Perinatal tissue and cells have many potential applications. While I ve mainly focused on placental, umbilical, and amniotic cell products in this area, some potential uses don t require living cells. As with just about everything, you need good data to back up any particular clinical use. That is often lacking in the broader perinatal cell and [ ] The post Weekly reads: DOJ claims $95M perinatal…
What might a state stem cell law that says FDA approval isn t needed have to do with FDA warning letters? A growing number of states have these anti-FDA stem cell laws. One of the issues with any specific such law like Florida s is that clinics and related firms in those states will use the laws [ ] The post Midweek news: another FDA warning Florida state stem cell law problems already appeared…
How well do FDA warning and untitled letters address what the agency sees as noncompliant activities by unproven stem cell clinics and supplier firms? One might think these letters work well given the implicit threat that not complying with them could lead to more severe action. For instance, the FDA can seek injunctions. Yet, that [ ] The post Weekly reads: FDA warning, Capricor pub vs. AdCom,…
They say you never forget your first international conference. They’re right. Last week, I attended ISSCR 2026 as an undergraduate student. I was admittedly nervous at the start, but by the time the end of the second day rolled around, and with it the all-attendee reception, all the ice had melted and the excitement was [ ] The post A Look Back on ISSCR 2026: the most exciting research appeared…
As I was watching the PCAC meetings late last week on popular so-called wellness or pop peptides, a neologism jumped to mind: kangaroo meeting. I almost felt like this PCAC meeting was a theatrical play. I can t decide if it was more tragedy or farce. We watched as some conflicted panel members participated and voted [ ] The post More farce or tragedy? What s ahead after RFK Jr. s PCAC kangaroo…
Why am I interested in MYC phosphorylation? What is MYC? Long-time readers of The Niche probably remember that the MYC family is one of my primary interests. These proteins are essential for normal development (and stem cell function) as well as contributing to the formation of many tumors when overexpressed or mutated. MYC was also [ ] The post Weekly reads: MYC phosphorylation, reverse protein…
So-called wellness peptides are even more in the spotlight this week as the pharmacy compounding advisory committee or PCAC launches a series of meetings to evaluate restoration of compounding of these unproven peptide drugs. This committee is supposed to take FDA staff guidance into consideration as it decides what to recommend to the agency. Typically [ ] The post Potentially highly-conflicted…
When immunology researchers talk about T cell stem cells (or stem T cells or T memory stem cells), are they talking more generally about hematopoietic stem cells? No, because those have much broader potential. The most primitive stem cell for T cells can make all the various kinds of mature T cells. It seems like [ ] The post Weekly reads: T cell stem cells, thymus as anti-aging organ, octopus…
There has been some discussion that the next-generation research on human stem cell-based embryo models (SCBEM) could someday warrant a Nobel Prize for some of those involved. At this point, however, I believe that s unlikely. How do we evaluate the worth of and reward innovative biomedical research? Let s start by talking a bit about Nobel [ ] The post Human embryo models (SCBEM) are powerful but…
Readers of The Niche will recall that I ve been skeptical of the efforts of the de-extinction firm Colossal Bio. For instance, I don t believe they de-extincted dire wolves. They did make woolly mice, maybe their fluffiest (in a real sense) achievement. The point of that apparently was to be on the road to de-extincting woolly [ ] The post Weekly reads: Colossal Bio Trump admin partnership, FDA…