October 31, 2020

The Niche

Knoepfler lab stem cell blog

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