Improved clinical course of autologous skeletal myoblast sheet (TCD-51073) transplantation when compared to a propensity score-matched cardiac resynchronization therapy population.
We recently reported a multi-center, single-arm, phase II study that evaluated the efficacy and safety of autologous skeletal myoblast sheet (TCD-51073) transplantation. The advantage of this procedure over a control group has not yet been analyzed. Seven patients with advanced heart failure due to ischemic etiology (TCD-51073 group, New York Heart Association (NYHA) class III; left ventricular ejection fraction (LVEF) <35 %) refractory to optimal medical and coronary revascularization therapy, received TCD-51073 at 3 study centers between 2012 and 2013 with a 2-year follow-up period. As previously reported, 112 patients received cardiac resynchronization therapy (CRT) with follow-up at the University of Tokyo Hospital between 2007 and 2014. Of them, 21 patients were selected for the control group by propensity score matching. No significant difference in baseline variables between the groups was observed. LVEF and NYHA class improved significantly in the TCD-51073 group during the 6-month study period (p < 0.05). During the 2-year follow-up, 7 patients (33 %) in the CRT group and no patient in the TCD-51073 group died due to cardiac disease or received VAD implantation (p = 0.128 by the log-rank test). In conclusion, transplantation of TCD-51073 is clinically advantageous in facilitating LV reverse remodeling, improving HF symptoms, and preventing cardiac death in patients with ischemic etiology when compared to background-matched patients receiving CRT.
Department of Therapeutic Strategy for Heart Failure, Graduate School of Medicine, University of Tokyo, 7-3-1 Hongo, Bunkyo-Ku, Tokyo, 113-8655, Japan. imamurate-int@h.u-tokyo.ac.jp.
Teruhiko
T
Imamura
Department of Therapeutic Strategy for Heart Failure, Graduate School of Medicine, University of Tokyo, 7-3-1 Hongo, Bunkyo-Ku, Tokyo, 113-8655, Japan. kinugawa-tky@umin.ac.jp.
Koichiro
K
Kinugawa
Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine, Osaka, Japan.
Yasushi
Y
Sakata
Department of Cardiovascular Surgery, Osaka University Graduate School of Medicine, Osaka, Japan.
Shigeru
S
Miyagawa
Department of Cardiovascular Surgery, Osaka University Graduate School of Medicine, Osaka, Japan.
Yoshiki
Y
Sawa
Department of Cardiovascular Surgery, Tokyo Women's Medical University, Tokyo, Japan.
Kenji
K
Yamazaki
Department of Cardiac Surgery, Graduate School of Medicine, University of Tokyo, Tokyo, Japan.
Minoru
M
Ono
D000328:Adult; D000368:Aged; D058406:Cardiac Resynchronization Therapy; D006333:Heart Failure / Q000209:etiology / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D032448:Myoblasts, Skeletal / Q000637:transplantation*; D017202:Myocardial Ischemia / Q000150:complications / Q000628:therapy*; D057216:Propensity Score; D016896:Treatment Outcome; D016277:Ventricular Function, Left / Q000502:physiology*
Cardiac death; Heart failure; Ischemic cardiomyopathy; Regeneration; Skeletal myoblast transplantation