a donor and so I just encourage people to go and get tested, it's a simple thing. You can change someone's life forever."

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'Like finding a needle on the bottom of the ocean': Local teen finds perfect bone marrow match - CTV News Edmonton

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Newswise Injecting hydrogels containing stem cell or exosome therapeutics directly into the pericardial cavity could be a less invasive, less costly, and more effective means of treating cardiac injury, according to new research from North Carolina State University and the University of North Carolina at Chapel Hill.

Stem cell therapy holds promise as a way to treat cardiac injury, but delivering the therapy directly to the site of the injury and keeping it in place long enough to be effective are ongoing challenges. Even cardiac patches, which can be positioned directly over the site of the injury, have drawbacks in that they require invasive surgical methods for placement.

We wanted a less invasive way to get therapeutics to the injury site, says Ke Cheng, Randall B. Terry, Jr. Distinguished Professor in Regenerative Medicine at NCStates Department of Molecular Biomedical Sciences and professor in the NCState/UNC-Chapel Hill Joint Department of Biomedical Engineering. Using the pericardial cavity as a natural mold could allow us to create cardiac patches at the site of injury from hydrogels containing therapeutics.

In a proof-of-concept study, Cheng and colleagues from NCState and UNC-Chapel Hill looked at two different types of hydrogels one naturally derived and one synthetic and two different stem cell-derived therapeutics in mouse and rat models of heart attack. The therapeutics were delivered via intrapericardial (iPC) injection.

Via fluorescent imaging the researchers were able to see that the hydrogel spread out to form a cardiac patch in the pericardial cavity. They also confirmed that the stem cell or exosome therapeutics can be released into the myocardium, leading to reduced cell death and improved cardiac function compared to animals in the group who received only the hydrogel without therapeutics.

The team then turned to a pig model to test the procedures safety and feasibility. They delivered the iPC injections using a minimally invasive procedure that required only two small incisions, then monitored the pigs for adverse effects. They found no breathing complications, pericardial inflammation, or changes in blood chemistry up to three days post-procedure.

Our hope is that this method of drug delivery to the heart will result in less invasive, less costly procedures with higher therapeutic efficacy, Cheng says. Our early results are promising the method is safe and generates a higher retention rate of therapeutics than those currently in use. Next we will perform additional preclinical studies in large animals to further test the safety and efficacy of this therapy, before we can start a clinical trial.

I anticipate in a clinical setting in the future, iPC injection could be performed with pericardial access similar to the LARIAT procedure. In that regard, only one small incision under local anesthesia is needed on the patients chest wall, says Dr. Joe Rossi, associate professor in the division of cardiology at UNC-Chapel Hill and co-author of the paper.

The research appears inNature Communicationsand was supported by the National Institutes of Health and the American Heart Association. Dr. Thomas Caranasos, director of adult cardiac surgery at UNC-Chapel Hill, also contributed to the work.

-peake-

Note to editors: An abstract follows.

Minimally invasive delivery of therapeutic agents by hydrogel injection into the pericardial cavity for cardiac repair

DOI:10.1038/s41467-021-21682-7

Authors: Dashuai Zhu, Zhenhua Li, Ke Cheng, North Carolina State University; Thomas Caranasos, Joseph Rossi, University of North Carolina at Chapel HillPublished:March 3, 2021 inNature Communications

Abstract:Cardiac patch is an effective way to deliver therapeutics to the heart. However, such procedures are normally invasive and difficult to perform. Here, we developed and tested a method to utilize the pericardial cavity as a natural mold for in situ cardiac patch formation after intrapericardial (iPC) injection of therapeutics in biocompatible hydrogels. In rodent models of myocardial infarction (MI), we demonstrated that iPC injection is an effective and safe method to deliver hydrogels containing induced pluripotent stem cells-derived cardiac progenitor cells (iPS-CPCs) or mesenchymal stem cells (MSCs)-derived exosomes. After injection, the hydrogels formed cardiac patch-like structure in the pericardial cavity, mitigating immune response and increasing the cardiac retention of the therapeutics. With robust cardiovascular regeneration and stimulation of epicardium-derived repair, the therapies mitigated cardiac remodeling and improved cardiac functions post MI. Furthermore, we demonstrated the feasibility of minimally-invasive iPC injection in a clinically-relevant porcine model as well as in human patients. Collectively, our study establishes iPC injection as a safe and effective method to deliver therapeutics to the heart for cardiac repair.

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Pericardial Injection Effective, Less Invasive Way to Get Regenerative Therapies to Heart - Newswise

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This article was originally published here

Comput Biol Med. 2021 Feb 22;131:104293. doi: 10.1016/j.compbiomed.2021.104293. Online ahead of print.

ABSTRACT

BACKGROUND: Coronavirus disease 2019 (COVID-19) is an emerging infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Up to 20%-30% of patients hospitalized with COVID-19 have evidence of cardiac dysfunction. Xuebijing injection is a compound injection containing five traditional Chinese medicine ingredients, which can protect cells from SARS-CoV-2-induced cell death and improve cardiac function. However, the specific protective mechanism of Xuebijing injection on COVID-19-induced cardiac dysfunction remains unclear.

METHODS: The therapeutic effect of Xuebijing injection on COVID-19 was validated by the TCM Anti COVID-19 (TCMATCOV) platform. RNA-sequencing (RNA-seq) data from GSE150392 was used to find differentially expressed genes (DEGs) from human induced pluripotent stem cell-derived cardiomyocytes (hiPSC-CMs) infected with SARS-CoV-2. Data from GSE151879 was used to verify the expression of Angiotensin I Converting Enzyme 2 (ACE2) and central hub genes in both human embryonic-stem-cell-derived cardiomyocytes (hESC-CMs) and adult human CMs with SARS-CoV-2 infection.

RESULTS: A total of 97 proteins were identified as the therapeutic targets of Xuebijing injection for COVID-19. There were 22 DEGs in SARS-CoV-2 infected hiPSC-CMs overlapped with the 97 therapeutic targets, which might be the therapeutic targets of Xuebijing injection on COVID-19-induced cardiac dysfunction. Based on the bioinformatics analysis, 7 genes (CCL2, CXCL8, FOS, IFNB1, IL-1A, IL-1B, SERPINE1) were identified as central hub genes and enriched in pathways including cytokines, inflammation, cell senescence and oxidative stress. ACE2, the receptor of SARS-CoV-2, and the 7 central hub genes were differentially expressed in at least two kinds of SARS-CoV-2 infected CMs. Besides, FOS and quercetin exhibited the tightest binding by molecular docking analysis.

CONCLUSION: Our study indicated the underlying protective effect of Xuebijing injection on COVID-19, especially on COVID19-induced cardiac dysfunction, which provided the theoretical basis for exploring the potential protective mechanism of Xuebijing injection on COVID19-induced cardiac dysfunction.

PMID:33662681 | DOI:10.1016/j.compbiomed.2021.104293

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Network pharmacology and RNA-sequencing reveal the molecular mechanism of Xuebijing injection on COVID-19-induced cardiac dysfunction - DocWire News

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ST. LOUIS, Mo. Researchers in St. Louis are providing some much needed clarity about how COVID-19 impacts the human heart. COVID has been linked to cardiovascular complications for some time, but up until now its been a mystery as to how exactly the virus is interfering with the heart. For example, does the virus actually infect the heart itself? Or does it just cause inflammation which effects the cardiovascular system? Now, a team from Washington Universitys School of Medicine says theres evidence COVID-19 infects and replicates within carriers heart muscles cells.

This is of course bad news for the heart, which experiences cell death and muscle contraction issues as a result. In pursuit of an answer, the team used stem cells to create heart tissue modeling a COVID-19 infection.

Early on in the pandemic, we had evidence that this coronavirus can cause heart failure or cardiac injury in generally healthy people, which was alarming to the cardiology community, says senior author Kory J. Lavine, MD, PhD, in a university release.

Even some college athletes who had been cleared to go back to competitive athletics after COVID-19 infection later showed scarring in the heart. There has been debate over whether this is due to direct infection of the heart or due to a systemic inflammatory response that occurs because of the lung infection, the associate professor of medicine continues. Our study is unique because it definitively shows that, in patients with COVID-19 who developed heart failure, the virus infects the heart, specifically heart muscle cells.

Researchers also used stem cells to create tissues simulating heart muscle contractions. This process helped researchers to conclude that besides just killing heart muscle cells, COVID interferes with the organs contractions.

Notably, study authors add all of this heart damage can happen to an infected individual even if they show no signs of bodily inflammation.

Inflammation can be a second hit on top of damage caused by the virus, but the inflammation itself is not the initial cause of the heart injury, Lavine explains.

While this certainly isnt the first virus to impact the heart, the research team reports nothing is status quo when it comes to COVID-19. They explain that COVID-19 evokes a unique immune response dissimilar to anything seen when other viruses make contact with the heart.

COVID-19 is causing a different immune response in the heart compared with other viruses, and we dont know what that means yet, the researcher reports. In general, the immune cells seen responding to other viruses tend to be associated with a relatively short disease that resolves with supportive care. But the immune cells we see in COVID-19 heart patients tend to be associated with a chronic condition that can have long-term consequences. These are associations, so we will need more research to understand what is happening.

