September 30, 2020

The Niche

Knoepfler lab stem cell blog

The interactome of the adult stem cell universe

adult stem cell clinicAdult stem cell clinics are growing fast across the U.S. and the world.Many questions surround them. How do they get patients? How does the money flow? How does the FDA view them? How do all the different parties interact?In science when we study how various proteins or other molecules interact as a system we sometimes call it an “interactome”.I’ve attached a handy-dandy flow chart of my impression of the adult stem cell interactome. A key factor in this system is money.

Of course there are variations on this system. For example, some clinics simply take stem cells and inject them back into patients themselves without handing off to another clinic and may or may not grow them first.

Other clinics do allogeneic transplants from one patient to a different one.

But this interactome largely shows you how adult stem cell clinics work and how the money flows, which for many of the clinics is of course the top priority. Note that the FDA may intercede at any step to “visit” or audit a clinic, potentially leading to actions ranging from nothing to more severe steps such as a warning letter or even involving the FBI.

I’ve highlighted two of the most common triggers for the FDA viewing a stem cell product as “more than minimally manipulated” (you can learn more about that here), but there are many other possible triggers and/or other concerns that the FDA might note.

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