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 »
There was a time when I thought transdifferentiation based approaches might quickly move into clinical trials. Then things kind of cooled off. We didn’t see many papers reporting methods to transdifferentiate cells. I still think that this technology, sometimes called direct reprogramming, has major potential. A new paper on making human brain cells this way got
Paper sparks renewed interest in transdifferentiation & clinical potential 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 »
A clinic called DVC Stem selling unproven stem cells has popped up prominently on the web recently. It’s a relatively new and in some ways puzzlingly dominant presence on the stem cell section of the Internet. We should pay attention to these kinds of changes on the web. They can impact many people’s healthcare choices,
Review of DVC Stem & marketing of unproven therapies Read More »
There are so many stem cell clinics out there that it can be hard to keep track of them and the news about them, but a big court victory against a Manhattan stem cell clinic by New York State Attorney General Letitia James is notable for several reasons. Injunction on Park Avenue Stem Cell clinic
New York wins $5.1 million in suit against Manhattan stem cell clinic Read More »
If you celebrate the Thanksgiving holiday I hope you had a nice one and, right before it started a new article popped on the scene about the CRISPR babies. Before we discuss those three gene-edited people, who are now growing up into little kids, we hit a milestone on our YouTube Stem Cell Channel with
Regenerative reads: 3 CRISPR babies, FDA warning, diabetes, pubs 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 »