Methods:

In this randomized, double-blind, placebo-controlled phase 2B trial (ixCELL-DCM), patients from 31 sites in North America with New York Heart Association class III or IV symptomatic heart failure due to ischemic dilated cardiomyopathy, who had left ventricular ejection fraction ≤35%, an automatic implantable cardioverter-defibrillator, and who were ineligible for revascularization procedures were randomly assigned (1:1) to receive ixmyelocel-T or placebo at the time of bone marrow aspiration and followed for 12 months. Randomization was done through an interactive (voice/web) response system. The pharmacist, treating physician, and coordinator at each site were unblinded, but the follow-up team was completely blinded. The primary endpoint was a composite of all-cause death, cardiovascular admission to hospital, and unplanned clinic visits to treat acute decompensated heart failure based on the blinded adjudication of an independent clinical endpoint committee. Primary efficacy endpoint analyses and safety analyses were done by modified intention to treat.