Top-Line Results for Ixmyelocel-T in Dilated Cardiomyopathy Announced
The clinical trial ixCELL-DCM is a multicenter, randomized, double-blind, placebo-controlled Phase 2b study evaluating the efficacy, safety and tolerability of transendocardial catheter-based injections of ixmyelocel-T vs. placebo in 114 patients with end-stage heart failure due to ischemic DCM. For these patients, no reasonable revascularization options (either surgical or percutaneous interventional) are likely to provide clinical benefit. The primary endpoint is the number of all-cause deaths, cardiovascular hospital admissions, and unplanned outpatient and emergency department visits to treat acute decompensated heart failure over the 12 months following administration of ixmyelocel-T vs. placebo.
The trial was designed to provide approximately 80% power to show a 46% difference in cardiac events for ischemic DCM patients treated with ixmyelocel-T vs. placebo. Results showed that during the 12 months following treatment, patients who received ixmyelocel-T demonstrated a reduction in the total number of deaths, cardiovascular hospitalizations or unplanned outpatient and emergency department visits to treat acute decompensated heart failure compared to placebo, meeting the study's primary endpoint. Full data results will be presented at the upcoming Late-Breaking Clinical Trial Sessions of the American College of Cardiology 65th Annual Scientific Session & Expo on April 4, 2016, and also will be submitted for publication.
The Food and Drug Administration has previously granted Ixmyelocel-T Orphan Drug designation for use in the treatment of DCM.
Ixmyelocel-T is a patient-specific, expanded multicellular therapy manufactured from the patient's own bone marrow utilizing Vericel's proprietary, highly automated, fully closed cell-processing system. The process selectively expands the population of mesenchymal stromal cells and alternatively activated macrophages, both responsible for production of anti-inflammatory and pro-angiogenic factors known to be important for repair of damaged tissue.
For more information visit Vcel.com.