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 …
As 2 FDA stem cell clinic suits slowly unfold, more action needed now Read More »
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. …
Romania fines 5 stem cell groups for alleged ‘dirty practices’ Read More »
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 …
Law firm blasts stem cell clinics in new ‘3 shocking facts’ video Read More »
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 …
A real FDA blacklist: what is it, who’s on it, & should some stem cell clinics be? Read More »
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 …
10 questions on FDA suits targeting stem cell clinics Read More »
California broke new ground with our stem cell law that went into effect on January 1. It requires stem cell clinic firms to post notices informing patients of important information such as the fact that their offerings are non-FDA approved. At this point, 4+ months into the enforcement period, I’m not sure if anyone has …
Update on state laws on stem cell clinics: California, Washington, & Florida Read More »
At the request of the FDA, the DOJ is suing for permanent injunctions against two stem cell clinic firms, U.S. Stem Cell, Inc. and California Stem Cell Treatment Center (and for the latter, its parent chain of around 100 clinics, Cell Surgical Network). What does this big development mean in practical terms and how might it …
Helpful Zettler insights from Q&A on FDA suits against stem cell clinics Read More »
There’s some also encouraging action at the state level on direct-to-consumer stem cell clinics operating without FDA approval including most recently in Washington State. Last year here in California we passed a bill into law that (1) requires stem cell clinics selling non-FDA approved therapies to post notices for patients and (2) instructs the state medical …
Washington State Bill to Require Unproven Stem Cell Clinics to Post Notices Read More »
Florida is a hot mess on the for-profit stem cell clinic front. My own state of California isn’t much better and actually has a great number of clinics, but more problems are coming to light in Florida, at least at this point. Now WLRN reports that a legislator in Florida has proposed a new bill to try to …
Florida bill aims to “crack down” on state’s for-profit stem cell clinics Read More »
What does the wide stem cell and regenerative medicine community think of California’s new stem cell law requiring that clinics selling non-FDA approved stem cell offerings make specific disclosures to prospective customers and that the state medical board keep track of how this all unfolds? You probably already know that I am supportive of the …
Reactions to California’s new stem cell law on non-FDA approved clinic offerings Read More »