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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Mayo Clinic charges patients just to talk about clinical trials?

The Mayo Clinic.

What if some legit place like The Mayo Clinic charged people just for the opportunity to talk to a doctor about possibly enrolling in a clinical trial? Imagine this kind of conversation. “Hey, Doc, I have this medical problem and heard you have a relevant clinical trial. Tell me about it.” Then the doctor fills …

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16 predictions for stem cells & regenerative medicine in 2022

regenerative medicine, stem cells 2021

The last few years in the stem cell and regenerative medicine arena have been complicated in many ways. Variables like surging stem cell clinics and COVID have made predictions harder.  Even so, trying to make predictions is useful and it’s fun to go over past year’s predictions. You can see my scorecard on my 2021 …

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Top stem cell stories of 2021: COVID, diabetes, human embryos, clinics in court

regenerative medicine, stem cells 2021

The past year was all over the place for the stem cell and regenerative medicine field. As you can see in my scoring of my 21 predictions for 2021, quite a few things were surprises in terms of what did and didn’t happen. Here’s an overview of the top stories of the year in our …

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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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