Title : To be Announced.......
Background: Mesenchymal stem cells (MSCs) remain a promising potential therapy for ischemic cardiomyopathy. We report the results of a prospective trial of patients receiving direct intramyocardial injection of MSCs while undergoing transmyocardial revascularization (TMR) or coronary artery bypass graft surgery (CABG).
Methods: A phase I trial was conducted on adult patients suffering from ischemic heart disease with depressed left ventricular ejection fraction who were scheduled to undergo TMR or CABG. Autologous MSCs isolated from bone marrow were expanded for three weeks prior to scheduled surgery. Following completion of surgical revascularization, MSCs were directly injected into ischemic myocardium. Safety and feasibility of therapy were assessed. Cardiac functional status and changes in quality of life were evaluated at one year.
Results: Patients underwent simultaneous MSC and surgical revascularization therapy. MSCs were successfully expanded and no significant complications occurred as a result of the procedure. Regional contractility in the cell-treated areas demonstrated improvement at 12 months compared to baseline (TMR+MSCs Δ strain: -4.6% ± 2.1%; P = 0.02. CABG+MSCs Δ strain: -4.2% ± 6.0%; P = 0.30). Quality of life was enhanced, with substantial reduction in angina scores at one year post-treatment (TMR+MSCs: 1.3 ± 1.2. CABG+MSCs: 1.0 ± 1.4).
Conclusions: In this phase 1 trial, direct intramyocardial injection of autologous MSCs in conjunction with TMR or CABG was technically feasible and could be performed safely. Preliminary results demonstrate improved cardiac function and quality of life in patients at one year after treatment.