Intramyocardial Transplantation of Umbilical Cord Mesenchymal Stromal Cells in Chronic Ischemic Cardiomyopathy: A Controlled, Randomized Clinical Trial (HUC-HEART Trial)

摘要: Background and objectives The HUC-HEART Trial (ClinicalTrials.gov Identifier: NCT02323477) was a controlled, prospective, phase I/II, multicenter, single-blind, three-arm randomized study of intramyocardial delivery human umbilical cord-derived mesenchymal stromal cells (HUC-MSCs) combined with coronary artery bypass-grafting (CABG) in patients chronic ischemic cardiomyopathy (CIC). trial aimed to assess (i) the safety efficacy cell transplantation during one-year follow-up, (ii) compare HUC-MSCs autologous bone-marrow- derived mononuclear (BM-MNCs) same clinical settings. Methods results Fifty-four who were receive (23×106) (n=26) or BM-MNCs (70×107) (n=12) combination CABG surgery. control (n=16) received no cells/vehicles but intervention. All screened at baseline 1, 3, 6, 12 months after transplantation. Forty-six (85%) completed follow-up. No short/mid-term adverse events encountered. Decline NT-proBNP (baseline∼ 6 months) both cell-treated groups; an increase left ventricular ejection fraction (LVEF) (5.4%) stroke volume (19.7%) noted (baseline∼6 only HUC-MSC group. Decreases also detected necrotic myocardium as 2.3% control, 4.5% BM-MNC, 7.7% groups. 6-min walking test revealed (14.4%) (23.1%) Conclusions Significant findings directly related justified their CIC. Stricter patient selection criteria precisely aligned dose intervals, rigorous follow-up by detailed diagnostic approaches would further help clarify responsiveness therapy.