StemCell Therapy

Rabbi Elie Abadie, M.D., senior rabbi, Jewish Council of the Emirates and Association of Gulf Jewish Communities.

Jonathan J. Bush, Jr., executive chair, Firefly Health.

Amy Abernethy, M.D., Ph.D., former principal deputy commissioner and acting chief information officer, U.S. Food and Drug Administration.

Deepak Chopra, M.D., founder, The Chopra Foundation and founder, Chopra Global.

Micah Aberson, executive vice president, Sanford Health.

George Church, Ph.D., founding core faculty and lead, Wyss Institute, Harvard University; professor of genetics, Harvard Medical School; professor of health sciences and technology, Harvard and Massachusetts Institute of Technology.

Gina Agiostratidou, Ph.D., program director, Type 1 diabetes program, The Leona M. and Harry B. Helmsley Charitable Trust.

Ellen Wright Clayton, M.D., J.D., Craig-Weaver Professor of pediatrics and professor of health policy, Center for Biomedical Ethics and Society, Vanderbilt University Medical Center and professor of law, Vanderbilt School of Law.

Rick Anderson, president and general manager, North America, DarioHealth.

Chelsea Clinton, D.Phil., M.P.H., vice chair, Clinton Foundation.

Stphane Bancel, CEO, Moderna.

Kelly L. Close, co-founder and chair of the board, The diaTribe Foundation.

Justin L. Barrett, Ph.D., president, Blueprint 1543, honorary professor of theology and the sciences, St. Andrews University, School of Divinity.

Francis S. Collins, M.D., Ph.D., director, U.S. National Institutes of Health.

Nir Barzilai, M.D., The Rennert Chair of Aging Research, professor of medicine and genetics and director, Nathan Shock Center of Excellence in the Biology of Aging, Albert Einstein College of Medicine.

Cindy Crawford, model and entrepreneur.

Marc Benioff, chair and CEO, Salesforce.

John F. Crowley, chair of the board and CEO, Amicus Therapeutics, Inc.

Paul Bloom, Ph.D., Brooks and Suzanne Ragen Professor of Psychology, Yale University.

Ray Dalio, founder, co-chair and co-chief information officer, Bridgewater Associates, New York Times best-selling author of "Principles: Life & Work."

Emma Bloomberg, founder and CEO, Murmuration.

Richard J. Davidson, Ph.D., professor of psychology and psychiatry, and founder and director of the Center for Healthy Minds, University of Wisconsin-Madison.

Albert Bourla, D.V.M., Ph.D., chair and CEO, Pfizer.

Grand Hospitaller, H.E. Dominique Prince de La Rochefoucauld-Montbel, Bailiff Grand Cross of Honour and Devotion in Obedience, The Sovereign Order of Malta.

Otis W. Brawley, M.D., Bloomberg Distinguished Professor of oncology and epidemiology, Johns Hopkins University.

Marilyn Glassberg, M.D., division chief of pulmonary medicine, critical care and sleep medicine; senior director of clinical research for strategy and growth, department of internal medicine, University of Arizona College of Medicine.

Dan Buettner, founder, Blue Zones.

Laurie H. Glimcher, M.D., president and CEO, Dana-Farber Cancer Institute, Richard and Susan Smith professor of medicine, Harvard Medical School, director, Dana-Farber/Harvard Cancer Center.

Ronald A. DePinho, M.D., Distinguished University Professor and past president, MD Anderson Cancer Center.

Dr. Jane Goodall, DBE, founder, the Jane Goodall Institute and U.N. Messenger of Peace.

Joseph M. DeVivo, president, hospital and health systems, Teladoc Health.

Scott Gottlieb, M.D., resident fellow, American Enterprise Institute and 23rd commissioner, U.S. Food and Drug Administration.

Spencer P. Eccles, co-founder and managing partner, The Cynosure Group.

Andre Goy, M.D., physician-in-chief of Oncology Services, Hackensack Meridian Health;chair, John Theurer Cancer Center; founding chair of Oncology, Hackensack Meridian School of Medicine.

Rev. Terrence P. Ehrman, C.S.C., Ph.D., visiting assistant teaching professor, department of theology, University of Notre Dame.

Kurt J. Griffin, M.D., Ph.D., Todd and Linda Broin Chair for Diabetes Research; director of clinical trials, The Sanford Project, Sanford Research; and associate professor, pediatric endocrinology, Sanford School of Medicine, University of South Dakota.

Michael E. Farkouh, M.D., Peter Munk Chair in Multinational Clinical Trials; director, Heart & Stroke/Richard Lewar Centre of Excellence; vice-chair, research and professor of medicine, department of medicine, University of Toronto.

Sanjay Gupta, M.D., award-winning chief medical correspondent, CNN and neurosurgeon.

Paul Farmer, M.D., Ph.D., Kolokotrones University professor and chair, department of global health and social medicine, Harvard Medical School; co-founder and chief strategist, Partners In Health.

Robert J. Hariri, M.D., Ph.D., founder, chair, and CEO, Celularity.

Anthony S. Fauci, M.D., director, National Institute of Allergy and Infectious Diseases, U.S. National Institutes of Health.

Katherine High, M.D., president, therapeutics, AskBio.

Judy Faulkner, founder and CEO, Epic.

Marc Hodosh, founder and co-host, "LIFE ITSELF."

David Feinberg, M.D., vice president, head of Google Health, Google.

Donald Hoffman, Ph.D., professor emeritus of cognitive sciences, University of California, Irvine.

Rev. Kevin T. FitzGerald, S.J., Ph.D., John A. Creighton University Professor and chair, department of medical humanities, Creighton University.

Jacquelyn Kulinski, M.D., director of the preventive cardiology program and associate professor of medicine, Medical College of Wisconsin.

Rene Fleming, soprano; arts and health advocate; artistic advisor, John F. Kennedy Center for the Performing Arts.

Samarth Kulkarni, Ph.D., CEO, CRISPR Therapeutics.

Robert C. Garrett, CEO, Hackensack Meridian Health.

Timothy A. Lash, president, West Health Policy Center.

Rebekah E. Gee, M.D., CEO, Louisiana State University Health Care Services; former secretary, Louisiana Department of Health.

William W. Li, M.D., president, medical director and CEO, The Angiogenesis Foundation.

Debra Houry, M.D., M.P.H., director, National Center for Injury Prevention and Control, U.S. Centers for Disease Control and Prevention.

Peter Libby, M.D., cardiovascular specialist, Brigham and Women's Hospital and Mallinckrodt Professor of medicine, Harvard Medical School.

Ryan Howard, founder and CEO, 100Plus.

Dan Liljenquist, senior vice president and chief strategy officer, Intermountain Healthcare.

Mark Hyman, M.D., head of strategy and innovation, Cleveland Clinic Center for Functional Medicine.

Shelley Lyford, president and CEO, Gary and Mary West Foundation.

Elder William K. Jackson, M.D., General Authority Seventy, The Church of Jesus Christ of Latter-day Saints.

Peter Marks, M.D., Ph.D., director, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration.

Jo Ann Jenkins, CEO, AARP.

Brandon Marshall, NFL athlete, co-founder, Project 375 and founder, House of Athlete.

Henry Ji, Ph.D., chair, president and CEO, Sorrento Therapeutics.

Mark McClellan, M.D., Ph.D., director, Duke-Robert J. Margolis, M.D., Center for Health Policy, and the Robert J. Margolis, M.D., Professor of Business, Medicine, and Policy, Duke University.

Thupten Jinpa, Ph.D., president, Compassion Institute.

Gary Mendell, founder and CEO, Shatterproof.

Carl June, M.D., the Richard W. Vague Professor in Immunotherapy and director of the Center for Cellular Immunotherapies, Perelman School of Medicine; director of the Parker Institute for Cancer Immunotherapy, University of Pennsylvania.

Jamie Metzl, J.D., Ph.D., founder and chair, OneShared.World.

Cigall Kadoch, Ph.D., professor, Dana-Farber Cancer Institute and Harvard Medical School; founder, Foghorn Therapeutics.

Matthew Might, Ph.D., professor and director, Hugh Kaul Precision Medicine Institute, University of Alabama at Birmingham.

Dean Kamen, president, DEKA R&D, chair ARMI, and founder, FIRST.

Rosalind Picard, Sc.D., professor, MIT Media Lab; chief scientist and chair, Empatica.

Allen J. Karp, executive vice president, healthcare management and transformation, Horizon Blue Cross Blue Shield of New Jersey.

Renato Poletti, president, Science and Faith (STOQ) Foundation and president, Foundation for Heritage and Cultural and Artistic Activities of the Church.

Kerry Kennedy, president, Robert F. Kennedy Human Rights.

Cardinal Gianfranco Ravasi, president, Pontifical Council for Culture.

Stephen K. Klasko, M.D., president, Thomas Jefferson University, CEO, Jefferson Health.

Elder Dale G. Renlund, M.D., Quorum of the Twelve Apostles, The Church of Jesus Christ of Latter-day Saints.

Aaron J. Kowalski, Ph.D., president and CEO, JDRF International.

David C. Rhew, M.D., chief medical officer and vice president of healthcare, Worldwide Commercial Business, Microsoft.

Maria Millan, M.D., president and CEO, California Institute for Regenerative Medicine.

