Last year around this time I presented my first stem cell awards of the year, in that case for 2010. You can see whom I thought deserved awards here. Now it is time for our 2011 stem cell awards. These awards reflect my opinions and those not mentioned will hopefully forgive me as there is […]
Stem Cell Awards for 2011 Read More »
Each year at this time I start thinking about what the next year will bring for the stem cell field and make predictions. This year is no different and I’ve been pondering what 2012 has in store for us. You can read my predictions for 2011 here and see how I fared. Not too bad, but overly optimistic
Stem cell predictions for 2012: Science, CIRM, ACT, trends Read More »
This past week was a wacky and wild one for the stem cell field. All kinds of crazy things happened all in one week. What does it all mean? Stem cells the new steroids for sports? Reports surface this week that NY Yankees pitcher Bartolo Colon, had received a non-FDA approved stem cell treatment for
A crazy week for stem cells: what the heck does it all mean? Read More »
Umbilical “stem cell” supplier Liveyon has suspended sales of its products according to the WaPo after a harsh FDA warning letter. While not fully shutting off the tap to the perinatal stem cell clinic universe, as other suppliers including in Utah seem to be continuing, this Liveyon voluntary hold will equal a major reduction in
Why did clinic supplier Liveyon halt sales but others kept going despite FDA? Read More »
If a picture is worth a thousand words, how about a Facebook video from a stem cell clinic? In my view it sure tells a story with some unusual twists. I wrote last week about this Facebook video by Kristin Comella, the leader of the publicly-traded stem cell clinic firm US Stem Cell, Inc. (USRM). As
Up your nose? OMG Facebook video moments from clinic sued by DOJ Read More »
A few dozen clinics in the US sell an unproven RNA therapy called supportive oligonucleotide therapy or SOT. The product comes from a Greek firm RGCC or Research Genetic Cancer Center, which also pre-tests patients’ gene expression to design the RNA product. Clinics marketing SOT in the US say it is intended to act by
Readers of The Niche have asked me many questions about stem cells for autoimmune disease but the puzzle of why women get these conditions more often than men hasn’t come up before here. For instance, why is MS so much more common in women than men? It’s remained somewhat of a mystery over the years.
Let’s start this week’s digest with a discussion of clonal expansion and mutations during cell and gene therapy development. Here’s the article that brought this to mind. Sickle cell gene therapy process may cause cancer-linked mutations in blood stem cells, Fierce Biotech. Clonal expansion This is a story about a non-CRISPR gene therapy using a
The New York Times just broke a story on Burst Biologics and Weill Cornell that fits with long-standing troubling questions about regenerative biologics producers. The story also bears on the doctors and hospitals like Weill Cornell that were or are customers of the suppliers. Further, what is the FDA’s role in all of this? The
Burst Biologics unapproved biologic used by Weill Cornell: was there a cover-up? Read More »
The FDA seems oddly slow in oversight of unproven stem cell clinic-related firms like one here in California called Invitrx Therapeutics. I’ve written before about Invitrx, but interactions between them and the FDA have continued including a new warning letter. It’s become a puzzling situation. More broadly, the FDA has done relatively little in the past
3rd Invitrx warning highlights FDA oversight weakness Read More »