May 31, 2020

The Niche

Knoepfler lab stem cell blog

Some stem cell clinics respond to Cell Stem Cell paper with ‘not me, them’

There has been relatively limited response from clinics themselves to the Cell Stem Cell paper that Leigh Turner and I published recently on the scope of the stem cell clinic industry in the U.S. Not Me stem cells

We found 570 stem cell clinics and there could easily be 50-100 more that escaped our search methods or that have popped up since we finished our search at the end of February. While not all the clinics necessarily require FDA approval depending on the type of stem cells and the uses, it seems almost certain that many should have gotten approval from the FDA for what they are doing before they started selling the unproven “treatments”.

One thing I was curious about before our paper even came out was what kind of response, if any, it would get from the stem cell clinics. It’s been pretty quiet from that quarter.

A few clinics talked to reporters who covered the paper and basically used some version of the same mantra, “not me, them”. This reminds me of the Family Circus “not me” cartoons (part of one is shown above).

Overall American stem cell clinics are in an awkward situation because on the one hand they want and need the attention of patients in order to make money, but on the other hand the clinics generally do not want critical attention or notice from regulators such as state medical boards, the FTC, or the FDA.

In the long run for some U.S. clinics, just saying essentially “not me, them” won’t cut it. Not everyone in this entire clinic industry selling unapproved and unproven stem cell therapies can be a “not me” unless of course the FDA never takes any real, meaningful, and proportionate action.

The more important question beyond what the clinics think is what the FDA thinks (the agency is aware of our paper) and what will they do if anything about this clinic industry situation? Doing nothing is no longer an option.

FDA?

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