Adipose-derived Regenerative Cells Treatment for Congestive Heart Failure
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.
• 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