October 25, 2020

The Niche

Knoepfler lab stem cell blog

More than minimal manipulation

2 min read

Below is a my interview with an FDA spokesperson on the upcoming April public meeting on the four recent draft guidances related to the regulation of HCT/Ps, including stem cell treatments. This meeting and the draft guidances could have substantial impact on future regulatory frameworks for stem cell treatments so I thought it important to reach out to the FDA to clarify the process. PK: When the FDA issues draft guidances is it a standard approach to have a public meeting of the kind …Read More

17 min read

When I started blogging in 2010 the stem cell arena was a very different place including the fact I could count the number of US stem cell clinics on one hand. This blog, called The Niche for many years, was just “Knoepfler Stem Cell Blog” back then. Also, back then the hot topic was the battle over the legality of federal funding of embryonic stem cell research. That battle is over, or at least in hibernation, with a 2013 federal court ruling allowing such funding …Read More