Search Results for: compassionate use

Results of FDA Reform Poll: speed up clinical trials & expand compassionate use

The poll I put up asking people their #1 top priority for FDA reform drew relatively big numbers of respondents. Speeding up clinical trials was clearly way out in front at #1. Expanding compassionate use was #2. These were followed by changing policy to no longer define lab-grown stem cells as drugs and FDA being …

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Therapeutic misconception & the planned Duke Cryo-Cell cord clinic

Duke Cryo-Cell therapeutic misconception

One of the core problems in the world of unproven stem cell clinics is something called therapeutic misconception. I’ll talk more about that in a minute, but first, let me tell you what brought this to mind now. Surprisingly, the story starts at Duke University. A Duke cell therapy team and the biotech Cryo-Cell have big …

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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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Fact-checking stem cell therapy for autism: still a risky idea

Duke-Curemark-autism-study-pamphlet

The other day I gave a talk in part about stem cell hype and mentioned as an example how the idea of already doing stem cell therapy for autism seems so misguided to me now.  On the whole, in my view there are major downsides and risks for autistic kids whose parents are already having …

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Fact-check: F grade for irresponsible stem cell COVID-19 cure piece

vitro biopharma stem cells covid 19

At times there’s been seriously bad journalism covering COVID-19 itself including implications of various things being a COVID cure. Of course, media coverage of stem cell research itself sometimes ends up being a train-wreck of hype too. More recently we’ve seen irresponsible journalism also around the specific idea of stem cells for COVID-19, but sometimes …

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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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Does Duke autism team partly have Panama stem cell clinic to thank for $10s of millions?

Drs.-Neil-Riordan-and-Joanne-Kurtzberg-MSCs-for-autism

What do a Panama stem cell clinic and the Duke autism program have in common? More than I might have imagined. There is a puzzle when it comes to the controversial idea of using cord blood for autism, because two of the strongest proponents are the autism cord blood program at Duke and for-profit, unproven …

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Politics & FDA clearance of 2 stem cell clinic COVID-19 efforts

Anand-Srivastava

The FDA and its CBER branch have been doing a good job overall in the last 3+ years to tackle the unproven stem cell clinic problem, but lately on the stem cells for COVID-19 front there is reason for real concern. I believe the agency is taking on major risk overall by clearing a vast number of …

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Mesoblast MSCs Quell Peds GvHD; On Road to FDA Approval?

MSCs-mesenchymal-stem-cells-stromal-cells-small

Graft-versus-host disease (GVHD) is counterintuitive In the weeks and months following a transplant, a major concern is the recipient’s immune system rejecting the “foreign” biological material. But in GVHD, the opposite happens: transplanted tissue unleashes a horde of T cells that spark a cascade of inflammation, within 100 days. Typically, GVHD follows a bone marrow …

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Overselling stem cells for COVID-19: WSJ article & UMN PR

EM-of-Novel-Coronavirus-SARS-CoV-2-that-causes-COVID-19

Many are  jumping on the bandwagon of trying stem cells for COVID-19 or testing other cellular therapies for the novel coronavirus disease, but there have been problems with either the rationales for the trials themselves or more often with how they portrayed. Sometimes there has even been outright hype. I’ve called this collective trend of …

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