Researchers further confirmed their stem cell findings when they examined the real heart tissues from four COVID-19 patients.

Even young people who had very mild symptoms can develop heart problems later on that limit their exercise capacity, Lavine concludes. We want to understand whats happening so we can prevent it or treat it. In the meantime, we want everyone to take this virus seriously and do their best to take precautions and stop the spread, so we dont have an even larger epidemic of preventable heart disease in the future.

The study is published in JACC: Basic to Translational Science.

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COVID-19 kills heart muscle cells, interferes with a patients heartbeat - Study Finds

Cardiac Stem Cells Comments Off on COVID-19 kills heart muscle cells, interferes with a patients heartbeat – Study Finds | March 8th, 2021

The reportbegins with an overviewofProgenitor Cell Product andpresents throughout its development.It provides a comprehensive analysis of all regional and key player segments providing closer insights into current market conditions and future market opportunities, along with drivers, trend segments, consumer behavior, price factors and market performance and estimates.Forecast market information, SWOT analysis, Progenitor Cell Product market scenario, and feasibility study are the important aspects analyzed in this report.

The Progenitor Cell Product was valued at 12500 Billion US$ in 2021 and is projected to reach 17700 Billion US$ by 2025, at a CAGR of 5.1% during the forecast period.

Top Companies in the Global Progenitor Cell Product Market:NeuroNova AB, StemCells, ReNeuron Limited, Asterias Biotherapeutics, Thermo Fisher Scientific, STEMCELL Technologies, Axol Bio, R&D Systems, Lonza, ATCC, Irvine Scientific

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This report segments the global Progenitor Cell Product Market based onTypesare:Pancreatic progenitor cells

Cardiac Progenitor Cells

Intermediate progenitor cells

Neural progenitor cells (NPCs)

Endothelial progenitor cells (EPC)

Others

Based on Application, the Global Progenitor Cell Product Market is Segmented into:Medical care

Hospital

Laboratory

For the comprehensive understanding of market dynamics, the global Progenitor Cell Product Market is analysed across key geographies namely: United States, China, Europe, Japan, South-east Asia, India and others. Each of these regions is analysed on the basis of market findings across major countries in these regions for a macro-level understanding of the market.

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Impact of the Progenitor Cell Product market report:

A comprehensive evaluation of all opportunities and risks in the market. Progenitor Cell Product market ongoing the developments and significant occasions. A Detailed study of business techniques for the development of the market-driving players. Conclusive study about the improvement plot of Progenitor Cell Product market for approaching years. Top to a bottom appreciation of market-express drivers, targets and major littler scale markets. Favorable impression inside imperative mechanical and publicize latest examples striking the market.

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What are the Progenitor Cell Product market factors that are explained in the report?

-Key Strategic Developments:The study also includes the key strategic developments of the Progenitor Cell Product market, comprising R&D, new product launch, M&A, agreements, collaborations, partnerships, joint ventures, and regional growth of the leading competitors operating in the market on a global and regional scale.-Key Market Features:The report evaluated key market features, including revenue, price, capacity, capacity utilization rate, gross, production, production rate, consumption, import/export, supply/demand, cost, market share, CAGR, and gross margin. In addition, the study offers a comprehensive study of the key market dynamics and their latest trends, along with pertinent market segments and sub-segments.Analytical Tools:The Global Progenitor Cell Product Market report includes the accurately studied and assessed data of the key industry players and their scope in the market by means of a number of analytical tools. The analytical tools such as Porters five forces analysis, SWOT analysis, feasibility study, and investment return analysis have been used to analyze the growth of the key players operating in the market.

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Progenitor Cell Product Market 2021 Competitive Insights And Global Outlook ReNeuron Limited, Asterias Biotherapeutics, Thermo Fisher Scientific, ...

Cardiac Stem Cells Comments Off on Progenitor Cell Product Market 2021 Competitive Insights And Global Outlook ReNeuron Limited, Asterias Biotherapeutics, Thermo Fisher Scientific, … | March 8th, 2021

Biologic aging is a complex process. There are several theories on why and how we age, and it is probable that none of them account for all the aspects. We are constantly exposed to both internal and external stimuli that, over time, facilitate the aging process. These stimuli include ionizing radiation, ultraviolet light, diet, exercise, oxidative stresses, and perhaps, worst of all, smoking. All of these can trigger intracellular processes, including DNA methylation, or epigenetic change, telomere shortening and damage, DNA damage, and mitochondrial dysfunction. These factors accelerate cellular senescencewhat is thought to be the critical factor in aging and has been shown to increase with age.1,2

Cellular senescence is a condition in which a cell has lost the ability to proliferate, and senescent cells increase in almost all organs and tissues as we age. Over time, these changes ultimately lead to the development of significant comorbidities and the cumulative functional deficits we acquire during aging. However, senescent cells are metabolically active and can produce cytokines and inflammatory proteinsthe senescence-associated secretory phenotypefurther accelerating aging and promoting malignancy. FIGURE 1 illustrates the effect of age and insults on senescence.

Accumulation of senescent cells is implicated as a cause of tissue reprogramming, osteoporosis, glaucoma, neurodegeneration, type 2 diabetes, changes in the microbiome, immune system dysfunction, dysfunctional tissue repair and fibrosis, and cancer.3 Recent data have shown the potential role of chemotherapy and radiation therapy in accelerating aging. Nowhere is chemotherapys effect in accelerating aging more apparent than in children and adolescents treated successfully for childhood malignancy.4 In these patients, by the time they reach aged 35 years, approximately 30% have the clinical phenotype of a person aged 65 years, as evidenced by dramatic increases in cardiac disease and new second malignancies.

At the University of North Carolina Lineberger Comprehensive Cancer Center, we have focused on the effects of chemotherapy and accelerated aging in cancer. To date, we have studied the effects of chemotherapy on childhood cancer, early breast cancer, and bone marrow transplantation. Our research has explored the role of p16INK4a expression, a robust marker of biologic aging, following on the work of Norman E. Ned Sharpless, MD, director of the National Cancer Institute. p16INK4a encodes for a protein that blocks cyclin-dependent kinase, analogous to the cyclin-dependent kinase inhibitors now used in breast cancer, including palbociclib (Ibrance), ribociclib (Kisqali), and abemaciclib (Verzenio), that prevent cells from entering the cell cycle.5 This leads to cellular senescence. In murine models, aging is associated with dramatic changes in p16INK4a expression in almost all organs over the animals lifespan.6 In human studies, p16INK4a expression is measured in T lymphocytes using a reverse transcription-polymerase chain reaction as a surrogate for aging in other tissues. Studies of p16INK4a expression using other immunohistochemistry methods suggest changes in T cells represent mirror changes in other tissue, and further research in this area is underway.

The change in p16INK4a with aging is not linear, and after 60 years, it appears to plateau for unclear reasons.7 It is possible that those older persons who would have had high levels of p16INK4a expression have already died of age-related illness such as cardiovascular disease, and current studies are addressing this issue.

The large dynamic range of p16INK4a expressionapproximately 10-fold over the human lifespanmakes it an ideal biomarker for study. In healthy children and adolescents, p16INK4a expression is low to undetectable, with high levels appearing in older persons. FIGURE 2 shows the effect of age on p16INK4a expression in 594 patients. These data give p16INK4a expression the potential to be an accurate predictor of cell senescence in an individual patient.

For example, if one hypothesizes that senescent cells are less likely to replicate to ameliorate the adverse effects of chemotherapy (ie, myelosuppression or mucositis), then investigators might be able to accurately predict between 2 patients of the same ageone with high p16INK4a expression and one with lowthat the patient with higher expression would have less cellular reserve and be more vulnerable to adverse effects. Studies are underway to determine if p16INK4a expression measured before treatment will prove to be a predictive marker of toxicity for currently used adjuvant chemotherapy regimens.

Investigators have examined several hundred patients with early breast cancer and a smaller number with childhood cancer and after bone marrow transplantation, and they have found that most chemotherapy regimens cause rapid and sustained increases in p16INK4a expression. Changes are seen shortly and dramatically after beginning chemotherapy, persist over time, and are irreversible.5,8,9 In adolescents and young adults treated with chemotherapy, significant increases in p16INK4a expression were associated with frailty and represented a 35-year acceleration in age among frail young adult cancer survivors. These data mimic what has been clinically noted in large study of adults who had childhood cancer: Approximately one-third of young adults and childhood cancer survivors aged 35 years have a disease phenotype of a person aged 65 years.4 Our group has also found that p16INK4a expression rose markedly in patients treated with allogeneic or autologous stem cell transplants for hematologic malignancies. These patients had a 2- to 3-fold increase in p16INK4a expression corresponding to 16 to 28 years of accelerated aging.10

We have noted similar findings in women with early-stage breast cancer. In patients treated with adjuvant or neoadjuvant chemotherapy, especially with anthracycline-based regimens (doxorubicin, cyclophosphamide, and taxanes with or without carboplatin), p16INK4a expression rose dramatically during chemotherapy and persisted during follow-up. On average, chemotherapy accelerated aging by approximately 17 years of life span, with acceleration of 23 to 27 years for those treated with anthracycline-based treatment.

