Search Results for: US Stem Cell

FDA Regenerative Advanced Therapy Designation Rules Are Up in Response to Cures Act

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The 21st Century Cures Act specifies some new FDA rules about investigational stem cell-based regenerative medicine therapies and perhaps most importantly defined a new class of product called a “Regenerative Advanced Therapy” or RAT, which is entitled to an expedited review. The FDA already has a new page up on RATs, which specifies the specifics of […]

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Quick journal club on IPSC anti-aging paper: cool, but outstanding questions

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A new Cell paper from Juan Carlos Izpisua Berlmonte’s group has made headlines about anti-aging across the globe because it suggests that the four core induced pluripotent stem cell (IPSC) factors use by Shinya Yamanaka to make IPSC can reverse aging. I’ve pasted the graphical abstract from the paper below and done a quick journal club style

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Chat with Michael Werner of ARM on Cures Act regenerative medicine provisions

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One of the hottest topics in the world of stem cells this year has been the REGROW ACT and at a larger level the movement for changes in FDA oversight of investigational regenerative medicine therapies (see my past posts on it here), so the related provisions in the 21st Century Cures Act are stirring much

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A collection of scientist responses to Trump election

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I’m organizing my own thinking on how Trump’s election will impact science and stem cell/regenerative medicine research in particular and will post on that soon, but for now here are some of the early responses I’ve seen where scientists comment on this big, unexpected event and key questions. These are in addition to the almost

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

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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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Cynata approval for 1st ever allo trial of IPSC-derived MSCs for GVHD

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Cynata

Cynata Therapeutics Limited has received approval from UK regulators to start a first-of-its-kind allogeneic IPSC-based trial of MSCs for graft versus host disease (GVHD). Cynata also had some big news a couple weeks back with a deal with Fujifilm. The company is aiming to recruit 16 patients to test whether the MSCs (a type of adult

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Federal judge blocks FDA action on Texas amniotic supplier

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The FDA issued a warning letter not long ago to Amniotic Therapies, LLC, a supplier of amniotic products including to one or more stem cell clinics, but now a federal judge in Texas has reportedly mostly blocked the FDA action in terms of the shutdown. The law firm representing Amniotic also issued a PR about the

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