November 24, 2020

The Niche

Knoepfler lab stem cell blog

Search Results for: amniotic

2 min read

There’s a lot of questionable “stem cell” injections these days involving purported amniotic stem cell or other perinatal (birth-related) material. Regulators are taking note including the FTC, which took some unprecedented action last year on this front. Now the FTC has announced that more than half a million $USD have been returned to consumers who got dubious “amniotic stem cell” material. From the FTC announcement: “According to the agency’s October 2018 complaint, Dr. Bryn Jarald Henderson, D.O. and the companies he owns and operates, …Read More

2 min read

Some amniotic stem cell clinics seem to be trying to have their cake and eat it too. Generally the amniotic stem cell clinics market their products as “stem cells” and the implication is that living stem cells are used to effectively treat many medical conditions. I have not seen it mentioned that what some of the clinics, perhaps most of them, inject into patients is really a “dead” extract of amniotic membranes instead. Not living cells.  Are the clinics injecting amniotic stem cells or …Read More

2 min read

The FDA issued a warning letter not long ago to Amniotic Therapies, LLC, a supplier of amniotic products including to one or more stem cell clinics, but now a federal judge in Texas has reportedly mostly blocked the FDA action in terms of the shutdown. The law firm representing Amniotic also issued a PR about the judge’s order. In its inspections, the FDA reported that it found some of the products were contaminated with pathogens. The company apparently disputes some aspects of the FDA’s claims …Read More

1 min read

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 …Read More