A Multicenter, Randomized, 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.
The main purpose of this research study is to determine the efficacy and safety of ixmyelocel-T (cells from your bone marrow) compared to placebo (an inactive solution) when given to subjects with ischemic dilated cardiomyopathy (IDCM-a condition where the heart muscle is weakened and does not pump blood properly) who have no reasonable options for surgery or other medical procedures to fix their heart. Ixmyelocel-T/placebo will be administered through an injection catheter to your heart muscle and you will be followed to evaluate the safety and effectiveness in improving your IDCM symptoms.
Heart & Vascular - Structural Heart Trials
Paul Huang, MD
Males and non-pregnant, non-lactating females age 30 to 86 years of age at screening with a diagnosis of ischemic dilated cardiomyopathy and a LVEF ≤35% by echocardiogram.