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 […]
FDA should freeze Duke EAP & probe $58 million Cryo-Cell deal linked to it Read More »
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
Fact-checking stem cell therapy for autism: still a risky idea Read More »
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
Fact-check: F grade for irresponsible stem cell COVID-19 cure piece Read More »
Last week I wrote a long post detailing the troubling multimillion-dollar reverberations between the Duke Autism Center and a for-profit stem cell clinic. The clinic in Panama is The Stem Cell Institute. The potential entanglements raise a bunch of questions and concerns. They center on questionable, unproven autism “treatments”. In Duke’s case, their own clinical
More Duke Autism Center backstory: stem cell ‘magic’ & money Read More »
What do a Panama stem cell clinic and the Duke Autism Center have in common? More than I might have imagined. It’s a remarkable story that needs telling. Duke Autism Center There is a puzzle when it comes to the controversial idea of using cord blood for autism. Why? Because two of the strongest proponents
Duke Autism Center has Panama clinic to thank for $10s millions? Read More »
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
Politics & FDA OK of 2 stem cell clinic COVID-19 efforts Read More »
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
Mesoblast MSCs Quell Peds GvHD; On Road to FDA Approval? Read More »
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
Overselling stem cells for COVID-19: WSJ article & UMN PR Read More »
The biotech Mesoblast is starting an expanded access study of its stem cell product for kids with a severe offshoot of COVID-19. The cellular drug in this case is remestemcel-L (more below). While most children fare better than adults in dealing with COVID-19, the rare subset of kids with COVID-19 for this study have more severe
New Mesoblast “COVID kid” stem cell study Read More »
It’s been a busy week for the cellular and regenerative medicine space for COVID-19 news with some possible ups including for Mesoblast and some definite downs. Starting with the more positive media buzz with have Mesoblast. Mesoblast made COVID19 news “Thinly traded Mesoblast Limited (NASDAQ:MESO) rockets 51% premarket on average volume in reaction to its announcement of an
COVID-19 cellular medicine buzz: Mesoblast, FTC hammer, more Read More »