Of note, docetaxel/cyclophosphamide regimens were associated with only 11 years of aging, and we found no evidence that anti-HER2 therapy affected p16INK4a expression. In these studies, accelerated aging due to chemotherapy represents estimates based on the trajectory of p16INK4a expression in normal patients over their lifespan. We are uncertain of the long-term implications of these changes. In our breast cancer studies, baseline p16INK4a expression was also associated with fatigue. In a recent unpublished analysis (Mitin N, et al), the difference between a patients baseline p16INK4a expression and a normal value for a patient of the same agethe p16 gapwas highly predictive of chemotherapy-induced peripheral neuropathy with taxane chemotherapy. We also found that baseline p16INK4a expression is a significant predictor of a p16 change, independent of age or chemotherapy type, with those patients having lower baseline p16INK4a expression being more likely to have greater changes with any chemotherapy regimen. The reasons for this are unclear, but patients of similar age with higher p16INK4a less ability to overcome tissue and organ damage. Not all chemotherapeutic agentsfor example, taxanes used as a single agentmay be associated with accelerated aging.11 More detailed studies of patients treated with different agents, including immunotherapeutic and other biologic therapies, and for different types of cancer are needed.

The long-term implications of changes in p16INK4a expression with chemotherapy are unknown, but our data suggest that higher levels may be indicators of frailty, a syndrome associate with increased comorbidity, poor quality of life, and shortened survival. p16INK4a expression has been associated with other diseases of aging, including cardiovascular disease, osteoporosis, and other common illnesses, and our chemotherapy-treated patients with accelerated aging may experience major problems 10 to 20 years after treatment, similar to young adults with cancer, and at a time when they are not likely to be followed by their oncologists.

However, these concerns should not mitigate the use of what has proven to be markedly effective treatment regimens that have dramatically improved overall survival in childhood cancer and breast cancer. It is too early to speculate, especially in breast cancer, whether nonanthracycline regimens with similar effectiveness to anthracyclines may be worth considering for patients with long life expectancy. The use of biomarkers in aging research, geroscience, is an exciting area of exploration, and p16INK4a expression is just one of the markers currently being studied.12 The implications of accelerated aging are being studied in other scenarios, and a broad range of studies are exploring interventions to ameliorate biological changes suggesting accelerated aging.

An excellent review of these issues and potential interventions is available13 and describes studies of exercise, diet and nutrition strategies, and senolytics. Learning about the effects of cancer treatment on aging is of major importance, as the clinical scenario of cancer is dominated by older adults who already may have a substantial comorbid illness at the time of diagnosis that might be accelerated by treatment. In children and young adults with cancer, learning how to assess and, in the future, intervene to prevent treatment-related accelerated aging is also a major need.

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Biomarkers Help Predict the Role of Chemotherapy in Biologic Aging - OncLive

Cardiac Stem Cells Comments Off on Biomarkers Help Predict the Role of Chemotherapy in Biologic Aging – OncLive | March 8th, 2021

Stem cells are found in all human beings, from the initial stages of human growth to the end of life. All stem cells are beneficial for medical research; however, each of the different kinds of stem cells has both limitations and promise. Embryonic stem cells that can be obtained from a very initial stage in human development have the prospect to develop all of the cell types in the human body. Adult stem cells are found in definite tissues in fully developed humans. Stem cells are basic cells of all multicellular animals having the ability to differentiate into a wide range of adult cells. Totipotency and self-renewal are characteristics of stem cells. However, totipotency is seen in very early embryonic stem cells. The adult stem cells owes multipotency and difference flexibility which can be exploited for next generation therapeutic options. Recently, scientists have also recognized stem cells in the placenta and umbilical cord blood that can give rise to several types of blood cells. Research for stem cells is being undertaken with the expectation of achieving major medical inventions. Scientists are attempting to develop therapies that replace or rebuild spoiled cells with the tissues generated from stem cells and offer hope to people suffering from diabetes, cancer, spinal-cord injuries, cardiovascular disease, and many other disorders.

The stem cell therapy market is segmented on the basis of type, therapeutic applications, cell source, and geography. On the basis of type, the stem cell therapy market is categorized into allogeneic stem cell therapy and autologous stem cell therapy. Allogeneic stem cell therapy includes transferring the stem cells from a healthy person (the donor) to the patients body through high-intensity radiation or chemotherapy. Allogeneic stem cell therapy is used to treat patients who do not respond fully to treatment, who have high risk of relapse, and relapse after prior successful treatment. Autologous stem cell therapy is a type of therapy that uses the persons own stem cells. These type of cells are collected earlier and returned in future. The use of stem cells is done to replace damaged cells by high doses of chemotherapy, and to treat the persons underlying disease. On the basis of therapeutic applications, the stem cell therapy market is segmented into cardiovascular diseases, wounds and injuries, musculoskeletal disorders, gastrointestinal diseases, surgeries, neurodegenerative disorders, and others. On the basis of cell source, stem cells therapy is segmented into bone marrow-derived mesenchyme stem cells, adipose tissue-derived mesenchyme stem cells, and cord blood or embryonic stem cells

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By geography, the market for stem cell therapy is segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. North America leads the stem cell therapy market owing to rising awareness among people, early treatment adoption, and new product innovations. Europe is the second leading market for stem cell therapy due to development and expansion of more efficient and advanced technologies. The Asia Pacific stem cell therapy market is also anticipated to grow at an increasing rate owing to increasing healthcare spending, adoption of western lifestyles, and growth in research and development. Asia Pacific is the fastest growing region for stem cell therapy as several players have invested in the development of new stem cell technologies. These factors are expected to drive the growth of the stem cell therapy market globally during the forecast period.

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The major player in the stem cell therapy market are Regenexx, Takara Bio Company, Genea Biocells, PromoCell GmbH, CellGenix GmbH, Cellular Engineering Technologies, BIOTIME, INC., Astellas Pharma US, Inc., AlloSource, RTI Surgical, Inc., NuVasive, Inc., JCR Pharmaceuticals Co., Ltd., Holostem Terapie Avanzate S.r.l., PHARMICELL Co., Ltd, ANTEROGEN.CO., LTD., The Future of Biotechnology, and Osiris Therapeutics, Inc. Rising demand for advanced stem cell therapies will increase the competition between players in the stem cell therapy market.

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Stem Cell Therapy Market Research Reveals Enhanced Growth During The Forecast Period 2017 2025 FLA News - FLA News

Spinal Cord Stem Cells Comments Off on Stem Cell Therapy Market Research Reveals Enhanced Growth During The Forecast Period 2017 2025 FLA News – FLA News | March 8th, 2021

SASKATOON -- An effort to increase stem cell donors within Black communities across Canada is being driven by a group of women whove had difficulty finding full genetic matches themselves.

Genetic matches are crucial for patients in need of stem cell transplants, such as those with leukemia and lymphoma, and matches are more commonly found within their own racial, ethnic and ancestral groups.

But the new Black Donors Save Lives campaign notes that fewer than two per cent of those in the Canadian Blood Services stem cell donor registry are Black.

And that decreases their chance of finding a match, campaign lead Sylvia Okonofua told CTVNews.ca in a phone interview. It becomes a numbers game for Black people on the stem cell waiting list, where its like finding a needle in a hay stack for them.

The recent University of Regina biochemistry graduate, with sights on becoming a hematologist, timed the virtual campaign to kick off during Black History Month.

It was overall frustrating to know that a patient from my community is so much less likely than other patients to be helped, she told CTVNews.ca. When you see that your people have a really, really low chance of being helped out, it takes you aback.

Okonofua noted part of the campaign uses TikToks, shareable infographics, and even an original song to get the message out and reach a wide audience.

And she said part of the outreach involves having Black stem cell recipients talk about their experiences with the health-care system and speak to the historical mistrust the Black community has towards the medical community.

She founded her campus chapter of Stem Cell Club, a non-profit organization with chapters across Canada which recruits Canadians as potential stem cell donors.

Registration for Black Donors Save Lives can be done online, where participants between the ages of 17 to 35 can fill out a questionnaire and have a swab kit mailed to their address. After they swab the inside of their cheeks and send the sample back, if there is a person in need, 90 per cent of donors will be asked to donate stem cells very similar to the way a person would be giving blood.

But a big difference is the donor is given a growth hormone a week before donation in order to increase the number of stem cells, as well as the process taking four to six hours.

Alternatively, one out of 10 donors will be asked if theyd like to donate stem cells via bone marrow surgery, which can take place over a day.

In 2017, Reve Agyepong experienced firsthand the lack of Black stem cell donors, to treat her sickle cell disease, which involve red blood cells becoming misshapen, which can block blood vessels and lead to damage to bones, brain, kidneys, and lungs, and can ultimately be fatal.

But Agyepong, who was born in Edmonton to Ghanaian parents, was fortunate to receive a stem cell transplant from her sister.

It is such a blessing to have a match within your own family because the percentages are just so low, she told CTVNews.ca by email. I am so fortunate to have found a match in my family or else transplant would have been off the table for me.

