I have a soft spot for fibroblasts, perhaps because one of the first immortalized cell lines I ever grew was NIH3T3. These are mouse fibroblasts that have been immortalized. They are very useful for a variety of experiments. I used them to study an oncogene called E2A-PBX1. Experience with fibroblasts including 3T3s I was amazed …
Weekly reads: fibroblasts, gene-editing, Mitalipov, personhood, embryos Read More »
I remember the first time I ever witnessed human cell division first hand and it was really excitement. I was working as a part-time tech in the Lane Lab at UC San Diego School of Medicine. We studied heart disease and grew human umbilical cord endothelial cell cultures. It was striking to see a plate …
Weekly reads: Vertex hold, new type of cell division in fish, CAR-T Read More »
If there’s one area of biologics where the FDA has been consistently busy lately it’s the perinatal cell therapy space. The agency has made it clear in the last year that allogeneic birth-related cell products are often drugs requiring premarket approval. This has mainly manifested at a practical enforcement level. We’ve seen actions taken in …
End of FDA “grace period” impacted perinatal cell therapy biotechs Read More »
The FDA has been busy with the COVID pandemic but it has many other things on its plate as well including cell therapies. Today I’m sharing some recent agency news and brief perspectives on it. FDA focus on clinic-related umbilical cord cell drug makers The agency warned an Idaho company that produces and sells umbilical …
FDA news: warning letter pattern, cancer moonshot, CAR-T & gene-editing guidance Read More »
If you celebrate the Thanksgiving holiday I hope you had a nice one and, right before it started a new article popped on the scene about the CRISPR babies. Before we discuss those three gene-edited people, who are now growing up into little kids, we hit a milestone on our YouTube Stem Cell Channel with …
Regenerative reads: 3 CRISPR babies, FDA warning, diabetes, pubs Read More »
Liveyon is a cord blood product marketer that distributed a batch of cells a couple of years back that led to many patients being hospitalized with infections. Some had sepsis and ended up in the ICU. It was thought at the time that about a dozen patients who had been injected with the Liveyon product …
Liveyon product hurt many more patients says new CDC study Read More »
Stem cell clinic firms often come and go rather quickly, but a few like Regenexx have persisted. It’s even become a brand name. I’ve been writing here on The Niche for more than twelve years about stem cell clinics. Regenexx has been around that whole time. Along with its founder Dr. Chris Centeno. Patients have …
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 »
For more than a year in my first job as a scientist I isolated cells from umbilical cord veins and then tossed the tissue away, never realizing there was more there that could be useful in the form of something called Wharton’s jelly. What’s in this article Umbilical cord histology & Wharton’s jelly | What …
What is Wharton’s jelly & its possible clinical uses? Read More »
Although in my years as a stem cell biologist I haven’t yet been in a leadership role at the International Society for Stem Cell Research or ISSCR, unproven stem cell clinics have claimed that I somehow speak for ISSCR. I am just a standard member of the group like thousands of other researchers. In fact, …
Recommended reads: ISSCR guidelines pushback, TB outbreak from regen product, pubs Read More »