The FDA has been busy with the COVID pandemic but it has many other things on its plate as well including cell therapies. Today I’m sharing some recent agency news and brief perspectives on it. FDA focus on clinic-related umbilical cord cell drug makers The agency warned an Idaho company that produces and sells umbilical …
FDA news: warning letter pattern, cancer moonshot, CAR-T & gene-editing guidance Read More »
Before starting the umbilical cord cell supplier and marketing firm Liveyon, John Kosolcharoen was involved in some alleged health care fraud. The feds brought a case against him related to prescription drugs. Older case coming to a head As Liveyon was having its misadventures in the stem cell clinic sphere, the status of that past …
Feds want $3M, prison for Liveyon founder in old fraud case Read More »
A new paper today in Stem Cells Translational Medicine on a small COVID-19 Phase 1/2a trial using an umbilical cord stem cell product reports a surprising degree of possible efficacy. What’s the scoop here and could there be some hype in the media about this new study such as one of the authors describing the …
Small umbilical cord stem cell COVID-19 trial: sign of efficacy? 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 »
Yesterday we learned that the FDA issued a warning letter to the cord stem cell firm, Cord for Life. In this warning, the FDA indicated that the firm’s product is actually a drug product and lacks necessary pre-market approvals. In addition, the agency highlighted apparent deviations from CGMP practices. The most important part of the …
Perspectives: FDA warns umbilical firm & continues stream of “mini-warning” letters Read More »
Magenta Therapeutics is a biotech company with a portfolio including stem cell products. Their most well known investigational drug product is an expanded umbilical cord stem cell product called MGTA-456, an “ex-Novartis” product. Magenta just released new trial data on MGTA-456, which I see as a case of good news-bad news, and investors seem to …
Magenta Therapeutics Good News-Bad News Trial Data Read More »
You probably remember Liveyon. It’s a marketer of an “umbilical cord stem cell” product that was recently recalled by the FDA. The recall was due to adverse events that may have included E. coli contamination somewhere before it was injected into patients, some of whom apparently got sick. Since it seemed like this recalled product was …
Stem cell clinic supplier Liveyon tries to regenerate itself after FDA recall Read More »
Stem cells for autism? After watching this area for many years, I’m not sure there’s any “there there”. There are logical reasons to think that certain stem cells might help many specific diseases, but in my view autism isn’t likely to be one of them. I hope I’m wrong, but today at least in 2018, …
Stem cells for autism: time to hit pause in 2018? Read More »
The FDA has issued a recall of the main stem cell product of a California firm called Liveyon that is linked to unproven stem cell clinics. The recall seems to have been due to “adverse reactions.” An emerging big player in the birth-related stem cell clinic area? I’ve been hearing the name Liveyon pop up …
FDA recalls Liveyon stem cell product: blow to big clinic supplier? Read More »
What do you get when celebrity podcaster Joe Rogan talks about stem cells? There can be big impact one way or another. I don’t believe his shows on stem cells have helped provide solid info. What do I mean? Patients can be strongly influenced by what they see on social media and YouTube videos pack …
Deconstructing Joe Rogan promotional stem cell video with Mel Gibson Read More »