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 »
Professor Joanne Kurtzberg’s clinical work at the Duke Autism Center on umbilical cord blood for autism and cerebral palsy (CP) involves a partnership with a publicly-traded cord blood banking firm called Cryo-Cell. Kurtzberg is also the Medical Director at the firm. In addition they have intellectual property in this area. The Duke team’s efforts, including …
Duke & Cryo-Cell plan big clinic for unproven infusions of kids Read More »
Amongst all that is bouncing around within the stem cell clinic maelstrom out there, one thing stands out for me as the most troubling. I’m talking about for-profit experimentation on children, such as injection of kids with unproven stem cells for autism or cerebral palsy by unproven clinics. In my opinion it’s almost always going …
Journal erred on Panama clinic stem cell for autism paper Read More »
Stem cells for autism? After watching this area for many years, I’m not sure there’s any “there there”. There are logical reasons to think that certain stem cells might help many specific diseases, but in my view autism isn’t likely to be one of them. I hope I’m wrong, but today at least in 2018, …
Stem cells for autism: time to hit pause in 2018? Read More »
When patient families reach out to me, one of the most common questions is whether stem cells for autism offer real hope. The short answer at this time remains “no”. Of course, it’s not as simple as just “no” because there isn’t enough data to be sure, but there is reason for major skepticism about …
Why I am still very skeptical about stem cells for autism Read More »
My lab is focused in part on chromatin states in stem cells and cancer including heterochromatin. In fact, my lab’s website is chromatin.com. Heterochromatin is dense, often inactive chromatin. By H&E staining and electron microscopy, heterochromatin looks dark compared to the rest of the nucleus, largely composed of euchromatin. Toward the end of my postdoc …
Weekly reads: heterochromatin, H3.3, Mesoblast bump Read More »
It’s a big challenge to get a cell therapy approved by the FDA and if you look at my list of FDA-approved stem cell therapies, it’s not as long as we might hope. FDA OK on cell therapy from Gamida Cell For this reason, it was excellent news to see that the FDA approved a …
Weekly reads: FDA nod on new cell therapy, gray hair, pong-playing cells Read More »
Toward the end of each year, I make stem cell & regenerative medicine predictions for the coming year. It’s a fun tradition here on The Niche that goes way back. The stem cell field has changed dramatically as reflected in each year’s predictions. Here’s a list of past predictions with my grades of how they …
2023 stem cell & regenerative medicine predictions Read More »
In today’s post I review the cord blood firm Cryo Cell International and discuss specific concerns I have about it. A major issue is their plan to open a clinic selling unproven cord cell infusions to kids. I believe this is risky both for the firm and more importantly for the children. What is Cryo …
Cryo Cell reviews: dubious cord cell clinic plans, risks, other issues Read More »