Leigh Turner

New data on stem cell clinics, INDs, & more including from FDA itself

arm slide fda trip program

The International Society for Cell & Gene Therapy or ISCT held a really interesting webinar yesterday on the FDA and unproven stem cell clinics. It was focused on the expiration of the FDA’s discretionary period on unproven stem cell clinics. What will the FDA do now? The webinar included some ideas and also quite a …

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More Duke autism program backstory: stem cell ‘magic’ & money

Duke-Curemark-autism-study-pamphlet

Last week I wrote a long post detailing the troubling multimillion-dollar reverberations between the Duke autism program and a for-profit stem cell clinic in Panama called The Stem Cell Institute. The potential entanglements between the Duke group and the Panama clinic raise a bunch of questions and concerns. They center on questionable, unproven autism “treatments”. …

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Review of clinic exposé film From Jail Cell to Stem Cell

Erin-Elizabeth

Stem cell clinics and suppliers have been getting into the business of making promotional films to generate more revenue, but now there’s something very different in the cinematic stem cell arena called From Jail Cell to Stem Cell by filmmaker Doug Orchard. It is at its heart an exposé film about some in my view particularly concerning stem …

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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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Stem cell & regenerative medicine good news & pubs

Rosie-Barrero-CIRM-stem-cell-good-news

There is always plenty of complicated, mixed-bag news on the stem cell and regenerative medicine front so it’s great to highlight when there’s some good news out there. Today’s post includes several such upbeat items. At the bottom I’ve included a list of some recent interesting publications as well. Good news on vision front: jCyte …

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Reprimand, $13K fine for bone marrow stem cell clinic doc

Dr_Matthew_Thorson

A Minnesota doctor running a stem cell clinic offering bone marrow injections for a variety of health conditions was subject to action by state medical regulators. The Star Tribune’s reporter Jeremy Olson has a new article on the action, which included a $13K+ fine. Olson’s piece has some of the key details: “Dr. Matthew Thorson …

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Another FDA letter to a stem cell clinic supplier: what’s the agency’s long game?

FDA-untitled-letter

The FDA just sent another untitled letter to a producer of a potentially non-compliant perinatal “stem cell” product that may be an unapproved drug. This follows past non-warning letters and/or inspection reports made public to Liveyon, R3 Stem Cell, Stemell, and others. RAPS has more on the story of the new letter here. This newest …

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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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StemGenex clinic bankruptcy reveals surprises including huge revenue

Stemgenex

How much money and how many patients do stem cell clinics like San Diego’s StemGenex make each year? A new court document has some insights from an unexpected angle. I’ve been following StemGenex for years here on The Niche. It’s been a rollercoaster ride. Things hit a new low today, perhaps marking the operational end …

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Turbulence! My new pub tracking 100s of stem cell clinics over 3 years

Knoepfler-2019-Regenerative-Medicine-stem-cell-clinic-study-Figure-1

I’m a biologist and genetics researcher, but as I have time I still squeeze in a little research on stem cell clinics when I can, and my new pub in Regenerative Medicine is notable for looking at changes in clinic firms in a unique kind of way. In the paper I went back to the …

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