September 29, 2020

The Niche

Knoepfler lab stem cell blog

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.

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