January 27, 2021

The Niche

Trusted stem cell blog & resources

FDA warning to Amniotic Therapies, LLC: impact on stem cell clinics?

Amniotic Therapies
Screenshot from archive of Amniotic Therapies website

The FDA’s CBER branch recently issued a warning letter to Amniotic Therapies, LLC.

The warning letter pertains to both AlphaGEMS-related products that are used by a number of stem cell clinics as well as problems determined at the manufacturing facility.

I went to the Amniotic Therapies website, but perhaps not coincidentally it is down, which could be due to the FDA warning. An archive of the site (screenshot above) provides information on their products.

Notably, CBER described the company’s products as unapproved biological drugs that do not meet minimal manipulation and homologous use criteria.

Given the numerous amniotic stem cell clinics out there in the US using apparently similar products, one wonders if further FDA action could be pending.

It is also interesting to speculate how this might impact the amniotic stem cell clinics since for many this was a probable supplier of amniotic material. In addition, I’ve also often wondered how amniotic suppliers and clinics get the material to begin with and do the mothers who gave birth realize where this material has gone?

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