October 27, 2020

The Niche

Knoepfler lab stem cell blog

Month: August 2016

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

1 min read

Journalist Melinda Beck has a new piece on fat stem cell clinics in the Wall Street Journal (WSJ) today that includes one very brief quote from me that I believe effectively ends up being an unintentional misquote because of a lack of context. Here in this blog piece I want to provide that important missing context. Melinda and I talked quite a lot about stem cells on the phone and I worked hard in that discussion to provide a great deal of depth as …Read More

4 min read

A stem cell/regenerative clinic firm called the Lung Institute is facing a filing of a proposed class action suit. Update: Note that this firm also goes by the name the Lung Health Institute and now as of 2019-2020 it does not appear to offer stem cells anymore, perhaps focusing on PRP. You might also find this WaPo article from 2019 useful:‘I’d need a drink’: WaPo deep dive on clinic firm Lung Health Institute. Is it possible that a growing number of lawsuits against stem …Read More

1 min read

The FDA continues to be very active with warning letters against makers of stem cell cosmetics even as it has been relatively dormant on stem cell clinics. You can read past posts on the long series of warning letters to manufacturers of stem cell cosmetic cream. Three new warning letters to stem cell cream makers popped up on the FDA site recently to makers Lavian Ltd, Sircuit Skin, and Annemarie Gianni Skin Care LLC. Lavian markets something called Resurgent Stem Cell Firming Activator, which the …Read More