October 31, 2020

The Niche

Knoepfler lab stem cell blog

Vermont zeroes in on unproven stem cell clinics

Vermont foliage
Vermont foliage. Image from web, labeled available for reuse.

A variety of states have stepped up to address unproven stem cell clinics within their borders and the latest is Vermont.

According to the VTDigger and writer Anne Wallace Allen, the Vermont Medical Society is planning a number of steps to address this situation. For example, at their encouragement a Vermont lawmaker will introduce legislation to regulate stem cell clinics in the state:

“Vermont lawmakers will be asked in the coming year to consider regulating stem cell clinics like Vitality Healthcare in Williston and Regenexx in Winooski, which promote using stem cells to heal tissue.

Sen. Ginny Lyons said she plans to introduce legislation that addresses how clinics inform patients of the risks and benefits of unproven treatments.”

Here in California we have a state law requiring patient notification by clinics about their non-FDA approved status. I am proud to have had a small role in our state’s law, but we could do more. Washington State has a similar law. A new, more comprehensive California state bill on clinics fizzled out this year, but could be reintroduced in the future.

Florida has attempted to pass stem cell clinic-related laws, but without success in the past few years. Texas has a stem cell clinic-related law, but it is somewhat more pro-stem cell clinic business.

Getting back to Vermont, what prompted the new activity? From the VTDigger article:

“The Vermont Medical Society asked Lyons to take action. In a resolution adopted at the society’s annual meeting Nov. 2, the society said the clinics “engage in aggressive and false marketing to the public, with promises that stem cell treatments can improve cosmetic appearance as well as help a variety of conditions ranging from arthritis to autism, COPD, neuropathy and chronic pain.”

Dr. Daniel Weiss, a pulmonologist and professor of medicine at the University of Vermont, said the number of stem cell clinics offering unproven therapies is escalating quickly. He said they are using untested therapies and could harm patients.”

My impression has been that Regenexx clinics are frustrated with being piled together with other kinds of stem cell clinics such as those selling unproven birth-related materials and fat stem cell clinics. While both of those other kinds of stem cells (some of which may not even have real living stem cells in them) appear to be considered drugs by the FDA so clinics selling them are mostly marketing unapproved drugs, the therapies offered by Regenexx clinics based on autologous bone marrow cells (and sometimes PRP) generally appear to be FDA compliant.

My main beef with Regenexx is that in my view rigorous clinical trials have not definitively proven their kinds of therapies are more effective than placebo control or standard of care injections. Frankly, the other kinds of clinics are definitely far more worrisome. Still, I’d say all of these fall into the “unproven” clinic category.

I’m glad to see more states addressing stem cell clinics. While Vermont may be more known for its foliage (see image above) than stem cells, it seems like every state needs to do something about unproven stem cells these days. Imagine not so long ago that back as late as 2008-2009 there were only a handful of clinics in the entire U.S. in only one or two states.

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