Hundreds of U.S. stem cell clinics selling experimental therapies without an FDA permit can expect to face the agencys enforcement arm and potential action from the federal government.
The Food and Drug Administration ended a three-and-a-half year grace period Monday designed to allow these clinics to come into compliance with its 2017 regenerative medicine policy. The agency has worked with federal law enforcement agencies to shut down the most egregious cases, including one that made several women blind.
Peter Marks, director of the FDAs Center for Biologics Evaluation and Research, has made clear for years that the agency will be stepping up its enforcement over these unproven treatments once the discretion period ends. It was supposed to end last November, but the FDA provided a six-month extension due to the pandemic.
Its a high priority that we get the message out there, that these products need investigational new drug applications, or should have a biologic license application submitted, or they should not be marketed, Marks said at the Food and Drug Law Institutes annual meeting May 20.
Clinics that sell these treatments say they are surgical procedures that dont require FDA regulation. The agency counters that these companies are making unproven and potentially harmful claims about products that fall under its regulations for human cells, tissues, and cellular and tissue-based products, or HCT/Ps.
The agency doesnt oversee what it defines as minimal manipulation of HCT/Ps, but thats a designation for procedures such as bone marrow transplants, which have been used in medical care for decades, to proceed without FDA oversight. The clinics offering the new and unproven treatments typically take someones fat cells and reprocess them into stem cells, with claims that these cells can treat a range of diseases from Parkinsons to heart disease and even Covid-19.
All cell therapies should be proven safe and effective in well-regulated clinical trials before being marketed to patients. In recent years, increasing numbers of patients have been harmed by such therapies, Sean Morrison ISSCR public policy committee chair and director of the Childrens Medical Center Research Institute at UT Southwestern, said in a statement to Bloomberg Law. We hope increased FDA enforcement will reduce the number unscrupulous clinics that take advantage of desperate patients.
The International Society for Stem Cell Research said it welcomed increased FDA enforcement of its regulations against the marketing of unproven cell therapies.
Its really time for FDA to start aggressively enforcing the law to protect patients from these products, which are risky, Liz Richardson, project director of health-care products for The Pew Charitable Trusts, said in an interview. They often cost people, not just in terms of their health, but in terms of their money, because a lot of these treatments are paid for out of pocket.
These clinics have harmed hundreds of patients since theyve proliferated, Pew found in a report released Tuesday on its health projects website. Pew identified 360 people harmed between 2004 and September 2020 by stem cell injections and other regenerative therapies. The data came from adverse events reports from medical literature, submissions to the FDAs adverse event reporting system, government publications, news articles, and online consumer reviews of stem cell businesses such as Google and Yelp.
Pew identified at least 21 patient deaths, as well as injuries that included life-threatening infections, blindness, cardiac arrest, and the growth of tumors and lesions.
Those incidences are probably much lower than the level of harm thats actually happening, Richardson said. We know that adverse events are underreported for any medical products, including those that are FDA regulated, and theres mandatory reporting involved. But for this, these products that are unapproved and unproven, the rate of underreporting is probably much higher.
While Richardson said she wants the FDA to be more aggressive in going after these clinics, she acknowledged there are limits on the agencys ability to pursue hundreds of clinics at once. Markss center is small and also regulates vaccines, monoclonal antibodies, convalescent plasma, and blood, and there are about 900 active investigational new drug applications for cell and gene therapies.
Pew will be tracking the agencys enforcement effort over the next several months.
Its important to acknowledge that there are limitations in what the agency can do, certainly, given their chronic underfunding. Thats a reality, Richardson said. It probably will be a slow ramp-up, given just the fact that we are still in the middle of a pandemic.
The Federal Trade Commission also has authority over businesses making illegal claims, and state medical boards and attorneys general also can make strides in protecting patients from potentially dangerous products, Richardson said. Its not just the FDAs job. Theres a role for other regulators in this space.
