FDA warning points to tougher regulation of fat stem cells & clinics

FDA logoLast week I blogged about how the FDA had issued a warning letter to a series of three co-owned fat stem cell clinics across the US.

What does this FDA action mean on the broader stem cell clinic arena, particularly to those selling fat stem cells?

The FDA is still in the process of getting public comment and finalizing draft guidelines related to stem cell clinical products including fat stem cells aka adipose stem cells and stromal vascular fraction or SVF.

Even so, the FDA just issued this new warning letter at least partially related to SVF to a series of co-owned clinics in CA, FL and NY here in the US going under the names Irvine Stem Cell Treatment Center, Miami Stem Cell Treatment Center, and Manhattan Regenerative Medicine Medical Group.

In the letter the FDA explicitly calls SVF a biological drug in this context and mentions that there’s no IND and no BLA (for more on these key acronyms see here) at the clinics.

As discussed in the comments on my first post on this warning letter, the FDA language is a bit puzzling in the language used in the part calling the SVF a drug. The letter first mentions several target conditions as an implied possible reason for the definition as a drug and then only later indirectly mentions more than minimal manipulation as possibly involved. Non-homologous use is also mentioned. Overall this letter is not very clear. A helpful FDA reform would be a commitment to clear writing in its public communication.

Still the relatively unambiguous wording in the letter calling SVF a drug here is striking given that the FDA again has not to my knowledge finalized its guidance on SVF. It’s hard not to read the letter as meaning the FDA has every intention of defining SVF as a drug in many if not all cases.

This is a big deal because scores of stem cell clinics in the US are injecting SVF into patients on a daily basis without any FDA approval, licensing, etc. It’s not clear why these three co-owned clinics got the first FDA warning letter in the last few years on stem cells when there are all these other clinics doing very much the same thing. That’s also puzzling and leaves an important open question. More broadly as far as I know there’s no public information on how the FDA assesses which entities to focus its limited resources upon at any one given time.

What does this mean for all those other fat stem cell clinics out there? It’s bad news for them as the FDA could and really should be taking a close look at them too. The FDA is slow at times to take action as I’ve been critical of them about in the past, but once they get going, those not following the rules have reason to be concerned.

What about those recent still only draft FDA guidances (e.g. see a nice piece by Alexey on the situation with fat stem cells here)? I suppose they could change or take a long time to be finalized, but this warning letter can be viewed as a strong signal that the guidances are unlikely to change in their core points.

One of the largest collective users of SVF in the stem cell clinic world is Cell Surgical Network (CSN), with whom Irvine was previously affiliated. I contacted CSN more than a week ago by email for comment on the warning letter and to get their perspective on this development, but have not received a reply. To my knowledge, CSN has not been subject directly to FDA action, but I do not know when the apparent split with the Irvine clinics occurred.

Until more information about what the FDA is doing & thinking (at least as expressed by their written words) hits the  public domain, the key puzzles mentioned above will remain open for speculation. However, this letter possibly signals a major turning point for regulation of clinical use of adipose stem cells, particularly in the clinic realm.

10 thoughts on “FDA warning points to tougher regulation of fat stem cells & clinics”

  1. I see that dr steven victor seems to have time to comment on this website but is unable or unwilling to provide up to date financial statements for intellicell and its shareholders

  2. @Paul – great post on the licensing and approval issue.

    It’s important to separate the legal debate from the “is it safe and effective?” debate as it may turn out that some SVF/MSC therapies offered by unregulated clinics are indeed safe and effective in retrospect, but would in that case have not been carried out according to the letter of the law.

    It would be a pity to tar the potential of MSC therapies with the same brush used to sweep out the illegal clinics. Fortunately, there are over 100 ongoing clinical trials using SVF, so we should gain insights into effectivity before long.

  3. There must be better ways of looking after the interests of patients? But, I guess that if you are a Food and Drug Administration then everything has to be about regulating either food or a drug. My cells don’t fit their schema, IMHO.

    By interfering with autologous MSC therapies, the FDA is sliding into the business of regulating the practice of medicine. What will they go after next? Platelet Rich Plasma?

