Search Results for: warning letter

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

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John-Zhang-with-3-person-IVF-baby

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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Stem cell clinic-related biz threatens researcher with lawsuit, wants retraction

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turner-leigh

University of Minnesota bioethicist Leigh Turner has been threatened with a lawsuit by a stem cell clinic-related business. Lawsuit threats in this arena come up every so often and as much as they are unpleasant realities, they can also reveal some important aspects of the stem cell arena. Ars Technica reported yesterday that Leigh’s recent paper

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Burt Northwestern Stem Cell MS Trial Part 3: Funding, Patient Perspectives, & the Future

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Stem-cells-for-MS-trial-concerns-e1493137263166

Today’s post is the last of a three-part series on the Burt stem cell trials at Northwestern. This piece is focused on funding and the future of the trial, and also includes perspectives from patients. You can read Part 1 here and Part 2 here, which focused on issues related to potential encouragement of patient fundraising that unintentionally releases

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Burt Northwestern Stem Cell MS Trial Part 1: Big Promise & Tough Questions

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Curing-Multiple-Sclerosis-Stem-Cells

Dr. Richard Burt of Northwestern University has been doing cutting edge research on the use of stem cells for autoimmune disorders for more than a decade. The core idea behind the work that Burt and other research teams are doing is that stem cells may have revolutionary potential to somehow counteract the autoimmunity that causes

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

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Richard-Burt-Warning-Letter-e1490745772151

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

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Dr.-Scott-Gottlieb

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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A nation of stem cell miracles? CNN puff piece on clinic patient & Trump blows it

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Celltex

Would you believe in a stem cell miracle? Sometimes the mainstream media stumbles in its coverage of the stem cell world and a recent CNN puff piece on a patient of stem cell clinic Celltex is a prime example of just how extreme this can get. The CNN piece focuses on a Celltex patient who self-reports perceived

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