January 25, 2021

The Niche

Trusted stem cell blog & resources

Jonathan Kimmelman

3 min read

The FDA is holding its first 2016 stem cell meeting today and you can read about some impressions of the morning session of this meeting here. In this post, I’m focusing on the afternoon session, which has been mostly on policy and ethics, including on stem cell clinics. Jonathan Kimmelman from McGill University got the afternoon going with his excellent talk “Ethics, Evidence, and Regulatory Approval for Cell-Based Interventions“. Jonathan started his talk addressing the stem cell clinic situation in the U.S. and asking more broadly how …Read More

3 min read

There’s a big FDA stem cell meeting coming along next week that has gotten much attention, but many people didn’t realize there’s also an FDA meeting on stem cells this week too in three days on September 8th. I pasted this week’s meeting schedule at the bottom of this post from the FDA page. The meeting is a workshop entitled, “Public Workshop: Scientific Evidence in the Development of Human Cells, Tissues, and Cellular and Tissue-Based Products Subject to Premarket Approval”. The meeting next week on September …Read More

4 min read

I am often critical of for-profit stem cell clinics on this blog for numerous reasons. For instance, one thing that concerns me greatly about these clinics is that they charge patients to get experimental “treatments” that have not been proven to be safe or effective. But as some patients have pointed out to me over the years, certain FDA-approved stem cell clinical trials also charge patients to receive unproven stem cell therapies. Should someone (even if that someone is an academic clinical researcher) be able …Read More

3 min read

A committee of the International Society for Stem Cell Research (ISSCR) did one heck of a document dump yesterday on stem cell policy, releasing a whole bunch of policy recommendations on stem cells and more. The torrent from ISSCR included a 37-page policy statement itself as well as several papers in top journals including the Lancet, Science, and Nature. This output was the product of the members of a special  ISSCR Task Force, whose members I have listed at the bottom of this post. Who …Read More

5 min read

A new report from the National Academies of Sciences (NAS), Engineering, and Medicine here in the US recommends a policy significantly more cautious on first read for 3-person IVF than that in place now in the UK. My initial take on this new 164-page report is that it is very well thought out and the recommendations are both appropriate and prudent. I’m still reading the report so it is possible I may feel differently at the end or that others may point out concerns …Read More

2 min read

Now we have an interesting panel starting on questions of governance on human gene editing. This will focus on institutional and national levels of governance. Pilar N. Ossorio, University of Wisconsin, Madison, and Morgridge Institute for Research, is introducing the panel. Key question: how should emerging technologies being governed? Jonathan Kimmelman, from McGill, was the first speaker. How do we evaluate risk versus benefit with human genetic modification? Particularly how to answer this question in the context of clinical trials? Benefit should be defined as …Read More