You want sauerkraut on those stem cells? Defining the term “unlicensed” stem cell clinic

It may come as an annoyance or surprise to some folks in the non-compliant stem cell clinic world that there are laws, rules, and licensing involved in giving stem cell transplants to patients. (To be clear here, this post is focused on clinics transplanting propagated stem cell drug therapies that the FDA views as more than minimally manipulated (i.e. “351s”). Note added on March 21).

Hot dog cartWhen I refer to some of these dubious clinics as “unlicensed”, what do I mean?

To do some specific things with biologics such as stem cell products intended for clinical use, clinics must have an approved Biological License Application (BLA) from the FDA.

I would say it is reasonable to call clinics that are in this area and that do not have a BLA by the moniker “unlicensed”.

Disturbingly some of these clinics do not even know what a BLA is, while others know about it but intentionally blow it off.

A stem cell clinic may also be “unlicensed” if the practitioner there is unlicensed in one of the following ways:

  • Unlicensed in that state or country
  • Not a doctor at all
  • Has had his/her license revoked

I would also call a clinic “unlicensed” if it is treating patients with a stem cell drug (i.e. propagated or otherwise more than minimally manipulated stem cells) without an IND, Investigational New Drug, approval from the FDA.

However, the term “non-compliant” is just as apt.

Strangely, some people take offense at the idea that stem cell providers should have to have any kind of license at all!

What the heck?

If the cart down the street needs a license to sell me a hotdog (see picture above from Wikipedia) and the person cutting my hair needs a license and I need a license to drive my car, can anyone seriously argue that a guy injecting a billion stem cells IV into patients and charging each patient $20K a pop should not need licensing to run his stem cell clinic?

I recently did a stem cell political cartoon expressing my concerns about a deregulated stem cell future in which a stem cell clinic may need no more licensing than a coffee stand.

3 thoughts on “You want sauerkraut on those stem cells? Defining the term “unlicensed” stem cell clinic


  1. Paul it is important to note that the FDA has created a legitimate regulatory pathway for companies to bring cell therapy products to market which do not have a license. There is no “license” for products regulated under the 361 pathway.

    Because this is a perfectly legitimate pathway to market it is inappropriate to suggest to the public that products without a “license” are not legitimate. This is why I prefer the term “non-compliant”.

    There are challenges with some of these products and the way some companies have brought them to market but nonetheless it is a perfectly compliant and legal pathway to market in both US and Europe.


    • You are right that I should have been clearer that I was referring to clinics offering propagated stem cell products for transplantation.


  2. True,
    There is no ‘license” involved to treat patients with a new drug. But there is a license or ‘approval’ to investigate a new drug under an IND.

    For typical private clinic doctors, I think they falsely fear IND or BLA applications for the following:
    1. Ignorance about stem cell biology (Not keeping up with new development)
    2. Inability to manage a study
    3. Inability to raise funds for a study
    4. Complexity of IND or BLA application.
    5. Losing an opportunity to directly generate revenue
    6. Other

    I hope everyone will soon help resolve these issues because it is true that many patients are consenting to be treated with stem cells, almost all of them have to be treated under a controlled IND study.

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