Has the FDA given up on regulating stem cell clinics?

rp_FDAADF-300x252.pngWhat the heck happened to the FDA when it comes to regulating stem cell clinics?

Has it given up?

Or does it just seem that way because it moves in slow motion?

The FDA might as well have thrown in the towel because, as I like to say, the stem cell field moves in dog years. Often times 7 years’ worth of stem cell happenings take place in just one human calendar year. An example of this warp speed is the approximate doubling of the number of stem cell clinics in the US in the last year or so.

There was a time when I was perhaps naive enough that I thought that regulatory agencies legally tasked with oversight of biologics would take swift action against violators, particularly if the products or procedures in question were not proven to be safe or effective. Patients are at serious risk.

Throw in some evidence of predatory behavior and dubious public claims and lack of training at some clinics, and the FDA in the US, for example, surely would do something about it as thousands of patients get these dubious interventions. Right?

I’m no so sure anymore.

I still believe in appropriate regulation of stem cell-based medical products and interventions. The FDA has now won their recent legal case on regulating proliferated stem cell products as biological drugs and it would seem they should if anything be energized to put the stem cell clinic sphere in order.

Cue crickets chirping.

The FDA appears at least on the surface not to be doing much of anything on stem cell clinics even as the number of dubious stem cell clinics in the US has stormed past 100. One problem right up the FDA’s alley for regulation is that these places are selling and using unapproved products and devices, and in that way putting patients at serious risk. For example, as best as I can tell there has been no recent FDA action on stromal vascular fraction (SVF), a product that the FDA has, at least in the past, defined in no uncertain terms as a biological drug. Meanwhile more and more clinics sell SVF treatments and it is spiraling out of control.

What is happening as a result of this lack of action by the FDA is bad for the stem cell field and for biomedical science more generally in addition to putting patients at risk as they literally pay to be participants in unapproved, for-profit human experiments. The reputation of the stem cell field overall is also in jeopardy.

It’s a weird situation. On the one hand the FDA holds those with good intentions (e.g. biotech and academic researchers working to do clinical trials) to appropriate, relatively strict standards, but on the other hand turns an apparent blind eye to an entire unregulated industry of stem cell clinics.

Even as the number of dubious clinics rockets upward, in the past year or so the FDA has issued no warning letters in this sphere and as best as I can tell not done much of anything. If the lack of FDA action meant that the stem cell clinic sphere was becoming more responsible and safer then I’d be cheering that, but instead I think it reflects some change at the FDA that is not encouraging.

The FDA has a unique opportunity to do something to help remedy this situation and clarify the regulatory sphere related to stem cells this year as it is slated to release new guidance sometime in 2014 on amongst other things SVF and other fat stem cell products. Will they punt? Will they stand firm? At this point, it’s anybody’s guess.

Here are the pertinent sections to focus on in the page linked to above:

  • Draft Guidance for Industry: Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue Based Products
  • Draft Guidance for Industry: Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception
  • Draft Guidance for Industry: Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) from Adipose Tissue: Regulatory Considerations

The FDA tells me they are taking actual actions too in this arena, but they cannot discuss it and the action is not apparent in the public sphere…yet.

However, effectively their inaction or slow motion action has created what I have termed “default deregulation” and this will only become more entrenched as the number of dubious clinics and untrained physicians pitching “stem cell” interventions without regulatory approval continues to skyrocket.

I often talk to the clinics and as appropriate I sometimes tell them they are not following FDA regulations, etc.

I’m not sure if I can even say that anymore since the FDA seems to be in effective hibernation on stem cell clinics.

Are the clinic operators right they can pretty much do whatever they want with whatever devices and products they feel like without worrying about the FDA? I’m not sure anymore because it feels like the FDA is all talk and no action lately on stem cell clinics. Well, actually, no talk and no action.

14 thoughts on “Has the FDA given up on regulating stem cell clinics?”

  1. Quick question: Who regulates physicians? I thought the State Medical Boards were the regulators and not the FDA? Could this be the missing element to the quandary of people believing the FDA are not acting appropriately?

