Search Results for: drugs

Reciprocal CRISPR gene editing in pediatric glioma: defining mechanisms & testing drugs

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My lab’s new paper in Communications Biology focused on high-grade pediatric glioma that have mutant histone variant H3.3 and we did something fairly novel that we are calling reciprocal CRISPR. Kids with these tumors have a near zero survival rate within a few years of diagnosis so we as a field desperately need something new to give …

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Fat stem cells are drugs & more: FDA final guidances point to a new era

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Are fat stem cells a drug? Today the FDA definitively indicated “yes” without leaving much of any room for exceptions on this question. This morning the FDA made a major announcement on stem cell policy regarding its current thinking on oversight of regenerative medicine and issued four guidances, including two each in final and in …

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‘Are fat stem cell clinics selling unapproved drugs?’ reporters ask in talking about our new paper

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Our new paper in the journal Cell Stem Cell on the large stem cell clinic marketplace in the U.S. documented a wide range of different kinds of clinics, stem cells used, and conditions claimed to be treated, but here I want to focus on the fat stem cell clinics in this post. I’m going to try …

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FDA Draft Guidance Views Fat Stem Cells As Drugs

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With a new document released today the FDA is more clearly on a path to regulate dubious stem cell clinics in the US. Update: in the years since this post, the FDA has more concretely defined autologous adipose stem cells as drug products. There are more than 100 such American clinics that are selling stem …

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These are your stem cells on drugs…any questions?

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How do “drugs” influence stem cells? Here’s the straight dope. Those of us in the trenches of the stem cell research field spend an inordinate amount of time talking about stem cell treatments (i.e. you inject stem cells into a person hoping for a medical benefit), and far too little time discussing endogenous stem cells. …

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Court in Regenerative Sciences Case: Propagated Stem Cells Are Drugs

A long-standing debate in the commercial stem cell arena has focused on whether stem cells grown in a lab prior to clinical use as a transplantation product are biological drugs subject to full FDA vetting. The alternative view has been that such stem cell products are not drugs, but rather are simple human cellular and …

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Full page JAMA ad from FDA warns docs on foreign drugs

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I opened the most recent edition of Journal of the American Medical Association (JAMA) and found a striking full-page ad from the FDA. It’s unclear if this is the first ever such advertisement. I have been unable to find a similar one on the Internet at least. Has anyone seen such ads before? The JAMA …

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MiMedx (MDXG) placental “stem cell magnet” drugs attract FDA attention and lawsuit

ABC News just reported that the FDA is allgedly “cracking down” on the publicly traded company, MiMedx (MDXG), which sells a placental derivative touted for healing powers. The Wall Street Journal is also following the story. According to ABC News: MiMedx is a publically traded, for-profit company that takes donated human placentas — solicited via a website featuring …

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Celltex FDA FOIA letter #2: no safety concerns with our stem cells, which really are not drugs

A FOIA request that I made with the FDA in mid-December 2012 has at long last revealed  letters from Celltex  to the FDA that previously were not in the public domain. The reason for the FOIA and for these blog posts is to shed some light on important issues that particularly relate to patient safety. I …

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Nordstrom hawking super expensive, non-FDA approved stem cell cosmetic drugs

What’s the deal with Nordstrom and stem cells? Are they going to rename themselves “Nordstem”? I grew up in Bellevue, WA, home of the Nordstrom’s family and of the Nordstrom department store chain. I believe the flagship store was just across Lake Washington in Seattle. I don’t like shopping as perhaps most guys feel, but …

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