June 1, 2020

The Niche

Knoepfler lab stem cell blog

FDA Warning Letter

2 min read

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 warning letter is the clarity it brings that, yes, allogeneic umbilical cord stem cell and other perinatal stem cell products generally are drugs requiring a cleared IND and a …Read More

4 min read

The US has been bursting at the seams with unproven stem cell clinics for years, which in my view necessitates some kind of bold action by the FDA and other governmental agencies so I’ve wondered what new FDA Commissioner Dr. Scott Gottlieb would do on this front. The lead up to and beginning of a likely crackdown A subset of these clinics are particularly risky and egregious in their behavior. While this subset constitutes may be “only” one or two hundred such clinics out …Read More

3 min read

Do the hundreds of unproven fat stem cell clinics in the U.S. like Stemgenex have a tenable future without working with the FDA? It seems less certain now in 2018 than it did in 2017, and that’s a good thing in my view. Stemgenex received an FDA warning letter yesterday that included a list of many troubling issues at the clinic. This warning letter just adds to difficult issues facing this clinic firm including a proposed class action patient lawsuit against it that that could get class …Read More

4 min read

Early in 2016, we started hearing about patient allegations of having been blinded in Florida by at least one stem cell business and several allegations seemed linked to a publicly-traded company called U.S. Stem Cell, Inc. (USRM). In turn, there have been a number of lawsuits involving USRM, including one filed just a few months ago. Some of the cases of lost vision reportedly were documented by independent physicians including Dr. Thomas Albini. In 2017, the FDA issued a warning letter to USRM’s business U.S. Stem …Read More

5 min read

A new stem cell clinic lawsuit has popped up and this one, like some others, relates to a patient alleging vision loss due to a non-FDA approved stem cell offering and involves U.S. Stem Cell, Inc. (formerly called Bioheart). American stem cell clinics market direct-to-consumer stem cell offerings for a whole medical dictionary’s worth of health conditions including vision loss. However, while stem cells have real promise for being the basis of future, safe and effective treatments for various forms of vision loss based …Read More

1 min read

The FDA continues to be very active with warning letters against makers of stem cell cosmetics even as it has been relatively dormant on stem cell clinics. You can read past posts on the long series of warning letters to manufacturers of stem cell cosmetic cream. Three new warning letters to stem cell cream makers popped up on the FDA site recently to makers Lavian Ltd, Sircuit Skin, and Annemarie Gianni Skin Care LLC. Lavian markets something called Resurgent Stem Cell Firming Activator, which the …Read More