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FDA Regenerative Medicine Advanced Therapy RMAT designations jump to 36

September 24, 2019 / Professor Paul Knoepfler, Ph.D. / 2 Comments

Peter-Marks-Regenerative-Medicine-Advanced-Therapy-Designation-RMAT-

This post includes my updated list of firms/products that have received FDA regenerative medicine advanced therapy designation or RMAT, which are in the public domain. The numbers really jumped in the last month. I’m assuming for the purposes of this resource page that all self-reports are accurate. Note that the links embedded into the firm […]

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Magenta Therapeutics Good News-Bad News Trial Data

November 4, 2018 / Professor Paul Knoepfler, Ph.D. / 2 Comments

Magenta Therapeutics is a biotech company with a portfolio including stem cell products. Their most well known investigational drug product is an expanded umbilical cord stem cell product called MGTA-456, an “ex-Novartis” product. Magenta just released new trial data on MGTA-456, which I see as a case of good news-bad news, and investors seem to

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Mulling over latest CRISPR tumult, this one from Nat Biot pub on DNA lesions

July 17, 2018 / Professor Paul Knoepfler, Ph.D. / 4 Comments

If it seems to you like dramatic cautionary tales about CRISPR accompanied by all sorts of media are coming at us more frequently, it’s not your imagination. In the latest yesterday, it was reported in a new paper led by Allan Bradley that CRISPR-Cas9 results in sometimes large-scale chromosomal lesions at or even away from the

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Updated FDA granted RMAT List (85)

January 10, 2018 / Professor Paul Knoepfler, Ph.D.

Today’s post includes a list of firms/products that have self-reported that they have received FDA regenerative medicine advanced therapy designation or RMAT. Sometimes people call these “r mat” with a space. As of December 12, 2023 there are 85 RMATs in the public domain. I also include FDA data on RMAT submissions via an FDA RMAT resource

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7 tech hurdles to human germline CRISPR

November 6, 2017 / Professor Paul Knoepfler, Ph.D.

Human germline CRISPR raises major bioethical considerations, but what about technical issues? Setting aside the many ethical issue about the general idea of human modification itself, could this really work? Yes in theory it could, but there are some very tough technological challenges that could and likely would cause failures or unacceptable outcomes at many steps

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DNA Ahead Game & More Struts Its Stuff

October 11, 2016 / Professor Paul Knoepfler, Ph.D. / 1 Comment

Editor’s note: this is a guest post from Dr. Semenow on her new educational DNA game that also invokes stem cells. She has the remarkable distinction of having been the first woman who was a science Ph.D. student at Caltech. Stay tuned for my coming interview with her on her experiences in science. Her Kickstarter campaign

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Interview with Fredrik Lanner who is CRISPR’ing healthy human embryos

September 26, 2016 / Professor Paul Knoepfler, Ph.D. / 2 Comments

ssistant-Professor-Fredrik-Lanner--e1474733944943

In the past year there has been a great deal of attention given to the potential use of CRISPR-Cas9 for gene editing in human embryos. An important recent development, described in a new NPR article by Rob Stein, is the use of CRISPR-Cas9 in healthy human embryos for developmental biology research by assistant professor Fredrik

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Gaetan Burgio New Data & Theory on NgAgo versus CRISPR

July 31, 2016 / Professor Paul Knoepfler, Ph.D. / 3 Comments

By Gaetan Burgio CRISPR/Cas9 genome editing has dramatically changed our way to perform biological experiments. While highly efficient and easy to use, one limitation with CRISPR/Cas9 mediated genome editing technology is the occurrence of off-target effects and the restriction of the PAM recognition sequence. Many modifications from the original system have been proposed to improve

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Hateful politics infiltrate human genome editing debate in France

June 27, 2016 / Professor Paul Knoepfler, Ph.D. / 1 Comment

By Elliot Hosman Summary. A campaign calling for a moratorium on using CRISPR in human embryos was launched by a prominent French organization fighting for narrow understandings of life and family. A recent campaign calling for a ban on “transgenic” human embryos was launched by one of France’s most prominent organizations fighting for “science”-backed “one-man-one-woman”

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Will new gene editing tech NgAgo challenge CRISPR?

May 15, 2016 / Professor Paul Knoepfler, Ph.D. / 17 Comments

2020 Update: early NgAgo reports have been mostly discredited and there is doubt on its function as a gene-editing method. What could be better than CRISPR for gene editing? A new genetic modification technology called NgAgo has some researchers really excited. How does it compare to CRISPR? I’ll admit it that as a scientist who works on

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