See the article here:
FDA to Crack Down on Stem Cell Clinics With Unproven Therapies - Bloomberg Law
- 100 plus years of stem cell research20 years of ISSCR - PMC - March 26th, 2024
- Stem Cell Science and Human Research Studies Ahead of Cargo Arrival - NASA Blogs - February 18th, 2024
- Stem cell research project to launch into space - Fox Weather - January 24th, 2024
- Breakthrough in cancer research opening up stem cell therapy to more people. How you can get involved - 69News WFMZ-TV - January 20th, 2024
- Stem Cell Research Heading to the ISS on Axiom Mission 3 - ISS National Lab - January 18th, 2024
- No, Rep. Steve Scalise Didn't Vote Against Stem Cell Research From Which He Is Now Benefiting - The Dispatch - January 12th, 2024
- Applications are open for the Maryland Stem Cell Research Fund - Technical.ly - January 4th, 2024
- Global Stem Cell Therapy Market to Reach USD 928.6 Million by 2031: Says Allied Market Research - Yahoo Finance - November 19th, 2023
- Current state of stem cell-based therapies: an overview - PMC - November 3rd, 2023
- Dynamic Stem Cell Therapy Uncovers Research in Advance Regenrative Medicine - Yahoo Finance - November 3rd, 2023
- Research Fellow (Aging and Cancer Stem Cell Laboratory ... - Times Higher Education - October 15th, 2023
- Qkine Collaborates with the Cambridge Stem Cell Institute to Facilitate Same-Day Access to Key Research Products for Researchers at the Cambridge... - September 27th, 2023
- Stem cells: a comprehensive review of origins and emerging clinical ... - September 25th, 2023
- Stem Cell Research and Communicating Science | GBH - GBH News - September 20th, 2023
- Stem cell research reveals the earliest stages of a human life - SBS News - September 10th, 2023
- Stem Cell Therapy Market Size 2023 | Innovative Research Methodologies with Emerging Trends and Opportuni - Benzinga - September 10th, 2023
- Autologous Stem Cell and Non-Stem Cell Based Therapies Market Research, Current Trends, Key Industry Play - Benzinga - September 8th, 2023
- Stem Cell Therapy Market 2023 Business Statistics and Research ... - The Knox Student - August 28th, 2023
- Autologous Stem Cell Based Therapies Market Analysis, Research ... - Chatfield News-Record - July 19th, 2023
- Global Stem Cell Market Projected to Reach $14 Bn by 2028: Ken Research - Yahoo Finance - July 11th, 2023
- Theradaptive Awarded Manufacturing Assistance Grant by the Maryland Stem Cell Research Fund - Benzinga - July 10th, 2023
- Bionano Announces Presentation of OGM Utility Across Stem Cell Therapy Applications at the International Society for Stem Cell Research (ISSCR) Annual... - June 19th, 2023
- Sana Biotechnology Highlights Preclinical Data from Hypoimmune and Fusogen Platforms at the International Society for Stem Cell Research (ISSCR) 2023... - June 17th, 2023
- Induced Pluripotent Stem Cell (iPSC) Global Market Report 2023: Effective Research Programs Hold Key in Roll Out of Advanced iPSC Treatments - Yahoo... - June 17th, 2023
- Lung and heart stem cell research paves way for new COVID-19 treatments - Medical Xpress - June 14th, 2023
- Toxicology PhD student cultivating giant leaps in stem cell research ... - June 4th, 2023
- Harvard Stem Cell Institute (HSCI) - May 26th, 2023
- Findings may lead to improved insulin-secreting cells derived from stem ... - May 26th, 2023
- Cell Press: Stem Cell Reports - May 26th, 2023
- Stem cell research could enable blood to be made in other parts of the body - Medical Xpress - May 26th, 2023
- Construction of myocardial patch with mesenchymal stem cells and poly ... - May 22nd, 2023
- Cedars-Sinai to Send Stem Cells to the Space Station to Aid in the ... - May 22nd, 2023
- researchers expand human blood stem cells | Institute for Stem Cell ... - May 22nd, 2023
- A Look Inside Stem Cells Helps Create Personalized Regenerative ... - May 17th, 2023
- Exclusive Research Report on Msenchymal Stem Cell and Exosome Diagnostics and Therapies Market to Witness Comp - openPR - May 17th, 2023
- The Future of Stem Cell Research: Master of Science in ... - The Daily | Case Western Reserve University - May 10th, 2023
