Research Brief: Scope of training for those providing unproven stem cell interventions in the U.S.
New research from the University of Minnesota, Mayo Clinic, Albany Medical College, and the Illinois Department of Financial and Professional Regulations shows some U.S. facilities selling unlicensed and unproven stem cell interventions are employing physicians and other clinicians who are practicing outside their professional scope of training.
In a research letter published Tuesday in the journal JAMA, the study's authors focused on businesses located in California, Florida and Texas — the three states with the largest concentrations of clinics offering these interventions. Using a database of companies, researchers analyzed websites to determine which specific diseases and injuries business claimed to treat.
After identifying practitioners at the clinics, researchers then used state medical board licensing data and the Federation of State Medical Board Physician Data Center to determine whether their professional training prepared them to treat individuals with the diseases and injuries these companies purported to address with stem cells.
The study found:
- 608 clinicians working at 166 companies — of which, 66% of these individuals were licensed physicians, with the remaining workers being physician assistants, nurses, complementary and alternative medicine practitioners and other individuals;
- of the 166 companies, 157 employed at least one physician and 81 had at least one with formal training matching the diseases and injuries the businesses claimed to treat;
- among orthopedic-focused clinical practices, 77% (68 companies) had at least one physician with training that matched the conditions the practices claimed to treat;
- of clinics that sold stem cell interventions for non-orthopedic indications, 19% (13 companies) employed physicians operating within their professional scope of training.
“I'm unsurprised, but nonetheless alarmed, by the large number of individuals who administer unlicensed and unproven stem cell interventions and who are unqualified to treat the individuals they claim they are helping. This activity could expose patients to foreseeable and preventable risks,” said Leigh Turner, an associate professor in the Center for Bioethics.
“The responsible translation of regenerative medicine requires qualified clinicians to administer innovative protocols to patients in order to help ensure patients receive the best care,” said Zubin Master with Mayo Clinic’s Biomedical Ethics Research Program.
The paper concludes that state medical boards should consider the scope of training of physicians when investigating complaints of licensees thought to violate professional standards.
While this study reveals individuals operating outside of their scope of training, further research should focus on providing additional details concerning the background and training of those involved in the direct-to-consumer marketplace for unproven and unlicensed stem cell interventions.
This study was conducted with support from a Federation of State Medical Boards grant.