The FDA has a unique mechanism called RMAT or regenerative medicine advanced therapy designation. It’s intended to move investigational regenerative therapies forward more effectively. RMAT data I recently updated The Niche RMAT list and it has jumped to 85. The FDA has approved many new RMATs this year. The data on how many applications the FDA […]
I’ve written before about Liz Parrish and her life-extension firm BioViva. Now they appear to have connections with another entity called Integrated Health Systems or IHS, according to a new Wired article. Some of what is going on with IHS and maybe BioViva in Mexico seems extremely risky to me. BioViva, Parrish, and Integrated Health Systems The
Weekly reads: BioViva & life-extension clinic, RMATs, universal cells Read More »
This post includes my updated list of firms/products that have received FDA regenerative medicine advanced therapy designation or RMAT, which are in the public domain. The numbers really jumped in the last month. I’m assuming for the purposes of this resource page that all self-reports are accurate. Note that the links embedded into the firm
FDA Regenerative Medicine Advanced Therapy RMAT designations jump to 36 Read More »
Our California stem cell agency, CIRM, started as a baby even before I came to California in 2006 to start my lab here at UC Davis School of Medicine, but now CIRM or to use its full name the California Institute for Regenerative Medicine is I’d say a full-grown, mature adult at about age 13
Poll on refunding CIRM on eve of informational legislative hearing Read More »
The year of 2018 has already been a wild one for stem cell news. There are many developments on a variety of fronts. Here are some of the most notable news bites of the last month or so. RMATs RMAT Wave. The FDA continues its warp-speed issuance of Regenerative Medicine Advanced Therapy (RMAT) designations with
Stem cell news July 2018: RMATs, RTT, MiMedx mess, clinic family ties & more 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
Updated FDA granted RMAT List (85) 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 »
In the same way perhaps that some excited relatives or parents-to-be both gush and worry about a baby before it is even born, our field has been transfixed for a week by the Mitalipov paper on CRISPR’ing human embryos even though the paper just now came out. Now that the paper is out, we can
Review of Mitalipov paper CRISPR’ing human embryos: transformative work on the edge Read More »
Can a stem cell clinic business get FDA RMAT designation? At least one announced it was trying, but now seems to have given up. Stem cell clinic business US Stem Cell, Inc. has reportedly announced that it is at least temporarily abandoning its efforts at getting Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA. The
US Stem Cell bid for FDA RMAT rejected? Read More »
Many stem cell clinics are in a bind in 2017 in the new RMAT approval reality. Stem cell clinics say that they only want to help people by providing stem cell therapies to patients in a speedier way that they claim getting FDA approval for a trial just doesn’t allow, but that doesn’t ring true.
FDA warp speed RMAT approval nukes stem cell clinic excuses Read More »