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

efficacy in Phase II based on improvements in levels of alertness and functional speech we have observed, especially in those patients with significant injuries.”

Nabil Dib, MD, MSc, FACC, the Co-Investigator at the Mercy Gilbert Medical Center, Chandler Regional Medical Center in Gilbert, Arizona site commented, “We are extremely excited about the Data Safety Monitoring Board’s report on the first 15 patients treated and are encouraged by our preliminary observations of the improvements of the patients’ clinical symptoms. We look forward to completing patient enrollment into Phase II and the final analysis of this very important clinical trial. Cell therapy potentially has significant application in stroke patients that may change the way that we treat patients with cerebrovascular accidents.”

Lev Verkh, PhD, Stemedica’s Chief Regulatory and Clinical Development Officer, commented, “Stemedica achieved this significant milestone by demonstrating the safety of the product at all doses studied in this trial. We are also encouraged that this treatment resulted in clinical benefits in patients with this diagnosis. The Phase II portion of this trial is open for enrollment (http://clinicaltrials.gov/ct2/results?term=stemedica).”

Nikolai Tankovich, MD, PhD, FASLMS, President and Chief Medical Officer of Stemedica noted, “Our current and planned clinical trials are directed toward the entire spectrum of ischemic disease, from the early onset of the vascular damage in metabolic syndrome, to the acute damage of myocardial infarction and chronic damage as evidenced by the stroke patients in this trial. By expanding Stemedyne-MSC cells in our proprietary low oxygen process, we produce MSCs that have higher levels of the critical factors necessary for vascular repair as compared to cells expanded in normal oxygen.”

More than 800,000 Americans suf
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