May 28, 2020

The Niche

Knoepfler lab stem cell blog

stem cell lawsuit

3 min read

The unproven stem cell clinic firm US Stem Cell Inc. is in a world of hurt. If a federal judge says you can no longer sell your key commercial offering, how do you survive as a company? US Stem probably has been thinking about that possibility for months. Still, it’s not yet clear where the company goes from here now that this has become a reality. Where do things stand looking ahead? There’s financial pressure. The company’s stock ($USRM) has been a penny stock …Read More

3 min read

In the latest blow to the unproven stem cell clinic industry, a California federal district court judge just granted class status to a lawsuit against the fat stem cell clinic Stemgenex. (update: Stemgenex has since filed for bankruptcy). What this means in practical terms is that the lawsuit alleging fraud in marketing by the clinic firm amongst other allegations will proceed and may have 100s of patients involved. Many of these people paid nearly $15K per treatment to the company. Presumably some customers got …Read More

2 min read

The  unproven stem cell clinic StemGenex appears to now be called Advanced Cell Medicine. StemGenex is facing a proposed class action lawsuit by patients and it also recently received an FDA warning letter. StemGenex is notable too in that it seemed to be considering taking some extreme action against perceived critic websites including potentially the California Stem Cell Agency, CIRM. Could it be trying to put some of the past behind it? A reader of The Niche tipped me off in the comments recently …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

In a precedent-setting decision, a federal court has ruled for the FDA against a key stem cell clinic firm called U.S. Stem Cell, Inc. The court granted summary judgment for the FDA in its suit seeking a permanent injunction against the Florida stem cell clinic firm. While the company is likely going to appeal, this is a major defeat for them and for the hundreds of other unproven fat stem cell clinics in the U.S. It’s a big victory for science, regenerative medicine, and patients. …Read More

4 min read

It’s been less than a year since the FDA sued for a permanent injunction against a major stem cell clinic firm in Florida, but there has been much back and forth in court filings in the lawsuit between them and the firm, US Stem Cell. Now the case is with the judge. My prediction remains that the feds will prevail, but it seems worthwhile to look at some of US Stem Cell’s arguments. Note as a sort of disclaimer that I’m not an attorney …Read More