Search Results for: warning letter

2017 stem cell predictions: score card at 1/2-way point

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In December of each year I make a list of stem cell predictions for the coming year, and I made 20 such predictions for 2017 so I’m wondering how I’m doing so far on these now that it’s June. Below is my work-in-progress scorecard for these so far. Positive news from Asterias on trial for stem cell-based […]

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

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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

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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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

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

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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Rick Perry resigns from stem cell clinic Celltex, where he earned $175K

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Former Texas governor Rick Perry, now the Trump Department of energy (DoE) nominee, has a long association with the Texas stem cell clinic, Celltex. He was a patient of Celltex, which some years back infused Perry with non-FDA approved stem cells. The company received a warning letter from the FDA and since that time has

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