The FDA and its CBER branch have been doing a good job overall in the last 3+ years to tackle the unproven stem cell clinic problem, but lately on the stem cells for COVID-19 front there is reason for real concern. I believe the agency is taking on major risk overall by clearing a vast number of […]
Politics & FDA OK of 2 stem cell clinic COVID-19 efforts 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 »
What is platelet-rich plasma or PRP injection cost and is it worth trying? The goal of today’s post is to fact-check PRP based on the scientific literature and educate readers including on PRP cost. What is in this article PRP is getting more popular | Is it worth it? | What exactly is PRP?
What is PRP injection cost, risks, & possible benefits Read More »
To get at addressing what’s the real deal on the idea of cellular therapies for COVID-19, I did a short email Q&A interview with Dr. Sean Morrison. Sean is Chair of the Public Policy Committee at ISSCR and Director of Children’s Research Institute at UT Southwestern. He was also President of ISSCR in 2015-2016, and
Interview with Sean Morrison on cellular therapies for COVID-19 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 »
Back in May, the FDA cautioned a stem cell clinic firm called R3 Stem Cell and its leader David Greene about what they were doing. Importantly, the agency indicated that some of R3’s stem cells may be unapproved drug products. FDA and R3 Stem Cell While the FDA didn’t send R3 Stem Cell a formal warning
We’re seeing more muddy waters in the stem cell universe. A chiropractic stem cell and alternative medicine clinic has popped up calling itself, of all things, CIRM. On another front, an already controversial docuseries set to air tomorrow combines interviews with prominent academic stem cell scientists and unproven stem cell clinic folks, muddying the waters.
Muddy waters: stem cell clinic calls itself CIRM & docuseries sparks controversy 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 »
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 »