{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,19]],"date-time":"2026-08-19T10:43:33Z","timestamp":1787136213525,"version":"build-2736575974"},"reference-count":21,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"4","content-domain":{"domain":["www.ahajournals.org"],"crossmark-restriction":true},"short-container-title":["JAHA"],"published-print":{"date-parts":[[2017,4,5]]},"abstract":"\n Background<\/jats:title>\n When transplanted into failing heart, autologous somatic tissue\u2013derived cells yield functional recovery via paracrine effects that enhance native regeneration. However, the therapeutic effects are modest. We developed a method in which scaffold\u2010free cell sheets are attached to the epicardial surface to maximize paracrine effects. This Phase I clinical trial tested whether transplanting autologous cell\u2013sheets derived from skeletal muscle is feasible, safe, and effective for treating severe congestive heart failure.<\/jats:p>\n <\/jats:sec>\n \n Methods and Results<\/jats:title>\n \n Fifteen ischemic cardiomyopathy patients and 12 patients with dilated cardiomyopathy, who were in New York Heart Association functional class\n II<\/jats:styled-content>\n or\n III<\/jats:styled-content>\n and had been treated with the maximum medical and\/or interventional therapies available, were enrolled. Scaffold\u2010free cell sheets of 3 to 9\u00d710\n 8<\/jats:sup>\n cells derived from autologous muscle were transplanted over the\n LV<\/jats:styled-content>\n free wall via left thoracotomy, without additional interventional treatments. There were no procedure\u2010related major complications during follow\u2010up. The majority of the ischemic cardiomyopathy patients showed marked symptomatic improvement in New York Heart Association classification (pre: 2.9\u00b10.5 versus 6\u00a0months: 2.1\u00b10.4,\n P<\/jats:italic>\n <0.01; 1\u00a0year: 1.9\u00b10.3,\n P<\/jats:italic>\n <0.01) and the Six\u2010Minute Walk Test with significant reduction of serum brain natriuretic peptide level (pre: 308\u00b172\u00a0pg\/mL versus 6\u00a0months: 191\u00b156 versus 1\u00a0year: 182\u00b146,\n P<\/jats:italic>\n <0.05), pulmonary artery pressure, pulmonary capillary wedge pressure, pulmonary vein resistance, and left ventricular wall stress after transplantation instead of limited efficacy in dilated cardiomyopathy patients.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n Cell\u2010sheet transplantation as a sole therapy was feasible for treating cardiomyopathy. Promising results in the safety and functional recovery warrant further clinical follow\u2010up and larger studies to confirm this treatment's efficacy for severe congestive heart failure.<\/jats:p>\n <\/jats:sec>\n \n Clinical Trial Registration<\/jats:title>\n \n URL<\/jats:styled-content>\n :\n http:\/\/www.umin.ac.jp\/english\/<\/jats:ext-link>\n . Unique identifier:\n UMIN<\/jats:styled-content>\n 000003273.\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1161\/jaha.116.003918","type":"journal-article","created":{"date-parts":[[2017,4,5]],"date-time":"2017-04-05T20:55:43Z","timestamp":1491425743000},"update-policy":"https:\/\/doi.org\/10.1161\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":150,"title":["Phase I Clinical Trial of Autologous Stem Cell\u2013Sheet Transplantation Therapy for Treating Cardiomyopathy"],"prefix":"10.1161","volume":"6","author":[{"given":"Shigeru","family":"Miyagawa","sequence":"first","affiliation":[{"name":"Department of Cardiovascular Surgery, Osaka University Graduate School of Medicine, Osaka, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Keitaro","family":"Domae","sequence":"additional","affiliation":[{"name":"Department of Cardiovascular Surgery, Osaka University Graduate School of Medicine, Osaka, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yasushi","family":"Yoshikawa","sequence":"additional","affiliation":[{"name":"Department of Cardiovascular Surgery, Osaka University Graduate School of Medicine, Osaka, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Satsuki","family":"Fukushima","sequence":"additional","affiliation":[{"name":"Department of Cardiovascular Surgery, Osaka University Graduate School of Medicine, Osaka, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Teruya","family":"Nakamura","sequence":"additional","affiliation":[{"name":"Department of Cardiovascular Surgery, Osaka University Graduate School of Medicine, Osaka, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Atsuhiro","family":"Saito","sequence":"additional","affiliation":[{"name":"Department of Medical Innovation, Medical Center for Translational and Clinical Research, Osaka University Hospital, Osaka, 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Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masahiro","family":"Takeuchi","sequence":"additional","affiliation":[{"name":"Department of Clinical Medicine, School of Pharmacy Kitasato University, Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yoshiki","family":"Sawa","sequence":"additional","affiliation":[{"name":"Department of Cardiovascular Surgery, Osaka University Graduate School of Medicine, Osaka, 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