Background: Transplantation of autologous myoblast cells has been shown to yield functional recovery of the failing heart via paracrine effects. We have introduced skeletal myoblast cell (SMBc) sheet methods for treating severe heart failure (HF), in which scaffold-free cell-sheets are attached on the epicardial surface to maximize the paracrine effects. Aim: The aim of this study is to evaluate the mid-term outcome and therapeutic efficacy of SMBc sheet transplantation for treating severe HF due to ischemic cardiomyopathy. Methods: This study enrolled 15 patients with chronic advanced HF despite optimum treatments. Scaffold-free cell-sheets containing SMBc (average: 5.4 ± 3.0 × 108 cells) was transplanted over the left ventricular (LV) free wall via the left thoracotomy without concomitant procedures. Results: All patients discharged from the hospital without procedure-related complications and lethal arrhythmias. NYHA functional class was significantly decreased (2.9 ± 0.5 to 1.9 ± 0.3 P < .05) and 6-minute walk distance was increased (405 ± 111 to 489 ± 158m P < .05) at 1 year, while these values maintained until the latest follow-up. Echocardiographically, LV systolic and diastolic diameters significantly decreased and ejection fraction significantly increased. In addition, incidence of requiring in-hospital treatment for HF was significantly decreased after SMBc sheet treatment (0.84 to 0.15 event/year P < .01). Conclusions: Mid-term outcome of SMBc sheet transplantation for ischemic cardiomyopathy was acceptable for safety, improvement of their quality of life and functional recovery, including reduced PVR.
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