Walter Ricciardi, M.D., full professor in hygiene, Universit Cattolica del Sacro Cuore, Rome; president, Mission Board for Cancer of the European Commission; president, World Federation of Public Health Associations.

Princess Dina Mired, immediate past president, Union for International Cancer Control; patron of SIOP; honorary president of EORTC; special envoy for NCD's Vital Strategies; member of WHO Expert Group for the Elimination of Cervical Cancer.

Sheri L. Robb, Ph.D., professor, Indiana University School of Nursing.

William C. Mobley, M.D., Ph.D., associate dean for neurosciences initiatives, and interim director of the Sanford Institute for Empathy and Compassion, department of neurosciences, University of California San Diego.

Robert S. Rosenson, M.D., Director of Metabolism and Lipids, professor of medicine and cardiology, Icahn School of Medicine at Mount Sinai.

Dariush Mozaffarian, M.D., Dr.P.H., dean, Friedman School of Nutrition Science and Policy, Tufts University.

Frank J. Sasinowski, J.D., M.P.H., director, Hyman, Phelps & McNamara.

Michael Murray, Ph.D., president, Arthur Vining Davis Foundations.

Roy Schoenberg, M.D., M.P.H., president and co-CEO, Amwell.

Julien Musolino, Ph.D., associate professor, department of psychology, Rutgers University.

John Sculley, managing partner, Sculley Advisors.

David B. Nash, M.D., founding dean emeritus and the Raymond C. and Doris N. Grandon Professor of Health Policy, Jefferson College of Population Health.

Stephen Shaya, M.D., managing director, Akkad Holdings; executive servant leader, J&B Medical.

Timothy O'Connor, Ph.D., Mahlon Powell Professor of Philosophy, Indiana University.

Jerrell W. Shelton, chair, president and CEO, Cryoport.

Emmanuel "Manny" Ohonme, president and CEO, Samaritan's Feet International.

Andrew C. von Eschenbach, M.D., president, Samaritan Health Initiatives; former Commissioner U.S. Food and Drug Administration and 12th Director, National Cancer Institute.

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The Vatican's Pontifical Council for Culture and The Cura Foundation "Unite to Prevent" - PRNewswire

Particle sorting is a fundamental method in various fields of medical and biological research. However, existing sorting applications are not capable for high-throughput sorting of large-size (>100 micrometers) particles. Here, we present a novel on-chip sorting method using traveling vortices generated by on-demand microjet flows, which locally exceed laminar flow condition, allowing for high-throughput sorting (5 kilohertz) with a record-wide sorting area of 520 micrometers. Using an activation system based on fluorescence detection, the method successfully sorted 160-micrometer microbeads and purified fossil pollen (maximum dimension around 170 micrometers) from lake sediments. Radiocarbon dates of sorting-derived fossil pollen concentrates proved accurate, demonstrating the methods ability to enhance building chronologies for paleoenvironmental records from sedimentary archives. The method is capable to cover urgent needs for high-throughput large-particle sorting in genomics, metabolomics, and regenerative medicine and opens up new opportunities for the use of pollen and other microfossils in geochronology, paleoecology, and paleoclimatology.

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Breakthrough in purification of fossil pollen for dating of sediments by a new large-particle on-chip sorter - Science Advances

DUBLIN--(BUSINESS WIRE)--The "Growth Opportunities in Gene Therapies, Cancer, Disease Treatment & Monitoring, Surgical Applications and Cosmetics" report has been added to ResearchAndMarkets.com's offering.

This edition of the Life Science, Health & Wellness Technology Opportunity Engine (TOE) consists of insights across gene therapies, cancer, neurological, allergic and respiratory diseases treatment and monitoring. Further, novel drugs, drug delivery systems, surgical support applications, artificial intelligence-based imaging, as well as telehealth systems are discussed. Some innovations cover the upcoming innovations in cosmetics, acne treatment, food packing, and natural extract processing technologies

The Life Science, Health & Wellness TOE will feature disruptive technology advances in the global life sciences industry. The technologies and innovations profiled will encompass developments across genetic engineering, drug discovery and development, biomarkers, tissue engineering, synthetic biology, microbiome, disease management, as well as health and wellness among several other platforms.

The Health & Wellness cluster tracks developments in a myriad of areas including genetic engineering, regenerative medicine, drug discovery and development, nanomedicine, nutrition, cosmetic procedures, pain and disease management and therapies, drug delivery, personalized medicine, and smart healthcare.

Innovations in Life Sciences, Health & Wellness

For more information about this report visit https://www.researchandmarkets.com/r/2d6ood

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2021 Growth Opportunities in Gene Therapies, Cancer, Disease Treatment & Monitoring, Surgical Applications and Cosmetics - ResearchAndMarkets.com...

(Precision Vaccinations)

Florida-based Longeveron Inc. announced the completion of the Companys Phase I/II clinical study of the use of Lomecel-B to improve immune response to influenza vaccine in subjects with Aging Frailty.

Longeveron stated in a press release issued on April 15, 2021, 'it is anticipated that the top-line trial results will be announced in the 3rdquarter of 2021.'

Lomecel-B is an allogeneic, bone marrow-derived medicinal signaling cellproduct manufactured under current good manufacturing practicesby Longeveron.

The company says 'Lomecel-B has the potential to reduce inflammation associated with Aging Frailty and to promote an anti-inflammatory state by releasing anti-inflammatory molecules, which can balance the immune system and improve the function of B lymphocytes.

As B cells are responsible for antibody production in response to vaccines, Lomecel-B may boost antibody generation and immunity following vaccination in subjects with Aging Frailty.'

Completion of this clinical study to investigate Lomecel-B as a new therapeutic approach to boost immune response serves as an important initial step to meet the critical unmet medical need for those with Aging Frailty, who often respond poorly to vaccines, said Sean Leng, MD, Ph.D., Professor of Medicine, Molecular Microbiology and Immunology at Johns Hopkins University School of Medicine and Bloomberg School of Public Health and the studys principal investigator.

Aging Frailty is a life-threatening geriatric condition affecting approximately 15% of Americans over 65 or 8.1 million individuals. Aging Frailty patients are vulnerable to poor clinical outcomes compared to their age-matched peers despite sharing similar comorbidities and demographics. Therefore it is considered by some as an extreme form of unsuccessful aging.

Geoff Green, CEO of Longeveron. From the inception of Longeveron, we have focused our efforts on using a regenerative medicine approach to treat chronic, aging-related diseases and conditions, such as frailty and Alzheimers disease, with the goal of improving healthspan.

Miami-basedLongeveron is a clinical-stage biotechnology company developing cellular therapies for specific aging-related and life-threatening conditions.

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Infusion Improves Immune Response of Aging Frailty Following Flu Shot - PrecisionVaccinations

Roches gene therapy unit Spark Therapeutics has penned a $645 million-plus biobucks pact with Bayer-backed Senti Biosciences for new tech aimed at tweaking next-gen gene therapies.

Under the deal, Spark will maneuver Senti Bios gene circuit tech to drive the development of gene therapy 2.0. specifically directed toward specific cell types in the central nervous system, eye or liver.

Fierce 15 winner Senti Bios approach involves what it calls gene circuits, essentially tweaking a cells genetic code which can morph in order to address the severity of a disease, all the while limiting side effects.

Internally, the Californian biotech is applying its gene circuit tech specifically toward allogeneic chimeric antigen receptor natural killer cells, a growing area of interest in oncology.

Senti Bios lead assets out of this platform include SENTI-202 for acute myeloid leukemia, SENTI-301 for hepatocellular carcinoma and others for undisclosed solid tumor targets.

And its not just cancer: Senti Bio believes its on to something big, and it says it can also target a whole host of other areas and gene therapy delivery modalities such as immunology, neuroscience, cardiovascular disease, regenerative medicine and genetic diseases.

At the start of the year, it got off a major $105 million series B funding round, building on the initial $53 million it got off three years back. It also has the backing of some big names, with Leaps by Bayer and Amgens VC arm as well as Matrix Partners China, Mirae Asset Capital, Ridgeback Capital, Intel Capital, New Enterprise Associates, 8VC and Lux Capital all pitching in for its latest cash haul.

RELATED: Spark Therapeutics nabs CMO from new owner Roche

Now, it has a major pact with Spark/Roche that will see the biotech nab an undisclosed upfront payment and a mixture of biobucks, all of which could see Senti Bio bring home $645 million-plus.

For its part, Senti will be responsible for designing, building and testing cell type- and disease specific-synthetic promoters for use in certain CNS-, ocular- or liver-directed gene therapies.

Spark, meanwhile, holds an option to exclusively license a defined number of synthetic promoters emerging from the collab for use in developing gene therapy products in specified indications.

Should it hit go on that option, Spark will be responsible for conducting preclinical, clinical and sales work for any gene therapies that use Senti Bios licensed synthetic promoters.

We view gene circuits as a critical component of any advanced cell and gene therapy, regardless of therapeutic area or delivery modality, said Tim Lu, M.D., Ph.D., CEO of Senti Bio.

This collaboration with Spark Therapeutics aligns with our goal of enabling truly dynamic therapies that have the ability to discriminate between certain cell types, selectively express various payloads, and respond to diverse disease environments.

We are extremely impressed by the capabilities and know-how of Spark Therapeutics specifically in the area of gene therapy, and we look forward to bringing our mutual expertise together under this collaboration to harness the power of gene circuits to develop gene therapies that are clinically meaningful to patients.

