The regular emails and phone calls I get from patients asking questions about stem cell therapy are a powerful reminder of the fact that research in our field can be very personal. Sometimes individuals who receive experimental stem cell therapy (or other cell therapies) and seem to have a positive outcome can end up becoming […]
Overplaying N=1 in the stem cell therapy world Read More »
The FDA grace period for stem cell clinics and others using regenerative medicine products like stem cells is over. It appears the agency is serious about enforcement moving forward. They have released several statements about the end of what they call the “enforcement discretion” period, which just means in English a grace period for marketers
Translating the FDA’s Q&A on end of stem cell grace period Read More »
The FDA filed two suits against unproven stem cell clinic firms in 2018 seeking permanent injunctions against them including US Stem Cell in Florida and Cell Surgical Network, et al. here in California. There’s been a major new development in this story that I see as good news. Court rejects US Stem Cell clinic appeal
US Stem Cell clinic loses appeal, could impact pending Cali case? Read More »
Ready for the latest recommended weekly reads in the world of stem cells and the regenerative medicine space including a bunch of important new FDA posts & changes? This post has quite a lot on the FDA since it had a very big week with several new items of major importance to the cellular and regenerative
Weekly reads: FDA news, goosebump stem cells, MSCs, autophagy 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 »
A Minnesota doctor running a stem cell clinic offering bone marrow injections for a variety of health conditions was subject to action by state medical regulators. The Star Tribune’s reporter Jeremy Olson has a new article on the action, which included a $13K+ fine. Olson’s piece has some of the key details: “Dr. Matthew Thorson
Reprimand, $13K fine for bone marrow stem cell clinic doc 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’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 »
When people discuss “fat stem cells” they usually mean “stromal vascular fraction” or SVF. While references to fat or adipose stem cells can sometimes mean non-SVF materials, these days adipose SVF gets the most attention. But, does anyone have a clear picture of this biologic? Fortunately, it’s starting to come more into focus in recent years
What is stromal vascular fraction or SVF? Read More »
It’s been a big week already for the stem cell field due to the court ruling against US Stem Cell Inc. and that the FDA can define stromal vascular fraction (SVF) as a drug (see my old rough sketch of how SVF is sometimes manufactured; my impression is that the company does this slightly differently).
Reactions to historic stem cell clinic court loss, new court order, & what happens next? Read More »