Search Results for: 21st century cures

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 »

President Mills Leaving, CIRM Needs New Leader to Navigate Future Challenges

Randy-Mills

CIRM announced today that its President and CEO, Randy Mills, is soon leaving for a new job as President of the National Marrow Donor Program/Be The Match in Minnesota. Update: Dr. Maria Millan, the CIRM Vice President of Therapeutics, will be its leader starting July 1 until a new leader is chosen. For this kind of …

President Mills Leaving, CIRM Needs New Leader to Navigate Future Challenges 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 »

How Scott Gottlieb may transform the FDA’s approach to stem cells

Dr.-Scott-Gottlieb

The Trump FDA commissioner nominee Dr. Scott Gottlieb could dramatically alter how the agency regulates investigational stem cell therapies. How might such changes unfold? There are potential upsides and downsides to  the seismic shift that could be in the offing. Gottlieb has written in the past about his perception of FDA over-regulation of stem cells such …

How Scott Gottlieb may transform the FDA’s approach to stem cells Read More »

A nation of stem cell miracles? CNN puff piece on clinic patient & Trump blows it

Celltex

Would you believe in a stem cell miracle? Sometimes the mainstream media stumbles in its coverage of the stem cell world and a recent CNN puff piece on a patient of stem cell clinic Celltex is a prime example of just how extreme this can get. The CNN piece focuses on a Celltex patient who self-reports perceived …

A nation of stem cell miracles? CNN puff piece on clinic patient & Trump blows it Read More »

Good stem cell news on trials, FDA, cool new papers & more

Pericyte-paper

In the whirlwind that is the stem cell and regenerative medicine world, there are many concerning things that need attention, but also good stuff happens too and this post focuses on the positive. The Asterias spinal cord injury clinical trial, a phase 1/2a trial called SCiStar, continues to make encouraging news with a clean safety profile …

Good stem cell news on trials, FDA, cool new papers & more Read More »

Top stem cell & regenerative medicine headlines of the week

Some stem cell news headlines from the past week for you folks. Neuroscience: New nerves for old. Fixing stuff like strokes and paralysis. Cambridge’s Gurdon Institute and Stem Cell Institute receive five-year funding boost. Money flow to stem cells FDA “talks” stem cells in NEJM, “Clarifying Stem-Cell Therapy’s Benefits and Risks”, published on same day that 21st Century …

Top stem cell & regenerative medicine headlines of the week Read More »