P4604Insights into left ventricular remodelling and clinical outcomes after Wharton's jelly multipotent stem cells transcoronary administration in a pilot cohort of CIRCULATE-AMI Trial (NCT03404063)

Abstract Introduction CIRCULATE-Acute Myocardial Infarction Trial (NCT03404063) is a double-blind controlled trial (RCT) that is randomizing consecutive patients with their first, large AMI (LVEF ≤45% and/or cMRI -infarct size ≥10% of LV) successfully treated by infarct-related artery (IRA) primary percutaneous coronary intervention reperfusion (TIMI ≥2) to transcoronary administration of Wharton Jelly Multipotent Stem Cells (WJMSCs) vs. placebo (2:1), preceded by evaluation of safety, WJMSCs myocardial uptake, and echocardiographic, cMRI and SPECT left ventricular remodelling and hemodynamic changes in pilot study cohort (PSC). Purpose To evaluate LV remodelling and hemodynamic features following WJMSCs transplantation in CIRCULATE-AMI PSC. Methods Ten consecutive patients (age 32–65 years) were administered 30 000 000 WJMSCs via the infarct-related artery at ≈5–7 days after AMI using transradial approach and a coronary-non-occlusive catheter dedicated to cell delivery. Within 3 years of follow up SPECT was performed at baseline and 1 year, echo and cMRI were performed at baseline, 1 year and 3 years. Results 3-year observation (cMRI) shows a significant decrease of median left ventricular mass (LVM) between WJMSCs administration and 1 year 140 g (IQR 128–150) vs. 97 g (95–128), that is sustained at 3 years 93 g (80–119), p0,05 for all. Furthermore, there was a significant increase in stroke volume measured by SPECT baseline vs. 1 year (53.3±7.6 ml vs. 68.2±5.2ml); cMRI baseline vs. 1 year vs. 3 years (72.7±5.2 ml vs. 96.9±8.1 ml vs. 93.2±7.8 ml) and Echo (64.3±2.9 ml vs. 68.8±4.1 ml vs. 81.9±7.1 ml), p