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Senti Biosciences in $645M Spark pact to drive gene circuits into the fast lane - FierceBiotech

Anthony Atala receives an award for his innovations in 3D printing to create human organs at the Smithsonian Magazines 2016 American Ingenuity Awards after at National Portrait Gallery on December 8, 2016 in Washington, DC. Photo credit: Leah Puttkammer, Getty Images

Regenerating a solid organ for transplant might be years away from reaching patients. But regenerative medicine technology as a tool for discovering and testing new drugs? Thats already happening.

In Winston-Salem, North Carolina, scientists are 3D printing miniature organs that replicate the anatomy and function of a heart, liver, lungs, even the brain, said Anthony Atala, a professor of urology at Wake Forest University. Their lifetimes last just months, but thats more than enough time to assess a drug in ways that lab tests or even animal tests cannot.

After tens of millions of dollars of investment, by the time a drug gets into a Phase 1 clinical trial through the FDA, 90% of those drugs end up failing, Atala said, speaking on March 24 during the Oracle Health Sciences Connect 2021 conference. Its due to the testing that is not really accurate. Therefore, the strategy is to create these miniature organs.

Atala is the director of the Wake Forest Institute for Regenerative Medicine (WFIRM), which is conducting research on about 40 different tissues and organs. So far, the institute has launched 15 technologies that use human cells to engineer tissues and organs.

The drug testing happens on organoids, an invitro system that stands in for an organ. These miniature organs can be made in both healthy and diseased states, Atala said. These chips can create the human equivalent of physiological responses. For example, scientists can prompt a heart attack or a stroke to assess what a drug would do to an organ affected by those conditions.

WFIRMs drug discovery research represents a convergence of technologies. This body-on-a-chip technology is used to screen libraries of compounds for both safety and efficacy ahead of animal studies and clinical trials, Atala said. Data are cataloged at every step of the process. Artificial intelligence can then be applied to find patterns in the data, improving predictive modeling for drug development.

The Wake Forest research is being conducted as part of the Humanoid Sensor Consortium, a partnership comprised of pharmaceutical companies, academic institutions, and government agencies. The WFIRMs own drug discovery collaborators include the Biomedical Advanced Research and Development Authority (BARDA), which has provided $25 million for research into potential countermeasures to chemical agents. The Defense Threat Reduction Agency (DTRA) has provided more than $26 million in funding for the development of countermeasures for nerve agents.

The technologies that are closest to helping patients are part of a new approach to personalized medicine. The miniature organs are used to help oncologists make treatment decisions. A patients own tissue is used create tumors on a chip, which is then used to test different chemotherapies. These chips are currently being evaluated in clinical trials.

Instead of trying out a treatment for six months and finding out it doesnt work, and then trying another regimen, by then the tumor might be too far gone, Atala said. We can now try to define what the best treatment is before the patient receives the first dose.

Regenerated organs are on the way, Atala said. Engineered skin products are entering the market. The next regenerative tissue products will be a bit more complex, taking on tubular structures. WFIRM has regenerated urethras by taking a small tissue sample from a patient and expanding those cells in a lab. Those cells populate a bioresorbable scaffold, which can then be implanted in the patient.

Solid organs pose the biggest challenge for regenerative medicine. These organs are comprised of many more cells that must be nourished by blood supply. WFIRMs research includes kidneys. A small tissue sample from a patient is expanded in a lab, yielding kidney units capable of producing urine. These kidney units can then be implanted in the patient. Atala said that this research is advancing to Phase 3 testing for patients in end-stage renal failure.

When WFIRM started in 2004, the scientists did not begin the research with an eye on which patients could be helped most by regenerative medicine technology, Atala said. But now, it seems the greatest area of need appears to be kidney transplant patients.

As you know, 80% of patients on the transplant wait list are actually waiting for a kidney, Atala said. So, if we can make a dent in that population, that would be a great thing.

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Regenerative medicine is already changing the way drugs are discovered and tested - MedCity News

VANCOUVER, British Columbia--(BUSINESS WIRE)-- Aspect Biosystems, a privately held biotechnology company pioneering the development of bioprinted therapeutics, is pleased to announce a new joint development program with JSR Corporation, a global leader in advanced materials innovation. This collaboration builds on the existing partnership between the two companies and will see the combining of Aspects proprietary microfluidic 3D bioprinting platform with JSRs advanced materials technology to develop implantable vascularized tissues for kidney regeneration and other applications in regenerative medicine.

The vascularized implantable tissues we develop through this collaboration will enable the next generation of regenerative medicine solutions by supporting longer-term function of therapeutic cells in the body, said Tamer Mohamed, President and CEO of Aspect Biosystems. We are excited to work with JSRs innovative team based in Japan, a country at the forefront of regenerative medicine, and we look forward to continue making breakthroughs with our broadly applicable technology platform.

In our work through JSR Life Sciences, we are seeing the need for advanced, innovative materials continue to grow throughout the biosciences, said Toru Kimura, CTO of JSR Corporation. This joint development program with Aspect Biosystems is testament to that and an important step in enabling and accelerating highly impactful areas in regenerative medicine.

About Aspect Biosystems

Aspect Biosystems is a biotechnology company creating bioprinted therapeutics as medicines of the future. Aspect is applying its microfluidic 3D bioprinting technology internally to develop these advanced cell therapies and partnering with leading researchers and industry innovators worldwide to tackle the biggest challenges in regenerative medicine. Learn more at http://www.aspectbiosystems.com.

About JSR Corporation

JSR Corporation is a multinational company with research-oriented organization that pursues close collaborations with leading innovators in a number of industries that are a key to the present and future welfare of human society: life sciences, synthetic rubbers, electronic materials, display and optical materials. JSR Corporation conducts its global life sciences business through JSR Life Sciences LLC. JSR Life Sciences provides specialized materials, products and services to the biopharma and life sciences industries both directly and through its subsidiaries MEDICAL & BIOLOGICAL LABORATORIES CO., LTD, KBI Biopharma, Inc., Selexis SA, and Crown Biosciences. Learn more at http://www.jsr.co.jp/jsr_e/ and https://www.jsrlifesciences.com/

View source version on businesswire.com: https://www.businesswire.com/news/home/20210330005431/en/

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Aspect Biosystems and JSR Corporation Enter Collaboration to Develop Bioprinted Vascularized Tissues for Regenerative Medicine - BioSpace

Stem cell therapy, also known as regenerative medicine, has been around for decades, but in recent years, the use of and interest in stem cell therapy has increased exponentially. The dramatic utilization of stem cell therapy, and the increasing government spend related to these novel techniques, have now caught the eye of federal regulators and prosecutors. In this client alert, we profile some brief context of stem cell therapy, the governments regulations governing these techniques, and some of the best practices for those interested in this emerging space.

Stem cells are cells from which all other cells with specialized functions are generated (i.e., the bodys raw materials). Stem cells may duplicate themselves to create more stem cells or they may generate cells with a specific function like blood or brain cells.

Stem cell therapy is used to repair or replace damaged tissue or cells within the body. Many in the medical community are hopeful that stem cell therapy can be used to treat a wide array of conditions and diseases from multiple sclerosis to vision loss to traumatic spinal cord injuries to Lou Gehrigs disease just to name a few.

The Food and Drug Administration (FDA) oversees and regulates stem cell therapy treatments. While the FDA has acknowledged that stem cell therapy has the potential to treat diseases or conditions for which few treatments exist, there are still only a few treatments that have actually been approved by the FDA. Many treatments are still only in early investigatory stages.

The FDA has recognized the massive potential that stem cell therapy has in allowing patients treatments for various conditions. Consequently, in 2017, the FDA issued guidance indicating its intent to exercise enforcement discretion as a means to support and expedite the development of regenerative medicine products. This enforcement discretion period was to allow innovators time to determine whether to submit an Investigational New Drug (IND) or marketing application and, if such an application is needed, to prepare and submit the application as appropriate. The FDA, however, has made clear its enforcement discretion policy only applies to products that do not raise potential significant safety concerns. What the FDA considers significant is debatable, creating uncertainty and ambiguity for those who might be relying on the FDAs enforcement discretion period.

Initially, the FDA stated that its enforcement discretion period would last through November 2020. But in July 2020, the FDA extended its enforcement discretion period through May 2021 a fast-arriving date. It remains unclear whether the FDA intends to extend the time period of its enforcement discretion any further, but either way, stem cell therapy providers would be well-served by planning for and expecting enforcement efforts to ramp up in the near future.

In 2019, the FDA went to great lengths to warn consumers of the potential fraud that may arise from what it called stem cell therapy hype, and encouraged consumers to make sure any stem cell therapy treatments were either approved or being studied as an IND. The FDAs concerns have led to multiple enforcement actions, including one just last month. On February 1, 2021, for example, the government announced the indictment of Ashton Derges, a healthcare provider in Missouri, who marketed stem cell shots as a successful treatment for various conditions, including COVID-19. According to the indictment, Derges was paid nearly $200,000 by patients for the stem cell shots, none of which actually contained stem cells at all. While this alleged fraud was not particularly sophisticated, it nonetheless marked a significant development: the governments first criminal prosecution of those touting stem cell therapies.

