One of the most concerning new trends in the stem cell arena is the explosive growth of chains of for-profit stem cell clinics in the US.
This kind of franchising of stem cell for-profit operations deeply concerns me in terms of its potential risks to increasing numbers of patients and to the stem cell field as a whole.
I recently did an interview series with the leaders of one such chain, the Cell Surgical Network. It’s a group of dozens of linked clinics with a menu including stem cell interventions for a whole spectrum of conditions. You can read my posts Part 1 & Part 2, as well as my concerns in Part 3.
Cell Surgical Network is not alone.
Another similar kind of stem cell clinic chain is called Stem.MD.
It describes itself as a “national regenerative medical practice” of 50 clinics and 55 doctors. That’s a huge and apparently growing number of clinics in 45 cities.
It worries me when I see operations such as Cell Surgical Network and Stem.MD offering panacea-like menus of fixes for nearly whatever ails you. The number & nature of claims being made is astonishing. How can they treat potentially dozens of diverse medical conditions (this link is just for ortho-related issues)? As a stem cell scientist who closely follows clinical translation of stem cells I have to say I’m extremely skeptical.
Stem.MD makes quite a few rather bold medical claims on its website. For example, remarkably, they claim on their treatments page that they can provide “a treatment for every condition” and a cure for many common injuries. See a screenshot below from their website with red lines added by me for emphasis.
They also make a great many other big claims including sometimes using the word “cure”.
I’d like to see research backing up these claims of cures and panacea treatments, but I was unable to find concrete support of the claims.
The FDA, legal and regulatory issues
Another critical issue for chains of stem cell clinics like Stem.MD is regulatory approval status.
Cell Surgical Network claimed in their interview with me that they do not need any FDA approval.
Stem.MD claimed for some time on their website (see screenshot at right with red circle by me) that their interventions are/were FDA approved.
They have now taken that rather bold claim down after I asked them about it via an email to Dr. Joseph Purita, which was replied to by Omar Salah of the company.
At least part of the Stem.MD menu of interventions at their dozens of clinics includes stromal vascular fraction (SVF)-like items, which as best as I can tell are not FDA approved and seem to be considered by the FDA to be biological drugs requiring rather lengthy FDA vetting before use in patients.
Treating a huge diversity of medical conditions with fat or bone marrow products with some of the conditions seemingly unrelated to fat or bone sure seems to raise issues of nonhomologous use as well, a big concern for the FDA.
Another major regulatory issue more broadly for networks of stem cell clinics relates to Institutional Review Boards or IRBs. Are all the separate clinics & physicians in clinic chains covered under their own separate IRBs in such networks? I am not sure, but I kind of doubt it. Do they have IRB approval for every type of product used? Every condition treated?
Pro-athlete connection as selling point?
One of the big selling points used by Stem.MD is their claimed success in treating professional athletes such as Bartolo Colon. This claim is featured prominently in the images shown on their website such as the one below.
Adequate physician training?
A key question about this kind of franchising setup is whether all the providers at all of these clinics are adequately trained.
It’s hard to say, but that’s a very high hurdle, especially as the chains rapidly expand and include many doctors perhaps treating specific conditions for which they are not board certified specialists.
I’ve talked before about how I believe that a weekend course, for example, on stem cells is not anywhere close to sufficient to rigorously prepare a physician to safely and ethically administer stem cell interventions or to properly follow up on patients with complex medical conditions that may be outside of the physician’s area of expertise.
One wonders if the provider of a short stem cell course to physicians could face shared legal liability if one of the doctors they “trained” finds themselves in a malpractice suit over a stem cell treatment later on? It’d hard to say and I’m no lawyer, but there would seem likely to be at the very least some sizable potential for risk.
I expect these chains to continue to proliferate across the US barring some major new development. I am extremely concerned about patient safety, the risks to the newly recruited physicians who are newbies to the stem cell world, and the huge risks to the entire stem cell field should there be major negative outcomes from these chains.