umbilical cord stem cells

FDA news: warning letter pattern, cancer moonshot, CAR-T & gene-editing guidance

/ / Leave a Comment
FDA

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 »

Feds want $3M, prison for Liveyon founder in old fraud case

/ / Leave a Comment
John Kosolcharoen, Liveyon

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 »

Why did clinic supplier Liveyon halt sales but others kept going despite FDA?

/ / 1 Comment
Liveyon-reincarnated

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 »

Perspectives: FDA warns umbilical firm & continues stream of “mini-warning” letters

/ / 1 Comment
umbilical-cord-blood, umbilical cord blood stem cells

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 Good News-Bad News Trial Data

/ / 2 Comments
Magenta

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 »

Stem cell clinic supplier Liveyon tries to regenerate itself after FDA recall

/ / 33 Comments
Liveyon-reincarnated

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 »

Subscribe to Our Newsletter

Be the first to know about the latest developments in stem cell and regenerative medicine research.