But blatant fraud is not the only type of stem cell therapy case the government has expressed interest in investigating. A primary concern of the government is the marketing and use of unproven stem cell treatments as miracle cures. A good case study of the risks associated with aggressive marketing of stem cell therapy is a case out of Florida involving US Stem Cell Clinic Inc. The clinic was marketing stem cell therapy to treat conditions and diseases such as Parkinsons disease, stroke, and brain injuries none of which were approved by the FDA. And, much of the marketing that US Stem Cell Clinic used promised almost miraculous results. As a result, last year, the FDA successfully permanently enjoined the US Stem Cell Clinic from selling or providing those stem cell therapy treatments. Notably, this case was pursued by the FDA despite the FDA explicitly stating its intent to be lenient with emerging stem cell therapy treatments.

Stem cell therapy is a groundbreaking medical tool with great possibilities to treat a plethora of diseases and conditions. As the industry continues to expand, so will the governments interest. Our firm continues to see an uptick in cases involving stem cell therapy treatments. And we have successfully assisted clients in avoiding unnecessary scrutiny by the FDA and other government regulators.

If you are in the stem cell therapy industry or are considering offering stem cell therapy treatments, we recommend that you:

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The Governments Watchful Eye on Fraud Stemming from Stem Cell Therapy - JD Supra

Dublin, April 01, 2021 (GLOBE NEWSWIRE) -- The "Automated and Closed Cell Therapy Processing Systems Market By Cell Processing Steps, Scale of Operations, End Users and Geographical Regions: Industry Trends and Global Forecasts, 2020 - 2030" report has been added to ResearchAndMarkets.com's offering.

The "Automated and Closed Cell Therapy Processing Systems Market: Focus on Apheresis, Expansion, Harvest, Fill/Finish, Cryopreservation, Thawing, 2020-2030" report features an extensive study of the current market landscape and future opportunities associated with the automated and closed cell therapy processing systems. The study also features a detailed analysis of key drivers and trends related to this evolving domain.

One of the key objectives of the report was to estimate the existing market size and the future growth potential of the automated and closed cell therapy processing systems. Based on various parameters, such as number of cell therapies under development, expected pricing, likely adoption rates, and potential cost saving opportunities from different automated and closed cell processing systems, we have developed informed estimates of the evolution of the market, over the period 2020-2030.

Advanced therapy medicinal products (ATMPs), such as cell therapies and gene therapies, have revolutionized the healthcare sector. Over the past two decades, more than 30 ATMPs have been approved. Moreover, according to a recent report (published by The Alliance for Regenerative Medicine), over 1,050 clinical trials are currently being conducted by over 1,000 companies, worldwide, focused on the evaluation of cell and gene therapies.

However, despite the numerous advances in this field, there are certain challenges that need to be addressed in order to achieve commercial success. For instance, the current cell therapy manufacturing process is labor-intensive, time consuming and costly. Further, the production of most of these specialized therapeutic products requires manual labor and are typically carried out discretely (open processing), thereby, rendering the processes difficult to scale-up, with high risk of contamination.

Another concern faced by cell and gene therapy manufacturers is batch-to-batch variability, given that even a minor change in the production protocol can affect the quality of the resulting product. Consequently, cell therapies are exorbitantly priced, ranging from USD 300,000 to USD 500,000 per dose.

Experts believe that some of the existing challenges related to cell therapy manufacturing can be addressed through the adoption of automated and closed cell processing systems. These solutions have been demonstrated to be capable of enabling stakeholders to manage various aspects of the cell therapy manufacturing process efficiently, while complying to global regulatory standards. Other benefits of such systems include reduced risk of contamination, optimum utilization of facility and resources, limited in-process variation and consistent product quality.

Further, the use of such automated systems enable significant reductions (in the range of 40% to 90%) in labor costs. In recent years, the cost saving potential of these systems, coupled to their ability to streamline and simplify the complex cell therapy processing (from initial cell collection till final formulation), has effectively captured the interest of several stakeholders engaged in this domain. Given the growing demand for cost-effective, personalized medicine, coupled to the benefits of automated and closed systems, we believe that this niche market is poised to witness significant growth in the foreseen future.

Scope of the Report

An insightful product competitiveness analysis, taking into consideration various relevant parameters, such as supplier power (based on the experience/expertise of the developer in this industry) and portfolio-related parameters, such as number of systems offered, cells supported, type of culture supported, scale of operation, applications, end users, support services offered, regulatory certifications/accreditations obtained and key product specifications.

Elaborate profiles of industry players that are currently offering automated and closed cell therapy processing systems, featuring an overview of the company, its financial information (if available), and a detailed description of the system(s) they offer. Each profile also includes a list of recent developments, highlighting the key achievements, partnership activity, and the likely strategies that may be adopted by these players to fuel growth, in the foreseen future.

An analysis of the various partnerships pertaining to automated and closed cell therapy processing systems, which have been established since 2016, based on several parameters, such as year of partnership, type of partnership model adopted, type of therapy, type of cell processing step, key automated and closed cell processing systems, partner's focus area, most active players (in terms of number of partnerships signed), and geographical location of collaborators.

A detailed assessment of the current market landscape, featuring an elaborate list of over 60 automated and closed systems, along with information on the cell therapy processing step for which they are designed (apheresis, separation, expansion, harvest, fill/finish, cryopreservation and thawing), their key features (traceability, user-friendliness, configurability and scalability, process monitoring, touch-screen user interface, data management, integration with other systems and alert system), product specifications (length, width, depth, height and weight), type of cells supported (stem cells and immune cells), type of cell culture (adherent and suspension), scale of operation (pre-clinical, clinical and commercial), application (research and therapeutic), end users (hospitals/medical centers/clinics, research institutes/academic institutes, laboratories, commercial organizations), key support services offered (product support, technical support, training, installation, qualification/validation, maintenance, regulatory support and others) and regulatory certification/accreditations obtained (GMP/cGMP, GAMP, GCP, GTP/cGTP, IEC standards, ISO standards, 21 CFR Part 11 and other).

The report features detailed transcripts of interviews held with the following industry stakeholders:

Key Questions Answered

Companies Mentioned

For more information about this report visit https://www.researchandmarkets.com/r/ly01kj

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Global Automated and Closed Cell Therapy Processing Systems Market Trends and Forecasts, 2020-2030: Cell Processing Steps, Scale of Operations, End...

WILLOWBROOK, Ill., March 31, 2021 /PRNewswire/ --Based in Willowbrook, Illinois, Russell Health, a national marketer and distributor of specialty medical products and services,was recently announced as one of The Silicon Review's "50 Leading Companies of the Year 2021."The feature strategically places the Russell Health brand alongside other tech innovators in industries including marketing, finance, software, sustainability, leadership and health. Russell Health's Profile features a Q&A with the leading tech publication covering the history of the Russell Health brand, services offered, anticipated trends in Stem Cell Recruitment Therapy, continued product category research, and more. Read the full feature here.

About Russell Health: Russell Health and its partners have distributed regenerative therapy products nationwide and achieved profound clinical outcomes in multiple therapeutic areas including cosmetics, wound care, pain management, podiatry, orthopedic, optometry and gynecology.

With their partners and suppliers, they work to provide innovative life-changing and sustaining products and therapies to patients and healthcare providers around the world.

Stem Cell Recruitment Therapy products take advantage of the body's ability to repair itself. Responsibly sourced acellular tissue allografts are helping people of all ages to recover from injuries and get their life back.

Quote about the current landscape and anticipated trends in Stem Cell Recruitment Therapy:

"We do not distribute 'Stem Cells' or 'Stem Cell Procedures'. All our products are acellular and do not contain live stem cells. By using a combination of growth factors and other endogenously synthesized molecules, Stem Cell Recruitment Therapyproducts help to assist the body with repair, reconstruction and supplementation of the recipient's tissue, as mentioned above. During the pandemic, we have seen a lot of patients and physicians searching for alternative treatments like ours that are safe and effective without posing any additional risks of infection while providing the clinic."(Ryan Salvino, CEO of Russell Health)

Quote about Russell Health's involvement in Stem Cell Recruitment Therapy research:

"We are currently working with some of the top leaders in the regenerative medicine field to continue to grow and provide new innovative products to our customers and their patients. We are always looking for new breakthrough products in the market to stay abreast on the new technologies and innovations in the field. We are consistently documenting patient results to provide clinicians with testimonialson how effective the Stem Cell Recruitment Therapy products are and how they are positively affecting patients' lives." (Jonathan Benstent, Vice President of Russell Health)

Visit Russell Health online to learn more about Stem Cell Recruitment Therapy. For media inquiries or to contact the Russell Health team directly, please visit http://www.russellhealth.comor email [emailprotected].

Contact: Veronica BennettPhone: 844-249-6200Email: [emailprotected]Mailing Address: 621 Plainfield Rd., Willowbrook, IL 60527Online: http://www.russellhealth.comSocial Media: http://www.linkedin.com/company/russell-health/

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Russell Health Highlighted in the Silicon Review's '50 Leading Companies of the Year 2021' - PRNewswire

By Pat Anson, PNN Editor

A California stem cell company has announced positive results from a small, early-stage clinical trial of an experimental stem cell therapy for knee osteoarthritis.

The Phase 1/2a trial conducted by Personalized Stem Cells (PSC) involved 39 patients with knee osteoarthritis who were given a single injection of autologous mesenchymal stem cells derived from their own body fat. Safety was the primary objective of the trial and there were no serious adverse events reported by the company.

