~ STEMEDICA Completed Enrollment In First Cohort of Patients With Ischemic Stroke Utilizing Allogeneic Mesenchymal Stem Cells ~
(Source: October 21 2011; Stemedica Cell Technologies, Inc.)
Stroke Study Marks First Use of Unique Stem Cells in Human Trials
Stemedica Cell Technologies, Inc., a leader in adult allogeneic stem cell manufacturing, research and development, announced today that its specially formulated ischemic adult allogeneic mesenchymal stem cells have been successfully used to treat the first cohort of patients in an ischemic stroke study conducted at the University of California, San Diego (UCSD). A total of 35 patients will be enrolled in the clinical trial entitled: "A Phase I/II, Multi-Center, OpenLabel Study to Assess the Safety, Tolerability and Preliminary Efficacy of a Single Intravenous Dose of Allogeneic Mesenchymal Bone Marrow Cells to Subjects with Ischemic Stroke."
Lev Verkh, PhD, Stemedica’s Chief Regulatory and Clinical Development Officer, commented: "All patients in the first cohort received an initial dose of adult allogeneic stem cells and no product related adverse events were reported. An Independent Data Safety Monitoring Board (DSMB) reviewed the safety data for the subjects including adverse events, laboratory data and vital signs and based on that review, the DSMB unanimously voted for the study to proceed to the next dose."
The Principle Investigator Michael Levy, MD, PhD, FACS, Chief of Pediatric Neurosurgery at Children’s Hospital San Diego (CHSD) and Professor of Neurological Surgery at the University of California, San Diego (UCSD) commented that "he is pleased with the safety profile demonstrated in this initial phase of the study and is looking forward to completing Cohorts 2 and 3 given the promising results to date."
Patients in this study have significant functional or neurologic impairment that confines them to a wheelchair or requires home nursing care or assistance with the general activities of daily living and have received the ischemic stroke diagnosis at least six months prior to enrollment in this study.
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 strokerelated medical costs and disability.
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