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 […]
Fun pictures & 7 observations on the country from Australia trip Read More »
Over the weekends I try to catch up on more diverse reading and sometimes come up with a list of stuff I want to get to during this time, but I also put together weekend reads usually on Fridays as a kind of TGIF on The Niche for the wider audience here. So here’s the
TGIF weekend reads: senolytics, new CRISPR, stem cells, & 3 wacky things Read More »
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
Stem cell news July 2018: RMATs, RTT, MiMedx mess, clinic family ties & more Read More »
Every year in December I go out onto a limb and make stem cell predictions for the coming year as I did in late 2017 for this year. Then usually around the 1/2-way point through the year I check in on how the predictions are faring so far at that point. In this post I give
Midterm grades on my 20 x 2018 stem cell predictions Read More »
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
A real FDA blacklist: what is it, who’s on it, & should some stem cell clinics be? Read More »
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
My new Cell Stem Cell piece: too much carrot & not enough stick on stem cell oversight Read More »
Ain’t nothing like the real thing…right? No, by the ‘real thing’ I’m not talking about Coke versus Pepsi or Coke versus Diet Coke, but rather stem cells. (On a side note there’s still some people who apparently believe the stem cell myth that there are stem cells in Pepsi). I get a regular stream of
Stem-ish cells: what’s the real thing? Read More »
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
Possible safety concerns from new stem cell, RPE vision loss study report Read More »
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
Stem cell & regenerative medicine news: cool pubs, people, ARM, & more Read More »
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
10 questions on FDA suits targeting stem cell clinics Read More »