Search Results for: zettler

Helpful Zettler insights from Q&A on FDA suits against stem cell clinics

Patti-Zettler

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 …

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FDA should freeze Duke EAP & probe $58 million Cryo-Cell deal linked to it

cryo cell infusion clinic marketing

I recently found concerning SEC filings from the biotech Cryo-Cell about a deal it has with a Duke team for infusions of children with unproven umbilical cord cells. This turns out to be a $58 million deal. It relates in a major way to a Duke compassionate use or expanded access program (EAP) that already had raised …

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Duke & Cryo-Cell plan big clinic for unproven infusions of kids

cryo cell duke stem cells autism cp

Professor Joanne Kurtzberg’s clinical work at the Duke Autism Center on umbilical cord blood for autism and cerebral palsy (CP) involves a partnership with a publicly-traded cord blood banking firm called Cryo-Cell. Kurtzberg is also the Medical Director at the firm. In addition they have intellectual property in this area. The Duke team’s efforts, including …

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2 State AG’s sue ‘Stem Cell Centers’ clinics including for alleged fraud

Travis-Autor

Some readers suggested earlier this year that I look into a clinic firm called ‘Stem Cell Centers’ with its owner Travis Autor. I didn’t have time to do much since I’ve been very busy in the lab before the state Attorney Generals of Iowa and Nebraska sued them based on a number of allegations including …

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In landmark step, judge does not defer to FDA in stem cell clinic chain case, orders full trial

Judge-Jesus-Bernal

In what could be a serious legal warning sign for the stem cell field, California federal district court Judge Jesus Bernal denied the government’s motion for summary judgement against Cell Surgical Network, et al. related to their marketing of an unproven fat stem cell product via their chain of clinics. The FDA is seeking a …

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Right To Try law has a big loophole that’s an opening for bad actors

piggyback-ride-right-to-try-1

There appears to be a big, risky loophole in the relatively new national Right To Try law. Some folks apparently anticipated this problem long ago, but I think most of us weren’t aware of it. Update: More specifically, some law and policy experts were writing about this and other potential loopholes in 2018. I recommend …

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Reactions to historic stem cell clinic court loss, new court order, & what happens next?

SVF2

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). …

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As 2 FDA stem cell clinic suits slowly unfold, more action needed now

salvador-dali-the-persistence-of-memory-throw-blankets

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 …

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