Safety and Efficacy of Autologous Skeletal Myoblast Sheets (TCD-51073) for the Treatment of Severe Chronic Heart Failure Due to Ischemic Heart Disease

• Sawa Yoshiki

  Department of Cardiovascular Surgery, Osaka University Graduate School of Medicine

• Yoshikawa Yasushi

  Department of Cardiovascular Surgery, Osaka University Graduate School of Medicine

• Toda Koichi

  Department of Cardiovascular Surgery, Osaka University Graduate School of Medicine

• Fukushima Satsuki

  Department of Cardiovascular Surgery, Osaka University Graduate School of Medicine

• Yamazaki Kenji

  Department of Cardiovascular Surgery, Tokyo Women’s Medical University

• Ono Minoru

  Department of Thoracic Surgery, Graduate School of Medicine, University of Tokyo

• Sakata Yasushi

  Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine

• Hagiwara Nobuhisa

  Department of Cardiology, Tokyo Women’s Medical University

• Kinugawa Koichiro

  Department of Therapeutic Strategy for Heart Failure, Graduate School of Medicine, University of Tokyo

• Miyagawa Shigeru

  Department of Cardiovascular Surgery, Osaka University Graduate School of Medicine

Bibliographic Information

Other Title

• LATE BREAKING CLINICAL TRIAL (JCS 2015) : Safety and Efficacy of Autologous Skeletal Myoblast Sheets (TCD-51073) for the Treatment of Severe Chronic Heart Failure Due to Ischemic Heart Disease

Abstract

Background:Poor survival outcomes for patients with severe heart failure (HF) and the donor shortage for heart transplantation warrant the development of myocardial regenerative therapy. We performed a multicenter, phase II study to evaluate the safety and efficacy of autologous skeletal myoblast sheets (TCD-51073).Methods and Results:In 3 study sites, we enrolled 7 patients with severe chronic HF due to ischemic heart disease despite maximal therapy, all of whom underwent transplantation of TCD-51073. No serious arrhythmia was reported, and no changes were noted in the frequency of ventricular extrasystole frequency. The primary efficacy endpoint of the change in left ventricular ejection fraction (LVEF) on gated blood-pool scintigraphy at 26 weeks after transplantation showed that 5 subjects were responders (classified as “improved” or “unchanged”). In addition, LVEF on echocardiography improved over time, with a change in LVEF of 7.1±2.8% at 26 weeks posttransplantation. Among the 7 subjects, 6 showed improvement in New York Heart Association functional class by at least 1 class. The 6-min walk distance was 410.1±136.1 m before transplantation and 455.4±103.7 m at 26 weeks after transplantation.Conclusions:This study demonstrated the feasibility and safety of the transplantation of TCD-51073 in the patients with severe chronic HF due to ischemic heart disease, suggesting that TCD-51073 might maintain or improve cardiac function, symptoms, and physical function. (Circ J 2015; 79: 991–999)

Journal

• Circulation Journal

  Circulation Journal 79 (5), 991-999, 2015

  The Japanese Circulation Society

Keywords

• Heart failure
• Multicenter study
• Myoblast sheets
• Regenerative therapy

Details

• CRID: 1390001205109167872
• NII Article ID: 130005066251
• NII Book ID: AA11591968
• DOI: 10.1253/circj.cj-15-0243
• ISSN: 13474820
• ISSN: 13469843
• NDL BIB ID: 026342554
• PubMed: 25912561
• Web Site: https://ndlsearch.ndl.go.jp/books/R000000004-I026342554
• Web Site: https://www.jstage.jst.go.jp/article/circj/79/5/79_CJ-15-0243/_pdf
• Web Site: https://search.jamas.or.jp/link/ui/2015281965
• Text Lang: en
• Data Source:
  • JaLC
  • NDL
  • Crossref
  • PubMed
  • CiNii Articles
  • KAKEN
• Abstract License Flag: Disallowed