September 25, 2020

The Niche

Knoepfler lab stem cell blog

21st Century Cures Act stem cells

6 min read

Are fat stem cells a drug? Today the FDA definitively indicated “yes” without leaving much of any room for exceptions on this question. This morning the FDA made a major announcement on stem cell policy regarding its current thinking on oversight of regenerative medicine and issued four guidances, including two each in final and in draft form. There will be a 90-day comment period for the latter. Are today’s developments a good thing overall? I’d say “yes”, although there are still some ambiguities and …Read More

6 min read

Stem cell clinical trials have a certain gravitational pull for me as I’m always fascinated by them and since the new Cynata trial is moving forward, I recently did an interview their CEO, Dr. Ross A. Macdonald to find out more. PK: Cynata’s recently initiated clinical trial aims to treat GVHD as have other stem cell-related trials such as Prochymal so I’m interested to learn more about how this product and this trial are unique. Can you fill me in? In many ways, our trial …Read More

5 min read

The Trump FDA commissioner nominee Dr. Scott Gottlieb could dramatically alter how the agency regulates investigational stem cell therapies. How might such changes unfold? There are potential upsides and downsides to  the seismic shift that could be in the offing. Gottlieb has written in the past about his perception of FDA over-regulation of stem cells such as in this piece in the WSJ. There he made a number of assertions that signal his view at least back then that when it comes to regulation of stem …Read More

2 min read

In the whirlwind that is the stem cell and regenerative medicine world, there are many concerning things that need attention, but also good stuff happens too and this post focuses on the positive. The Asterias spinal cord injury clinical trial, a phase 1/2a trial called SCiStar, continues to make encouraging news with a clean safety profile and additional hints at possible positive indicators of efficacy. With the usual, important caveats such as that this is early and it is not an RCT, the SCiStar momentum …Read More