A days ago the news came about Mesoblast not getting FDA approval for its MSC product for GvHD. The MSC area has had a rough few years with various clinical trials including for COVID. The “stem cells for heart disease” arena has also had a tough time. Here’s more news along these lines: BioCardia pauses enrollment in PhIII trial […]
Weekly reads: BioCardia, HeLa suit, illegal bio lab in CA 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 »
Almost two years ago I publicly called on the FDA to freeze the unproven cord cell expanded access program (EAP) at the Duke Autism Center. Duke has been infusing kids with autism spectrum disorder (ASD) with unproven cord cells and requiring large payments for this. The cost was as much as $15,000. A halt and a
Why did Duke autism team halt its troubling pay-for-play program? Read More »
Are there any guidelines for genomics studies of famous dead people like sequencing their genomes? It doesn’t seem like it. I remember when I first heard of the idea of trying to clone John Lennon from an old molar. Fortunately, as far as I know no one ever tried that, but it wouldn’t surprise me if
Pros & cons of dead celebrity genomics Read More »
A team led by Harvard professor David Sinclair had a recent Cell paper on reprogramming to fight aging that I reviewed here on The Niche. I thought the paper was exciting and important. Note that in vivo reprogramming was first done more than a decade ago. Sinclair did have a novel fast-forward aging method and overall
Weekly reads: oocytes from males, David Sinclair longevity inc, diabetes, He Jiankui Read More »
I usually associate NPR with solid journalism so I was scratching my head about a recent puff piece by WHYY on stem cell microneedling. Is this journalism or product promotion? The NPR piece by Maiken Scott doesn’t ask important questions. Scott received stem cell microneedling herself using a product from a company called AnteAGE. How
WHYY oh WHYY: NPR puff piece on risky stem cell microneedling 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
It’s that time of year again when I grade my previous year’s predictions for the stem cell & regenerative medicine space. Overall, I did better than a typical year. I give the 2022 predictions an A- overall. This exercise can be kind of fun but also humbling. For example, I tend to be too optimistic
Grading my 2022 regenerative medicine predictions Read More »
Earlier this year Chinese researcher He Jiankui finished his prison sentence. When I saw that news I wondered about the next chapter for him. It seems he’s already back in the lab doing genetics research. At least that’s according to a blog by He Jiankui himself. Can we trust that what he has written on his website is
He Jiankui says he’s back in the lab after prison for CRISPR babies Read More »
An FDA FOIA dump of text messages of former Commissioner Stephen Hahn suggests that a Texas regenerative firm called Direct Biologics benefited from political pressure on him in mid-2020. Then he was asked again to help in early 2021. This was shortly before he resigned at the start of the Biden Administration. The push came from
FDA leader Stephen Hahn was pressured to aid Texas firm Direct Biologics Read More »