FDA’s CBER fires off 3 more warning letters on cellular biologics for a total of 12 in 2024

Something seems to have dramatically changed with the FDA at its Center for Biologics Evaluation and Research or CBER. Did they start handing out free Red Bull by the case? So many recent FDA warnings on cell and tissue biologics CBER is the part of the FDA that regulates regenerative medicine products like stem cells,

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Weekly reads: Rusty Gage & stem cell awards, ASCL1, stem cells for a vulture

Rusty Gage

There should be more stem cell awards. Why not recognize more scientists and advocates? I used to do a Stem Cell Person of the Year Award. I have thought about bringing it back. What do you think? Scroll through some past posts on the Stem Cell Person of the Year Award. ISSCR gives out stem

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Given their legal conflict, will Cryo-Cell & Duke still turn to donor units for kids with CP?

Duke Cryo-Cell therapeutic misconception

The Parent’s Guide to Cord Blood Foundation recently announced that Cryo-Cell and its long-time partner, a Duke pediatric cell therapy team, have made a key change. They will begin offering infusions of unrelated, unproven cord blood to pediatric patients with cerebral palsy (CP). These are called donor infusions. Up until now, they had mainly focused

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Joe Rogan shows more love for unproven stem cells despite risks

Cellular Performance Institute, CPI Tijuana

Joe Rogan just keeps glowing about clinics offering unproven stem cells like most recently the Cellular Performance Institute in Tijuana. Often Joe talks about his own experiences getting stem cells, but other times he refers anecdotally to others who supposedly had great experiences. While it’s not unusual for some celebrities to get stem cells at

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Weekly reads: stem cell patches, helicase editing, hearing loss, Astellas, Dr. No

New research on stem cell patches is exciting. However, more broadly, “stem cell patches” can mean very different things. What I’m talking about here are the types of patches that can repair holes or other problems with tissues. This is a powerful regenerative approach. In contrast, I’m not a fan of the type of stem cell

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Cryo-Cell alleges Duke acted “fraudulently” related to pediatric cord cell deal

Cryo Cell, Cryo-Cell

Cord blood banker Cryo-Cell and Duke have had a long-running agreement. The potentially multi-million dollar deal has focused on the development of possible umbilical cord blood therapies for pediatric patients. A major first goal has been to open an infusion clinic, which I have been very skeptical about for various reasons. For instance, one big

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Beyond naming: embryo models and the importance of public dialogue

mouse embryo models, human embryo models

Who decides what to name something new in science like “human embryo models”? Also, not to get too philosophical right off the bat, but what is the point of a name? It’s about a shared understanding of what we’re talking about. But, very often, both out in the world and in the various fields of

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Weekly reads: hit pause on human life, CIRM pause, 23andMe data, blast from the past

Remember cryonics, the idea that you could hit pause on human life? This relies on the super-cold power of liquid nitrogen or some other ultra-freezing method. Apparently cryonics is still a thing and there are people with even just their heads frozen. A new story claims a different way to hit the pause button on

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Readers’ question: do stem cells for Long COVID make sense including for brain fog?

stem cells for Long COVID

Do stem cells for Long COVID make sense including for associated brain issues? Two readers of The Niche asked me this question recently. Let’s discuss it. Stem cells for Long COVID worth trying? What is Long COVID? A sizable fraction of people who get COVID-19 never fully recover. They may have symptoms like fatigue, brain

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