This is a phase 2b, Multicenter, Randomize, Double –blind, placebo-controlled, parallel group study to evaluate the efficacy, safety, and tolerability of transendocardial injection of IXMYELOCEL-T in subjects with heart failure due to ischemic dilated cardiomyopathy (IDCM). Ixmyelocel-T is a patient-specific, expanded multicellular therapy under investigation for the treatment of subjects with heart failure (HF) due to ischemic dilated cardiomyopathy (IDCM).
The objective of this study is to assess the efficacy, safety and tolerability of ixmyelocel-T compared to placebo (vehicle control) when administered via transendocardial catheter-based injections to subjects with end stage heart failure due to IDCM, who have no reasonable revascularization options (either surgical or percutaneous interventional) likely to provide clinical benefit.
Up to 10 subjects will be involved in this Trial at The Methodist Hospital. Approximately 35 centers in the United States and Canada are expected to participate. The study will enroll 108 patients.