Intracoronary Cardiosphere-Derived Cells After Myocardial Infarction: Evidence of Therapeutic Regeneration in the Final 1-Year Results of the CADUCEUS Trial

Acute myocardial infarction (MI) results in the replacement of living heart muscle by a fibrous scar. Although traditional therapeutic strategies (timely reperfusion and optimal drug- and device-based therapies) have reduced MI-associated mortality (1), new approaches are needed for patients in whom left ventricular (LV) dysfunction develops (2). To that end, over the past decade, cell therapy has emerged as a promising treatment strategy. Multiple cell types including bone marrow mononuclear cells (3-6), bone marrow mesenchymal cells (7), and adipose tissue–derived cells (8) have been used in the setting of acute or convalescent MI, but efficacy has been inconsistent (3-6) and, overall, modest (9). Six-month primary endpoint analysis of the proof-of-concept, prospective, randomized, controlled CADUCEUS (CArdiosphere-Derived aUtologous stem CElls to reverse ventricUlar dySfunction) trial (10) demonstrated the feasibility of harvesting, expanding, and delivering autologous CDCs (11) by intracoronary infusion in post-MI patients. We found that autologous CDCs appear to be safe and effective in decreasing scar size, increasing viable myocardium, and improving regional myocardial function at 6 months post-treatment. However, whether these effects are sustained at 1 year after cell administration is unknown. Here, we report the final 1-year endpoint results of the CADUCEUS trial, including a comprehensive magnetic resonance imaging (MRI) analysis of myocardial regeneration and clinical correlates of regenerative efficacy.