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 including Stem MD.
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.
Super-sized Claims
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.
How so?
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.
Bottom Line
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.
Hello doctors please lend me a question here, for stem cells what is the best way to assure quality? Is there a systematic way to lay some patients doubt about quality of the cells that will be produced? I am assuming that there are different grades of quality. Also if it is quality then how long does it take? Talking time, it must be time consuming for assessments. I am asking this because i had friends working in some network clinics in PlacidWay. Thanks
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Hello Paul,
I am Chris Lindholm the COO of Cell Surgical Network, and I find your article misleading and outright disingenuous. Your title for this article “Claims of Stem Cell Cures by Clinic Chain, Stem.MD” leads the READER to believe you are focusing on this sole company, but you include our Network’s name (Cell Surgical Network) throughout the article implying that we make claims and post testimonials – something we have so far refrained from doing.
You post examples of Stem.MD making claims and using testimonials but nowhere do you give examples of us making claims or using testimonials. The reason you have not posted any examples of our Network making claims and testimonials is that we DO NOT do so. This form of journalistic malfeasance is despicable and borderline libel.
For a PhD and researcher who claims to have the best interest of patients at the root of his mission, you do a shabby job of explaining in detail your reasons for being against our group and network of physicians. I love your short and incomplete statement about FDA regulations: “Cell Surgical Network claimed in their interview with me that they do not need any FDA approval.” Why do you pass over the reasoning of Dr. Berman and Dr. Lander? The FDA regulates Medical Devices and Drugs as physicians Dr. Berman and Dr. Lander have the authority from the State Medical Boards to use any FDA approved drug or equipment off-label if in doing so would improve patient care.
If you aspire to be a serious journalist, you need to post Dr. Berman’s response to your 3 part interview with Cell Surgical Network, which you have conveniently dismissed since Dr. Berman responded to your off base assessment of our Network.
I understand PhD’s, Scientists, and Researchers have a need to protect their grants to help keep Universities laboratories opened to continue their experiments on mice and other animals. This triggers a concern with me with the posting publicly traded stocks on your blog. One may conclude you may be trying to manipulate the stock market stock prices of publicly traded companies that you comment on in your blog? For an “award winning” blogger, who clearly has the ability to influence public opinion about certain stocks and companies within the field of regenerative medicine, you seem to be trying to manipulate individual’s thoughts and set a certain tone against those you do not agree with. In all your postings I have not read any disclaimers about the stocks you personally own or if any of these stocks you have posted on your blog are in your employer’s endowment? Journalistic fairness and integrity is about balance, honesty, accuracy, and distancing oneself from conflicts of interest.
Chris,
I can see that you are very angry since you’ve lashed out so much in your comment with allegations and insults. I won’t take it personally.
I am a bit puzzled, however, as to some of the points you raise.
For example, it seems perfectly reasonable to me to point out in a blog post the parallels between Cell Surgical Network and Stem.MD, of which there are quite a few that in turn raise important issues related to networks of stem cell clinics more generally. There are also some differences as well that are mentioned.
Also, as best as I can tell I never raised the issue of testimonials even once in the piece at all so I’m not sure why you mentioned that. As to claims, it seems that both networks make some of them, but again in different ways.
If you’ll read Parts 1 and 2 of my interview with Drs. Lander and Berman, you will see that they already explained their reasoning as to why they do not believe they need FDA approval. I just happen to disagree with them and I’ve pointed out why both on this blog and in cordial correspondence with them. I’ve also now invited them to comment again.
Your final allegation of a dastardly plot whereby I’m somehow manipulating the stock market seems quite the imaginative stretch to me. I have no stock in any of those companies in the stock ticker on my blog. Actually to my knowledge at this time I have no holdings of any stem cell-related biotech stock of any kind. I’ve been thinking I should invest, but haven’t.
Let’s continue the dialogue but please avoid personal attacks, which are against my blog’s comment policy too.
Best,
Paul
I forgot to buy Capicor stock, too…too busy writing grant applications.
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