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 stem cell reads: HSCT, old embryo models, aging stem cells

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stem cell

What is a stem cell therapy? Does it have to include stem cells put into the body? Would you include a therapy that uses differentiated cells made from stem cells? I generally do use the term in that broader way. A similar question comes to mind: what is regenerative medicine? Should it include both cell

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QC Kinetix review: concerns on huge regenerative clinic chain

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Tyler Vail, QC Kinetix

QC Kinetix is a relatively new regenerative clinic brand in the U.S. selling unproven cell therapies. I see several specific red flags including a class action lawsuit. They report having 150+ locations, making it potentially the largest chain of unproven clinics in the U.S. Collectively, these clinics could be seeing tens of thousands of customers.

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Weekly reads: Scott Gottlieb v. RFK Jr., DNA typewriters, Arnold Caplan

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Peter-Marks-Scott-Gottlieb-FDA

Remember former Trump’s FDA Commissioner Scott Gottlieb? Gottlieb’s back in the news in an interesting way related to the upcoming second Trump administration. I just wrote about what to expect from new FDA Commissioner nominee Marty Makary. In that piece, I noted that Scott Gottlieb first came to lead the FDA after a record of

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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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