The stem cell clinic industry selling unapproved “therapies” is ubiquitous and yet somehow still growing it seems. Many of us are encountering more of them including via ads and the clinics are basically all over the place. What should someone do if they see or have had a bad experience with a stem cell clinic …
Clinicaltrials.gov is a wonderful resource for its many users, whether a patient searching for a clinical trial to actually participate in or someone doing research as I have done, but it’s not perfect and some sponsors have been breaking the rules regarding its use. It’s a major problem in fact. Based on new draft guidance …
FDA outlines potential crackdown on Clinicaltrials.gov offenders Read More »
What’s Australia like from the science to the country? I enjoyed the ISSCR2018 Annual Meeting in Melbourne on stem cells and regenerative medicine a few weeks back(here is a post on the some of the notable science from Day 1), but I also got a chance to get to know Australia a bit too. Below I have …
Fun pictures & 7 observations on the country from Australia trip Read More »
By Claire Horner In 2016, a law firm in California began looking for individuals who were “misled or harmed by stem cell treatment” in the southern California area (which was discussed on this blog here). While there had been other lawsuits filed by plaintiffs against individual clinics, this firm was looking to take a different …
I’ve been blogging about stem cells now for about 8 years and the recent level of hype about and fluffy media coverage of Celularity, the biotech spun out of Celgene, ranks right up here with the most extreme past cases I’ve seen. What is Celularity and who is its leadership? It’s a new biotech focused …
Just one word placentas: Can Celularity live up to hype? Read More »
Today’s post includes a list of firms/products that have self-reported that they have received FDA regenerative medicine advanced therapy designation or RMAT. Sometimes people call these “r mat” with a space. As of December 12, 2023 there are 85 RMATs in the public domain. I also include FDA data on RMAT submissions via an FDA RMAT resource …
Australian stem cell biotech Mesoblast announced that it has received regenerative medicine advanced therapy (RMAT) designation from the U.S. FDA. This is very good news for the company and an encouraging development for the field. Interestingly, last month the FDA clarified that there is expanded RMAT designation that can include gene therapies too. At the Meeting …
Mesoblast gets FDA RMAT; List of 10 total designations so far Read More »
There is a scientist’s dilemma: should you speak out on important, sometimes controversial issues in science, where you not only can potentially have positive impact, but also risk being attacked for it? Or do you remain silent? I’ve now been blogging for more than 7 years. I’ve battled the often exploitive for-profit stem cell clinics …
Scientist’s dilemma: find a public voice on big issues or stay silent? Read More »
2,000 is a big number. As of this week I’ve now published 2,000 posts here on The Niche since I started back in early 2010. I can’t quite believe it myself. To celebrate that milestone, I have revamped The Niche in terms of its organization and style with the help of a very skilled web …
The Niche’s 2,000th post: where do we go from here? Read More »
One of the blogs I’ve really valued over the years was written by a pseudonymous academic blogger called DrugMonkey, but for two months the Monkey’s blog has been silent. Has he called it a day? Dropped the mic after successfully having big impact? What’s the deal? After many years could it be that the DrugMonkey decided to …