Abstract
Objectives: The ADVANCE clinical trial sought to define the safety, feasibility and efficacy of an intracoronary infusion of adipose derived regenerative cells in patients admitted with an acute ST-elevation myocardial infarction (STEMI) within 24 hours of successful primary PCI. Methods: In this randomized, double-blind, placebo-controlled trial (n=23, 2:1 randomization), within 24 hours of successful primary PCI following STEMI, a small volume liposuction was performed for fat harvest and ADRC isolation by an automated Celution® System, and intracoronary infusion within 12 hours of the liposuction. Results: 23 patients were enrolled to date (all male, age 58 years, BMI 28 kg/m 2 ). The liposuction procedure data are shown in the table TEMI patients were routinely treated with dual anti platelets and heparin. The decline in hemoglobin following the liposuction procedure from baseline over the 10 hours following the procedure was 10.2% ±7.6 (mean ± SD) Although two patients had >20% of Hb decline at anytime (maximum 20.8%), one of these patients returned to within 10% of baseline by 10 hours without transfusion. The liposuction procedure was completed in all but one patient (terminated early due to hypotension - resolved with termination of procedure). IC infusion of the ADRC suspension was performed successfully in all patients. No impediment of coronary TIMI flow was observed during or following cell infusion of these mesenchymal-like cells. No ventricular arrhythmias were observed during cell infusion. No major adverse cardiac or cerebral events (MACCE) occurred within 30 days of the procedures. Conclusion: Limited liposuction to harvest fat for ADRC stem cell isolation and subsequent intracoronary infusion of these autologous ADRCs can be performed safely in patients with acute STEMI under dual antiplatelets therapy, demonstrating feasibility of the therapeutic application of point-of-care cell therapy using ADRCs.
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