Unproven Stem Cell Therapies: A Growing Global Health Issue
How do we accelerate legitimate stem cell therapies while protecting patients from fraudulent clinics?
Read a summary of the discussion here.
While many promising stem cell therapies are in development for heart disease, macular degeneration, Parkinson’s disease, and more, ‘bad actor’ clinics worldwide are exploiting the excitement around stem cells to sell expensive, unproven therapies to vulnerable patients with limited options. These therapies are not only fraudulent and ineffective, but have in many cases caused significant harm to patients. Despite significant federal efforts to shut down these clinics, they continue to proliferate in the United States, creating challenges for regulators and patients alike.
Hear from experts Peter Marks, MD, PhD, Timothy Caulfield, LLM, FRSC, FCAHS, Valentina Fossati, PhD, and Jeffrey Kahn, PhD, MPH as they explore the science behind legitimate stem cell therapies and what these unproven stem cell clinics are offering patients. This discussion was moderated by NYSCF CEO & Founder Susan L. Solomon, JD.
What you’ll learn:
- How for-profit, experimental stem cell clinics pose a threat to patient care, global health, and stem cell research
- How to separate fact from fiction when it comes to stem cell therapies
- How we can ensure stem cell discoveries are translated into medicines in a responsible and ethical manner
In collaboration with 
About the Panelists
Peter Marks, MD, PhD – Director, Center for Biologics Evaluation and Research (CBER), Food & Drug Administration
- Dr. Marks is a top FDA regulator paving the way to advance regenerative medicines, including stem cell and gene therapies.
- Dr. Marks played a pivotal role in Operation Warp Speed, a federal effort aimed at accelerating the development of COVID-19 vaccines.
Timothy Caulfield, LLM, FRSC, FCAHS – Canada Research Chair in Health Law and Policy; Professor, Faculty of Law and School of Public Health; and Research Director, Health Law Institute at University of Alberta
- Mr. Caulfield is an expert in legal, policy, and ethical issues in medical research, and an outspoken debunker of scientific misinformation around the COVID-19 pandemic and unproven stem cell clinics.
- Mr. Caulfield is the host and co-producer of A User’s Guide to Cheating Death, and author of two bestsellers The Cure for Everything: Untangling the Twisted Messages about Health, Fitness, and Happiness and Is Gwyneth Paltrow Wrong About Everything?: When Celebrity Culture and Science Clash.
- Dr. Fossati leads NYSCF’s multiple sclerosis (MS) program, where she uses methods she has pioneered to convert patient stem cells into all major brain cell types, with the ultimate aim of enabling drug discovery and cell replacement therapies.
- As an MS patient and researcher, Dr. Fossati is committed to ensuring legitimate stem cell therapies advance while combating scientific misinformation about stem cells.
Jeffrey Kahn, PhD, MPH – Andreas C. Dracopoulos Director; Robert Henry Levi and Ryda Hecht Levi Professor of Bioethics and Public Policy, Johns Hopkins Berman Institute of Bioethics
- Dr. Kahn is a bioethicist focused on the intersection of ethics and health/science policy, including human and animal research ethics, public health, and ethical issues in emerging biomedical technologies.
- Dr. Kahn has served on multiple state and federal advisory panels and is currently chair of the National Academies of Sciences, Engineering, and Medicine’s Board on Health Sciences Policy.
Additional Resources
- Advancing the Development of Safe and Effective Regenerative Medicine Products, Peter Marks, MD, PhD; fda.gov
- Unproven stem-cell treatments can be dangerous. The hype needs to stop, Timothy Caulfield; theglobeandmail.com
- Patients Lose Sight After Stem Cells Are Injected Into Their Eyes, Denise Grady, nytimes.com
- FDA Warns About Stem Cell Therapies, fda.gov
- Nine Things to Know About Stem Cell Treatments; aboutstemcells.org
- We need better regulation of stem cell therapies, especially rogue clinics; David a. Pearce, statnews.com
- Unregulated Stem Cell Clinics Endanger Patients and Limit Research; William A Haseltine, forbes.com
Speaker Bios
Peter Marks, MD, PhD
Director, Center for Biologics Evaluation and Research (CBER)
Food & Drug Administration
Peter Marks received his graduate degree in cell and molecular biology and his medical degree at New York University and completed Internal Medicine residency and Hematology/Medical Oncology training at Brigham and Women’s Hospital in Boston. He has worked in academic settings teaching and caring for patients and in industry on drug development. He joined the FDA in 2012 as Deputy Center Director for CBER and became Center Director in January 2016.
