Vericel Reports Publication of Trial Rationale, Study Design for Phase 2b ixCELL-DCM Trial of Ixmyelocal-T for Heart Failure Due to Ischemic Dilated Cardiomyopathy

Vericel Corporation

, a leading developer of patient-specific expanded cellular therapies for the treatment of severe diseases and conditions, today announced the publication of the clinical trial rationale and study design for the company's Phase 2b ixCELL-DCM clinical trial of ixmyelocel-T in patients with advanced heart failure due to ischemic dilated cardiomyopathy (DCM) in the journal Cell Transplantation. On March 10, 2016, Vericel announced that the ixCELL-DCM trial met its primary endpoint of demonstrating a reduction in the total number of deaths, cardiovascular hospitalizations or unplanned outpatient and emergency department visits to treat acute decompensated heart failure during the 12 months following treatment with ixmyelocel-T compared to placebo. The ixCELL-DCM trial is believed to be the largest randomized, double-blind, placebo-controlled cell therapy clinical trial to treat heart failure due to ischemic DCM completed to date. The publication by Dr. Timothy Henry and colleagues (Henry T.D., Schaer G., Demaria A., et al., The ixCell-DCM Trial: Rationale and Design, Cell Transplantation, 2016) describes the study design, study population, treatment preparation and protocol, clinical endpoints, and statistical analysis plan for the ixCELL-DCM clinical trial. The full data results from the ixCELL-DCM trial are scheduled to 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.