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Big change for stem cell field with FDA quickly issuing RMATs

May 5, 2017 February 1, 2021 / By Professor Paul Knoepfler, Ph.D. / 2 Comments

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?

August 13, 2014 February 1, 2021 / By Professor Paul Knoepfler, Ph.D. / 2 Comments

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

July 9, 2012 February 1, 2021 / By Professor Paul Knoepfler, Ph.D. / 7 Comments

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

March 29, 2012 February 1, 2021 / By Professor Paul Knoepfler, Ph.D. / 3 Comments

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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Georgia AG & FTC win Superior Healthcare stem cell clinic case, seek $17 million

March 27, 2024 March 27, 2024 / By Professor Paul Knoepfler, Ph.D. / 2 Comments

STEVEN D. PEYROUX, Georgia stem cell clinic

An unproven Georgia stem cell clinic called Superior Healthcare and other co-defendants recently lost a key court case. Some of you may remember that the Attorney General (AG) of Georgia Chris Carr and the FTC have been collaborating on this case. Now we have the good news that they have won the case via a …

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Weekly reads: Alzheimer’s & lipid droplets, stem cells for COPD, fecal tx warning, med school teaching

March 24, 2024 March 23, 2024 / By Professor Paul Knoepfler, Ph.D. / Leave a Comment

So many things go wrong during the lead up to clinically-evident Alzheimer’s disease. This complex disease pathway has, in turn, led to a vast array of approaches to try to treat or prevent Alzheimer’s. Most of these efforts one way or another have something to do with the amyloid plaques and tangles that accumulate in the …

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Key Mayo Clinic stem cell webpage is overexuberant & outdated

March 21, 2024 March 30, 2024 / By Professor Paul Knoepfler, Ph.D. / 2 Comments

The Mayo Clinic does some great research on stem cells and regenerative medicine. However, at times I’ve felt that a few Mayo researchers are overexuberant. This mainly relates to certain not-yet-proven stem cell and related offerings. Fitting with that perception, the Mayo website also has some inaccurate stem cell content that leans toward overstating things. …

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Weekly reads: anti-aging tricks & treats, stealthy stem cells, Mammoth de-extinction milestone

March 10, 2024 March 9, 2024 / By Professor Paul Knoepfler, Ph.D. / 3 Comments

Anti-aging might already be the big regenerative medicine story of 2024 and it’s only early March. Anti-aging hype going to the dogs? One of my 20 stem cell and regenerative medicine predictions for 2024 was that longevity would continue to make big news including in some not-so-great ways. In just over two months there has …

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

March 3, 2024 March 2, 2024 / By Professor Paul Knoepfler, Ph.D. / 1 Comment

“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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