Search Results for: leigh turner

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

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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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Regulators in Canada order dozens of stem cell clinics to stop

Health-Canada-stem-cells

North America is seeing a major bump in actions by regulators against unproven stem cell clinics with a big step up in Canada. The action has sparked quite a bit of discussion and debate. Dozens of Canadian clinics were just told by Health Canada to stop selling unproven stem cells. Some of these clinics sold …

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50 stem cell influencers on Twitter to follow in 2019

stem cells on Twitter, top-stem-cell-influencers-Twitter

Who are the top stem cell and regenerative medicine influencers to follow on Twitter and elsewhere in 2019? Terrapin asked this kind of broad question to some within our community about 5 years ago and came up with a Top 50 list of stem cell influencers, which I like to joke I was “at the top …

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Sales of ‘zombie’, birth-related ‘stem cells’ continue to mushroom

zombie-stem

The birth-related stem cell clinic industry is a serious problem for patients, the stem cell field, and the FDA as the clinics sell more and more of what I think of as “zombie” injections. One of the biggest changes in the last 2 years in the unproven stem cell clinic arena was predicted by the …

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News bites: CIRM, anti-MSCs, & human eggs from stem cells

human-eggs-from-stem-cells-Saitou

Stem cells are always in the news so what’s up in the last week or two? CIRM News The dialogue over CIRM’s future is picking up a bit of steam. The San Francisco Chronicle did an in-depth piece on CIRM some weeks back and then opined that they didn’t feel supportive of another round of …

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Clinic versus clinic? Internecine conflicts among direct-to-consumer stem cell firms

Regenexx-blog

Stem cell clinics marketing non-FDA approved therapies directly to consumers have been in various tense situations at times with the FDA or academics over the years, but more recently these stem cell clinic-related firms also appear in conflict with each other sometimes. The most notable recent example of conflict involves Dr. Christopher Centeno of Regenexx …

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Animated map video shows wildfire spread of US stem cell clinics lacking FDA approval

stem-cell-clinic-animated-map-2010

There are now so many clinics selling non-FDA approved stem cell offerings across the U.S. that tens or hundreds of thousands of patients are at risk. How did we get here? What if we had a way of understanding how stem cell clinics spread across the U.S. in the first place? For example, an animated …

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