    1. Since you asked, speaking generally of the overall arena, while state medical boards regulate physicians, the FDA regulates the devices and products that stem cell clinics and their physicians use. If clinic doctors use unapproved devices AND/OR unapproved biological drugs (e.g. SVF no matter how or when it is made), AND/OR they use the stem cells in a non-homologous manner (e.g. using SVF to treat MS or autism, etc.), then it’s a no-brainer that the FDA is legally empowered to step in to protect patient safety and I believe it has a responsibility to do so quickly. Again from a general perspective, it would be prudent to consider the fact based on historical events that lack of action by the FDA over a given period of time of clinic/physician activity should not be misinterpreted by any particular clinics as FDA approval. Admittedly, though, the lack of apparent FDA action in this area in 2014 is puzzling and muddies the water a bit. They are supposed to issue guidance on the use of SVF sometime this year so perhaps that will be helpful. Who knows.

  2. I wonder if the FDA is getting tired of all the innuendo about how poorly they are doing their job. It really seems silly to me for anyone to be writing letters, calling, fretting, and wringing hands about clinics they have never visited, been treated at or know anything about. If the FDA is not competent, then why are we spending billions of taxpayer dollars to fund the agency? Has the FDA asked for the public’s assistance in policing stem cell clinics? I think some may be confusing the FDA with ISSCR. I am really surprised at how little faith many in the research industry have in the FDA. If the feeling is that they can’t do the job, then isn’t the better way to work through Congress and try to have the FDA commissioner replaced? Heads should roll if there are slackers at the FDA!

    Jeanne – I hate to be the bearer of bad news but StemGenex has been offering treatments for several years now.

  3. Brian I couldn’t agree more. When Mr Knoepfler calls them 100 “Dubious” stem cell clinics. Who is deciding they are dubious and why? Is someone being hurt or killed? More people died today from some FDA approved drug than will die from a stem cell treatment this decade. People choose to go to these clinics because most have nowhere to go. The FDA causes so many potentially lifesaving drugs to take decades to get to market that people will try anything to stay alive.

  4. Yes, “The FDA has now won their recent legal case on regulating proliferated stem cell products as biological drugs” and that is the problem. In that particular instance MSC from bone marrow were culture expanded but not extensively so. Since the FDA won it’s case the evidence just keeps mounting that this was a safe procedure:

    By classifying stem cells as drugs, FDA has effectively shut down any possibility of cost-effective, cultured autologous therapies for orthopaedic conditions… since drug manufacturing must be done in bulk in order to be economically feasible. Thus the practice of medicine has been stifled in favour of Big Pharma who go down the route of using donor MSC and a huge number of passages. And that really does cause medical problems:

    So, we see that the FDA has savaged a good work horse. That just served to leave the field wide open for the vendors of snake oil.

  5. Paul- this is very timely. Our Parkinson’s disease advocacy group just discovered that the Michael J Fox foundation has listed a stem cell company on their “Fox Trial Finder”. This company, Stemgenex, charges $15,000 for SVF. Here’s what they say on clinicaltrials.gov: “The purpose of this study is to determine the impact that treatment with a cellular concentrate derived from an individual’s own fat, known as the stromal vascular fraction (SVF), has on the quality of life of people with Parkinson’s disease (PD). SVF contains components with “regenerative” properties, including stem cells that may be capable of ameliorating specific disease conditions. This study is designed to evaluate quality of life changes in individuals with PD for up to 12 months following SVF treatment.”

    Our advocates have contacted the FDA and the MJ Fox foundation.


    1. Jeanne, thanks for your comment. There’s a huge challenge in this arena because you can multiple the one example you mentioned by about 100-fold just in the US today.

    2. i’m a bit confused.. your advising against stem cell tourism… but the tour company is doing a clinical trial… looks like they will fund a study that proves / disproves the efficiency of the method… isn’t that a good thing?

      1. Here’s my problem with this sort of clinical trial. Using intravenous injection of SVP for Parkinson’s disease is like treating cancer with aspirin. The aspirin is unlikely to cause harm, but also it certainly will have no effect on the cancer.

        But if aspirin is approved by the FDA, why not give it a try for your cancer, you might ask? If you agree that paying $15,000 for the chance to take aspirin for your cancer is worth the money, then we are fundamentally in disagreement about ethics.

        1. no ethical disagreement here… simple, concise. and in lay terms… thanks… as a 40 yr old with pd. i watch your work with great interest.. thanks again. please march forward. so many of us are holding to the dream.. if i can just hold it here.. if i can just not get worse. we need hope..

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