The Niche - Stem Cell Blog & Resources
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The Niche is the top, most authoritative stem cell and regenerative medicine blog on the web and the only one to our knowledge written by a professor. Source
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| Scope | National |
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| Language | English |
| Country | United States of America |
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Recent Articles
Search ArticlesCelebrating 20 years of iPS cells with a $200 contest
I have to admit to loving just about everything related to iPS cells. If you love them or other pluripotent stem cells enough, you might win $200. Maybe the clearest sign of my focus on iPS cells is this website’s URL, ipscell.com. In a way, it’s hard to believe it was 20 years ago that Shinya Yamanaka first reported reprogramming to make iPS cells. That paper was on mouse iPS cells. A human iPS cell paper quickly followed in 2007 from his team and other labs followed suit.
Weekly reads: aging clocks under the gun, more on R3 Stem warning, Capricor update, FDA perinatal tissue setback
Depending on who you ask, aging clocks might be the best thing since sliced bread or still relatively imprecise tools that aren’t ready for prime time use for healthcare of any kind. I fall somewhere in the middle. These clocks are getting better and they provide some predictive value, but probably much less than the hype surrounding them suggests. A new piece goes through some recent research and perspectives on the clocks. Aging clocks can’t tell time that well yet? Knoepfler pic.
Key FDA victory on stem cell clinics: permanent injunction against Cell Surgical Network, et al.
After many years bouncing around the courts, today the FDA finally prevailed in getting a permanent injunction against a chain of stem cell clinics, Cell Surgical Network, and its flagship clinic California Stem Cell Treatment Center as well as its remaining leader, Dr. Elliot Lander on use of an adipose cell preparation. Drs. Elliot Lander and Mark Berman of Cell Surgical Network. Sadly, Dr. Berman died while this court case was still unresolved.
Big implications for clinic arena from FDA warning to R3 Stem Cell, David Greene, & associated firms
I’ve followed a stem cell clinic firm called R3 Stem Cell for years and have had concerns about its practices. There are many R3 Stem Cell clinics both inside and outside the US. In my opinion, at times they seemed to be marketing unproven regenerative cell offerings. Based on past FDA actions and statements, some of these offerings could be classified as drugs by the FDA. Further, I’m not aware of the firm having drug-level approval from the FDA.
Weekly reads: Heidi Overton FDA commish nominee, NASA stem cells, aged brain organoids, cautious Nature iPS cell editorial
The question of the week might be: who is Heidi Overton? I’ve been wondering who the new FDA commissioner might be for months. Marty Makary, Vinay Prasad, and Tracy Hoeg all left in the spring. There’s a big leadership vacuum at the agency. Heidi Overton speaking at a meeting. FDA commissioner nomination soon? White House policy official and physician-scientist Heidi Overton has emerged as the top candidate to lead the FDA. Overton got the nomination this week.
Article on longevity & David Sinclair provides new insights but has issues
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 on unproven approaches to boost longevity too. For me, as someone advocating for science-based medicine, it all seems too much.
Weekly reads: DOJ claims $95M perinatal tissue fraud, 6-year peptide prison term, ALS patient story, worrisome MRT clinics
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 tissue space. It’s a true wild west. Amniotic tissue as part of the greater placental complex. Gray’s Anatomy.
Midweek news: another FDA warning & Florida state stem cell law problems already
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 as cover. What do I mean? The only FDA warning letter to a firm in that state since Florida state stem cell law was enacted?
Weekly reads: FDA warning, Capricor pub vs. AdCom, stem cells can count, hydra regeneration
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 next big possible step almost never happens.
A Look Back on ISSCR 2026: the most exciting research
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 palpable. A Look Back on ISSCR 2026. Enough preamble. Let’s get into some of the topics discussed at the meeting.