In fact, only one in four patients who need a stem cell transplant are able to find a matched donor within their family, with Black patients being less than half as likely as white patients to find a unrelated person they match with on a donor registry, according to the campaign.

For Jamaican-Canadian Dorothy Vernon-Brown, who helped inspire this months campaign, the current efforts are deeply personal. In 2013, she was diagnosed with acute myeloid leukaemia and was heartbroken to discover there were no stem cell matches in Canada's registry or internationally.

She ultimately received stem cells from her sister, who was a half-match, and has been spreading information to Black Canadians ever since, through her own advocacy group, Donor Drive for Dorothy.

Stem cell transplantation is a miracle for patients, and I wish people knew how easy it is to be a stem donor, she recounted on a Twitter thread for another stem cell awareness campaign. You could give someone an opportunity like my sister gave me, to be around and live the life I want. People want to live, so if that gift is in your hands, I appeal to you to see it as something significant to do in your life.

Okonofua and Vernon-Browns efforts are being aided by Dr. Warren Fingrut, a hematologist whos the director of the aforementioned Stem Cell Club.

He told CTVNews.ca in an email hes seen firsthand far too many patients from ethnic and racial minority groups in situations where they dont have fully-matched donors and are forced to seek other treatments.

I find this heart wrenching and I am very motivated to work to address this, Fingrut said.

That led to him founding his non-profit a decade ago, which has gone on to recruit more than 20,000 Canadians as stem cell donors, with more than 55 per cent being non-white. But in cases such as Vernon-Brown and others, those figures need to be much higher.

We started running national campaigns last year, focused on the recruitment of diverse peoples as donors, as well as males who are also preferred by transplant physicians (all else being equal) as they are associated with better outcomes for patients, Fingrut explained.

The campaign is also being done in partnership with several other groups, including the Katelyn Bedard Bone Marrow Association, Black Physicians of Canada, Black Medical Students Association of Canada and the National Black Law Students Association of Canada.

This campaign is one example of an initiative in the health-care sector, which seeks to address racial disparity impacting the care of Black patients, he wrote, noting Black people face many such disparities in access to care, and we want to see others in the health-care sector working with Black Canadians to tackle these issues and address them, in collaboration with Black communities.

Okonofua hopes next Black History Month, theyll be able to have in-person swabbing events in places of worship, community hubs, and cultural gatherings to show how easy it is.

Fingrut said this the first time his group has specifically engaged with one racial group and hopes to expand it to other ethnic and racial communities including South Asians, Indigenous peoples, and those of mixed ancestry in the near future.

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Meet the women hoping to recruit more stem cells donors from Black communities - CTV News

Bone Marrow Stem Cells Comments Off on Meet the women hoping to recruit more stem cells donors from Black communities – CTV News | February 19th, 2021

The life-changing phone call came at 4:30 in the morning on Christmas Eve.

All of a sudden, Ashley Peddle went from making final preparations for the holiday season to planning cancer treatments that had to start within days.

The East Greenwich resident, 37, had been experiencing fatigue, shortness of breath and headaches for some time, but when her husband Ryan encouraged her to get checked out, she chalked it up to being a busy mother of four kids 10 and younger. Finally, in the week leading up to Christmas, her symptoms became too much to bear as she could not even climb the steps in her house and was falling asleep on the couch around dinnertime.

She saw a doctor and later some troubling results of blood tests led to the early-morning phone call to get to the hospital immediately.

We rushed right to the emergency room and in about an hour or two, our world was kind of rocked with the diagnosis of leukemia, Ryan Peddle says. (Penn Medicine) was great and started her treatment right away because the type of leukemia she has is very aggressive, so the sooner she started, the better.

Two months and two rounds of chemotherapy after being told she has acute myeloid leukemia, Peddles prognosis is good, her husband said, but she is not out of the woods yet. She recently returned home after a six-week hospital stay but will soon go back to receive a stem cell transplant, also known as a bone marrow transplant, which will help restore her bone marrow, produce healthy blood cells and strengthen her immune system. In turn, she will be better suited to fighting the leukemia and preventing a reoccurrence down the line.

The best donors for stem cell transplants are usually a family member such as a sibling, but if they are not a match, an unrelated volunteer whose tissue type matches that of the patient may be used. Not only have Ashley and Ryan become educated about the process throughout their ordeal, but so have a group of Ashleys friends, who decided to take action when they learned how badly donors are needed.

Shawn Keating, also of East Greenwich, took the lead and helped organize a drive-thru bone marrow registration event in Peddles honor, which will be held this Saturday, Feb. 20, from 10 a.m. until 2 p.m., at Samuel Mickle School, 559 Kings Highway, in Mickleton. Sponsored by Be The Match which runs the largest and most diverse bone marrow registry in the world to help people battling blood cancers like leukemia and lymphoma the event will allow adults between the ages of 18 and 44 to join the national list of potential donors.

Ashley Peddle was diagnosed with leukemia and is in need of a bone marrow transplant. A registration event is being held Feb. 20 from 10 a.m. until 2 p.m. at Samuel Mickle School, 559 Kings Highway, in Mickleton.

In addition to supporting Peddle, who she has become friends with through their childrens sports and school activities, Keating had two other reasons for getting involved.

Her kids are the same age as mine and when you see this happen to somebody, you realize it could happen to anybody, she said. The other thing was, I went to sign myself up for Be The Match and I realized that at one point I had already requested the kit and in the busyness of things, I must have forgotten to send it back. So I reached out to them, got to talking and thought this was the best option, especially for busy people. Its as easy as driving through, getting swabbed and being done. I just thought it would be an easier way to get as many people on the registry as possible.

Bree Amborn works for an organization called The Icla da Silva Foundation, which is a recruitment center for Be The Match, and she will be running Saturdays event. She said people can expect a simple process to getting registered, as they just need to fill out some forms on their phone and do a swab in each cheek for 10 seconds without even leaving their car.

Those who cannot attend but still want to join Be The Match can text PeddleStrong to the number 61474 or visit join.bethematch.org/PeddleStrong and have a kit mailed to their home. Amborn added that it is especially important to increase the numbers of donors in the African-American community, as Black patients chances of finding a match are only 23%, compared to 77% for white patients.

The need is super, super high to add more people and to work in diverse communities and increase those populations on the registry as well, she said, so if a patient is a person of color they have the same chances of finding their match as if the patient is white.

Amborn will be able to answer any questions people have on Saturday. She was actually a donor herself while in college; after signing up she found out she was a match for a 50-year-old woman battling myelofibrosis.

It was an extremely easy process and Be The Match was awesome, she said. They pay for everything, they organize everything and they schedule everything, and as the donor you just show up. Youre literally able to change someones life.

I think people have a misconception of how the donation process works, but 80% of the time the donation is actually taken from your bloodstream. It looks very similar to donating platelets, where you have a needle in each arm, they take blood out of one arm, they separate your stem cells from your blood and give you your blood back in the other arm. Theres a couple more steps to the process but thats really the basics. Youre awake the whole time and its not a surgery.

Keating is hopeful that when people hear that, their fears will disappear and they will be eager to register. She doesnt know what to expect for Saturdays turnout, predicting, we could get 50 people or we could get 300. But already the response in East Greenwich has been impressive, with more than 50 volunteers slated to be in attendance.

Some, like Keating and Jacqueline DAngelis, are bringing their teenaged children to help as well.

Like I told my daughter, we cant cure cancer, but we can certainly help others by collecting these swabs, said DAngelis, a neighbor of the Peddles who has known them for seven years.

Theres going to be a lot of people from our community out there this weekend to support Ashley and support this mission to increase that number. Ashley is such a wonderful part of the community and its nice to see how everyone can band together and try to make something good out of this difficult and trying situation for her family. Its nice to see so many families parents and their teenagers coming out to volunteer in the cold in the middle of a pandemic to do something nice.

Although the Peddles have been quarantining since Ashley returned home because her immune system is compromised, Ryan plans on stopping by the event and showing his appreciation for the volunteers and those joining the list.

I didnt know anything about the registry beforehand or else Id have been on it, he said. Thats one of the reasons were pushing this drive, to get as many people on the registry as we can. They may not help Ashley but theyll help someone just like her.

He said his wifes spirits have remained high during her treatment. One of the toughest parts was when she was in the hospital and could not get in-person visits from their daughter and three sons, ages 10, 8, 7 and 4. They were able to FaceTime frequently, however, for much-needed emotional support.

The family is also grateful for the outpouring of assistance from those around them.

Were honestly overwhelmed by the support weve received, Ryan said. Our kids are pretty active in sports and other activities in the township, and through that weve made a lot of really good friendships and met a lot of really great people. So many of them are stepping up, not only for this drive but to give blood, to donate platelets, to cook meals, to drop off little things for the kids like Valentines. Its just been overwhelming and we couldnt be more proud of the town we live in.

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N.J. mom of 4 has leukemia. A bone marrow registry is being held Saturday. - nj.com

Bone Marrow Stem Cells Comments Off on N.J. mom of 4 has leukemia. A bone marrow registry is being held Saturday. – nj.com | February 19th, 2021

In people with polycythemia vera (PV), the bone marrow produces too many blood cells. This overproduction can lead to complications, such as abnormal blood clotting, unusual bleeding, and an enlarged spleen.