The secondary objective of the trial was to assess the effectiveness of the therapy with the Knee Injury and Osteoarthritis Outcome Score (KOOS), a survey that asks patients about their pain, other symptoms, daily function, quality of life, and recreational activities. Nearly 80% of study participants improved above the minimal important change (MIC), with an average improvement over baseline of 2.2 times the MIC.

Osteoarthritis is a progressive joint disorder caused by painful inflammation of soft tissue, which leads to thinning of cartilage and joint damage in the knees, hips, fingers and spine.

Results from the PSC study have been submitted to the FDA for review. The company hopes to get approval for a larger, Phase 2 randomized study of its stem cell therapy later this year.

We are pleased at the strong safety profile and efficacy results in this FDA-approved clinical study of stem cell therapy for knee osteoarthritis, said PSC founder and CEO, Dr. Bob Harman. We are proud to have reached this milestone in our first FDA approved clinical trial. This data supports our progress in the larger placebo-controlled clinical study.

While the FDA has approved hundreds of clinical trials of stem cells, it has not approved a single stem cell product as a treatment for arthritis or any orthopedic condition. That hasnt stopped stem cell clinics from offering regenerative medicine to patients or veterinarians from using it on animals.

VetStem Biopharma, the parent company of PSC, pioneered the use of adipose derived stem cells in veterinary medicine. Its laboratory has processed stem cells for nearly 14,000 dogs, cats, horses and other animals for use by veterinarians in the U.S. and Canada.

The 15 years of veterinary experience with adipose derived stem cell therapy of our parent company, VetStem Biopharma, provided the basis for our FDA study submission and approval and provided valuable insights into the study design and conduct, said Harman.

In addition to the Phase 2 trial for osteoarthritis, PSC plans to pursue FDA approval for a stem cell trial to treat traumatic brain injuries in humans. A clinical study using PSCs stem cell platform to treat respiratory distress syndrome in COVID-19 patients is currently underway.

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Positive Results From Stem Cell Trial for Knee Osteoarthritis - Pain News Network

GOLDEN, CO / ACCESSWIRE / April 3, 2021 / Vitro Biopharma, Inc. (formerly Vitro Diagnostics, Inc.) announced the appointment of Dr. Caroline Mosessian, PhD, DRSc, FACMPE, ACHE as its acting Director of Regulatory Affairs. Dr. Mosessian has an extensive background in regulatory science including a PhD, MS and Masters in Healthcare Administration degrees from USC in LA. In 2016 she was honored with the prestigious Top Ranked US Executive Award awarded to the top 1% of the millions of active executives in the United States. She is a trusted advisor for strategic development and operations to a variety of technology firms promoting innovation excellence to enhance quality of life for patients, caregivers and providers while optimizing outcomes and overall corporate success. In addition to regulatory expertise, she has extensive experience in the development, management and licensing of intellectual property, government and private fund raising, strategic planning and clinical research operations. She is fluent in several languages that support her international business development skills. She is also actively involved in local, national and international charitable organizations that emphasize humanitarian aid.

She has led numerous clinical studies of medical devices and pharmaceuticals through regulatory agency approval including the FDA and EMA leading to successful development of multi-million dollar clinical programs. She presently assists Vitro Biopharma in the guidance, drafting and submission of its pending IND phase I application to the FDA (Randomized, Double-blinded, placebo-controlled study of the safety and efficacy of therapeutic treatment with AlloRx Stem Cells in adults with COVID-19). As a result, the FDA has authorized several expanded access/compassionate use INDs that employ IV infusion of AlloRx Stem Cells in the treatment of COVID-19 patients.

These results together with several additional clinical studies using MSCs are now providing substantial clinical evidence of safety and efficacy of stem cell therapy for COVID-19. Furthermore, since MSC therapy is independent of the genome of the virus, this MSC therapy is likely to be effective in treatment of COVID-19 patients infected with new variants resulting from viral mutation.

Dr. Jack Zamora, MD and CEO said, "We are elated to add Dr Mosessian to our regulatory team targeting FDA approval of AlloRx Stem Cells. She has been instrumental in establishing a strong working relationship between Vitro Biopharma and the FDA. She will also be a key driver of the execution of our pending Phase I trial and future INDs targeting additional indications of AlloRx Stem Cells."

Dr. Mosessian said, "I am inspired by Vitro Biopharma's mission to deliver innovative solutions and access to regenerative therapies to deliver unmet needs of the vulnerable patients. I feel fortunate to become part of the team thriving to achieve such an ambitious goal."

John Evans C.F.O. and Chairman of the Board said "We are pleased to have Caroline join the Board of Directors of the company, she adds such a wide breadth of experience in the regulatory, clinical and legal areas of board governance.

ABOUT VITRO BIOPHARMA

Out of years of research, we developed our patent-pending and proprietary line of umbilical cord derived stem cells AlloRx Stem Cells now being used in offshore regenerative medicine clinical trials. Our stem cells are used in regenerative medicine clinical trials with our partner in the Cayman Islands http://www.DVCStem.com. We have a recently approved clinical trial using our AlloRx Stem Cells to treat musculoskeletal conditions at The Medical Pavilion of the Bahamas http://www.tmp-bahamas.com in Nassau. Our nutraceutical stem cell activation product, STEMulize complements AlloRx Stem Cells as an adjuvant therapy to optimize therapeutic outcomes.

Vitro Biopharma has a proprietary and scalable manufacturing platform to provide stem cell therapies to critically ill Coronavirus patients and other conditions including multiple sclerosis, OA, Crohn's disease, and numerous medical conditions that are under-treated by the current standard of care. Our cGMP manufacturing is CLIA, ISO9001, ISO13485 certified and we are FDA registered. Our stem cells have been shown to be safe and effective in Phase I clinical trials.

Forward-Looking Statements

Statements herein regarding financial performance have not yet been reported to the SEC nor reviewed by the Company's auditors. Certain statements contained herein and subsequent statements made by and on behalf of the Company, whether oral or written may contain "forward-looking statements". Such forward-looking statements are identified by words such as "intends," "anticipates," "believes," "expects" and "hopes" and include, without limitation, statements regarding the Company's plan of business operations, product research and development activities, potential contractual arrangements, receipt of working capital, anticipated revenues, and related expenditures. Factors that could cause actual results to differ materially include, among others, acceptability of the Company's products in the market place, general economic conditions, receipt of additional working capital, the overall state of the biotechnology industry and other factors set forth in the Company's filings with the Securities and Exchange Commission. Most of these factors are outside the control of the Company. Investors are cautioned not to put undue reliance on forward-looking statements. Except as otherwise required by applicable securities statutes or regulations, the Company disclaims any intent or obligation to update publicly these forward-looking statements, whether as a result of new information, future events or otherwise.

CONTACT:Dr. Jack Zamora, MDChief Executive OfficerVitro Biopharma, Inc.(303) 999-2130 x 1www.vitrobiopharma.com

SOURCE: Vitro Diagnostics, Inc.

View source version on accesswire.com: https://www.accesswire.com/638885/Vitro-Biopharma-Retains-Leading-Health-Care-Executive-as-Acting-Director-of-Regulatory-Affairs-Director

Link:
Vitro Biopharma Retains Leading Health Care Executive as Acting Director of Regulatory Affairs & Director - Benzinga

The Latest Regenerative Medicine market evaluates the capabilities, organizations, infrastructure, determines measures to achieve success. Detailed Overview of the global Regenerative Medicine market allows the industry players to plan growth strategies and align them with their operating business models. The research study gives a better understanding of the key growth factors, transformations and risk management priorities in the global Regenerative Medicine market during the years 2021-2026.

It is a phenomenal compilation of important studies that explore the competitive landscape, segmentation, geographical expansion, and revenue, production, and consumption growth of the Regenerative Medicine Market. Players can use the accurate market facts and figures and statistical studies provided in the report to understand the current and future growth of the global Regenerative Medicine Market.

Research Report on Regenerative Medicine Market added by AllTheResearch consist of Growth Opportunities, Development Trends, and Forecast 2026. The global Regenerative Medicine Market size was valued at US$ 13.56 Mn in 2018 and is expected to grow at a CAGR of 23% for the forecast period ending 2026 reaching a Market value of US$ 55.67 Mn.

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Top players Covered in Regenerative Medicine Market Study are:

Above mentioned companies were scrutinized to assess the competitive landscape of the global Regenerative Medicine market. The report provides company profiles of each player. Each profile includes company product portfolio, business overview, company governance, company financials, business strategies, manufacturing locations, and production facilities, company sales, recent developments, and strategic collaborations & partnerships, new product launches, company segments, application diversification, and company strength and weakness analysis.

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This Regenerative Medicine market report provides insights on new trade regulations, import-export analysis, industry value chain analysis, market size, consumption, production analysis, capacity analysis, regional and segment market share, product launches, product pipeline analysis, the impact of Covid-19 on the supply chain, key regions, untapped markets, patent analysis, product approvals, continuous innovations, and developments in the Market.

Based on type, Regenerative Medicine market report split into

Based on Application Regenerative Medicine market is segmented into

Regional Analysis Covered in this Report are:

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Industry Overview of Regenerative Medicine: Market Report Based on Development, Scope, Share, Trends, Forecast to 2026 The Bisouv Network - The...