    Big government and big business are seldom satisfied with just a slice of the pie. Usually they end up being stopped only when resource limitations make further growth uneconomic.

    The FDA has a history of growing its bailiwick by more than minimal manipulation of language.

    1. @Brian,
      We don’t see entirely eye to eye and that’s OK. One thing I’d add is that the clinics don’t see the cells as yours. They may say so and claim patient empowerment, but really they see the cells as a profitable product so in this sense of the idea of cells as a product the clinics have that in common with the FDA, which is ironic.

  4. Paul, You stated, “This is a big deal because scores of stem cell clinics in the US are injecting SVF into patients on a daily basis without any FDA approval, licensing, etc.”
    What does that actually mean? What kind of licensing is needed? Surely, you aren’t insinuating that there are clinics operating with no licensed doctors administering the treatments. I’m not aware of a special license for stem cell treatments that is needed. What kind of approval will the FDA bestow on those that are worthy and what will they need to be doing to get it? What does your etc. include? Etc. can mean a whole lot of things. I’d like details.

    As for the FDA shutting down clinics, patients who want treatment will just have to endure the additional hardship and risk to their health of having to go offshore.

    1. @Barb,
      If your stem cell product like SVF is a drug (and this drug definition is decided by the FDA, not by the clinic), then to give it to patient in a lawful manner you need a number of things.

      You need the licensing I was speaking of in the form of a BLA or Biologics License Application.
      You also need an IND or Investigational New Drug application.
      And with these things you need to work with the FDA to figure out a plan to then administer this drug to patients within the real clinical trial system to safety test how it works.

      Many clinics have claimed that SVF (cell fraction purified from fat) is not a drug and hence not subject to these rules. However, the recent FDA draft guidelines, past FDA written guidance, and now this most recent FDA warning letter all point toward fat stem cells being a drug.

      The bottom line?

      In my view, what this means in 2016 is that all those clinics & their doctors out there selling fat stem cells without any kind of FDA approval should probably stop doing so and talk with the FDA before resuming. I’m not naive enough to think that will happen across the board, but it would be in the best interest of the doctors to avoid the risk of possible future FDA action against them and this would be safest for patients.

      You are right that the FDA actually enforcing its rules in the US could mean more patients engaging in medical tourism abroad, but I don’t believe that possibility is a good justification for the FDA to instead fail to do its job. IN that kind of scenario, you could make the same argument about other federal/law enforcement agencies not being firm because it might drive people to do certain things outside the US, but again I don’t think that holds water and makes good common sense.

  5. One major point in the Warning letter was the reference to the fact that the HCT/P used was adipose tissue which is structural tissue.
    There are two major mistakes here by the FDA
    First of the tissue is lipoaspirate which like bone marrow aspirate is not structural tissue but
    MORE IMPORTANTLY the HCT/P is the SVFC and NOT the adipose tissue and is a cellular product

  6. FDA has become a bunch of reckless fools sitting at the top. They move to regulate fecal matter and retreat. Clamping down on anything seems to be the norm and their incapacity to understand the stem cell field is spelling tragedy to many patients. Of course any fool can come up with some regulatory language to keep it broad and tailor to specific enforcement actions. I think this is a big mistake on FDA’s part to regulate adipose-derived stem cells. I feel so because within the body there is no “homologous” definition for adipose tissue or its constituents, which the FDA clearly does not understand. Fat tissue is deposited all over the body and the deposition pattern varies widely across individuals and races. Moreover, given that the fat tissue is readily altered without any harm to the body, such as in weight loss or gain, there is no clear biological basis of limiting the procedures to “minimal manipulation” as total disruption of the tissue is harmless. Such idiotic FDA restrictions actually put patient lives in extreme danger by shutting down avenues for beneficial treatments. It should be about the patient first. IMO, FDA can do all the regulations it wants, but these days the patients have given up and do not give a damn to FDA and increasing number of doctors are caring less for FDA as well. FDA actions in the stem cell field are only increasingly alienating both patients and doctors.

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