In rare cases, scar tissue may replace the bone marrow. When this happens, the bone marrow can no longer produce enough healthy blood cells. Experts refer to this condition, which is a type of chronic leukemia, as myelofibrosis (MF). It can sometimes lead to acute myeloid leukemia, though this is rare.

People with PV have a shorter-than-average life expectancy. Some of the possible complications of the disease can be life threatening.

Getting treatment can help reduce the risk of certain complications from PV, including blood clots. As a result, a person will likely lead a longer and healthier life with this disease if they receive treatment.

According to an article in Blood Cancer Journal, the median survival time for people with PV is 14 years after diagnosis. The authors take this survival time from a study in which half of the participants were still alive 14 years after diagnosis.

Younger people tend to live for longer with the disease. Research suggests that the median survival time for those under 60 years of age is 24 years following diagnosis.

Multiple factors affect the outlook and life expectancy of people with PV, including:

Blood clots are the most common cause of death in people with PV. When blood clots form in blood vessels, they can block the flow of blood to vital organs. This can lead to life threatening complications, such as stroke, heart attack, and venous thrombosis.

Treatment for PV can help relieve symptoms and lower the risk of blood clots. In this way, it also reduces a persons risk of life threatening complications.

In most cases, healthcare providers prescribe regular blood draws to treat PV. Blood draws reduce the number of blood cells in the body, which may help improve blood flow.

Healthcare providers may also prescribe low dose aspirin to help prevent the formation of blood clots. Additionally, they may prescribe other medications, such as hydroxyurea (Hydrea) or busulfan (Myleran).

If a person develops MF as a complication of PV, their healthcare provider may prescribe one or more of the following treatments:

These treatments may help improve symptoms, increase life expectancy, or both.

For example, scientists have found that stem cell transplants may help improve long-term survival in people with MF. However, this treatment comes with a high risk of life threatening side effects. It is especially risky for older adults and people with other health conditions. As a result, healthcare providers often avoid prescribing this treatment.

Some studies have found that treatment with JAK inhibitors may also improve survival rates in people with MF. However, when scientists reviewed the available evidence on Jakafi and Inrebic, they found that the quality of evidence on survival rates is limited. More research is necessary to confirm how these treatments affect life expectancy.

Early research involving people with PV found that the median survival time for those who did not receive treatment was less than 2 years after diagnosis. This research took place before the medical community recognized blood draws as a treatment option, and it reflects the high risk of blood clots in people not receiving treatment.

People with PV who do not receive treatment are more likely to develop blood clots. According to the Leukemia & Lymphoma Society, 4060% of people with untreated PV may develop blood clots within 10 years of diagnosis.

Scientists have not yet developed a cure for PV. However, healthcare providers may prescribe blood draws, medications, or other treatments to help manage symptoms, reduce the risk of complications, and increase life expectancy in people with this disease.

Researchers are also continuing to develop and test potential new treatments for PV, such as the anticancer drug imatinib mesylate (Gleevec) and novel types of JAK inhibitors.

In some cases, a persons healthcare provider may encourage them to take part in a clinical trial. In this type of study, participants receive an experimental treatment. People interested in learning more about the potential benefits and risks of taking part in a clinical trial can talk with their healthcare provider or the researchers running the study.

When a person receives a diagnosis of PV, getting treatment is important. Treatment may help minimize symptoms, lower the risk of complications, and improve life expectancy.

A persons recommended treatment plan for PV will depend on many factors, including their age, overall health, and whether they have developed certain complications.

People with PV who wish to learn more about their treatment options and outlook should talk with their healthcare provider.

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Polycythemia vera life expectancy: With treatment and more - Medical News Today

Bone Marrow Stem Cells Comments Off on Polycythemia vera life expectancy: With treatment and more – Medical News Today | February 19th, 2021

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Novartis and the Bill & Melinda Gates Foundation have partnered on a single-dose, in vivo gene therapy for sickle cell disease (SCD). The Foundation will offer funding for development of the therapy.

Existing gene therapy approaches to sickle cell disease are difficult to deliver at scale and there are obstacles to reaching the vast majority of those affected by this debilitating disease, said Jay Bradner, a hematologist and president of the Novartis Institutes for BioMedical Research (NIBR). This is a challenge that calls for collective action, and we are thrilled to have the support of the Bill & Melinda Gates Foundation in addressing this global unmet medical need.

The announcement comes only a day after bluebird bio announced that it has placed its Phase I/II and Phase III trial of LentiGlobin gene therapy for sickle cell disease (SCD) on temporary suspension. The cause is a Suspected Unexpected Serious Adverse Reaction (SUSAR) of acute myeloid leukemia (AML).

HGB-206 is the companys ongoing Phase I/II trial of LentiGlobin for SCD. It includes three cohorts, A, B and C. In Group C, a refined manufacturing process designed to increase vector copy number was used.

Group C also received LentiGlobin for SCD manufactured from hematopoietic (blood) stem cells (HSCs) collected from peripheral blood after mobilization with plerixafor, instead of by way of bone marrow harvest, which was the method used in Groups A and B.

HGB-210 is their ongoing Phase III single-arm open-label trial. It is evaluating efficacy and safety of LentiGlobin for SCD in patients between two years and 50 years of age with sickle cell disease.

Which underlines that even though gene therapy is making headway, it is still a cutting-edge technology.

SCD is a hereditary blood disease that affects millions of people globally, with more than 300,000 born with it each year. It primarily affects people of African descent, and sub-Saharan Africa bears about 80% of the disease burden. It affects the structure of red blood cells, causing a distinct sickle shape, which decreases the ability of red blood cells to transport oxygen efficiently.

Gene therapies might help end the threat of diseases like sickle cell, but only if we can make them far more affordable and practical for low-resource settings, said Trevor Mundel, president of Global Health at the Gates Foundation. Whats exciting about this project is that it brings ambitious science to bear on that challenge. Its about treating the needs of people in lower-income countries as a driver of scientific and medical progress, not an afterthought. It also holds the promise of applying lessons learned to help develop potentially curative options for other debilitating diseases affecting low-income populations, such as HIV.

Novartis also announced today that the U.S. Food and Drug Administration (FDA) approved the expanded indication for Entresto (sacubitril/valsartan) to decrease the risk of cardiovascular death and hospitalization for heart failure in adults with chronic heart failure. The biggest benefit was for patients with left ventricular ejection fraction (LVEF) below normal.

The expansion was based on data in the PARAGON-HF Phase III trial.

This approval is a significant advancement, providing a treatment to many patients who were not eligible for treatment before because their ejection fraction was above the region we normally considered reduced, said Scott Solomon, professor of Medicine at Harvard Medical School and Brigham and Womens Hospital, and PARAGON-HF Executive Committee co-chair. We can now offer a treatment to a wider range of patients who have an LVEF below normal.

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Novartis and Gates Foundation Team Up To Deliver Affordable Sickle Cell Gene Therapy - BioSpace

Bone Marrow Stem Cells Comments Off on Novartis and Gates Foundation Team Up To Deliver Affordable Sickle Cell Gene Therapy – BioSpace | February 19th, 2021

A desperate family is facing a nervous wait after a stem cell donor finally found to give their four-year-old daughter a new chance at life fell ill.

Little Adeline Davidson has been waiting more than two years for the procedure to treat a rare form of blood cancer, and several arrangements with donors have fallen through during that time.

The Alness youngster had been due to go under the knife in Glasgow this week after it appeared that the search for a match had eventually come to an end.

But the family encountered yet another setback as the procedure was cancelled when the stem cell donor fell ill.

Adelines parents Steph, 26, and Jordan, 28, say their daughters transplant now hangs in the balance as they face an agonising wait to find out what is wrong with the donor.

They say the plans could be thrown into disarray with top level talks and a possible world-first procedure required if tests show that the illness is Covid-related.

The family will only be able to find out the nature of the donors condition after he is operated on and the cells removed.

If the donor has coronavirus, a team of international surgeons will assemble to debate whether it would be safe for Adeline to undergo the transplant.

Mrs Davidson said: We have been waiting more than two whole years for our ill child to get a bone marrow transplant.

The hospital have told me that the donor has to donate, and then they release the information on the cause of his illness.

If it is Covid, that would mean they would have to ask international doctors and surgeons if they could go ahead.

They have never given a child thats Covid-negative marrow from someone who is Covid-positive.

If they decide not to proceed, we are back to looking for someone else to begin the search again, which is just a crazy, horrible thought. I dont even want to think about it.

Mrs Davidson added that she would consider going ahead even if the cells have come from someone with coronavirus.

She said: I think we have to go with the doctors word, but Id be so frightened.

We wouldnt have another choice though, unfortunately.

If they, as professionals, believe doing it would outweigh the risks, we would just have to believe that too.

Over the last two years, Adeline has endured around 85 blood transfusions, one anaphylactic shock and emergency helicopter and ambulance transfers to hospital.

Mrs Davidosn added: There is potential for even worse news but we just hope that it isnt Covid he has.

If it isnt Covid, then everything moves along as it was meant to be.

