The FDA and its CBER branch have been doing a good job overall in the last 3+ years to tackle the unproven stem cell clinic problem, but lately on the stem cells for COVID-19 front there is reason for real concern. I believe the agency is taking on major risk overall by clearing a vast number of […]
Politics & FDA OK of 2 stem cell clinic COVID-19 efforts Read More »
I wrote last week about the Nebraska and Iowa state Attorney Generals filing lawsuits against stem cell clinic firms and three individuals also named as defendants. Although I went into detail about the individuals including leader Travis Autor and the firms, I didn’t yet go into much depth on the state lawsuits themselves in that
Q&A with Roxland on stem cell clinic suits by Iowa & Nebraska 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 »
It’s been a busy week for the cellular and regenerative medicine space for COVID-19 news with some possible ups including for Mesoblast and some definite downs. Starting with the more positive media buzz with have Mesoblast. Mesoblast made COVID19 news “Thinly traded Mesoblast Limited (NASDAQ:MESO) rockets 51% premarket on average volume in reaction to its announcement of an
COVID-19 cellular medicine buzz: Mesoblast, FTC hammer, more Read More »
When the number of stem cell clinical studies and trials listed for COVID-19 first started spiraling upward it seemed likely that stem cell clinics and other firms in that arena would get interested. I thought that we’d see the unproven regenerative medicine coronavirus bandwagon quickly grow. Unfortunately, there are reasons to be increasingly concerned here. For instance,
As clinics buzz about coronavirus, COVID19 patient given non-FDA-approved exosomes? Read More »
The FDA needs to do more about clinics and suppliers of unproven “exosome therapies.” FDA on 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
FDA needs to act boldly on unproven exosome therapies Read More »
Remember our old friends Liveyon? Their leader John Kosolcharoen? Liveyon’s continuing metamorphosis This biologics supply firm has gone through several stages of corporate metamorphosis as a supplier of biologics including at first a purported living umbilical cord stem cell product. That stem cell thrust ultimately landed a dozen or more people in the hospital as
Liveyon is back (again) with unproven exosome product Read More »
What’s Liveyon up to these days? A new, somewhat mysterious short film that serves as an advertisement for unproven exosomes has some of us scratching our heads. It seems to point to Liveyon. Can you guys as readers of The Niche help solve the puzzle of who’s behind this wild “cinematic commercial” and what the
Mystery of wild sci-fi film ad for unproven exosomes: Liveyon? 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 »