Search Results for: rmat

Big change for stem cell field with FDA quickly issuing RMATs

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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?

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Science

What kind of scientist are you and do you engage in transactional science? 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

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Transformative idea for peer review: reviewing & grading the reviewers

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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

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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: stem cell therapy for vision loss, cancer self-experimentation, Slovenia, 14-day rule

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limbal stem cell deficiency LSCD, stem cell therapy for vision loss

Is there a proven stem cell therapy for vision loss? When I started The Niche back in early 2010, one major area of hope was that there might one day be a stem cell therapy for vision loss or even blindness. Maybe even a cure for blindness. While we’re not there yet as a field,

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Unapologetic He Jiankui eager for more human germline gene editing with help from tech bros

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He Jiankui lab, He Jiankui

For a few years, biophysicist He Jiankui might have been one of the most recognizable scientists on the planet. He made three “CRISPR babies” or gene edited people. However, his gene editing went badly and as best as we can tell his efforts did not result in precision edits. It’s unclear if he had institutional

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Given their legal conflict, will Cryo-Cell & Duke still turn to donor units for kids with CP?

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Duke Cryo-Cell therapeutic misconception

The Parent’s Guide to Cord Blood Foundation recently announced that Cryo-Cell and its long-time partner, a Duke pediatric cell therapy team, have made a key change. They will begin offering infusions of unrelated, unproven cord blood to pediatric patients with cerebral palsy (CP). These are called donor infusions. Up until now, they had mainly focused

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Cryo-Cell alleges Duke acted “fraudulently” related to pediatric cord cell deal

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Cryo Cell, Cryo-Cell

Cord blood banker Cryo-Cell and Duke have had a long-running agreement. The potentially multi-million dollar deal has focused on the development of possible umbilical cord blood therapies for pediatric patients. A major first goal has been to open an infusion clinic, which I have been very skeptical about for various reasons. For instance, one big

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ISCT launches new resource on unproven cell & gene therapies

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ISCT, ISCT guide

The International Society for Cell & Gene Therapy or ISCT is a great organization in our field. They have launched a new guide to help healthcare providers navigate this complex area. Click on the image below to check it out. This new resource is important because healthcare providers, researchers, and the public need authoritative information.

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Big spike in FDA warning letters to unproven biologics firms

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Dr. Peter Marks, Director of CBER, FDA warning

This year already appears to be a record one for cell and tissue therapy-related warning letters the FDA. Directly or indirectly, these come from the FDA’s Center for Biologics Evaluation and Research or CBER. Something unusual seems to be happening. FDA’s CBER has been exceptionally active in 2024 including on cell & tissue products I’ve

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