We are aware that on the register there was no-one else, so we were lucky this guy popped up.

If all goes well, Adeline will receive her transplant in four weeks.

The latest setback comes almost two years to the day since her transplant journey began.

In December, the family were dealt a devastating blow as health officials postponed her procedure, scheduled to take place in January, due to Brexit complications.

The four-year-old requires a specific type off marrow, processed by a centre outwith the UK, which is then brought to the country by road.

Life-saving transplant for Highland youngster postponed due to delays caused by Brexit

Early last year, the family were forced to turn to the register and launch a public appeal in search for multiple new donors due to an array of complications.

Mrs Davidson praised Adelines resilience but admits it breaks her heart to not be able to see her daughter progress onto school in August.

She said: The first year I was so positive lets get on with it, this needs done and I never thought why us?

I just thought we have so much to be grateful for and thankful for.

However, the whole of the second year, Im just thinking is someone messing with us because thats what it feels like.

She added: Adelines been so good. She hardly complains and I just think its because she has no idea whats shes missing, which is sort of a good thing but sad.

She is lucky thats shes an outgoing kid. She is behind, she has not socialised and although she is switched on, shes probably not as far on as her peers.

Even now, she should have been staring primary one in August this year but shes not even been to nursery. Its hellish.

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Heartbreak for family of cancer-stricken four-year-old as stem cell donor falls ill at last minute - Press and Journal

Bone Marrow Stem Cells Comments Off on Heartbreak for family of cancer-stricken four-year-old as stem cell donor falls ill at last minute – Press and Journal | February 19th, 2021

Stem cells are undifferentiated cells which are capable of differentiating into any type of cell that make-up the human body and thus, are capable of producing non-regenerative cells such as neural and myocardial cells.

Statistics:

The global stem cells market is estimated to account forUS$ 9,941.2 Mnin terms of value in2020and is expected to reachUS$ 18,289.9 Mnby the end of2027.

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GlobalStem CellsMarket: Drivers

Approval and launch of new products is expected to propel growth of the global stem cells market over the forecast period. For instance, in December 2019, BioRestorative Therapies, Inc. received a Notice of Allowance on its patent application for a method of generating brown fat stem cells from Israeli Patent Office.

Moreover, increasing number of stem cell banking resource centers is also expected to aid in growth of the market. For instance, in March 2020, Stemlife Berhad, a cord blood bank in Malaysia, started a Stem Cell Banking Resource Center in Jerudong Park Medical Center, Brunei.

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Statistics:

Adult stem cells held dominant position in the global stem cells market in 2019, accounting for81.2%share in terms of value, followed by Human Embryonic Stem Cells and Induced Pluripotent Stem Cells, respectively

Figure 1. GlobalStem CellsMarket Share (%), by Value, by Cell Type, 2019.

GlobalStem CellsMarket: Restraints

High cost of stem cell therapy is expected to hinder growth of the global stem cells market. For instance, Bioinformant a research firm engaged in stem cell research, reported that the cost of stem cell therapy ranges between US$ 5,000-8,000 per patient and in some cases it may rise as much as US$ 25,000 or more depending on the complexity of the procedure.

Moreover, restrictions on research activities related to stem cells had hampered the growth of embryonic stem cells historically and resulted in its meager share in the total market in spite of its advantages over adult stem cells.

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GlobalStem CellsMarket: Opportunities

R&D in stem cell donation is expected to offer lucrative growth opportunities for players in the global stem cells market. For instance, in March 2020, researchers from Dankook University and Catholic University, South Korea, reported investigation of the types and degrees of physical and psychological discomfort experienced by hematopoietic stem cell donors before, during, and after the donation process.

Moreover, adoption of online distribution channel is also expected to aid in growth of the global stem cells market. For instance, The US Direct-to-Consumer Marketplace for Autologous Stem Cell Interventions, published in the journal Perspectives in Biology and Medicine, in 2018, the number of new stem cell businesses with websites doubled on average every year between 2009 and 2014, in the U.S.

The global stem cells market was valued atUS$ 9,112.0 Mnin2019and is forecast to reach a value ofUS$ 18,289.9 Mnby2027at aCAGR of 9.1%between2020 and 2027.

Figure 2. GlobalStem CellsMarket Value (US$ Mn), and Y-o-Y Growth (%), 2019-2027

Market Trends/Key Takeaways

Adoption of stem cells for the treatment of various diseases is expected to propel growth of the global stem cells market. For instance, in January 2020, researchers at University of Houston developed biologic cardiac pacemaker-like cells by taking fat stem cells and reprogramming them as an alternative treatment for heart conditions such as conduction system disorders and heart attacks.

Moreover, increasing investment in stem cell therapies is also expected to aid in growth of the market. For instance, in July 2018, the Emory Orthopaedics & Spine Center, in collaboration with Sanford Health, Duke University, Andrews Institute, and Georgia Institute of Technology, received US$ 13 million grant from the Marcus Foundation for a multicenter clinical trial studying stem cell options for treating osteoarthritis. The Phase 3 trial was initiated in March 2019, and is expected to complete by December 2021.

GlobalStem CellsMarket: Competitive Landscape

Major players operating in the global stem cells market include Advanced Cell Technology, Inc., Angel Biotechnology Holdings PLC, Bioheart Inc., Lineage Cell Therapeutics., BrainStorm Cell Therapeutics, Inc., California Stem Cell Inc., Celgene Corporation, Takara Bio Europe AB, Cellular Engineering Technologies, Cytori Therapeutics Inc., Osiris Therapeutics, and STEMCELL Technologies Inc.

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GlobalStem CellsMarket: Key Developments

Major players in the market are focused on adopting collaboration and partnership strategies to expand their product portfolio. For instance, in September 2018, STEMCELL Technologies signed an exclusive license agreement with Brigham and Womens Hospital for rights to commercialize technologies for the generation of human pluripotent stem cell-derived kidney organoids.

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Stem Cells Market to Inspire a Growth up to US$ 18289.9 Million at a 9.1% CAGR by 2027 - PharmiWeb.com

Cardiac Stem Cells Comments Off on Stem Cells Market to Inspire a Growth up to US$ 18289.9 Million at a 9.1% CAGR by 2027 – PharmiWeb.com | February 19th, 2021

We can absolutely cut the number of cancer deaths down so that one day in our lifetimes it can be a rare thing for people to die of cancer, said Patrick Hwu, MD, president and CEO of Moffitt Cancer Center in Florida and among gene therapys pioneers. It still may happen here and there, but itll be kind of like people dying of pneumonia. Its like, He died of pneumonia? Thats kind of weird. I think cancer can be the same way.

The excitement returned in spades in 2017 when the FDA signed off on a gene-therapy drug for the first time, approving the chimeric antigen receptor (CAR) T-cell treatment tisagenlecleucel (Kymriah; Novartis) for the treatment of B-cell precursor acute lymphoblastic leukemia. At last, scientists had devised a way to reprogram a persons own T cells to attack tumor cells.

Were entering a new frontier, said Scott Gottlieb, MD, then the FDA Commissioner, in announcing the groundbreaking approval.

Gottlieb wasnt exaggerating. The growth in CAR T-cell treatments is exploding. Although only a handful of cell and gene therapies are on the market, FDA officials predicted in 2019 that the agency will receive more than 200 investigational new drug applications per year for cell and gene therapies, and that by 2025, it expects to have accelerated to 10 to 20 cell and gene therapy approvals per year.1

Essentially, you can kill any cancer cell that has an antigen that is recognized by the immune cell, Hwu said. The key to curing every single cancer, which is our goal, is to have receptors that can recognize the tumor but dont recognize the normal cells. Receptors recognizing and then attacking normal cells is what can cause toxicity.

Cell therapy involves cultivating or modifying immune cells outside the body before injecting them into the patient. Cells may be autologous (self-provided) or allogeneic (donor-provided); they include hematopoietic stem cells and adult and embryonic stem cells. Gene therapy modifies or manipulates cell expression. There is considerable overlap between the 2 disciplines.

Juliette Hordeaux, PhD, senior director of translational research for the University of Pennsylvanias gene therapy program, is cautious about the FDAs predictions, saying shed be thrilled with 5 cell and/or gene therapy approvals annually.

For monogenic diseases, there are only a certain number of mutations, and then well plateau until we reach a stage where we can go after more common diseases, Hordeaux said.

Safety has been the main brake around adeno-associated virus vector (AAV) gene therapy, added Hordeaux, whose hospitals program has the institutional memory of both Jesse Gelsingers tragic death during a 1999 gene therapy trial as well as breakthroughs by Carl June, MD, and others in CAR T-cell therapy.

Sometimes there are unexpected toxicity [events] in trials.I think figuring out ways to make gene therapy safer is going to be the next goal for the field before we can even envision many more drugs approved.

In total, 3 CAR T-cell therapies are now on the market, all targeting the CD19 antigen. Tisagenlecleucel was the first. Gilead Sciences received approval in October 2017 for axicabtagene ciloleucel (axi-cel; Yescarta), a CAR T-cell therapy for adults with large B-cell non-Hodgkin lymphoma. Kite Pharma, a subsidiary of Gilead, received an accelerated approval in July 2020 for brexucabtagene autoleucel (Tecartus) for adults with relapsed or refractory mantle cell lymphoma.

