June 3, 2020

The Niche

Knoepfler lab stem cell blog

FDA fast track

4 min read

There is considerable interest in FDA regulatory reform here in the U.S. for stem cell therapies. The goal is to get new treatments to patients faster, but is there a way to do that without sacrificing proven safety and efficacy? You need convincing data on both safety and efficacy or speed becomes dangerous. A group called the Bipartisan Policy Center (BPC) recently issued a report related to these central questions of American regulation of new stem cell products. You can see a screenshot from the cover …Read More

2 min read

What are the most interesting questions for the stem cell field in 2014 right now? What’s on your mind? I’m not going to give this deep thought, but rather just list those questions bouncing around at the moment in no particular order. You can see a lot of translational/clinical things are on my mind. I’ve put possible answers, but these are highly speculative and/or based on hope in some cases. What’s next for ACT’s hESC-based clinical trials and Takahashi’s iPS cell-based clinical study for macular …Read More