351 companies are selling unapproved stem cell treatments in the U.S.

New study demonstrates the growing risk of an unregulated market.

The study, which was published today in Cell Stem Cell, found that 570 clinics in almost every state in the U.S. are marketing unproven stem cell interventions for a range of ailments, including orthopedic injuries and neurological disorders. The two authors of the study, Paul Knoepfler and Leigh Turner, told us why this is so risky and what people who are interested in stem cell therapy need to look out for.

ResearchGate: Can you explain the findings of your study and their significance?

Leigh Turner and Paul Knoepfler: We found that there is a very large, broadly distributed direct-to-consumer stem cell clinic market in the US that has an unexpectedly wide geographic reach. Businesses marketing “stem cell treatments” and “therapies” cluster in such states as California, Florida, Texas, Colorado, Arizona, and New York, but it is important to understand that by now they have proliferated across the U.S. Collectively these businesses constitute a relatively new industry in the US that for all practical purposes attracts little attention from federal and state regulatory bodies. Our findings suggest that one potential driver of the growth of this industry has been a lack of effective regulation by the FDA, the FTC, and state medical boards. We hope that by documenting this industry in our paper we will promote more robust regulatory activity.

RG: What prompted you to look the distribution of unregulated stem cell treatments in the US?

Turner and Knoepfler: We decided to research the geographic distribution of clinics because we felt it was important to determine where these operations are located. Are they all clustered in big cities? Are they limited to particular states? Can they be found across the U.S?

It was striking to find stem cell clinics in almost every US state. Viewed collectively, we realized we had discovered a very large market. Despite this widespread national distribution, the hot spot phenomenon was also interesting and important. Certain metropolitan areas such as the greater Los Angeles, Denver, Miami, and Dallas regions have unusual concentrations of businesses marketing stem cells directly to consumers. In such areas, many patients may only have to drive minutes to get to a stem cell clinic. This raises the risk that large numbers of patients in the US may be exposed to both health and financial risks.

RG: What are the risks associated with false marketing and the administration of unapproved stem cell interventions?

Turner and Knoepfler: While we didn’t address whether the marketing that we documented was accurate or was compliant with FDA regulations, our study raises concerns about risks that non-FDA approved products and interventions pose to patients and perhaps to contemporary stem cell research. Risks to patients include potential harm to health from interventions t hat generally have little data supporting them, the low probability of benefit from these experimental interventions, and financial risks given the cost of these procedures. There is also a risk to the stem cell research field if there are negative outcomes. It is possible that if patients are harmed as a result of receiving unapproved stem cell interventions, the public may come to lose trust in the stem cell field.

RG: Why do you think the clinics are most concentrated in California?

Turner and Knoepfler: At this point in our research we have not determined clear reasons why certain regions of the country have so many stem cell clinics, but some ideas come to mind. For instance, the relatively large number of clinics in California and in particular Southern California could in part be due to this region having a greater interest in and acceptance of alternative medicine. Another possible factor is the robust cosmetic industry in this state, which may serve as a gateway to stem cell clinic development and recruitment of patients. It’s also worth noting that the Medical Board of California has been the subject of intense criticism.

RG: Is there any indication that the advertised stem cell treatments actually work?

Turner and Knoepfler: We recognize that some patients visit U.S. clinics and claim to benefit from stem cell interventions. However, many of the businesses we studied make dramatic marketing claims that do not appear to be based on credible peer-reviewed safety and efficacy data. They do not appear to have conducted meaningful pre-clinical research. The onus is on these business to establish that their “stem cell treatments” work and they have not done the difficult work required to obtain credible data supporting their claims. The direct-to-consumer marketplace is complicated, there are different kinds of clinics and business models, and we want to be cautious about making categorical assertions that fail to take into account differences in marketing claims and clinical practices. Still, patients should be wary whenever they encounter businesses marketing “stem cell therapies” for ALS, multiple sclerosis, Alzheimer’s disease, dementia, autism, cerebral palsy, spinal cord injuries, Parkinson’s disease, and twenty or thirty additional diseases and injuries.

RG: Why are there not yet regulations in place for stem cell treatments?

Turner and Knoepfler: There are federal regulations related to human cells, tissues, and cell-and-tissue-based medical products. The most relevant regulation is 21 CFR 1271. Regulations governing human subjects research and other subjects are also relevant, though not directly focused on stem cell interventions. While 21 CFR 1271 needs to be updated and would benefit from greater clarity in some sections, I believe the most serious concerns are related to regulatory inaction rather than the regulations themselves. The FDA has tried to bring clarity to how this organization interprets federal regulations by issuing a series of draft guidances, which help clarify how terms such as “minimal manipulation” of cells and “homologous use” of cells should be interpreted.  The FDA is holding a public meeting about these draft guidances later this year.  What appears to be lacking is the meaningful enforcement of existing regulations. Many U.S. businesses market unapproved stem cell interventions that raise serious questions about regulatory compliance. Despite making dramatic claims about “stem cell therapies” for many ailments, these businesses operate without any signs that the FDA has investigated their marketing claims or manufacturing processes.

RG: What should people who are interested in stem cell therapy do?

Turner and Knoepfler: Patients should start by determining whether any meaningful “stem cell therapies” exist for whatever health problems they face. Many businesses advertise “stem cell treatments” but that doesn’t mean whatever is being administered to patients deserves that label. It’s very easy for patients to be misled. It can be tempting to say that patients need to educate themselves and look for warning signs and red flags but what are they supposed to do when much of the information available to them is inaccurate? We would ask a different set of questions. What should regulators responsible for overseeing stem cell interventions do? Are they regulating the marketplace as they should? Do they have the resources and staff members they need to provide effective regulatory oversight? Patients shouldn’t be solely responsible for navigating their way through the direct-to-consumer marketplace for stem cell interventions. Regulatory bodies need to provide more effective protections.

Image credit Alex Priomos