2015 年 22 巻 2 号 p. 165-170
We have investigated the safety and efficacy of skeletal myoblast cell (SMBc) sheet transplantation for treating severe heart failure, in which scaffold-free cell-sheets are placed on the epicardial surface to maximize the paracrine eff ects. First-in-human clinical trial enrolled 4 DCM patients with LVAD, all of who successfully underwent transplantation of SMBc sheet without major complications, while 2 patients weaned off LVAD. The subsequent Phase I/IIa clinical trial enrolled 7 DCM patients and 8 ICM patients. As a result, symptoms, tolerance for exercise and incidence of heart failure were signifi cantly improved and cardiac function was recovered in the majority of the patients. SMBc sheet transplantation was feasible, safe and potentially effective to date and therefore further clinical follow-up and accumulation of the cases are required to establish the proof-of-concept of this treatment.