Stemedica Cell Technologies announced the launch of a phase 2b/3 clinical trial to assess the safety, efficacy and tolerability of a single IV injection of allogenic mesenchymal stem cells in patients with chronic ischemic stroke.
According to a release from the company, the multicenter, randomized, double-blind study is expected to enroll approximately 300 individuals, who will be divided into two cohorts and receive either a single injection of allogeneic mesenchymal stem cells and standard treatment or placebo and standard treatment.
Stemedica reported positive results from a phase 1/2 study of the same therapeutic at three locations in Arizona and California. Trial data demonstrated an excellent safety profile, as well as statistically significant improvements in NIH Stroke Scale for neurological assessment, and Geriatric.
ارسال به دوستان