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FDA Grants IND Approval For Phase 2a Clinical Trial Using CardioCell’s Itmsc Therapy To Treat Dilated Chronic Heart Failure


4/2/2014 10:50:40 AM

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SAN DIEGO--(BUSINESS WIRE)--CardioCell LLC has just received the FDA’s investigational new drug (IND) approval for a United States-based, Phase IIa clinical study using its allogeneic stem-cell therapy to treat subjects with chronic heart failure (CHF), which generates more than 1 million hospitalizations annually. Preparation is underway to initiate the study, “A Phase IIa, Single-Blind, Placebo-Controlled, Crossover, Multi-Center, Randomized Study to Assess the Safety, Tolerability and Preliminary Efficacy of a Single Intravenous Dose of Ischemia-Tolerant Allogeneic Mesenchymal Bone Marrow Cells to Subjects With Heart Failure of Non-Ischemic Etiology,” at Emory University, Northwestern University and the University of Pennsylvania in May 2014.

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