Within the whirlwind that is the stem cell and regenerative medicine entire world, there are many concerning things that need attention, but also good stuff occurs too and this post focuses on the positive.
The Asterias spinal cord injury clinical trial , the phase 1/2a trial called SCiStar, is constantly on the make encouraging news with a clean basic safety profile and additional hints at possible positive indicators of effectiveness. With the usual, important caveats such as that this is earlier and it is not an RCT, the SCiStar momentum is beneficial. I’ m excited to see what the future holds with this one including from an RCT. You can read my job interview from last month with Asterias leadership here .
I remain very interested in ViaCyte’ s trial too using a stem cell capsule product for treatment of Diabetes. Their joining forces with BetaLogics a year ago just made their position even more powerful.
I’ m going to do a post quickly on an analysis on the total number of stem cell plus regenerative medicine trials compared to historical data I gathered. Stay tuned on that. I’ m guessing it’ lmost all be good news.
Recently, we also noticed evidence of fast action from FDA in response to the 21st Century Cures Act in terms of providing a clear document on Regenerative Advanced Therapy designations and applications. It’ s nevertheless unclear how the Cures stem cell provisions will play out there, but I consider quick, clear action from the FOOD AND DRUG ADMINISTRATION to be a positive. I wish they were this fast upon other stuff like dealing with stem cell clinics marketing unapproved drug products.
There have been a number of cool papers recently that I recommend reading through: