July 15, 2020

The Niche

Knoepfler lab stem cell blog

US Stem Cell

3 min read

The FDA via the DOJ has sued to get permanent injunctions against US Stem Cell, Inc. (USRM) and California Stem Cell Treatment Center/Cell Surgical Network (CSN). Both firms use an unapproved fat stem cell product in patients called stromal vascular fraction (the SVF production process is pictured at right) that the FDA indicates is generally going to be a drug product requiring premarket approval. You can see my first quick take on these federal suits here as well as initial responses to the suits …Read More

2 min read

It was interesting to see that this blog The Niche was cited in the lawsuit filing by the DOJ in the U.S.A. vs. California Stem Cell Treatment Center, Cell Surgical Network (CSN), et al. case. Yeah, that lawsuit. This suit is part of the DOJ action yesterday that along with the other suit against US Stem Cell seeks permanent injunctions against these firms related to their use of stem cells. Here’s the passage in paragraph 60 of the suit by the DOJ citing this interview that I …Read More

3 min read

I emailed the CSO of US Stem Cell, Kristin Comella, for any reaction to today’s big news of the DOJ filing suit against two stem cell clinic firms including hers seeking injunctions. I also emailed the leaders of the other firm, California Stem Cell Treatment Center/Cell Surgical Network. It’s important to include the clinic firms’ perspectives for balance as this story develops. US Stem Cell’s PR firm and Cell Surgical Network both emailed back. US Stem Cell has issued a response to the action …Read More

4 min read

The DOJ and FDA are seeking permanent injunctions in federal court against two of the most widespread and influential of the for-profit, unproven stem cell clinic firms in the U.S. This story is breaking so I’ll have more later this week. The take home is that I see this action as a positive, probably historic turning point for dealing with the for-profit stem cell clinic problem in the U.S. Update: US Stem Cell says it intends to fight the DOJ in court. According to the Washington …Read More