There once was a place called The Morrow Institute here in California run by a physician named David Morrow. This clinic did various kinds of cosmetic procedures and also unproven, non-FDA approved fat stem cell-related stuff too for some years. Last month during some research on clinics I found several media links (e.g. here) from […]
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).
Reactions to historic stem cell clinic court loss, new court order, & what happens next? Read More »
Attorney Richard Jaffe, who has been an advocate for clinics to have the right to sell and patient to buy unproven therapies such as the stem cells sold by clinics and unproven cancer therapies, just did a kind of shocking u-turn on a specific point. Jaffe and I have very different philosophical views of the
Attorney Jaffe, fan of less oversight, still clobbers Florida stem cell clinic firm Read More »
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 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 »