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Stemedica Advances to Phase II Stroke Trial with Lead Product Stemedyne-MSC
Date:7/10/2013

San Diego, CA (PRWEB) July 10, 2013

Stemedica Cell Technologies, Inc., a leader in adult allogeneic stem cell manufacturing, research and development, announced today the completion of enrollment and treatment of patients in a Phase I study with Stemedica’s lead product Stemedyne-MSC. These specially formulated ischemic adult allogeneic mesenchymal stem cells have been manufactured at Stemedica’s cGMP compliant facility and have been successfully used to treat patients in an ischemic stroke study: “A Phase I/II, Multi-Center, Open-Label Study to Assess the Safety, Tolerability and Preliminary Treatment Efficacy of a Single Intravenous Dose of Allogeneic Mesenchymal Bone Marrow Cells to Subjects with Ischemic Stroke.”

The primary goal of the Phase I study was to assess the safety and tolerability of treatment with Stemedyne-MSC as determined by the incidence and severity of adverse events, clinically-significant changes on clinical laboratory tests, vital signs, physical and neurologic examinations in patients with a clinical diagnosis six months post ischemic stroke. The secondary goal was to assess the clinical effects of treatment on neurologic, functional, and motor deficits.

Fifteen patients were treated in this dose escalation Phase I study. Patients received one dose of Stemedyne-MSC via intravenous administration. An Independent Data Safety Monitoring Board reviewed safety data for subjects including adverse events, laboratory data and vital signs. Based on the review, they unanimously voted for the trial to proceed to Phase II.

Michael Levy, MD, PhD, FACS, the Principle Investigator and John Crawford, MD, Co-Investigator at the University of California, San Diego (UCSD) clinical site commented, “We are optimistic that we will continue to see
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