There are Good Actors and Bad Actors out there providing Regenerative Medicine treatments. It can seem nearly impossible for the general public, and even physicians to tell the difference.
A panel of academic and private practice physicians, who are leaders in the new area of Orthopedic Regenerative Medicine, got together recently and outlined the following expectations of “Good Actors”:
• Clinics should use a treatment registry (collecting patient outcomes over time)
• They should provide candidacy grades to patients (i.e. everyone is NOT a candidate for these therapies)
• They should use expanded informed consent (meaning that patients need to be informed of the risks, benefits, and alternatives when considering an investigational therapy)
• They should publish research on new orthopedic applications and use an IRB (Institutional Review Board)
• Advertising should be grounded in science (i.e. claiming that you can treat severe arthritis by growing a new joint is not based in any known clinical research)
• Imaging guidance should be used to place cells
• The minimum level of evidence needed before using Regenerative Medicine treatment for new orthopedic applications should be a case series to a comparison trial
(These Delphi panel findings and methods have been submitted for publication to a medical journal.)
The following are examples of egregious behavior that warrant a professional sanction:
• Claiming that Amniotic and Umbilical Cord Tissues have Stem Cells
• Alternative Medicine Clinics performing Stem Cell Procedures
• Advertising a cure for conditions including COPD and neuropathy and stating that stem cells could reverse and repair damage caused by these diseases.
• Paying a marketing company that runs seminars with professional salespeople as presenters.
• Holding seminars providing inaccurate information about what services their clinic offers and misrepresenting the clinical research on stem cells.
The FDA is very interested in supporting advances in the field of Regenerative Medicine. Unfortunately, the policing on the ground has been slow. This has opened the door for these Bad Actors to flourish.
“We want to facilitate innovation. We seek a regulatory process that accommodates the complexity of developing these therapies, and takes measure of their tremendous and near-term potential…There are a small number of unscrupulous actors who have seized on the clinical promise of regenerative medicine, while exploiting the uncertainty, in order to make deceptive, and sometimes corrupt, assurances to patients based on unproven and, in some cases, dangerously dubious products…”
– FDA commissioner Scott Gotlieb, 2017