On February 5, 2021, the FDA approved another CD19-directed therapy for relapsed/refractory large B-cell lymphoma, lisocabtagene maraleucel (liso-cel; JCAR017; Bristol Myers Squibb). The original approval date was missed due to a delay in inspecting a manufacturing facility (see related article).

Idecabtagene vicleucel (ide-cel; bb2121; Bristol Myers Squibb) is under priority FDA review, with a decision expected by March 31, 2021. The biologics license application seeks approval for ide-cel, a B-cell maturation antigendirected CAR therapy, to treat adult patients with multiple myeloma who have received at least 3 prior therapies.2

The number of clinical trials evaluating CAR T-cell therapies has risen sharply since 2015, when investigators counted a total of 78 studies registered on the ClinicalTrials.gov website. In June 2020, the site listed 671 trials, including 357 registered in China, 256 in the United States, and 58 in other countries.3

Natural killer (NK) cells are the research focus of Dean Lee, MD, PhD, a physician in the Division of Hematology and Oncology at Nationwide Childrens Hospital. He developed a method for consistent, robust expansion of highly active clinical-grade NK cells that enables repeated delivery of large cell doses for improved efficacy. This finding led to several first-in-human clinical trials evaluating adoptive immunotherapy with expanded NK cells under an FDA Investigational New Drug application. He is developing both genetic and nongenetic methods to improve tumor targeting and tissue homing of NK cells. His eff orts are geared toward pediatric sarcomas.

The biggest emphasis over the past 20 to 25 years has been cell therapy for cancer, talking about trying to transfer a specific part of the immune system for cells, said Lee, who is also director of the Cellular Therapy and Cancer Immunology Program at Nationwide Childrens Hospital, at The Ohio State University Comprehensive Cancer Center Arthur G. James Cancer Hospital, and at the Richard J. Solove Research Institute.

The Pivot Toward Treating COVID-19 and Other Diseases

However, Lee said, NKs have wider potential. This is kind of a natural swing back. Now that we know we can grow them, we can reengineer them against infectious disease targets and use them in that [space], he said.

Lee is part of a coronavirus disease 2019 (COVID-19) clinical trial, partnering with Kiadis, for off-the-shelf K-NK cells using Kiadis proprietary platforms. Such treatment would be a postexposure preemptive therapy for treating COVID-19. Lee said the pivot toward treating COVID-19 with cell therapy was because some of the very early reports on immune responses to coronavirus, both original [SARS-CoV-2] and the new [mutation], seem to implicate that those who did poorly [overall] had poorly functioning NK cells.

The revolutionary gene editing tool CRISPR is making its initial impact in clinical trials outside the cancer area. Its developers, Jennifer Doudna, PhD, and Emmanuelle Charpentier, PhD, won the Nobel Prize in Chemistry 2020.

For patients with sickle cell disease (SCD), CRISPR was used to reengineer bone marrow cells to produce fetal hemoglobin, with the hope that the protein would turn deformed red blood cells into healthy ones. National Public Radio did a story on one patient who, so far, thanks to CRISPR, has been liberated from the attacks of SCD that typically have sent her to the hospital, as well from the need for blood transfusions.4

Its a miracle, you know? the patient, Victoria Gray of Forest, Mississippi, told NPR.

She was among 10 patients with SCD or transfusion-dependent beta-thalassemia treated with promising results, as reported by the New England Journal of Medicine.5 Two different groups, one based in Nashville, which treated Gray,5 and another based at Dana-Farber Cancer Institute in Boston,6 have reported on this technology.

Stephen Gottschalk, MD, chair of the department of bone marrow transplantation and cellular therapy at St Jude Childrens Research Hospital, said, Theres a lot of activity to really explore these therapies with diseases that are much more common than cancer.

Animal models use T cells to reverse cardiac fibrosis, for instance, Gottschalk said. Using T cells to reverse pathologies associated with senescence, such as conditions associated with inflammatory clots, are also being studied.

Hordeaux said she foresees AAV being used more widely to transmit neurons to attack neurodegenerative diseases.

The neurons are easily transduced by AAV naturally, she said. AAV naturally goes into neurons very efficiently, and neurons are long lived. Once we inject genetic matter, its good for life, because you dont renew neurons.

Logistical Issues

Speed is of the essence, as delays in producing therapies can be the difference between life and death, but the approval process takes time. The process of working out all kinks in manufacturing also remains a challenge. Rapid production is difficult, too, because of the necessary customization of doses and the need to ensure a safe and effective transfer of cells from the patient to the manufacturing center and back into the patient.7

Other factors that can slow down launches include insurance coverage, site certification, staff training, reimbursement, and patient identification. The question of how to reimburse has not been definitively answered; at this point, insurers are being asked to issue 6- or even 7-figure payments for treatments and therapies that may not work.8

CAR T, I think, will become part of the standard of care, Gottschalk said. The question is how to best get that accomplished. To address the tribulations of some autologous products, a lot of groups are working with off -the-shelf products to get around some of the manufacturing bottlenecks. I believe those issues will be solved in the long run.

References

1. Statement from FDA Commissioner Scott Gottlieb, MD, and Peter Marks, MD, PhD, director of the Center for Biologics Evaluation and Research on new policies to advance development of safe and effective cell and gene therapies. News release. FDA website. January 15, 2019. https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-and-peter-marks-md-phd-director-center-biologics. Accessed January 13, 2021.

2. Bristol Myers Squibb provides regulatory update on lisocabtagene maraleucel (liso-cel). News release. Bristol Myers Squibb; November 16, 2020. Accessed January 11, 2021. https://news.bms.com/news/details/2020/Bristol-Myers-Squibb-Provides-Regulatory-Update-on-Lisocabtagene-Maraleucel-liso-cel/default.aspx

3. Wei J, Guo Y, Wang Y. et al. Clinical development of CAR T cell therapy in China: 2020 update. Cell Mol Immunol. Published online September 30, 2020. doi:10.1038/s41423-020-00555-x

4. Stein R. CRISPR for sickle cell diseases shows promise in early test. Public Radio East. November 19, 2019. Accessed January 11, 2021. https://www.publicradioeast.org/post/crisprsickle-cell-disease-shows-promise-early-test

5. Frangoul H, Altshuler D, Cappellini MD, et al. CRISPR-Cas9 gene editing for sickle cell disease and -Thalassemia. N Engl J Med. Published online December 5, 2020. DOI: 10.1056/NEJMoa2031054

6. Esrick EB, Lehmann LE, Biffi A, et al. Post-transcriptional genetic silencing of BCL11A to treat sickle cell disease. N Engl J Med. Published online December 5, 2020. doi:10.1056/NEJMoa2029392

7. Yednak C. The gene therapy race. PwC. February 5, 2020. Accessed January 11, 2021. https://www.pwc.com/us/en/industries/healthindustries/library/gene-therapy-race.html

8. Gene therapies require advanced capabilities to succeed after approval. PwC website. Accessed January 11, 2021. https://www.pwc.com/us/en/industries/health-industries/library/commercializing-gene-therapies.html

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The Untapped Potential of Cell and Gene Therapy - AJMC.com Managed Markets Network

Cardiac Stem Cells Comments Off on The Untapped Potential of Cell and Gene Therapy – AJMC.com Managed Markets Network | February 19th, 2021

TOKYOand BOTHELL, Wash., Feb. 18, 2021 /PRNewswire/ --Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") and Seagen Inc. (Nasdaq:SGEN) today announced completion of submissions for two supplemental Biologics License Applications (sBLAs) to the U.S. Food and Drug Administration (FDA) for PADCEV (enfortumab vedotin-ejfv). One submission, based on the phase 3 EV-301 trial, seeks to convert PADCEV's accelerated approval to regular approval. The second submission, based on the pivotal trial EV-201's second cohort, requests an expansion of the current label to include patients with locally advanced or metastatic urothelial cancer who have been previously treated with a PD-1/L1 inhibitor and are ineligible for cisplatin.

The FDA is reviewing both applications under the Real-Time Oncology Review (RTOR) pilot program. The RTOR program aims to explore a more efficient review process to ensure that safe and effective treatments are available to patients as early as possible.

"The FDA's review of our applications under Real-Time Oncology Review supports our efforts to expand PADCEV's availability as a treatment option for more patients as quickly as possible," said Andrew Krivoshik, M.D., Ph.D., Senior Vice President and Oncology Therapeutic Area Head, Astellas. "Locally advanced or metastatic urothelial cancer is an aggressive disease with limited treatment options."

The sBLA for regular approval of PADCEV in the U.S. is supported by data from the global EV-301 phase 3 confirmatory trial, which compared PADCEV to chemotherapy in adult patients with locally advanced or metastatic urothelial cancer who were previously treated with platinum-based chemotherapy and a PD-1/L1 inhibitor. The trial's primary endpoint was overall survival of patients treated with PADCEV vs. chemotherapy, and full results were presented at the 2021 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU) and published in the New England Journal of Medicine.[1]

The second submission, for a label expansion in the U.S., is based on results from the second cohort of EV-201, a pivotal phase 2 clinical trial evaluating PADCEV in patients with locally advanced or metastatic urothelial cancer who had received prior immunotherapy treatment but were not eligible for cisplatin. The trial's primary endpoint was objective response rate, and full results were presented at ASCO GU.[2]

"Advanced bladder cancer patients urgently need more treatment options," said Roger Dansey, M.D., Chief Medical Officer, Seagen. "Based on recently presented clinical trial results, PADCEV could address a significant unmet need for more patients with advanced urothelial cancer after initial immunotherapy treatment."

