SAFEty and efficacy of autologous bone marrow – derived mononuclear stem cell therapy in patients with severe chronic ischemic Heart Failure – rationale and design

Abstract

The main aim of this study is to explore the safety and efficacy of autologous bone marrow – derived mononuclear stem cell therapy in patients with severe chronic ischemic heart failure on short to medium-term (1-3 months). The SAFE-HF trial is a prospective, single center, two-arm, controlled trial with blind evaluation of endpoints. Target population will consist of patients with heart failure due to prior extensive myocardial infarction and left ventricle ejection fraction of less than 35% – namely the population with the highest risk of adverse events and the highest mortality. All patients will be treated with the state of the art reperfusion – primary percutaneous coronary intervention and also with guidelinebased optimal medical therapy. The stem cell injection will be performed 1 to 3 months after the acute event; evolution of stem cell treated patients will be compared with matched control–cases. Comprehensive assessment of outcomes will be done at 1 and 3 months follow-up; serum biomarkers, cardiac structural and physiological parameters, functional capacity and health-related quality of life will be evaluated. This pilot study possibly will serve as a foundation for designing future trials.