As part of its stepped up approach to unproven stem cell marketing, the FDA issued another warning letter to a perinatal (birth-related) stem cell supplier. It’s interesting to see the FDA doing more specifically about suppliers and not just focusing on clinics. It seems that in some subsectors of the stem cell arena that certain […]
FDA warns another perinatal stem cell supplier Stemell Read More »
The New York State Attorney General (AG) filed suit this week against a Manhattan stem cell clinic. It’s a landmark case. The defendants are Image Plastic Surgery, LLC, Park Avenue Stem Cell, and Joel B. Singer, M.D. The clinic markets adipose stem cell injections for a variety of health conditions. Park Avenue Stem had belonged
Why NY AG suit against Manhattan stem cell clinic is such a big deal 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 »
When the FDA has a major problem with something, it can issue a warning letter or more rarely it can file suit in court for an injunction against the particular party. The FDA has now done both of these things on different fronts with Beverly Hills stem cell clinic doctor and cosmetic surgeon, Dr. Mark Berman.
The Joint Commission apparently has given some kind of seal of approval to the unproven stem cell clinic-related firm, the Lung Institute, or as it is now often called the Lung Health Institute. For me this raises concerns about the Joint Commission itself or at least its ambulatory care accreditation program through which Lung Health
Red flag for Joint Commission for its gold seal approval to former stem cell clinic firm Read More »
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
FDA under Scott Gottlieb goes large on stem cell clinics with crackdown likely Read More »
Is fat-free always a good thing…even for unproven stem cell clinics? It must be a challenge for a stem cell clinic firm like US Stem Cell, Inc. (USRM) to face an imminent possible future where it cannot sell injections of its main product, fat stem cells, in the US. After all, “US” and “Stem Cell”
Is clinic firm US Stem Cell sued by FDA prepping for fat-free future? Read More »
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
Sizing Up Sizzling FDA Warning Letter to Fat Stem Cell Clinic Stemgenex Read More »
By Jeanne Loring Stem cells boldly go… Last week at the New York Stem Cell Foundation (NYSCF) conference at Rockefeller University in New York City, we announced our collaborative project to study the effects of microgravity on neurons derived from patient-specific induced pluripotent stem cells. The press release is here. Susan Solomon, the CEO of
Stem Cells in Space Read More »
What happens when one of the most exciting stem cell biotechs ViaCyte teams up with a firm like CRISPR Therapeutics to use a combination of gene editing and cell therapy? Hopefully a synergistic partnership emerges that in this case can develop an effective stem cell-based therapy for diabetes. You can see a press release on
ViaCyte & CRISPR Therapeutics team up to battle diabetes Read More »