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Improved clinical course of autologous skeletal myoblast sheet (TCD-51073) transplantation when compared to a propensity score-matched cardiac resynchronization therapy population

  • Original Article
  • Tissue Engineering / Regenerative Medicine
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Abstract

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.

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Acknowledgments

We appreciate all of the investigators and site staff who participated in this clinical study.

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Authors and Affiliations

  1. Department of Therapeutic Strategy for Heart Failure, Graduate School of Medicine, University of Tokyo, 7-3-1 Hongo, Bunkyo-Ku, Tokyo, 113-8655, Japan

    Teruhiko Imamura & Koichiro Kinugawa

  2. Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine, Osaka, Japan

    Yasushi Sakata

  3. Department of Cardiovascular Surgery, Osaka University Graduate School of Medicine, Osaka, Japan

    Shigeru Miyagawa & Yoshiki Sawa

  4. Department of Cardiovascular Surgery, Tokyo Women’s Medical University, Tokyo, Japan

    Kenji Yamazaki

  5. Department of Cardiac Surgery, Graduate School of Medicine, University of Tokyo, Tokyo, Japan

    Minoru Ono

Authors
  1. Teruhiko Imamura
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  2. Koichiro Kinugawa
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  3. Yasushi Sakata
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  4. Shigeru Miyagawa
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  5. Yoshiki Sawa
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  6. Kenji Yamazaki
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  7. Minoru Ono
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Corresponding authors

Correspondence to Teruhiko Imamura or Koichiro Kinugawa.

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Disclosure

UMIN study Identifier: UMIN000008013. Sponsor/Name of Grant: Terumo Corporation. All authors except for T.I. serve as investigators in this trial. K.K. and Yoshiki Sawa have received joint research funds provided by Terumo Corporation. K.K. and T.I. are an endowed chair sponsored by Terumo Corporation.

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Imamura, T., Kinugawa, K., Sakata, Y. et al. Improved clinical course of autologous skeletal myoblast sheet (TCD-51073) transplantation when compared to a propensity score-matched cardiac resynchronization therapy population. J Artif Organs 19, 80–86 (2016). https://doi.org/10.1007/s10047-015-0862-9

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  • DOI: https://doi.org/10.1007/s10047-015-0862-9

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