Abstract
Heart transplantation and ventricular assist device for the patients with end-stage heart failure are limited by availability and durability due to limited donor or device-related complication. Thus, complementation or a new alternative is needed for the treatment of severe heart failure. Based on the results of basic experiments, we applied skeletal myoblast cell sheet transplantation in a clinical setting using cell-sheet methods with temperature-responsive dish for the treatment of heart failure patient from 2007. After confirming the safety of this treatment, we started a clinical trial of myoblast cell sheet transplantation as sole therapy. According to these results, in 2015, myoblast cell sheet transplantation with ischemic cardiomyopathy was approved by the Japanese government and now this treatment was covered by Japanese health insurance. Here we report our approach and future perspective of cardiac regenerative therapy using this new treatment method for severe heart failure including new strategy incorporating regenerative therapy in the conventional treatment of heart failure including VAD and heart transplantation.
This is a preview of subscription content, log in via an institution to check access.
Similar content being viewed by others
Change history
17 February 2021
A Correction to this paper has been published: https://doi.org/10.1007/s10047-020-01201-z
References
Nakatani T, Fukushima N, Ono M, Saiki Y, Matsuda H, Nunoda S, et al. The registry report of heart transplantation in Japan (1999–2014). Circ J. 2016;80:44–50.
Kirklin JK, Naftel DC, Pagani FD, Kormos RL, Steenson LW, Blume ED, et al. Sixth INTERMACS annual report: a 10,000-patient database. J Heart Lung Trans. 2014;33:555–64.
Shimizu T, Yamato M, Kikuchi A, Okano T. Two-dimensional manipulation of cardiac myocyte sheets utilizing temperature-responsive culture dishes augments the pulsatile amplitude. Tissue Eng. 2001;7:141–51.
Memon IA, Sawa Y, Fukushima N, Matsumiya G, Miyagawa S, Taketani S, et al. Repair of impaired myocardium by means of implantation of engineered autologous myoblast sheets. J Thorac Cardiovasc Surg. 2005;130:1333–411.
Miyagawa S, Saito A, Sakaguchi T, Yoshikawa Y, Yamauchi T, Imanishi Y, et al. Impaired myocardium regeneration with skeletal cell sheets—a preclinical trial for tissue-engineered regeneration therapy. Transplantation. 2010;90:364–72.
Sawa Y, Miyagawa S, Sakaguchi T, Fujita T, Matsuyama A, Saito A, et al. Tissue engineered myoblast sheets improved cardiac function sufficiently to discontinue LVAS in a patient with DCM: report of a case. Surg Today. 2012;42(2):181–4.
Poglajen G, Gregoric ID, Radovancevic R, Vrtovec B. Stem cell and left ventricular assist device combination therapy. Circ Heart Fail. 2019;12:e005454.
Sawa Y, Yoshikawa Y, Toda K, Fukushima S, Yamazaki K, Ono M, et al. Safety and efficacy of autologous skeletal myoblast sheets (TCD-51073) for the treatment of severe chronic heart failure due to ischemic heart disease. Circ J Off J Jpn Circ Soc. 2015;79:991–9.
Menasche P, Alfieri O, Janssens S, McKenna W, Reichenspurner H, Trinquart L, et al. The myoblast autologous grafting in ischemic cardiomyopathy (MAGIC) trial: first randomized placebo-controlled study of myoblast transplantation. Circulation. 2008;117:1189–200.
Hare JM, Fishman JE, Gerstenblith G, Velazquez DD, Zambrano JP, Suncion VY, et al. Comparison of allogeneic vs. autologous bone marrow-derived mesenchymal stem cells delivered by transendocardial injection in patients with ischemic cardiomyopathy: the POSEIDON randomized trial. JAMA. 2012;308:2369–79.
Traverse JH, Henry TD, Pepine CJ, Willerson JT, Chugh A, Yang PC, et al. TIME trial: effect of timing of stem cell delivery following ST-elevation myocardial infarction on the recovery of global and regional left ventricular function final 2-year analysis. Circ Res. 2018;122:479–88.
Hare JM, DiFede DL, Castellanos AM, Florea V, Landin AM, El-Khorazaty J, et al. Randomized comparison of allogeneic vs. autologous mesenchymal stem cells for non-lschemic dilated cardiomyopathy: POSEIDON-DCM trial. J Am Coll Cardiol. 2017;69:526–37.
Kawamura M, Miyagawa S, Miki K, Saito A, Fukushima S, Higuchi T, et al. Feasibility, safety, and therapeutic efficacy of human induced pluripotent stem cell-derived cardiomyocyte sheets in a porcine ischemic cardiomyopathy model. Circulation. 2012;126(suppl 1):S29–S37.
Author information
Authors and Affiliations
Corresponding author
Ethics declarations
Conflict of interest
Y.S. received a research grant and patent fee from Terumo Corporation. K.D., S.M. and K.T. have no conflict of interest.
Additional information
Publisher's Note
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
Rights and permissions
About this article
Cite this article
Domae, K., Miyagawa, S., Toda, K. et al. New treatment strategy for severe heart failure: combination of ventricular assist device and regenerative therapy. J Artif Organs 24, 1–5 (2021). https://doi.org/10.1007/s10047-020-01185-w
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s10047-020-01185-w