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 »
A firm called Utah Cord Bank has been in the news related to stem cell clinics over the past year or two. Now they have received an FDA Warning Letter for a variety of manufacturing issues. Utah Cord Bank Background In terms of some brief backstory, Utah Cord Bank first popped up on my radar …
FDA warning to stem cell clinic supplier Utah Cord Bank Read More »
The Mayo Clinic does some great research on stem cells and regenerative medicine. However, at times I’ve felt that a few Mayo researchers are overexuberant. This mainly relates to certain not-yet-proven stem cell and related offerings. Fitting with that perception, the Mayo website also has some inaccurate stem cell content that leans toward overstating things. …
Key Mayo Clinic stem cell webpage is overexuberant & outdated Read More »
How much does stem cell therapy cost in 2024? How have prices changed? To authoritatively answer these questions now we need data from the present and past along with expert perspectives. Some surprises come up in this new analysis. In this article Intro | Stem Cell Therapy Cost: $10,000-$20,000 | Why do stem cells cost so much? …
I’ve had concerns about an American unproven clinic firm called R3 Stem Cell for many years. They sell unproven stem cell-related “treatments” via dozens of affiliated locations. I put quotes around treatments because in my view there is no good evidence here for claims of treating numerous serious illnesses. The goal of today’s post is …
Fact-checking troubling R3 Stem Cell clinic chain Read More »
If there’s one area of biologics where the FDA has been consistently busy lately it’s the perinatal cell therapy space. The agency has made it clear in the last year that allogeneic birth-related cell products are often drugs requiring premarket approval. This has mainly manifested at a practical enforcement level. We’ve seen actions taken in …
End of FDA “grace period” impacted perinatal cell therapy biotechs Read More »
I am in the unique position of being a stem cell scientist who has no commercial interest in selling therapies so I can be impartial on giving patients and consumers guidance. In today’s post I give an overview of stem cell therapy and provide an expert, unbiased guide to navigating this area. This post is …
Updated patients guide to stem cell therapy for 2024 Read More »
The FDA has been busy with the COVID pandemic but it has many other things on its plate as well including cell therapies. Today I’m sharing some recent agency news and brief perspectives on it. FDA focus on clinic-related umbilical cord cell drug makers The agency warned an Idaho company that produces and sells umbilical …
FDA news: warning letter pattern, cancer moonshot, CAR-T & gene-editing guidance Read More »
For more than a year in my first job as a scientist I isolated cells from umbilical cord veins and then tossed the tissue away, never realizing there was more there that could be useful in the form of something called Wharton’s jelly. What’s in this article Umbilical cord histology & Wharton’s jelly | What …
What is Wharton’s jelly & its possible clinical uses? Read More »
Some readers suggested earlier this year that I look into a clinic firm called ‘Stem Cell Centers’ with its owner Travis Autor. I didn’t have time to do much since I’ve been very busy in the lab before the state Attorney Generals of Iowa and Nebraska sued them based on a number of allegations including …
2 State AG’s sue ‘Stem Cell Centers’ clinics including for alleged fraud Read More »