- Exclusive Research Report on Stem Cell Therapy for Diabetes and ... - Digital Journal - May 9th, 2023
- Aging melanocyte stem cells and gray hair | National Institutes of ... - May 5th, 2023
- Mouse hair turns gray when certain stem cells get stuck - May 5th, 2023
- Science-First Skincare Company Michal Morrison Secures Exclusive World-Wide License of Proprietary STEM6 Molecule, Supported by Over 25 Years of... - May 5th, 2023
- BioCentriq and panCELLa execute research agreement to study stem cell-derived Natural Killer cell expansi - Benzinga - May 3rd, 2023
- Hair turning gray? Study finds a stem cell 'glitch' may be the cause - May 1st, 2023
- Elevai Labs Announces Research Grant Award and Partnership to Better Characterize the 'Payload' of ELEVAI's Stem Cell-derived Exosomes - Yahoo Finance - April 27th, 2023
- Why does hair turn gray? A new study says 'stuck' stem cells may ... - NPR - April 27th, 2023
- Study advances understanding of how melanocyte stem cells work to color ... - April 21st, 2023
- Stem cell research and therapy legislation to be replaced, says ... - Bahamas Tribune - April 21st, 2023
- Stem Cell Research (journal) - Wikipedia - April 21st, 2023
- Scientists Are About to Try to Create Stem Cells in Space - April 21st, 2023
- Stem Cell Research & Therapy | Articles - BioMed Central - April 16th, 2023
- Stem Cell Junk Yards Reveal a New Clue About Aging | WIRED - April 16th, 2023
- Global Stem Cells Market Research Report 2023: Implications - April 16th, 2023
- Stem cell research can help people with hard- | EurekAlert! - April 16th, 2023
- University Of Edinburgh's stem cell research gets funding boost - India Education Diary - April 14th, 2023
- Two major stem cell research projects supported with more than ... - University of California, Santa Cruz - April 8th, 2023
- Cancer detection predicts tumors before they form: discovery - March 29th, 2023
- Stem cell therapy: a potential cure for hearing loss? - March 29th, 2023
- Turkey's Only Stem Cell Production Application and Research Center - Expat Guide Turkey - March 24th, 2023
- Stem Cell Research Article, Embryonic Cells Information, Cell Therapy ... - March 24th, 2023
- Scientists create mice with cells from 2 males for 1st time - March 19th, 2023
- QBRI concludes stem cells symposium - Gulf Times - March 17th, 2023
- 2020 California Proposition 14 - Wikipedia - March 17th, 2023
- Stem Cell Reports | Journal | ScienceDirect.com by Elsevier - March 17th, 2023
- Stem cell therapy MSC-NP found to ease inflammatory activity of brain ... - March 12th, 2023
- Stem Cell Research | Office of Research Compliance | SIU - March 12th, 2023
- Heart disease study shows hope for stem cell treatment - March 4th, 2023
- Stem cells drive antler regeneration | Science - March 4th, 2023
- Stem Cell Research: Argumentative Essay - Free Essay Example - Edubirdie - March 4th, 2023
- Stem Cell Research | Thermo Fisher Scientific - US - March 4th, 2023
- Stem cell controversy - Wikipedia - February 28th, 2023
- National Institutes of Health grant funds interdisciplinary ... - February 27th, 2023
- Research Associate in Cancer Stem Cell Research job with ... - Times Higher Education - February 25th, 2023
- Pioneering Stem Cell Research Conference at The Aga Khan ... - The Aga Khan University - February 25th, 2023
- Scientists grapple with ethics of stem cell research - STAT - February 17th, 2023
- Research Associate in Stem Cell Neurobiology job with KINGS ... - Times Higher Education - January 30th, 2023
- Stem cells: past, present, and future | Stem Cell Research & Therapy ... - January 12th, 2023
- Edu Thesis & Essay: Stem cell research outline top writers online! - January 12th, 2023
- Stem Cell Biology Research Program | Johns Hopkins Institute for Cell ... - January 5th, 2023
- Stem cell population identified is vital for bone regeneration: Research - ThePrint - January 5th, 2023
- Leading scientist 'blown away' by UAE advances in stem cell research - The National - December 15th, 2022
- The Stem Cell Assay Market Is Set To Grow At A 20% Annual Rate, Due To The High Prevalence Of Chronic Diseases As Per The Business Research Company's... - December 13th, 2022
Recent Comments