Who Will Regulate Stem Cell Therapy Clinics Now that FDA Can’t?
(Thursday, September 1, 2022)
This week’s court ruling to deregulate the most common form of autologous stem cell therapies would allow clinics to openly offer these treatments without the fear of FDA. The court, however, only ruled in favor of the medical practice but not the marketing claims made by the providers to lure their patients to opt for such treatments. Hence, future regulations or policies should focus on the veracity of the claims made by the providers. Autologous stem cell therapies, where a patient’s cells are harvested from one part of the body such as fat or bone marrow, and then implanted in another location on the same patient’s body, are the most common form of stem cell treatments offered widely. However, the evidence for their benefits is sketchy at best as very few controlled clinical trials have been conducted with these therapies, practically none in the US. Most of the evidence in support of these therapies is anecdotal. Most physicians offering these treatments could not afford formal IND applications and the clinical trial operations needed to run such trials, so fearing FDA’s enforcement action, most stem cell clinics in the US operated in secrecy. Now that such clinics can openly operate, we should have more data available publicly on the use and outcome of these therapies in the real-world setting. There are two potential consequences, first, it should help standardize the treatment protocols offered at such clinics to reduce the risk to patients from scrupulous providers. Second, it would create opportunities to generate real-world evidence in support of the claims, which in turn could improve the options available. However, since FDA cannot regulate these practices, these new rules/policies would need to be created and enforced by professional medical organizations such as the American Medical Association (AMA) and consumer protection agencies like the Federal Trade Commission (FTC). Stem cell therapies have been very popular with patients for the last 2 decades. But so far, they were relegated to the secret world of the patient-doctor confidentiality with rare public disclosure. The new regulatory environment could open doors to real world evaluation of these therapies in a more practical and affordable ways. It’s a new world indeed. Amazing what one court decision could do to change the entire industry.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC