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.
January 01, 1900
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.