Newswise WINSTON-SALEM, NC - March 30, 2021 - Personalized medicine research for aggressive abdominal cancers at Wake Forest Baptist Health received a boost from a $2.5 million grant from the National Cancer Institute that supports research efforts at Wake Forest Organoid Research Center (WFORCE), a joint effort between the Wake Forest Baptist Comprehensive Cancer Center and the Wake Forest Institute for Regenerative Medicine (WFIRM) to tailor personalized therapy for patients.

The funding supports development of a new drug testing platform to predict treatment outcomes for patients. The platform leverages tissue bioengineering advances and genomic technologies to reconstruct and grow patient-derived tumor organoids (i.e., fragments of a patients cancer) in the presence of different drugs to predict clinical responses of patients and guide treatment selection.

Creation of an organoid begins with a tissue biopsy of the tumor. Cells from this biopsy are then used to grow small tumors called organoids in the lab which behave similarly to the original tumor. The organoid model can accurately represent what occurs inside a patients body. Lastly, the best chemotherapy treatment is chosen by exposing the organoids to the various potential treatments and observing their response.

Konstantinos Votanopoulos, M.D., Ph.D., professor of surgery and director of WFORCE, and Lance D. Miller, Ph.D., associate professor in cancer biology, are the principal investigators of the grant, with Shay Soker, Ph.D., chief science officer and WFIRM professor, as a co-investigator.

WFORCE, which brings together researchers and clinicians to leverage the use of tissue organoid technology to tailor personalized therapy for patients, was formed in early 2020. To be awarded a competitive R01 grant of this size speaks to the need and transformational potential of WFORCE which combines world class multi-disciplinary clinical trial and patient care expertise through the NCI-designated Wake Forest Baptist Comprehensive Cancer Center and ground-breaking innovation and technology through WFIRM.

Every time cancer cells multiply, they generate the next generation of cancer cells with new properties, Votanopoulos said. As the cancer progresses, the patient ends up with not just a single tumor, but many different tumor clones with variable biologic behavior and response to treatment. Accurate mapping of tumor clonality, combined with response of each clone to therapy is the key for the development of personalized treatment strategies tailored to each patient separately.

Specifically, the research will look at determining clonality-based treatment response of high prevalence cancers such as colon, as well as very rare cancers with incidence less than 1 per 100,000 patients, such as appendiceal, that have spread throughout the abdomen where they grow as metastatic lesions on the surfaces of different organs.

How patients respond to treatment varies widely, and this represents a major clinical challenge our grant seeks to address, Miller said. This genetic variation that occurs when the cancer cells multiply is believed to explain why most, but not all of a patients cancer can initially respond well to chemotherapy, but eventually return in a drug-resistant form.

Soker said the project will generate new knowledge of how certain mutations, alone or in combination, impact response to specific drugs, adding that results of these studies will be leveraged in a future clinical trial.

Other key personnel on the grant are surgeon Edward A Levine, MD, pathologist Stacey ONeill, MD, tumor immunologist David Soto-Pantoja, MD,and bioinformatics expert Guangxu Jin, MD.

About the Comprehensive Cancer Center: The center is designated by the National Cancer Institute (NCI) as acomprehensive cancer center, one of three in North Carolina, and one of 51 in the country and has held this designation continuously since 1990. The designation recognizes Wake Forest for the highest levels of expertise and a commitment to patient care, cancer research, including clinical trials, and education. The rapid pace of discovery and the early availability of many new cancer treatments at NCI-designated Comprehensive Cancer Centers, gives us an advantage in offering our cancer patients early access to the latest therapies and treatment options, sometimes even months or years before non-NCI cancer centers.Wake Forest has a team of 120 clinicians representing all aspects of cancer care including those in the fields ofhematology and oncology,gynecologic oncology,radiation oncology,surgical oncologyandcolon and rectal surgery.

About the Wake Forest Institute for Regenerative Medicine:The Wake Forest Institute for Regenerative Medicine is recognized as an international leader in translating scientific discovery into clinical therapies, with many world firsts, including the development and implantation of the first engineered organ in a patient. Over 400 people at the institute, the largest in the world, work on more than 40 different tissues and organs. A number of the basic principles of tissue engineering and regenerative medicine were first developed at the institute. WFIRM researchers have successfully engineered replacement tissues and organs in all four categories flat structures, tubular tissues, hollow organs and solid organs and 15 different applications of cell/tissue therapy technologies, such as skin, urethras, cartilage, bladders, muscle, kidney, and vaginal organs, have been successfully used in human patients. The institute, which is part of Wake Forest School of Medicine,is located in theInnovation Quarterin downtown Winston-Salem, NC,andis driven by the urgent needs of patients. The institute is making a global difference in regenerative medicine through collaborations with over 400entitiesand institutions worldwide,through its government, academic and industry partnerships, its start-up entities, and through major initiatives in breakthrough technologies, such as tissue engineering, cell therapies, diagnostics, drug discovery, biomanufacturing, nanotechnology, gene editing and 3D printing.

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$2.5M award to fund joint organoid research program at Wake to treat aggressive cancers - Newswise

insightSLICE provide a deep analysis of the Global Regenerative Medicine Marketwhich evaluates business solutions, assess, research and development, application, benefits, advantage, scope, and operations. This report offers an in-depth analysis and development ofindustry major manufacturers, key drivers, opportunity, challenge, international suppliers also deep study on risks and entry barriers. It also offers competitive analysis on thelatest technology, trend, innovation, future scope, Industry Share, sales, revenue generation, investment analysis, and overall business scenario.

These studies also involve the important achievements of the market, research & development, new product launch, regional growth, leading competitors over the universal and local scale. The industry report analysis and insights of manufacturers steeringgrowth, revenue, share, supply, opportunity, challenges, and restrain development. It also the expansion of Industry regional as well as global fats and figure.

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Competitive landscape:

Competitive analysis was carried out in the report. This competitive analysis provides insightful data about industry market leaders. The purpose is to help customers understand the existing market participants and potential market participants in the industry. The way the report is made allows customers not only to make the right decisions about the industry, but also to maintain steady growth in the industry in the long run. The purpose is to guide customers towards the steady development of their industry growth.

Manufacturers covered in this report are:

3M Group, Novartis AG and Integra Lifesciences Holdings Corporation.

An overview of the markets regional outlook:

The Global Regenerative Medicine report provides information about market regions, which are further broken down into sub-regions and countries. In addition to market share in each country and region, this chapter of this report also contains information about profit opportunities. This chapter of the report mentions the share and market growth rate of each region, country, and subregion over the estimated time period.

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The impact of Covid-19 on this market:

The coronavirus (COVID-19) pandemic has affected every aspect of global life. The study comprehensively covers the impact of the COVID-19 pandemic on the Global Regenerative Medicine market and its key market segments. In addition, it covers the current and future impact of the pandemic and provides the post-COVID-19 situation to gain a deeper understanding of trends and dynamic changes in market conditions.

In addition, insightSLICE has access to a wide range of regional and global well-known paid databases, which helps the company determine regional and global market trends and dynamics. The research also includes key strategic developments, including R&D, new product launches, mergers and acquisitions, agreements, collaborations, partnerships, joint ventures, and the regional development of major competitors operating in the market on a global and regional scale.

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Finally, the Global Regenerative Medicine Market report is a source of convincing research reports that can accelerate your business exponentially. The report provides the main regional settings, economic conditions, and the value, benefits, restrictions, generation, supply, demand, and market development speed and figures of the project.

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Regenerative Medicine Market is Expected to Develop at a Substantial CAGR in the Coming Years 2020 to 2030 | 3M Group, Novartis AG and Integra...

DUBLIN, April 1, 2021 /PRNewswire/ -- The "Cell Therapy Market Forecast to 2027 - COVID-19 Impact and Global Analysis By Therapy Type; Product; Technology; Application; End User, and Geography" report has been added to ResearchAndMarkets.com's offering.

According to this report the global cell therapy market is expected to reach US$ 12,563.23 million by 2027 from US$ 7,260.50 million in 2019. It is estimated to grow at a CAGR of 7.2% from 2020-2027. The growth of the market is attributed to increasing prevalence of chronic diseases, rising adoption of regenerative medicines, and surging number of approvals for cell-based therapies. However, the high cost of cell therapy manufacturing hinders the growth of the market.

The cell therapy market, based on therapy type, is bifurcated into allogeneic and autologous. In 2019, the allogeneic segment accounted for a larger share owing to the availability of substantial number of approved products for clinical use. For instance, in 2018, Alofisel developed by TiGenix (Takeda) is the first allogeneic stem cell-based therapy approved for use in Europe.

Chronic diseases, such as cardiovascular disorders, neurological disorders, autoimmune disorders, and cancer, are the leading causes of death and disability worldwide. As per the Centers for Disease Control and Prevention (CDC), in 2019, nearly 6 in 10 people suffered from at least one chronic disease in the US. Cardiovascular diseases (CVDs) are a significant cause of mortality owing to the hectic lifestyle. As per the World Health Organization (WHO), CVDs are the number 1 cause of death globally, taking an estimated 17.9 million lives each year. Cancer is among the leading causes of mortality worldwide, and the disease affects a huge population; therefore, it acts as a huge financial burden on society. According to the WHO, in 2018, ~9.6 million deaths occurred due to cancer globally. However, growing research on developing effective treatments for the disease is positively affecting the market growth. Gene therapy and cell therapy are transforming the cancer treatment landscape; for example, Novartis Kymriah is used to treat diffuse large B-cell lymphoma. The launches of more such products would be driving the demand for cell therapy, thus driving the growth of the cell therapy market in the coming years.

