Search Results for: US Stem Cell

Fun pictures & 7 observations on the country from Australia trip

Melbourne-The-Lanes

What’s Australia like from the science to the country? I enjoyed the ISSCR2018 Annual Meeting in Melbourne on stem cells and regenerative medicine a few weeks back(here is a post on the some of the notable science from Day 1), but I also got a chance to get to know Australia a bit too. Below I have […]

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Stem cell news July 2018: RMATs, RTT, MiMedx mess, clinic family ties & more

MiMedx

The year of 2018 has already been a wild one for stem cell news. There are many developments on a variety of fronts. Here are some of the most notable news bites of the last month or so. RMATs RMAT Wave. The FDA continues its warp-speed issuance of Regenerative Medicine Advanced Therapy (RMAT) designations with

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A real FDA blacklist: what is it, who’s on it, & should some stem cell clinics be?

FDA-Blacklist

I didn’t know until recently that the FDA has a blacklist, which is called the “FDA Debarment List”. You can check it out here. Should one or more particularly egregious unproven stem cell clinic operators should be on the list given their risk-taking with patients in the name of profit? There aren’t any on there

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My new Cell Stem Cell piece: too much carrot & not enough stick on stem cell oversight

carrot-and-sticks

I have a new Cell Stem Cell piece out today that aims to take stock of today’s stem cell regulatory oversight in the U.S., Japan, and elsewhere including Australia, Canada and India. I use a carrot and stick metaphor for encouraging legit research and taking regulatory action on serious non-compliant activities, respectively. Where is stem cell

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Possible safety concerns from new stem cell, RPE vision loss study report

Figure-1-Mehat-et-al.-AAO-Journal-2018-810x1024-1

With stem cells for vision loss, first we want to be sure a treatment won’t make things worse. Several teams around the globe are rigorously studying stem cell-based approaches to vision loss via regulatory-compliant studies including for macular degeneration with some results cautiously upbeat on safety from early phase analyses, but data from a new study on

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Stem cell & regenerative medicine news: cool pubs, people, ARM, & more

Tanabe-Figure-1B

How does one keep up with all the regenerative medicine and stem cell happenings? There is always something happening in the stem cell and regenerative medicine field ranging from science to policy matters. This post is an update on some recent stem cell happenings that I see as notable or interesting. New Pubs Direct reprogramming

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10 questions on FDA suits targeting stem cell clinics

SVF2

The FDA via the DOJ has sued to get permanent injunctions against US Stem Cell, Inc. (USRM) and California Stem Cell Treatment Center/Cell Surgical Network (CSN). Both firms use an unapproved fat stem cell product in patients called stromal vascular fraction (the SVF production process is pictured at right) that the FDA indicates is generally

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