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FDA chides US doc who genetically modified human embryo in reported 3-person IVF

August 4, 2017 / Professor Paul Knoepfler, Ph.D. / 1 Comment

The FDA sent a stern letter today to Dr. John Zhang, PhD, MD, the physician who last year created a genetically modified human embryo in the U.S. and then exported it to Mexico where he self-reported creating a genetically modified baby boy. While the genetically modified baby created in Mexico was reportedly seemingly OK, it’s not clear […]

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Reading the tea leaves as new FDA commish Gottlieb blogs on regenerative medicine

July 11, 2017 / Professor Paul Knoepfler, Ph.D. / 3 Comments

New FDA Commissioner Dr. Scott Gottlieb, M.D., has in the past touched on stem cells and regenerative medicine therapies in speeches or written comments prior to starting his tenure at the agency. Now that he is Commissioner, he is poised to have direct impact on our field rather quickly and potentially with major changes in

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US Stem Cell bid for FDA RMAT rejected?

June 22, 2017 / Professor Paul Knoepfler, Ph.D. / 3 Comments

Can a stem cell clinic business get FDA RMAT designation? At least one announced it was trying, but now seems to have given up. Stem cell clinic business US Stem Cell, Inc. has reportedly announced that it is at least temporarily abandoning its efforts at getting Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA. The

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FDA warp speed RMAT approval nukes stem cell clinic excuses

June 15, 2017 / Professor Paul Knoepfler, Ph.D. / 1 Comment

Many stem cell clinics are in a bind in 2017 in the new RMAT approval reality. Stem cell clinics say that they only want to help people by providing stem cell therapies to patients in a speedier way that they claim getting FDA approval for a trial just doesn’t allow, but that doesn’t ring true.

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Big change for stem cell field with FDA quickly issuing RMATs

May 5, 2017 / 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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Wouldn’t you like to be a RAT too? Stem cell clinics apply for new FDA accelerated approval path

April 10, 2017 / Professor Paul Knoepfler, Ph.D. / 2 Comments

Are stem cell clinics going to somehow get the FDA to approve their stem cell interventions? To get recognized as legit? It seems they are trying now more than ever. Remember the REGROW Act that would have greatly reduced regulations on investigational stem cells and then how the 21st Century Cures Act passed with some

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FDA warns Northwestern’s Richard Burt on reporting patient deaths, other issues in stem cell trials

March 29, 2017 / Professor Paul Knoepfler, Ph.D. / 52 Comments

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The FDA recently issued a lengthy warning letter to Northwestern University over the clinical trial practices of its Dr. Richard Burt and this letter just popped up on the FDA website. To my knowledge this is an unprecedented event as I’m not aware of another warning letter to a major university for a stem cell trial. Burt received the FDA

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How Scott Gottlieb may transform the FDA’s approach to stem cells

March 14, 2017 / Professor Paul Knoepfler, Ph.D. / 2 Comments

The Trump FDA commissioner nominee Dr. Scott Gottlieb could dramatically alter how the agency regulates investigational stem cell therapies. How might such changes unfold? There are potential upsides and downsides to the seismic shift that could be in the offing. Gottlieb has written in the past about his perception of FDA over-regulation of stem cells such

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Poll: How will Trump’s FDA handle stem cells?

March 11, 2017 / Professor Paul Knoepfler, Ph.D. / 2 Comments

Poll: How will Trump’s FDA handle stem cells? Read More »

Good stem cell news on trials, FDA, cool new papers & more

January 31, 2017 / Professor Paul Knoepfler, Ph.D. / 2 Comments

In the whirlwind that is the stem cell and regenerative medicine world, there are many concerning things that need attention, but also good stuff happens too and this post focuses on the positive. The Asterias spinal cord injury clinical trial, a phase 1/2a trial called SCiStar, continues to make encouraging news with a clean safety profile

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