The COVID-19 outbreak was first reported in Wuhan (China) in December 2019. The pandemic is causing massive disruptions in supply chains, consumer markets, and economy across the world. As the healthcare sector is focusing on saving lives of COVID-19 patients, the demand for cell therapy is reducing worldwide.

Vericel Corporation; MEDIPOST; NuVasive, Inc.; Mesoblast Limited; JCR Pharmaceuticals Co. Ltd.; Smith & Nephew; Bristol-Myers Squibb Company; Cells for Cells; Stemedica Cell Technologies, Inc; and Castle Creek Biosciences, Inc. are among the companies operating in the cell therapy market.

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Key Topics Covered:

1. Introduction1.1 Scope of the Study1.2 Research Report Guidance1.3 Market Segmentation1.3.1 Global Cell Therapy Market - By Therapy Type1.3.2 Global Cell Therapy Market - By Product1.3.3 Global Cell Therapy Market - By Technology1.3.4 Global Cell Therapy Market - By Application1.3.5 Global Cell Therapy Market - By End User1.3.6 Global Cell Therapy Market - By Geography

2. Cell Therapy Market - Key Takeaways

3. Research Methodology3.1 Coverage3.2 Secondary Research3.3 Primary Research

4. Global Cell therapy- Market Landscape4.1 Overview4.2 PEST Analysis4.2.1 North America - PEST Analysis4.2.2 Europe- PEST Analysis4.2.3 Asia Pacific- PEST Analysis4.2.4 Middle East and Africa - PEST Analysis4.2.5 South and Central America - PEST Analysis4.3 Expert Opinions

5. Global Cell Therapy Market - Key Industry Dynamics5.1 Key Market Drivers5.1.1 Increasing Prevalence of Chronic Diseases5.1.2 Rising Adoption of Regenerative Medicines5.1.3 Increasing Number of Approvals for Cell-Based Therapies5.2 Key Market Restraints5.2.1 High Cost of Cell Therapy Manufacturing5.3 Key Market Opportunities5.3.1 Increasing Adoption of Cell Therapy in Developing Regions5.4 Future Trends5.4.1 Shift Toward Automated Cell Therapy Manufacturing5.5 Impact Analysis of Drivers and Restraints

6. Cell therapy Market - Global Analysis6.1 Global Cell therapy Market Revenue Forecast And Analysis6.2 Global Cell therapy Market, By Geography - Forecast And Analysis6.3 Market Positioning

7. Cell therapy Market Analysis - By Therapy Type7.1 Overview7.2 Cell therapy Market Revenue Share, by Therapy Type (2019 and 2027)7.3 Allogeneic7.3.1 Overview7.3.2 Allogeneic: Cell therapy Market - Revenue and Forecast to 2027 (US$ Million)7.4 Autologous7.4.1 Overview7.4.2 Autologous: Cell therapy Market - Revenue and Forecast to 2027 (US$ Million)

8. Cell therapy Market Analysis - By Product8.1 Overview8.2 Cell therapy Market Revenue Share, by Product (2019 and 2027)8.3 Consumables8.3.1 Overview8.3.2 Consumables: Cell therapy Market - Revenue and Forecast to 2027 (US$ Million)8.4 Equipment8.4.1 Overview8.4.2 Equipment: Cell therapy Market - Revenue and Forecast to 2027 (US$ Million)8.5 Systems and Software8.5.1 Overview8.5.2 Systems and Software: Cell therapy Market - Revenue and Forecast to 2027 (US$ Million)

9. Cell therapy Market Analysis - By Technology9.1 Overview9.2 Cell therapy Market Revenue Share, by Technology (2019 and 2027)9.3 Viral Vector Technology9.3.1 Overview9.3.2 Viral Vector Technology: Cell therapy Market - Revenue and Forecast to 2027 (US$ Million)9.4 Genome Editing Technology9.4.1 Overview9.4.2 Genome Editing Technology: Cell therapy Market - Revenue and Forecast to 2027 (US$ Million)9.5 Somatic Cell Technology9.5.1 Overview9.5.2 Somatic Cell Technology: Cell therapy Market - Revenue and Forecast to 2027 (US$ Million)9.6 Cell Immortalization Technology9.6.1 Overview9.6.2 Cell Immortalization Technology: Cell therapy Market - Revenue and Forecast to 2027 (US$ Million)9.7 Cell Plasticity Technology9.7.1 Overview9.7.2 Cell Plasticity Technology: Cell therapy Market - Revenue and Forecast to 2027 (US$ Million)9.8 Three-Dimensional Technology9.8.1 Overview9.8.2 Three-Dimensional Technology: Cell therapy Market - Revenue and Forecast to 2027 (US$ Million)

10. Cell therapy Market Analysis - By Application10.1 Overview10.2 Cell therapy Market Revenue Share, by Application (2019 and 2027)10.3 Oncology10.3.1 Overview10.3.2 Oncology: Cell therapy Market - Revenue and Forecast to 2027 (US$ Million)10.4 Cardiovascular10.4.1 Overview10.4.2 Cardiovascular: Cell therapy Market - Revenue and Forecast to 2027 (US$ Million)10.5 Orthopedic10.5.1 Overview10.5.2 Orthopedic: Cell therapy Market - Revenue and Forecast to 2027 (US$ Million)10.6 Wound Management10.6.1 Overview10.6.2 Wound Management: Cell therapy Market - Revenue and Forecast to 2027 (US$ Million)10.7 Other Applications10.7.1 Overview10.7.2 Other Applications: Cell therapy Market - Revenue and Forecast to 2027 (US$ Million)

11. Cell therapy Market Analysis - By End User11.1 Overview11.2 Cell therapy Market Share, by End User, 2019 and 2027, (%)11.3 Hospitals11.3.1 Overview11.3.2 Hospitals: Cell therapy Market - Revenue and Forecast to 2027 (US$ Million)11.4 Research Institutes11.4.1 Overview11.4.2 Research Institutes: Cell therapy Market - Revenue and Forecast to 2027 (US$ Million)11.5 Others11.5.1 Overview11.5.2 Others: Cell therapy Market - Revenue and Forecast to 2027 (US$ Million)

12. Cell therapy Market - Geographic Analysis12.1 North America: Cell Therapy Market12.2 Europe: Cell therapy Market12.3 Asia Pacific: Cell Therapy Market12.4 Middle East and Africa: Cell Therapy Market12.5 South and Central America: Cell Therapy Market

13. Impact of COVID-19 Pandemic on Global Cell Therapy Market13.1 North America: Impact Assessment of COVID-19 Pandemic13.2 Europe: Impact Assessment of COVID-19 Pandemic13.3 Asia-Pacific: Impact Assessment of COVID-19 Pandemic13.4 Middle East & Africa: Impact Assessment of COVID-19 Pandemic13.5 South & Central America: Impact Assessment of COVID-19 Pandemic

14. Cell Therapy Market- Industry Landscape14.1 Overview14.2 Growth Strategies Done by the Companies in the Market, (%)14.3 Organic Developments14.3.1 Overview14.4 Inorganic Developments14.4.1 Overview

15. Company Profiles15.1 Vericel Corporation15.1.1 Key Facts15.1.2 Business Description15.1.3 Products and Services15.1.4 Financial Overview15.1.5 SWOT Analysis15.1.6 Key Developments15.2 MEDIPOST15.2.1 Key Facts15.2.2 Business Description15.2.3 Products and Services15.2.4 Financial Overview15.2.5 SWOT Analysis15.2.6 Key Developments15.3 NuVasive, Inc.15.3.1 Key Facts15.3.2 Business Description15.3.3 Products and Services15.3.4 Financial Overview15.3.5 SWOT Analysis15.3.6 Key Developments15.4 Mesoblast Limited15.4.1 Key Facts15.4.2 Business Description15.4.3 Products and Services15.4.4 Financial Overview15.4.5 SWOT Analysis15.4.6 Key Developments15.5 JCR Pharmaceuticals Co. Ltd.15.5.1 Key Facts15.5.2 Business Description15.5.3 Products and Services15.5.4 Financial Overview15.5.5 SWOT Analysis15.5.6 Key Developments15.6 Smith & Nephew15.6.1 Key Facts15.6.2 Business Description15.6.3 Products and Services15.6.4 Financial Overview15.6.5 SWOT Analysis15.6.6 Key Developments15.7 Bristol-Myers Squibb Company15.7.1 Key Facts15.7.2 Business Description15.7.3 Products and Services15.7.4 Financial Overview15.7.5 SWOT Analysis15.7.6 Key Developments15.8 Cells for Cells15.8.1 Key Facts15.8.2 Business Description15.8.3 Products and Services15.8.4 Financial Overview15.8.5 SWOT Analysis15.8.6 Key Developments15.9 Stemedica Cell Technologies, Inc15.9.1 Key Facts15.9.2 Business Description15.9.3 Products and Services15.9.4 Financial Overview15.9.5 SWOT Analysis15.9.6 Key Developments15.10 Castle Creek Biosciences, Inc.15.10.1 Key Facts15.10.2 Business Description15.10.3 Products and Services15.10.4 Financial Overview15.10.5 SWOT Analysis15.10.6 Key Developments

16. Appendix16.1 About the Publisher16.2 Glossary of Terms

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Worldwide Cell Therapy Industry to 2027 - Increasing Prevalence of Chronic Diseases is Driving the Market - PRNewswire

Regenerative medicine is a segment of translational research in molecular biology and tissue engineering. It involves the process of regeneration of human cells, tissues, or organs to re-establish their normal functions through stimulation of bodys repair system. They are widely used in the treatment of many degenerative disorders occurring in the areas of dermatology, orthopedic, cardiovascular and neurodegenerative diseases. Stem cell therapy is the available tool in the field of translational regenerative medicine. It has gained importance in the past few years as it is a bio-based alternative to synthetic options. Stem cells have high power of regeneration. Hence, these enable production of other cells in the body. This has increased demand for stem cell therapy in the treatment of degenerative diseases. Currently, stem cell therapy has applications in the treatment of diseases such as autism, cancer, retinal diseases, heart failure, diabetes, rheumatoid arthritis, Alzheimers. Extensive research is being carried out on stem cell therapy. The Centre for Commercialization of Regenerative Medicine (CCRM) has reported around 1900 active clinical trials undergoing currently. It also reported 574 active industry-sponsored cell therapy clinical studies, 50 of these are in phase 3 development. Hence, stem cell therapy is projected to contribute to the growth of the translational regenerative medicine market. However, ethical issues in the use of embryonic stem cells is likely to restrain the market.

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Rising prevalence of degenerative diseases, aging population, rapid growth of emerging countries, and technical advancements in developed countries are the major factors fueling the growth of the translational regenerative medicine market.

The global translational regenerative medicine market has been segmented based on product type, therapy, application, and region. In terms of product type, the market has been categorized into cellular and acellular. The cellular segment dominated the global market in 2016. Based on therapy, the global translational regenerative market has been segmented into cell therapy, gene therapy, immunotherapy, and tissue engineering. Immunotherapy is projected to be the fastest growing segment during the forecast period. In terms of application, the market has been segmented into orthopedic & musculoskeletal, cardiology, diabetes, central nervous system diseases, dermatology, and others. Cardiology and orthopedic & musculoskeletal are anticipated to be the fastest growing segments of the global translational regenerative medicine market.In terms of region, the global translational regenerative medicine market has been segmented into North America, Latin America, Europe, Asia Pacific, and Middle East & Africa. North America dominated the global regenerative medicine market owing to a large number of leading companies and expansion of research and development activities in the U.S. Increased medical reimbursement and advanced health care also drive the market in the region. Orthopedic is the leading application segment contributing to the growth of the market in the region. Asia Pacific is forecasted the huge growth because of large consumer pool, rising income, and health care expenditure. However, the market in Asia Pacific could face challenges such as high cost of bio-based medicines and stringent regulatory policies.

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The global translational regenerative medicine market is dominated by key players such as CONMED Corporation, Arthrex, Inc., Organogenesis, Inc., Nuvasive, Inc., Osiris Therapeutics, Inc., Celgene Corporation, Brainstorm Cell Therapeutics Inc. and Medtronic.

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Translational Regenerative Medicine Market: Immunotherapy is projected to be the fastest growing segment during the forecast period - BioSpace

Scientists in the field of regenerative medicine have long been interested in using muscle stem cells to repair injuries, but growing the cells in the lab has proven to be challenging. Now, a team of Australian researchers is suggesting an alternative: a naturally occurring protein that regenerates muscle.

A team from the Australian Regenerative Medicine Institute at Monash University discovered that a protein called NAMPT (nicotinamide phosphoribosyltransferase) stimulates the growth of muscle stem cells and healing in zebrafish and mice. They published their findings in the journal Nature.

The researchers started by studying the cells that migrated to injury sites in zebrafish. They discovered that a particular group of immune cells called macrophages stimulated the regeneration of muscle stem cells.

Macrophages are known to migrate to injury sites, where some remove debris that appears immediately and others stay for long-term cleaning. But the Australian scientists discovered eight genetically distinct macrophagesonly one of which seemed to be involved in the regeneration of muscle stem cells.

They went on to discover that the macrophages with those regenerative abilities released NAMPT. So they tried removing the macrophages from the fish and then adding NAMPT to the aquarium water. It worked: Muscle stem cells started to grow and promote healing, showing that the protein took over for the missing macrophages, the researchers said.

RELATED: Stem cells don't repair injured hearts, but inflammation might, study finds

Several regenerative medicine research teams are focused on harnessing the healing power of macrophages. Researchers from the Cincinnati Children's Hospital Medical Center, for example, discovered that the inflammatory response to stem-cell injections into the heart activated macrophages, which in turn promoted healing.

The Monash-led research team did further studies with NAMPT, which included placing patches that contained the protein into mouse models of muscle-wasting disease. They observed significant muscle healing and are now in discussions with biotech companies about taking the technique into clinical trials, they said in a statement.

They believe NAMPT-based therapies could prove useful in treating a range of conditions including muscular dystrophy, limb injuries and muscle wasting due to aging.

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Zebrafish reveal regenerative protein that could inspire new treatments for muscle-wasting diseases and aging - FierceBiotech

Bloomberg

(Bloomberg) -- Crown Resorts Ltd. Chief Executive Officer Ken Barton stepped down, bowing to days of pressure after a scathing regulatory report found the Australian casino operator facilitated money laundering and wasnt fit to hold a license in Sydney.Barton will leave immediately, Melbourne-based Crown said in a statement Monday. Helen Coonan will lead the company as executive chairman while the board oversees a search for a new CEO.The report last week by former judge Patricia Bergin was particularly critical of Barton, saying he didnt have the skills for the job. His departure leaves Coonan to find a path out of a crisis that has left Australias largest casino company also facing regulatory pressure at its main operations in Melbourne and Perth.The board is determined to maintain the momentum as Crown takes significant steps to improve our governance, compliance and culture, Coonan said. I will continue to lead on implementation of Crowns ambitious reform program.Crown shares rose 1.1% to A$10.00 in early trading in Sydney, valuing the company at A$6.8 billion ($5.3 billion).After a year-long inquiry for the state gaming watchdog in New South Wales, Bergin recommended an overhaul of Crown before the company could start gaming operations at its new A$2.2 billion Sydney casino. The New South Wales gaming regulator, the Independent Liquor and Gaming Authority, is due to consider the report at a board meeting on Feb. 17.Barton is no match for what is needed at the helm of a casino licensee, Bergin wrote. Barton clung on and as recently as Friday was still assessing his position. He became CEO of Crown in early 2020 after a decade as chief financial officer.Both board nominees of Crowns biggest shareholder, James Packer, left the day after the report was released. Director Andrew Demetriou also resigned last week.Barton disclosed last year during Bergins investigation that Crown hadnt yet analyzed the accounts that were reportedly used by money launderers. He was also unaware for years that a major junket operator had a cash desk at Crowns Melbourne casino, even though the setup posed a money-laundering risk.Packers Casino Dream Dashed as Crown Seen Unfit for LicenseBartons evidence during the inquiry demonstrated a serious lack of judgment, Bergin wrote. His problems will not be cured by the appointment of people expert in the field who report to him, she said.Philip Crawford, chair of the Independent Liquor and Gaming Authority, said Feb. 11 there was a certain obviousness to the notion that Barton should step down.(Adds share price, regulatory pressure on Crown in third paragraph.)For more articles like this, please visit us at bloomberg.comSubscribe now to stay ahead with the most trusted business news source.2021 Bloomberg L.P.

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Global Regenerative Medicine Partnering Deals, Terms and Agreements Directory 2014-2020: Analysis of the Structure of Regenerative Medicine Agreements...

The globalREGENERATIVE MEDICINE marketis constantly evolving and presenting new avenues to stakeholders. The study on the REGENERATIVE MEDICINE market presents a comprehensive assessment of economic, social, and policy factors shaping the changing dynamic. The research offers data-validated insights into current opportunities in various segments and possible avenues during forecast period of 2020 20xy. The trends shaping the value chain assessment, degree of control by incumbent players, intensity of competition are analysed in the study with succinct recommendations and opinionsby market analysts.

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The study offers strategic scenario planning for the recent disruptions caused by Covid-19, a pandemicthatis still emerging. Further, the report has come out with popular strategic moves being made by players to regain agility and come on the growth trajectory as in the pre-Covid era. The research hasgleaned over the change in perspectives of governments and investors and the changing demand dynamic in various end-use industries for evaluating the growth dynamics on the REGENERATIVE MEDICINE market.

The factors that shaped high value-grab opportunities in various regions and consumer segments in the REGENERATIVE MEDICINE market are scrutinized, along with the inherent possibilities in the allied industries.The REGENERATIVE MEDICINE market was pegged at US$ xy mn/Bn and is projected to touch the mark of ab Mn/cd Bn by the end of the forecast period.The researchanalysts also point outsegments that emergedas data outliers,and attribute reasons for the same to offera holistic understatingofgrowth dynamics.

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Regenerative Medicine Market-Segmentation And Analysis By Recent Trends, Development And Growth By Regions To, Analysis, Forecast To 2026 KSU | The...