January 26, 2021

The Niche

Trusted stem cell blog & resources

Month: June 2018

5 min read

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 my 2018 predictions (pasted below) the 1/2-way point checkup. Things are off to a reasonably strong start for the old stem cell crystal ball.  For the grading, green is …Read More

2 min read

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 now that I could see. It’s a fairly short list. Why would FDA have such a thing more broadly? The blacklist is for those who have seriously broken regulations …Read More

3 min read

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 oversight today? Too much stem cell carrot and not enough stick? Some would probably say too little carrot and too much stick? Given how the stem cell arena can …Read More

2 min read

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 to be somewhat stream of consciousness notes from the talks and may have some outlined points rather than sentences. I have some questions or notes for myself that I …Read More

4 min read

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 emails from patients and sometimes phone calls asking questions about stem cells and especially stem cell treatments, but at times I’m not sure the treatment in question really involves …Read More

3 min read

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 is many things including an exciting technology that my own lab uses a lot, but it isn’t and never will be perfect or somehow magical. When this week’s story …Read More

3 min read

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 image below): And for a second consecutive year, people from different walks of life gathered at this event to figure out how they could contribute to the discussion. But …Read More

3 min read

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 the use of human embryonic stem cell (hESC)-derived retinal pigmented epithelial cells (RPEs) for macular degeneration are concerning in some ways. The paper in the AAO Journal from a …Read More

2 min read

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 pub. One of the more interesting recent papers was from direct reprogramming guru Marius Wernig as his team came out with a new transdifferentiation paper that strikingly reports conversion …Read More

3 min read

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 going to be a drug product requiring premarket approval. You can see my first quick take on these federal suits here as well as initial responses to the suits …Read More