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 events related to ADRCs harvesting or delivery. Post procedure adverse events were evenly distributed within two groups. In the ADRCs group, infarct size remained stable from baseline to 6 months while significant worsening was observed in controls (−3.0±3.8% and 5.2±3.4%, respectively; p=0.04) (Fig A). Peak VO2 improved in the ADRCs group, but worsened in controls (0.6±0.7 and -2.8±1.4 mL/kg/min respectively) (Fig B). There were no significant differences in LVEFs and LV volumes (by Echo and SPECT).
Conclusions: In this randomized, placebo-controlled, double-blind study, administration of ADRCs resulted in a stabilization of infarct size and improvement in maximal oxygen consumption. Harvesting and transendocardial delivery of ADRCs were safe and feasible. This study indicates that ADRCs have the potential to become a new and effective treatment for this patient population we have studied. A larger study should be undertaken to confirm these findings.
- © 2010 by American Heart Association, Inc.