Final Operational Milestone #4
We have now achieved the last of our 4 Milestones during the current reporting period for our CIRM CLIN1 grant. On July 24, 2020, the FDA provided approval to commence the Phase 1/Phase 2a clinical trial of NR1 cell therapy in subjects with chronic subcortical ischemic stroke. The Stanford University Administrative Panels on Human Subjects Research Institutional Review Board (IRB) approved the study to begin at Stanford University on November 10, 2020. The Data Safety Monitoring Committee (DSMC) charter has been established and the DSMC will convene following treatment of the first study subject in the clinical trial. All primary site personnel have been identified and received essential training on the project and their role.