September 27, 2020

The Niche

Knoepfler lab stem cell blog

Patricia Zettler

5 min read

In what could be a serious legal warning sign for the stem cell field, California federal district court Judge Jesus Bernal denied the government’s motion for summary judgment against Cell Surgical Network, et al. related to their marketing of an unproven fat stem cell product via their chain of clinics. The FDA is seeking a permanent injunction. You can read the new ruling here. The reasons why Bernal said he rejected the summary judgment request are concerning and don’t fit with my view of …Read More

6 min read

There appears to be a big, risky loophole in the relatively new national Right To Try law. Some folks apparently anticipated this problem long ago, but I think most of us weren’t aware of it. Update: More specifically, some law and policy experts were writing about this and other potential loopholes in 2018. I recommend this piece from Beth Roxland and Elisa A. Hurley on the The PRIM&R blog. What’s the deal? It seems to be a case of what I would call piggybacking …Read More

5 min read

It’s been a big week already for the stem cell field due to the court ruling against US Stem Cell Inc. and that the FDA can define stromal vascular fraction (SVF) as a drug (see my old rough sketch of how SVF is sometimes manufactured; my impression is that the company does this slightly differently). There is a wide range of opinions on the long-term meaning of this court ruling. Some like me view it as likely making a major positive difference, while others …Read More

3 min read

For me there was a sense of “finally” when just under 3 months ago the FDA filed suits via the DOJ against 2 stem cell clinic firms, U.S. Stem Cell (and its affiliate U.S. Stem Cell Clinic, collectively referred to here as USRM) and California Stem Cell Treatment Center/Cell Surgical Network (collectively referred to here as CSN) seeking permanent injunctions. However, since the filings in May not much of anything has changed on these fronts and it appears that the FDA has taken no action …Read More