Unproven Stem Cell Therapies: A Growing Global Health Issue
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.
Join experts Peter Marks, MD, PhD, Timothy Caulfield, LLM, FRSC, FCAHS, Jeffrey Kahn, MD, MPH, and Valentina Fossati, PhD as they explore the science behind legitimate stem cell therapies and what these unproven stem cell clinics are offering patients. The discussion will be 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
0:00 - Welcome from NYSCF CEO & Founder Susan L. Solomon
09:34 - How does the FDA regulate stem cell therapies?
16:53 - What is stem cell tourism and why is it a problem?
26:00 - Why is it dangerous to ignore FDA’s approval process?
33:16 - What is ‘right to try?’
44:25 - How can someone tell if a stem cell therapy is legitimate?
50:26 - How can physicians protect patients from predatory practices?
54:37 - What can we do to solve the problem of fake stem cell therapies?
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 (currently streaming on Netflix), 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.
Jeffrey Kahn, MD, MPH - Andreas C. Dracopoulos Director; Robert Henry Levi and Ryda Hecht Levi Professor of Bioethics and Public Policy, Johns Hopkins University 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.
Valentina Fossati, PhD - Senior Research Investigator, The NYSCF Research Institute
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.