Search Results for: humacyte

24 cell therapy & stem cell stocks I’m following

stem cell stocks

Stem cell stocks, meaning cellular therapy biotech companies, face many challenges, but their clinical research is crucial. These biotechs have ups and downs, sometimes at the same time. This is kind of the standard of “life” as any biotech company. It is definitely the case in the volatile stem cell and cell therapy arena. Today …

24 cell therapy & stem cell stocks I’m following Read More »

FDA Regenerative Medicine Advanced Therapy RMAT designations jump to 36

Peter-Marks-Regenerative-Medicine-Advanced-Therapy-Designation-RMAT-

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 »

RMAT List (51)

FDA-RMAT

Here is a list of firms/products that have self-reported that they have received FDA regenerative medicine advanced therapy designation or RMAT. I’m assuming for the purposes of this resource page that all self-reports are accurate. Note that the links embedded into the firm names are to relevant press releases. A special thanks to some folks …

RMAT List (51) Read More »

Mesoblast gets FDA RMAT; List of 10 total designations so far

Mesoblast-e1514313188176

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 »

Big change for stem cell field with FDA quickly issuing RMATs

Humacyte-e1493998220584

The 21st Century Cures Act has some important regenerative medicine language in it. One part of that was attempting to accelerate FDA review of promising investigation regenerative medicine therapies. The mechanism for this was a new designation called Regenerative Advanced Therapy, now renamed Regenerative Medicine Advanced Therapy (RMAT) Designation. I don’t think anyone was sure …

Big change for stem cell field with FDA quickly issuing RMATs Read More »

Wouldn’t you like to be a RAT too? Stem cell clinics apply for new FDA accelerated approval path

RAT-RMAT-designation

Are stem cell clinics going to somehow get the FDA to approve their stem cell interventions? To get recognized as legit? It seems they are trying now more than ever. Remember the REGROW Act that would have greatly reduced regulations on investigational stem cells and then how the 21st Century Cures Act passed with some …

Wouldn’t you like to be a RAT too? Stem cell clinics apply for new FDA accelerated approval path Read More »

Stem cell good news: CIRM funds new cutting edge studies

VC-01-post-implant-final1-e1503703572933

CIRM announced recently the funding of a number of exciting new studies. ViaCyte received additional funding to support its development of its hESC-based pancreatic progenitor cell product PEC-Direct clinic trials. This work is very promising. CIRM also funded additional diabetes-related research by Humacyte on engineering blood vessels for use in dialysis, which is very creative. I …

Stem cell good news: CIRM funds new cutting edge studies Read More »