January 23, 2023
1 minute read
Stemedica Cell Technologies announced the initiation of a Phase 2b/3 clinical trial evaluating the safety, efficacy and tolerability of a single IV injection of allogeneic mesenchymal stem cells in patients with chronic ischemic stroke.
According to a company release, the multicenter, randomized, double-blind trial will enroll approximately 300 patients, divided into two cohorts, to receive a single injection of allogeneic mesenchymal stem cells and You will receive either standard care or placebo plus standard care. process.
This study evaluates improvement in upper extremity clinical outcomes as measured by the Fugal-Meyer Scale from baseline to 6 months. The secondary trial endpoints will include changes from baseline in the Modified Rankin Scale and Barthel Index, as well as safety and tolerability, the company said.
“It is critical to address the enormous medical and social problems caused by approximately 10 million new strokes worldwide each year.” Nikolai TankovicMD, PhD, Stemedica’s president and chief medical officer said in a release: “We are encouraged that Stemedica’s Phase 2b/3 clinical trial has been conducted under the auspices of the FDA. [investigational new drug] We can validate the role our ischemia-tolerant mesenchymal stem cells can play in coping with this crisis. ”
Stemedica has reported positive results from Phase 1/2 trials of the same treatment at three locations in Arizona and California. The study data not only demonstrated an excellent safety profile, but also demonstrated the NIH Stroke Scale, Barthel Index for neurological assessment, Mini-Mental Status Exam for mental status, and Geriatric for degree of depression. showed a statistically significant improvement in the Depression Scale.
