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 »
One of the highlights of Day 1 of #ISSCR2018 for me so far was the talk by Lorenz Studer (Co-Founder of BlueRock) on the use of human embryonic stem cell (HESC)-derived dopamine neurons for Parkinson’s Disease. Note that for this post and if I have time any others on this meeting, they are probably going …
Lorenz Studer on Day 1 #ISSCR2018: HESC-based therapies for Parkinson’s Disease 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 …
Could potential associated cancer risks claw into CRISPR’s potential? The short answer from both previous and new data is that while CRISPR gene editing impacts the P53 pathway, which is involved in cancer along with having many other functions, this news is neither too surprising nor a fatal flaw, but some caution is warranted. CRISPR …
Could Cancer Risk Claw CRISPR’s Potential? Some Balanced Perspectives Read More »
By Anna Everette The title of this article is partially borrowed from a fascinating Lightning Presentation delivered by John Doench of Broad Institute at CRISPRcon this year. In his talk, Mr. Doench pointed out how we’ve been looking up to this promising technology for a while now, hoping it will deliver the anticipated results (see …
The Hope of CRISPRcon: Year 2, Guest Post by Anna Everette 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 »