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 …
Review of ExoFlo paper used to push Direct Biologics IND inside FDA finds red flags Read More »
I’m working to send out a big grant on Tuesday so I’m busier than ever but a few stem cell and regenerative medicine stories caught my eye. I can’t write grants 24/7 without a few breaks although sometimes it feels like that’s what I’m doing. Bat stem cell derivation Pluripotent bat stem cells as a …
Weekly stem cell reads: bat stem cells, brainier organoids, more Read More »
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 …
FDA leader Stephen Hahn was pressured to aid Texas firm Direct Biologics Read More »
The big news of the week was the big FDA stem cell in court by Judge Jesus Bernal here in California, who ruled in favor of a chain of stem cell clinics called Cell Surgical Network. The FDA had been seeking an injunction against the clinics. I believe the ruling was founded in part on …
Weekly reads: CRISPR, FDA stem cell loss, pioneering AMD study, MS, Verve Therapeutics Read More »
In a ruling that could turn FDA stem cell clinic oversight on its head, Federal District Court Judge Jesus Bernal last night ruled in favor of the stem cell clinic chain Cell Surgical Network and other defendants. The FDA had been seeking permanent injunction against them. Here’s the court ruling. Drs. Mark Berman and Elliot …
Judge drops a bomb on FDA in Cell Surgical Network stem cell clinic case Read More »
Exosome therapy is a still-experimental cell therapy approach aimed at treating specific diseases using secretions from cells. It’s novel since most attention on cell therapies has been given to using the actual cells themselves. In addition, this approach is a newer idea than using cells as the drug to treat diseases. Interestingly, the term “cell …
Fact-checking exosome therapy: costs, risks, & lack of data Read More »
As I’ve mentioned recently, it’s my busy time for medical school teaching and not long ago we did a GI lab that included one of my favorite structures in the course: taste buds. Taste buds The medical students seem fascinated with taste buds too. I can tell as their professor when something is particularly interesting …
Weekly reads: taste buds, organoids, good news on CRISPR safety Read More »
Does aging do something to time so it seems like as you get older that time goes by faster? Remember as a little kid when summer seemed to last forever and car rides could be agonizingly long? I’ve heard two theories on this. One is that the brain’s baseline of activity slows down with aging …
Weekly stem cell reads: aging & cells, iPS cell mutations, gut, more Read More »
I’ve tried to find some time to do some stem cell and other regenerative medicine reading too, but it’s been a busy week of teaching for me as a professor in our new academic year for the UC Davis School of Medicine. I help to teach the Histology part of the first-year curriculum. It’s an …
Regenerative medicine reads: retraction, FDA warning, CAR-T, ARM CEO Read More »
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 »