October 19, 2020

The Niche

Knoepfler lab stem cell blog

Stem Cell Scientists KO’d in round one versus unproven clinics: where’s the FDA?

One of the greatest and most infuriating ironies of the stem cell-based regenerative medicine universe is that while the FDA strictly regulates the progress of therapy development by Advanced Cell Technology (ACT) and Geron and other legitimate companies, at the same time mysteriously the FDA essentially leaves completely unregulated the companies within the U.S. offering stem cell based therapies that are entirely non-scientific and unproven.

What this means is that while ACT and Geron do everything by the books and must scientifically and rigorously prove every element of their proposed therapies over a period of years and years, any bozo can open a “stem cell clinic” in a strip mall, throw up a website, and start doing medical procedures (e.g. stem cell autologous transplants) with seemingly no regulation by the FDA at all. What the heck? How can this be true?

The proliferation of stem cell clinics offering non-FDA approved treatments has proven to be almost as rapid as the proliferation rate of stem cells themselves in culture.

These clinics are sprouting up all over the world including here in the U.S.

Their sole purpose?

Make money and damn the consequences.

The ISSCR had setup a mechanism whereby stem cell scientists and concerned patients could work together to at least attempt to reign in these clinics.

The effort by ISSCR was quietly ended several months ago when it was threatened with litigation by layers from the clinics in question. Today this unfortunate news was disclosed and the circumstances explained.

The risk for ISSCR of continuing was to potentially lose a court case that could financially cripple the organization.

The risk of the ISSCR giving in to the threat of being sued also should not be overlooked.

Stem cell clinics offering non-FDA approved, unproven treatments have won a major victory and will continue to put patients at risk with little hope of benefit. Why is the FDA not regulating these clinics? You got me.  The risks are extremely high as was illustrated by the recent death of a baby at a German stem cell clinic, which was subsequently shut down. Will it take a similar even in the U.S. for the FDA to get serious about this problem?

 

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