June 3, 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

4 min read

The 21st Century Cures Act has some important provisions that would impact the stem cell and regenerative medicine field.  What is driving these efforts is a widespread sense that the status quo of regenerative medicine oversight isn’t working very well. I’m talking with key stakeholders and still trying to sort out my thoughts on the stem cell provisions in Cures. What would it mean? Cures’ language on stem cells is nuanced and its provisions also are not so black and white as REGROW was in …Read More

3 min read

One of the hottest topics in the world of stem cells this year has been the REGROW ACT and at a larger level the movement for changes in FDA oversight of investigational regenerative medicine therapies (see my past posts on it here), so the related provisions in the 21st Century Cures Act are stirring much discussion today. The bill is called Cures for short and you can read the latest draft here. Cures may get a vote in Congress as early as tomorrow so this is …Read More