Stemedica announces clinical trial for IV stem cell treatment for chronic ischemic stroke

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.

The study will assess improvements in clinical outcomes of the upper-extremity of the body as measured on the Fugal-Meyer Scale from baseline through 6 months. Secondary study endpoints include change from baseline in the modified Rankin Scale and Barthel Index and safety and tolerability, the company stated.

“It is critical to address the enormous medical and social issues caused by approximately 10 million new cases of stroke each year around the world,” Nikolai Tankovich, MD, PhD, Stemedica president and chief medical officer, said in the release. “We are encouraged that Stemedica’s phase 2b/3 clinical trial under the FDA [investigational new drug] can validate the role that our ischemic tolerant mesenchymal stem cells can play in addressing this crisis.”

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, Barthel Index, Mini-Mental Status Exam for mental status and Geriatric Depression Scale for degree of depression, per the release.