August 15, 2020

The Niche

Knoepfler lab stem cell blog

21st Century Cures Act

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

3 min read

Can a stem cell clinic business get FDA RMAT designation? At least one announced it was trying, but now seems to have given up. Stem cell clinic business US Stem Cell, Inc. has reportedly announced that it is at least temporarily abandoning its efforts at getting Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA. The company’s penny stock $USRM has been gyrating for months and I had earlier wondered if could be some fake news about it. The USRM news now seems real and not …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