Search Results for: rmat

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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Is transactional science kicking transformative science’s butt?

Science

What kind of scientist are you? I suspect that all of us scientists like to think that most of the work that we do is transformative and that we are a transformative scientist. In science we hear quite a lot about the importance of transformative, innovative science. But can everyone be doing transformative science all the …

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Transformative idea for peer review: reviewing & grading the reviewers

Do you feel frustrated with the current peer review system in science? I have an idea that might help and it involves the revolutionary idea of reviewer accountability. In other words, authors and grant writers in essence review their reviewers. I’ve made this all the easier for you with templates that you can simply and …

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Dr Lookgood, dermatologist to the stars, gets FDA warning letter

Dr-LookGood1

If you ever had a really bad day, March 13, 2012 might have been just such a bad day for one Dr. Steven Victor, aka “Dr LookGood”, because he received an official warning letter from the FDA. Why? Dr. Victor, who reportedly greets each patient with the catch phrase “You look so much more beautiful than your picture”, is …

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Weekly reads: Vertex, stem cells for MS, Athersys, 900-day paper review at Nature

“While still early, these results support the continued progression of our VX-880 clinical studies, as well as future studies using our encapsulated islet cells, which hold the potential to be used without the need for immunosuppression,” said Bastiano Sanna, Ph.D., executive vice president and chief of cell and genetic therapies at Vertex.

Vertex Pharmaceuticals has a lot going for it right now on the cell therapy front. For instance, they have the strongest type 1 diabetes cell therapy pipeline after some recent acquisitions. Still it’s not a simple matter to succeed in the cell therapy space even with one therapy for one targeted disease. Trials are tough …

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Weekly reads: AL embryos ruling, blasting cancer, marrow organoids, beef inside rice plants

Multipotent & totipotent vs pluripotent stem cells, very early human embryos totipotent stem cells

Are small clusters of cells that make up 5-day-old human embryos equivalent to children? Biologically and in terms of just common sense, the answer is “no.” These tiny spheres have around 100 cells and no organs. Actual people have many trillions of cells, brains, and other organs. Alabama law on embryos may block IVF About …

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The zoo that is stem cells on Reddit

crazy carnival, stem cells on Reddit

Can you learn important things about stem cells on Reddit? Yes, you can, but it’s a wild experience at times. Researchers may often think about stem cells through the lens of traditional routes of communication like academic journals, but laypeople turn elsewhere to learn about regenerative medicine. This includes digging into stem cells on Reddit. …

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Weekly reads: brain aging, perinatal stem cell clinics, $1M lab meat fine bill

brain aging

What happens during brain aging and how can we tell if dementia is coming? Are there particular early hallmarks? There are an increasing number of medical tests for predicting or detecting dementia. Alzheimer’s disease can often be detected early. But what do patients or their doctors do with such information? Until recently there weren’t any …

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Weekly reads: cool olfactory tuft cells, T-cell therapy, NK cells

Olfactory epithelium, Olfactory histology

There’s a fascinating type of olfactory cell. These so-called tuft cells have unusual characteristics, especially for nose cells. I had never heard of them before until reading a new article. The inside of the nose may not seem like a very attractive place but there are cool “nose stem cells” in there.  More broadly, there …

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Weekly reads: MiMedX & Kimera Labs FDA warnings, NYT on Bryan Johnson, MUSE cell trial

AXIOFILL, MiMedx

Placental biologics firm MiMedx and exosome company Kimera Labs both recently received FDA warning letters. The letter to MiMedx was related to its placental biologics products and procedures. The new warning to Kimera Labs was about its exosome products and an amniotic product. Let’s compare these letters starting with the one to MiMedX. MiMedx warning letter …

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