Year 3

This has been a very exciting year for this project. We have grown our ALS clinic to over 200 patients in preparation for our uni-site combined stem cell and growth factor trial. At the same time we have completed a large range of studies that have enabled a 4,500 page IND application to be prepared and submitted to the FDA on March 16th 2016. . This includes sections on cell production, animal studies supporting the trial, production of a clinical protocol that will drive the trial and all of the regulatory components necessary to allow us to move forward at Cedars-Sinai. FDA will have a month to respond to our request for the clinical program to start. Providing we achieve FDA approval, we look forward to moving into patients with ALS thanks to the continual support of this CIRM disease team award.