In 2019 PADCEV received accelerated approval in the U.S. for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a PD-1/L1 inhibitor and a platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery in a locally advanced or metastatic urothelial cancer setting. PADCEV is currently only approved for use in the U.S.

About the EV-301 TrialThe EV-301 trial (NCT03474107) is a global, multicenter, open-label, randomized phase 3 trial designed to evaluate enfortumab vedotin versus physician's choice of chemotherapy (docetaxel, paclitaxel or vinflunine) in approximately 600 patients with locally advanced or metastatic urothelial cancer who were previously treated with a PD-1/L1 inhibitor and platinum-based therapies. The primary endpoint is overall survival and secondary endpoints include progression-free survival, overall response rate, duration of response and disease control rate, as well as assessment of safety/tolerability and quality-of-life parameters.

About the EV-201 TrialThe EV-201 trial (NCT03219333) is a single-arm, dual-cohort, pivotal phase 2 clinical trial of enfortumab vedotin for patients with locally advanced or metastatic urothelial cancer who have been previously treated with a PD-1 or PD-L1 inhibitor, including those who have also been treated with a platinum-containing chemotherapy (cohort 1) and those who have not received a platinum-containing chemotherapy in this setting and who are ineligible for cisplatin (cohort 2). The trial enrolled 128 patients in cohort 1 and 91 patients in cohort 2 at multiple centers internationally. The primary endpoint is confirmed objective response rate per blinded independent central review. Secondary endpoints include assessments of duration of response, disease control rate, progression-free survival, overall survival, safety and tolerability.

About Urothelial CancerUrothelial cancer is the most common type of bladder cancer (90 percent of cases) and can also be found in the renal pelvis (where urine collects inside the kidney), ureter (tube that connects the kidneys to the bladder) and urethra.[3] Globally, approximately 549,000 new cases of bladder cancer and 200,000 deaths are reported annually.[4]

About PADCEV (enfortumab vedotin-ejfv)PADCEV was approved by the U.S. Food and Drug Administration (FDA) in December 2019 and is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor, and a platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery or in a locally advanced or metastatic setting. PADCEV was approved under the FDA's Accelerated Approval Program based on tumor response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.[5]

PADCEV is a first-in-class antibody-drug conjugate (ADC) that is directed against Nectin-4, a protein located on the surface of cells and highly expressed in bladder cancer.5,[6] Nonclinical data suggest the anticancer activity of PADCEV is due to its binding to Nectin-4 expressing cells followed by the internalization and release of the anti-tumor agent monomethyl auristatin E (MMAE) into the cell, which result in the cell not reproducing (cell cycle arrest) and in programmed cell death (apoptosis).5 PADCEV is co-developed by Astellas and Seagen.

PADCEV Important Safety Information

Warnings and Precautions

Adverse ReactionsSerious adverse reactions occurred in 46% of patients treated with PADCEV. The most common serious adverse reactions (3%) were urinary tract infection (6%), cellulitis (5%), febrile neutropenia (4%), diarrhea (4%), sepsis (3%), acute kidney injury (3%), dyspnea (3%), and rash (3%). Fatal adverse reactions occurred in 3.2% of patients, including acute respiratory failure, aspiration pneumonia, cardiac disorder, and sepsis (each 0.8%).

Adverse reactions leading to discontinuation occurred in 16% of patients; the most common adverse reaction leading to discontinuation was peripheral neuropathy (6%). Adverse reactions leading to dose interruption occurred in 64% of patients; the most common adverse reactions leading to dose interruption were peripheral neuropathy (18%), rash (9%) and fatigue (6%). Adverse reactions leading to dose reduction occurred in 34% of patients; the most common adverse reactions leading to dose reduction were peripheral neuropathy (12%), rash (6%) and fatigue (4%).

The most common adverse reactions (20%) were fatigue (56%), peripheral neuropathy (56%), decreased appetite (52%), rash (52%), alopecia (50%), nausea (45%), dysgeusia (42%), diarrhea (42%), dry eye (40%), pruritus (26%) and dry skin (26%). The most common Grade 3 adverse reactions (5%) were rash (13%), diarrhea (6%) and fatigue (6%).

Lab AbnormalitiesIn one clinical trial, Grade 3-4 laboratory abnormalities reported in 5% were: lymphocytes decreased (10%), hemoglobin decreased (10%), phosphate decreased (10%), lipase increased (9%), sodium decreased (8%), glucose increased (8%), urate increased (7%), neutrophils decreased (5%).

Drug Interactions

Specific Populations

For more information, please see the full Prescribing Information for PADCEV here.

About Astellas Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. Furthermore, we are also looking beyond our foundational Rx focus to create Rx+ healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into value for patients. For more information, please visit our website athttps://www.astellas.com/en.

About Seagen Seagen Inc. is a global biotechnology company that discovers, develops and commercializes transformative cancer medicines to make a meaningful difference in people's lives. Seagen is headquartered in the Seattle, Washington area, and has locations in California, Canada, Switzerland and the European Union. For more information on our marketed products and robust pipeline, visit http://www.seagen.com and follow @SeagenGlobal on Twitter.

About the Astellas and Seagen CollaborationAstellas and Seagen are co-developing enfortumab vedotin under a collaboration that was entered into in 2007 and expanded in 2009.

Astellas Cautionary NotesIn this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management's current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas' intellectual property rights by third parties.

Information about pharmaceutical products (including products currently in development), which is included in this press release is not intended to constitute an advertisement or medical advice.

Seagen Forward Looking StatementsCertain statements made in this press release are forward looking, such as those, among others, relating to the potential conversion of PADCEV's current accelerated approval in the U.S. to regular approval and the potential expansion of the current PADCEV label to include patients with locally advanced or metastatic urothelial cancer who have been previously treated with a PD-1/L1 inhibitor and are ineligible for cisplatin, and the therapeutic potential of PADCEV, including its efficacy, safety and therapeutic uses. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include, without limitation, the possibility that the sBLA submissions based on the EV-301 and EV-201 second cohort clinical trials may not be accepted for filing by, or ultimately approved by, the FDA in a timely manner or at all; that the results of the EV-301 clinical trial may not be sufficient to convert PADCEV's accelerated approval in the U.S. to regular approval and that the results of the second cohort of the EV-201 clinical trial may not be sufficient to support the requested label expansion; that, even if PADCEV receives regular approval and even if the PADCEV label is expanded based on the results of the second cohort of the EV-201 clinical trial, the product labeling may not be as broad or desirable as requested or anticipated; and that setbacks in the development and commercialization of PADCEV could occur as a result of the difficulty and uncertainty of pharmaceutical product development, the risk of adverse events or safety signals, the failure of ongoing and subsequent clinical trials to establish sufficient efficacy, or as a result of adverse regulatory actions. More information about the risks and uncertainties faced by Seagen is contained under the caption "Risk Factors" included in the company's Annual Report on Form 10-K for the year ended December 31, 2020 filed with the Securities and Exchange Commission. Seagen disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

[1]Powles T, Rosenberg J, Sonpavde G, et al. Primary Results of EV-301: A Phase 3 Trial of Enfortumab Vedotin vs Chemotherapy in Patients With Previously Treated Locally Advanced or Metastatic Urothelial Carcinoma. ASCO Meeting Library 2021. https://meetinglibrary.asco.org/record/194738/abstract. Accessed February 11, 2021.[2] Balar AV, McGregor B, Rosenberg J, et al. EV-201 Cohort 2: Enfortumab vedotin in cisplatin-ineligible patients with locally advanced or metastatic urothelial cancer who received prior PD-1/PD-L1 inhibitors. ASCO Meeting Library 2021. https://meetinglibrary.asco.org/record/194731/abstract. Accessed February 11, 2021.[3]American Society of Clinical Oncology. Bladder cancer: introduction (5-2019). https://www.cancer.net/cancer-types/bladder-cancer/introduction. Accessed January 27, 2021.[4]Cancer today: data visualization tools for exploring the global cancer burden in 2020. https://gco.iarc.fr/today/home. Accessed January 27, 2021.[5]PADCEV [package insert] Northbrook, IL: Astellas Pharma Inc.[6]Challita-Eid P, Satpayev D, Yang P, et al. Enfortumab Vedotin Antibody-Drug Conjugate Targeting Nectin-4 Is a Highly Potent Therapeutic Agent in Multiple Preclinical Cancer Models. Cancer Res 2016;76(10):3003-13.

SOURCE Astellas Pharma Inc.

http://www.us.astellas.com

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Astellas and Seagen Announce Submission of Two Supplemental Biologics License Applications to the US FDA for PADCEV (enfortumab vedotin-ejfv) in...

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