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 »
A variety of states have stepped up to address unproven stem cell clinics within their borders and the latest is Vermont. According to the VTDigger and writer Anne Wallace Allen, the Vermont Medical Society is planning a number of steps to address this situation. For example, at their encouragement a Vermont lawmaker will introduce legislation
Vermont zeroes in on unproven stem cell clinics Read More »
Friday and Saturday showed a burst in FDA activity related to unproven stem cells and regenerative products including a warning letter to the unproven perinatal “stem cell” provider Liveyon. This was an unusual 48-hour period and a very good one for those who believe in science-based regenerative medicine but in my view a bad day
FDA spike: clinic supplier Liveyon warning letter & 483s; notice on exosome harms Read More »
Here in the U.S. we just had our big Thanksgiving holiday, but science goes, stem cells keep growing and needing attention, and it’s another weekend chance to catch up on our paper reading. Here’s this weekend edition of recommended reads including news items and pubs. From Cell Stem Cell: Single-Cell Transcriptome Analysis of Uniparental Embryos Reveals
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 »
The stem cell universe is populated by sometimes mysterious acronyms (see an image of a whole alphabet stem cell acronym soup), many of which refer to specific kinds of stem cells including one nebulous type called MUSE cells. MUSE cells clinical trials I’m not convinced that MUSE cells exist, but oddly there appear to be
MUSE cells are in 4 Japanese stem cell trials despite doubts Read More »
Back in May, the FDA cautioned a stem cell clinic firm called R3 Stem Cell and its leader David Greene about what they were doing. Importantly, the agency indicated that some of R3’s stem cells may be unapproved drug products. FDA and R3 Stem Cell While the FDA didn’t send R3 Stem Cell a formal warning
I’ve been concerned about a stem cell group called MD Stem Cells for many years. Now it comes under more scrutiny from a new must-read piece by Donna Young over at S&P Global. Young’s article reports a puzzling, purported right-to-try (RTT) program that MD Stem Cells appears to working on with Richard Garr. Note that
MD Stem Cells purported Right To Try program Read More »