A Justice Department press release details how a physician’s assistant (PA) in Texas was convinced of fraud related to amniotic fluid injections. This story tells us some important things about how Medicare handles things versus the FDA approach to such things. Amniotic fluid scam A jury found Ray Anthony Shoulders, a PA at a pain […]
Man could get 240 yrs for amniotic fluid for knees Medicare scam Read More »
Placental biologics firm MiMedx and exosome company Kimera Labs both recently received FDA warning letters. The letter to MiMedx was related to its placental biologics products and procedures. The new warning to Kimera Labs was about its exosome products and an amniotic product. Let’s compare these letters starting with the one to MiMedX. MiMedx warning letter
Weekly reads: MiMedX & Kimera Labs FDA warnings, NYT on Bryan Johnson, MUSE cell trial Read More »
Can you paradoxically kill yourself early by trying to cheat Death? For example, die through risky anti-aging approaches? The question came to mind because such longevity efforts have become more extreme. They also get more hype in the media. I’ve been following the anti-aging space mainly because many interventions involve risky stem cell injections. Those
Can trying to cheat death paradoxically kill you sooner? Read More »
For about as long as I’ve been writing The Niche, people have been asking about stem cells for MS. There’s a huge need for new therapies. While a chemo-based approach with autologous hematopoietic stem cell transplantation (HSCT) looks to work for certain cases of multiple sclerosis (although not yet approved in the US), other cell
Weekly reads: stem cells for MS, good news x2, extending dog years, Neuralink updates Read More »
In today’s post, I reviewed a stem cell clinic firm called Docere Clinics. In my opinion, there are some concerning issues here and reasons for caution. One type of procedure at Docere is particularly surprising and raises risks in my view. What is Docere Clinics? | What kind of stem cells does Docere use? | What they
Review of Docere Clinics run by Harry Adelson including total-body injections Read More »
Cell therapy companies face many hurdles. I wrote recently about four cell therapy biotechs that have been really struggling. Blogging here at The Niche for more than a dozen years, I’ve seen many companies even go under. That’s bad news for the field, for patients, and for investors. Today I wanted to highlight some cell therapy
3 cell therapy companies doing well: Vertex, Vericel, & Regeneron Read More »
Paolo Macchiarini is one of a small group of people in the stem cell universe whose misconduct has blown up in the press. Piero Anversa, Haruko Obokata, Hwang Woo-Suk, and some operators in the unproven stem cell clinic sphere come to mind. Macchiarini published quite a few seriously problematic papers, some of which just hung
Weekly reads: late Macchiarini retractions, stem cells & Lululemon Read More »
Neil Riordan may be most well-known for running the Panama stem cell clinic called simply enough the Stem Cell Institute, but he also has a U.S. firm Signature Biologics. The Panama clinic sells unproven umbilical cord cells grown in a lab for a host of medical conditions. I’ve had many concerns about it over the
FDA warns Neil Riordan U.S. perinatal firm Signature Biologics Read More »
The New York Times just broke a story on Burst Biologics and Weill Cornell that fits with long-standing troubling questions about regenerative biologics producers. The story also bears on the doctors and hospitals like Weill Cornell that were or are customers of the suppliers. Further, what is the FDA’s role in all of this? The
Burst Biologics unapproved biologic used by Weill Cornell: was there a cover-up? Read More »
CRISPR gene editing has made rapid progress heading from bench to bedside. Perhaps the fastest has been its progress toward clinical use to combat sickle cell disease. We’ll start with a new paper on one major effort here. CRISPR gene editing. This process often involves cutting DNA, which then can be used as an opening to
Weekly reads: CRISPR sickle cell, Parkinson’s, pig-human chimera concerns Read More »