Many are jumping on the bandwagon of trying stem cells for COVID-19 or testing other cellular therapies for the novel coronavirus disease, but there have been problems with either the rationales for the trials themselves or more often with how they portrayed. Sometimes there has even been outright hype. I’ve called this collective trend of […]
Overselling stem cells for COVID-19: WSJ article & UMN PR Read More »
The term Regenerative Medicine covers so much biomedical science these days including everything from just about any kind of cell therapy (not just stem cells) to CRISPR gene editing, and with the the COVID-19 pandemic, it seems this umbrella use of the term now includes potential treatment of viral illnesses. It can be hard to
Update on stem cells for COVID-19, Surgisphere scandal Read More »
Meet The Screamers. After being a scientist in one form or another for 30 years and blogging about stem cells and other science for more than 10 years, I’ve seen a lot of science hype. However, some science hype goes above and beyond the usual level to outright smack readers in the face. It almost
Meet The Screamers Science Hype Awards Read More »
The idea of testing stem cells for COVID-19 may be music to the ears of some folks as an opportunity, but to me from the beginning it sounded mostly like a spaghetti on the wall road to trouble. There is buzz out there that some kind of stem cells or other cells will help with
Field throws stem cells for COVID-19 like spaghetti on the wall Read More »
Friday and Saturday showed a burst in FDA activity related to unproven stem cells and regenerative products including a warning letter to the unproven perinatal “stem cell” provider Liveyon. This was an unusual 48-hour period and a very good one for those who believe in science-based regenerative medicine but in my view a bad day
FDA spike: clinic supplier Liveyon warning letter & 483s; notice on exosome harms Read More »
This post includes my updated list of firms/products that have received FDA regenerative medicine advanced therapy designation or RMAT, which are in the public domain. The numbers really jumped in the last month. I’m assuming for the purposes of this resource page that all self-reports are accurate. Note that the links embedded into the firm
FDA Regenerative Medicine Advanced Therapy RMAT designations jump to 36 Read More »
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.