Abstract 15644: The NHLBI and Cardiovascular Cell Therapy Research Network (CCTRN) TIME Trial: Two-Year Results

Background: The NHLBI-sponsored TIME Trial of the CCTRN investigated if the timing of stem cell delivery affects recovery of LV function following STEMI. It was a randomized, placebo-controlled trial of 120 patients with anterior STEMI randomized (2:1) to either 150 million autologous bone marrow mononuclear cells (BMCs) or cell-free placebo with intracoronary delivery on Day 3 or Day 7 following reperfusion with PCI in patients with LV dysfunction (LVEF ¬ Methods and Results: 85 patients (BMC=58; Placebo=27) returned for pre-specified 1 and 2-year follow-up MRIs. Data are presented as the aggregate of the Day 3 and Day 7 groups (means). While LVEF and regional wall motion increased in both groups between baseline and 6 months (p Conclusion: A significant reduction in infarct size and LV mass occurs during the initial six months following reperfused STEMI that is unaffected by BMC administration. After two years, the initial improvement in LV function remained stable in both groups but is accompanied by a small, non-significant increase in LV volumes. No safety concerns were observed in this high-risk STEMI cohort with moderate LV dysfunction. ClinicalTrials.gov Number, NCT00684021