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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Review of ExoFlo paper used to push Direct Biologics IND inside FDA finds red flags

ExoFlo from Direct Biologics

I wrote recently about how political pressure on FDA Commissioner Stephen Hahn in 2020 may have helped the Texas firm Direct Biologics move their product ExoFlo forward inside the agency. Today I analyze the ExoFlo Phase I clinical trial paper used in that push on Hahn to get the firm the IND for a Phase II …

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FDA leader Stephen Hahn was pressured to aid Texas firm Direct Biologics

Former FDA Commissioner Stephen Hahn.

An FDA FOIA dump of text messages of former Commissioner Stephen Hahn suggests that a Texas regenerative firm called Direct Biologics benefited from political pressure on him in mid-2020. Then he was asked again to help in early 2021. This was shortly before he resigned at the start of the Biden Administration. The push came from …

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Giostar stem cell clinic chain review, red flags, & lawsuit

Giostar

Some unproven stem cell clinics like one called Giostar have multiple locations sprouting up. To me the concern with that spreading is the potential of multiplying risks to consumers. It can be hard to get a clear take on what these clinics are doing too. What’s in this article What is Giostar? | Giostar review | …

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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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