Study to Assess Safety and Efficacy of Treating Symptomatic, Ischemic, Chronic Congestive Heart Failure Patients with an LVEF of ≤40% with Fresh, Uncultured, Autologous, Adipose-derived Regenerative Cells Isolated from Lipoaspirate.
Trial Parameters
Brief Summary
To investigate patients suffering from iHF and a LVEF of equal or less than 40% despite best medical treatment safety and efficacy of a single retrograde intra-cardiac venous (i.cv.) injection of UA-ADRCs isolated from lipoaspirate at the point of care, using the Transpose® RT / Matrase System (InGeneron, Houston, TX, USA) through an over-the- wire, small balloon catheter, advanced through the coronary si-nus and located within a coronary vein at the site of inter-est, versus patients on best medical treatment.
Eligibility Criteria
Inclusion Criteria * Have documented coronary artery disease with evidence of myocardial injury, LV dysfunction, and clinical evidence of heart failure * Have an EF ≤40% by cardiac MRI * Be receiving guideline-driven medical therapy for heart failure at stable and tolerated doses for ≥1 month before consent * Be a candidate for right heart cardiac catheterization * Have New York Heart Association class I, II, or III heart failure symptoms * If a female of childbearing potential, be willing to use one form of birth control for the duration of the study, and undergo a pregnancy test at baseline and within 36 h before treatment Exclusion Criteria * Indication for standard-of-care surgery (including valve surgery, placement of LV assist device, or imminent heart transplantation), CABG procedure, and PCI. Candidates cannot be UNOS 1A or 1B, and they must have documented low probability of being transplanted. * PCI within 3 months of randomization * CABG within 3 months of randomization * Va