Retinitis Pigmentosa stem cells

Groundbreaking Organoid Vision Clinical Study: Takahashi Q&A

Mandai-et-al-Stem-Cell-Reports-2017

Clinical trials using organoids are still rare and a Clinicaltrials.gov search for such organoid work largely brings up in vitro studies. A new clinical study in Japan where organoid material will actually be transplanted into patients is causing a lot of excitement. Masayo Takahashi (高橋 政代) is a pioneer in stem cell-based clinical trial work …

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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

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 …

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