The big news broke Friday that the FDA approved two new gene therapies for sickle cell disease. While the approvals were expected and the actual use of these treatments will be complex on several levels, this is a historic development. 2 FDA-approved gene therapies for sickle cell Friday’s news follows on recent UK approval for […]
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?
Stem cell therapy cost in 2024: data & analysis Read More »
Unproven stem cell clinic firm US Stem Cell and many others are apparently facing potential malpractice lawsuits. How it came to light via US Stem itself is somewhat surprising. US Stem Cell and malpractice notice The news popped up in an SEC filing by US Stem Cell, which I wasn’t even sure was still active
US Stem Cell says it & 10 others face malpractice suits Read More »
Does Medicare cover stem cell therapy? Readers of The Niche have regularly asked this question. They’re curious about insurance coverage too. The answer is “no” in almost every case, with some notable exceptions I’ll get to at the end of the post. Still, clinics appear to have already been charging Medicare for what collectively adds
I wrote recently about how political pressure on FDA Commissioner Stephen Hahn in 2020 may have helped the Texas firm Direct Biologics move their product ExoFlo forward inside the agency. Today I analyze the ExoFlo Phase I clinical trial paper used in that push on Hahn to get the firm the IND for a Phase II
Review of ExoFlo paper used to push Direct Biologics IND inside FDA finds red flags Read More »
When I’m asked about the most promising areas of stem cell clinical research, cell therapy for type I diabetes is near the top including work by a biotech called ViaCyte. Other firms are in the mix too, boosting the overall odds of success in the coming decade. It’s really that promising even though there are
ViaCyte purchase puts Vertex in driver’s seat on stem cells for diabetes Read More »
The news just keeps getting worse for Missouri state lawmaker Patricia Derges, who was indicted last year by the feds for an alleged stem cell scheme. She is now also being sued by a former patient. Derges, who is not a physician but rather an assistant physician, was providing supposed stem cell or related biological
The site Top Class Actions reports that StemGenex, a former stem cell clinic in LaJolla, CA will have to pay out big in a settlement for a class-action lawsuit alleging fraud. Who gets what in StemGenex lawsuit settlement? In the piece, StemGenex, Lead Doctor to Pay $3.65M for Fraudulent Stem Cell Therapy Scheme, we learn that
Clinic StemGenex & doc face $3.6 million class action settlement Read More »
Before starting the umbilical cord cell supplier and marketing firm Liveyon, John Kosolcharoen was involved in some alleged health care fraud. The feds brought a case against him related to prescription drugs. Older case coming to a head As Liveyon was having its misadventures in the stem cell clinic sphere, the status of that past
Feds want $3M, prison for Liveyon founder in old fraud case Read More »
As long as I’ve been writing The Niche as a professor here at UC Davis School of Medicine, people have been asking me about stem cell therapy for COPD. There is a lot of misinformation out there in this space. Let’s clear things up as to where the biomedical science stands today in late 2023
Stem cell therapy for COPD: challenges & hope Read More »