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. I also include FDA data on RMAT submissions via an FDA RMAT resource page. At this point as of May 2025, I have found
Updated FDA granted RMAT List (130) Read More »
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
Did blogger DrugMonkey drop the mic? Read More »
Two physicians are central to something called the SCOTS trial, Dr. Jeffrey Weiss and Steven Levy. Patients have claimed negative outcomes after participating in the trial. What’s going on here? SCOTS trial The recent NEJM paper reporting on the blinding of three patients in Florida may be just the beginning. More information has come out on negative
Dr. Jeffrey Weiss, SCOTS trial, & Patient Claims of Blindness Read More »
The FDA issued a warning letter not long ago to Amniotic Therapies, LLC, a supplier of amniotic products including to one or more stem cell clinics, but now a federal judge in Texas has reportedly mostly blocked the FDA action in terms of the shutdown. The law firm representing Amniotic also issued a PR about the
Federal judge blocks FDA action on Texas amniotic supplier Read More »