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 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 suffer a stroke annually and according to the American Heart Association, stroke is the fourth leading cause of death – costing an estimated $73.7 billion in 2010 for stroke-related medical costs and disability.
About Stemedica Cell Technologies, Inc.
Stemedica Cell Technologies, Inc. is a specialty bio-pharmaceutical company that is committed to the manufacturing and development of best-in-class allogeneic adult stem cells and stem cell factors for use by approved research institutions and hospitals for pre-clinical and clinical (human) trials. The company is a government licensed manufacturer of clinical grade stem cells and is approved by the FDA for its clinical trials for ischemic stroke, cutaneous photoaging and acute myocardial infarction. Additional information can be found at www.clinicaltrials.gov. Stemedica is currently developing regulatory pathways for a number of medical indications using adult allogeneic stem cells. The Company is headquartered in San Diego, California.
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