October 30, 2020

The Niche

Knoepfler lab stem cell blog

stem cell law

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

3 min read

It’s a funny thing how having this blog can provide insights into unexpected stem cell events and news going on around the world such as, most recently, action by the government of Romania on stem cell firms there for alleged “dirty practices”, news that as far as I know has only been reported in Romanian. How did I learn of this? I know a small amount of Romanian myself, but on my site I have a project called SCOPE, which provides a basic stem …Read More

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