The Niche

I’ve been debating whether to unfollow longevity enthusiasts David Sinclair and Bryan Johnson on X. I find their posts about various anti-aging efforts to be fascinating on one level but also very unsettling. For one thing, some posts seem close to medical advice to the public, yet neither is a physician. The statements often focus […] The post Article on longevity & David Sinclair provides new i…

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, s…

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 f…

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 m…

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 bu…

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…

Will using AI in biology be revolutionary? If you’re a scientist, how often do you use Chat GPT or similar AI for your biomedical research? For writing? Are you more annoyed or enthralled with how AI might impact biology and the daily work of biologists? In the middle? Whatever your answers, Anthropic is hoping that […] The post Weekly reads: Claude Science AI in biology & scientist obsolescence,…

Recently, I predicted that RFK Jr. may stack the key pharmacy compounding committee, called PCAC, with fans of unproven peptides. Kennedy wants the unproven “pop peptides”, as I call them, to be unleashed. If the PCAC advises allowing pop peptide compounding, it gives Kennedy more leverage to overrule FDA scientists. You might recall there are […] The post RFK Jr. fills key ad com PCAC with regen…

The last eighteen months have been an unprecedented time of unpredictability for the FDA, but moving forward we’re likely going to see an emerging consistency: a higher amount of FDA flexibility on rare diseases. It’s already begun and is likely to accelerate with Prasad and Makary gone. How is this manifesting? FDA flexes flexibility I […] The post Weekly reads: more FDA flexibility on rare dise…

Are stem cells for autism promising? The answer so far is a clear “no”. Even a Duke team that was for a time very upbeat about the potential of umbilical cord cell therapy for autism seems to have lost that enthusiasm. For example, they stopped their EAP of cord cells for autism. I also don’t […] The post RFK Jr. , stem cells for autism, & more clinics including one selling sheep cell injections …

I’ve been following the Huntington’s disease space carefully for about 15 years. I always hoped that some kind of promising gene therapy might emerge. Stem cell therapies or combination cell-gene therapies could have promise for Huntington’s too. Over the years, I got to know Judy Roberson, a wonderful HD patient advocate. I’m going to start […] The post Weekly reads: FDA reversal on Huntington’s…

I’ve often wondered why there hasn’t been more research on macrophage therapy. Macrophages are some of the coolest cells in the body. They are capable of not just eating other cells (hence their name), but also numerous other functions. Before we dive into that, below is the latest stem cell video from my collaboration with […] The post Weekly reads: macrophage therapy, Putin longevity push, huma…

One of the questions I get asked most often about pop peptides is why they are so popular. What puts the “pop” in pop peptides? Peptide mania After all, these peptides like Ipamorelin, BPC-157, and so on don’t have clinical trial data to support the uses for which they are being marketed. That makes them […] The post The FDA & compounding pharmacy telehealth connections on pop peptides appeared f…

If you take a statin to improve your lipid profile, someday could you undergo LDL gene editing instead? Might that day be sooner than we think? A new paper has generated great interest in this topic including in the media. LDL gene editing For example, we have: One-and-Done Heart Disease Prevention? Scientists Show It May […] The post Weekly reads: effective LDL gene editing, Chinese genetics gui…

I’ve been following Altos Labs since its inception. The institution has intriguing, ambitious goals. For that reason, it’s been interesting that in terms of news on Altos, things have been relatively quiet for the last 4+ years. Some big changes have happened recently though. Altos Labs is high on talent, but nicely low-key on PR […] The post Did Altos Labs just reprogram itself to focus on AI? P…