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 …
Therapeutic misconception & the planned Duke Cryo-Cell cord clinic Read More »
When I first learned about the multi-$10 million cord cell clinic deal between Duke and Cryo-Cell I couldn’t believe what I was reading. Duke’s involved in this? The problem: marketing unproven cells for kids Yes, this wasn’t some stem cell clinic operating out of a strip mall seeking to make big money off of injecting …
Vice tackles dicey Cryo-Cell Duke mega-million peds clinic plan Read More »
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 »
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 »
What is immune rejuvenation? How would that work and what would be the benefits? As we age, our immune systems can change in unhelpful and unhealthy ways. One such change is a drift in the balance of production of different kinds of immune cells. Such a shift can lead to too many of some immune …
Almost two years ago I publicly called on the FDA to freeze the unproven cord cell expanded access program (EAP) at the Duke Autism Center. Duke has been infusing kids with autism spectrum disorder (ASD) with unproven cord cells and requiring large payments for this. The cost was as much as $15,000. A halt and a …
Why did Duke autism team halt its troubling pay-for-play program? Read More »
We’ll begin this week’s recommended reads with some news on two wonderful stem cell scientists. While there are thousands of stem cell scientists, some stand out for their especially creative work. News on stem cell scientists Nobel laureate Yamanaka to retire as director of iPS cell center, Asahi Shimbun. Dr. Yamanaka will spend more time …
Recommended reads: stem cell scientists, eggs from blood, Cryo-Cell Read More »
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 …
Top stem cell stories of 2021: COVID, diabetes, human embryos, clinics in court Read More »
This week marked the release of new draft FDA guidance on cell and gene therapies. Is the FDA kind of like the guidance counselor at school or more like the principal? It probably depends on many factors. I also find it funny how pretty much everyone in academia and biotech industry works to be compliant …
Weekly reads: New FDA guidance, brains, MSCs, senescence Read More »
Every year I make stem cell and regenerative medicine predictions. Looking at my predictions for 2023, they reflect a wild year but in many ways a good one overall. Below I have graded my 2023 predictions. Overall, my crystal ball gave solid results. Some of the predictions have been condensed to keep things concise, but you …
2023 stem cell predictions grades reflect wild year for regenerative medicine Read More »