Abstract 17966: First In Man Transendocardial Injection of Autologous AdiPose-deRived StEm Cells in Patients with Non RevaScularizable IschEmic Myocardium (PRECISE)

Background: Stem cells from various origins have been tested in patients with IHD ranging from AMI to ischemic heart failure, including those from bone marrow, skeletal muscle, and blood. We present the first-in-man study to assess the safety and feasibility of autologous adipose-derived regenerative cells (ADRCs) delivered transendocardialy in patients with non revascularizable ischemic myocardium. Methods: 27 patients with no option for revascularization were randomized (3:1) to receive 44±17 × 106 of ADRCs or placebo. Up to 540 mL of subcutaneous adipose tissue was harvested from the abdomen using minimally invasive liposuction procedures, and ADRCs were obtained by Cytori's proprietary extraction, washing and concentration methods (the CelutionTM system). Feasibility endpoints (infarct size measured by MRI as percent of LV infracted and peak VO2) were evaluated at baseline and 6 months. Post-hoc comparisons were made using Student's t-test or repeated measures ANOVA. Results: There were no adverse eve...