Timothy Caulfield, LLM, FRSC, FCAHS
Canada Research Chair in Health Law and Policy
Professor, Faculty of Law and School of Public Health
Research Director, Health Law Institute
University of Alberta
Timothy Caulfield is a Canada Research Chair in Health Law and Policy, a Professor in the Faculty of Law and the School of Public Health, and Research Director of the Health Law Institute at the University of Alberta. His interdisciplinary research on topics like stem cells, genetics, research ethics, the public representations of science and public health policy has allowed him to publish over 350 academic articles. He has won numerous academic and writing awards and is a Fellow of the Royal Society of Canada and the Canadian Academy of Health Sciences. He contributes frequently to the popular press and is the author of two national bestsellers: The Cure for Everything: Untangling the Twisted Messages about Health, Fitness and Happiness (Penguin 2012) and Is Gwyneth Paltrow Wrong About Everything?: When Celebrity Culture and Science Clash (Penguin 2015). His most recent book is Relax, Dammit!: A User’s Guide to the Age of Anxiety (Penguin Random House, 2020). Caulfield is also the host and co-producer of the award winning documentary TV show, A User’s Guide to Cheating Death, which has been shown in over 60 countries, including streaming on Netflix in North America.
Valentina Fossati, PhD
Senior Research Investigator
The NYSCF Research Institute
Dr. Fossati leads NYSCF’s multiple sclerosis (MS) program and is a NYSCF–Druckenmiller Postdoctoral Fellow Alumna. She obtained her PhD in Biotechnology from the University of Bologna, and during her postdoctoral work at Mount Sinai School of Medicine, she studied immune system development. After being diagnosed with MS in 2009, Dr. Fossati shifted her research to better understanding this disease. Bringing stem cell expertise to MS research, she uses methods she has developed to convert patient stem cells into all major brain cell types, with the ultimate aim of enabling drug discovery and cell replacement therapies.
Jeffrey Kahn, PhD, MPH
Andreas C. Dracopoulos Director
Robert Henry Levi and Ryda Hecht Levi Professor of Bioethics and Public Policy
Johns Hopkins Berman Institute of Bioethics
Jeffrey Kahn, PhD, MPH, is the Andreas C. Dracopoulos Director of the Johns Hopkins Berman Institute of Bioethics, a position he assumed in July 2016. From 2011, he has been the inaugural Robert Henry Levi and Ryda Hecht Levi Professor of Bioethics and Public Policy. He is also Professor in the Dept. of Health Policy and Management of the Johns Hopkins Bloomberg School of Public Health. He works in a variety of areas of bioethics, exploring the intersection of ethics and health/science policy, including human and animal research ethics, public health, and ethical issues in emerging biomedical technologies.
Susan L. Solomon, JD
CEO & Founder
The NYSCF Research Institute
Susan L. Solomon is Founder and Chief Executive Officer of The New York Stem Cell Foundation Research Institute. A veteran healthcare advocate, Susan has received numerous awards for her work with NYSCF, including the New York State Women of Excellence Award, the Triumph Award from the Brooke Ellison Foundation, and recognition as a Living Landmark from the New York Landmarks Conservancy. Susan has decades of leadership experience in starting and building effective and focused organizations. She started her career as an attorney at Debevoise & Plimpton, then held executive positions at MacAndrews & Forbes and APAX (formerly MMG Patricof and Co.) She was the founder and President of Sony Worldwide Networks, the Chairman and CEO of Lancit Media Productions, and served as the founding CEO of Sothebys.com, prior to starting her own strategic management consulting firm Solomon Partners LLC in 2000.
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