It was a couple of years back that researcher He Jiankui claimed he made three “CRISPR babies.” No one would think about doing any kind of rogue gene-editing again, right? Not even somatic gene edits. After all, as far as we know he’s in jail. We still don’t know the health risks that these three […]
Ukraine clinic plans to sell CRISPR enhancements: hair color, skin, & breast size Read More »
Each year I metaphorically try to look into a crystal ball for stem cell predictions for the coming year and I did so for 2020, but the COVID-19 pandemic threw a monkey wrench into my predictions. It actually kind of blew some up. It also raised some interesting questions and dilemmas. For instance, do many
Grading my 20 stem cell predictions for 2020 Read More »
Stem cell clinics and suppliers have been getting into the business of making promotional films to generate more revenue, but now there’s something very different in the cinematic stem cell arena called From Jail Cell to Stem Cell by filmmaker Doug Orchard. It is at its heart an exposé film about some in my view particularly concerning stem
Review of clinic exposé film From Jail Cell to Stem Cell Read More »
The FDA dropped a lengthy, extremely critical warning letter on a supplier of unproven exosome product called EUCYT Laboratories. For broader context, exosome therapy has somehow burst onto the scene when there’s no good data yet in my view to back up its use in the clinic. The FDA is taking notice with letters already sent
Getting 30 F grades? FDA Strongly Warns Exosome Firm EUCYT Read More »
The FDA has stem cell clinics squarely on its radar screen now and it’s pulling the trigger with many letters going out to this problematic industry. In the past, sometimes years went by with no letters at all or one letter in total to stem cell clinics so this marks a major shift. Background on
Historic spring storm of FDA letters to stem cell clinic industry Read More »
The FDA needs to do more about clinics and suppliers of unproven “exosome therapies.” Dubious exosomes are sadly just the newest gimmick for some firms in the stem cell/regenerative medicine clinic arena right now. They are available at many stem cell and other clinics right now, but who knows what’s in the syringe? Also, people
FDA needs to act boldly on unproven exosome therapies Read More »
Every year in December and early January I do a post predicting some key events for the stem cell and regenerative medicine field for the upcoming year and today’s post contains my predictions for 2020. You can see my past 2019 predictions along with my grades for them here. I gave myself a B+ for
20/20 vision? The Niche’s 20 stem cell & regenerative medicine predictions for 2020 Read More »
Last year around this time I took my annual plunge to make 20 predictions for the coming year for the stem cell and regenerative medicine field. I even made a crystal ball graphic to highlight the complexity of the stem cell ecosystem into which these predictions were embedded (see image) for 2019. How’d I do?
B+ on my report card on my 20 stem cell predictions for 2019 Read More »
The FDA just sent another untitled letter to a producer of a potentially non-compliant perinatal “stem cell” product that may be an unapproved drug. This follows past non-warning letters and/or inspection reports made public to Liveyon, R3 Stem Cell, Stemell, and others. RAPS has more on the story of the new letter here. This newest
Another FDA letter to a stem cell clinic supplier: what’s the agency’s long game? Read More »
I finished listening to the first 6 episodes of the Bad Batch podcast last week. The series is by medical journalist Laura Beil. I think there will be a 7th episode that’s a Q&A. I highly recommend listening to the series even if parts are wrenching at times like how much patients and families have
Bad Batch podcast’s dark picture of perinatal stem cell industry Read More »