Humacyte

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

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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 …

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Big change for stem cell field with FDA quickly issuing RMATs

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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 …

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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 …

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Stem cell good news: CIRM funds new cutting edge studies

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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 …

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