August 3, 2020

The Niche

Knoepfler lab stem cell blog

stem cell lawsuit

2 min read

I’m becoming increasing convinced that patient suits against stem cell clinics are going to have strong impact, including based on the new steps taken by a particular law firm. For background, I’ve written extensively about these suits over the years and we’ve seen more recently that another academic group (Claire Horner, Evelyn Tenenbaum, Douglas Sipp, Zubin Master) has published a paper on the suits. The law firm stepping up against clinics is GRYC or Grossman, Roth, Yaffa, and Cohen. They not only have and continue to represent …Read More

2 min read

I didn’t know until recently that the FDA has a blacklist, which is called the “FDA Debarment List”. You can check it out here. Should one or more particularly egregious unproven stem cell clinic operators should be on the list given their risk-taking with patients in the name of profit? There aren’t any on there now that I could see. It’s a fairly short list. Why would FDA have such a thing more broadly? The blacklist is for those who have seriously broken regulations …Read More

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

5 min read

Will the adipose stem cell clinic firms facing permanent injunction suits by the FDA — U.S. Stem Cell Inc. (USRM) and California Stem Cell Treatment Center (CSCTC)/Cell Surgical Network (CSN) — cool it in the sense of voluntarily shutting down their commercial fat stem cell injections of customers soon pending the outcomes of the suits? Or will things heat up further? In the interview I did last week with Patti Zettler she mentioned the possibility of a voluntary stop by the clinics. The more …Read More