Title |
Cardiopoietic cell therapy for advanced ischemic heart failure: results at 39 weeks of the prospective, randomized, double blind, sham-controlled CHART-1 clinical trial
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Published in |
European Heart Journal, December 2016
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DOI | 10.1093/eurheartj/ehw543 |
Pubmed ID | |
Authors |
Jozef Bartunek, Andre Terzic, Beth A. Davison, Gerasimos S. Filippatos, Slavica Radovanovic, Branko Beleslin, Bela Merkely, Piotr Musialek, Wojciech Wojakowski, Peter Andreka, Ivan G. Horvath, Amos Katz, Dariouch Dolatabadi, Badih El Nakadi, Aleksandra Arandjelovic, Istvan Edes, Petar M. Seferovic, Slobodan Obradovic, Marc Vanderheyden, Nikola Jagic, Ivo Petrov, Shaul Atar, Majdi Halabi, Valeri L. Gelev, Michael K. Shochat, Jaroslaw D. Kasprzak, Ricardo Sanz-Ruiz, Guy R. Heyndrickx, Noémi Nyolczas, Victor Legrand, Antoine Guédès, Alex Heyse, Tiziano Moccetti, Francisco Fernandez-Aviles, Pilar Jimenez-Quevedo, Antoni Bayes-Genis, Jose Maria Hernandez-Garcia, Flavio Ribichini, Marcin Gruchala, Scott A. Waldman, John R. Teerlink, Bernard J. Gersh, Thomas J. Povsic, Timothy D. Henry, Marco Metra, Roger J. Hajjar, Michal Tendera, Atta Behfar, Bertrand Alexandre, Aymeric Seron, Wendy Gattis Stough, Warren Sherman, Gad Cotter, William Wijns, for the CHART Program |
Abstract |
Cardiopoietic cells, produced through cardiogenic conditioning of patients' mesenchymal stem cells, have shown preliminary efficacy. The Congestive Heart Failure Cardiopoietic Regenerative Therapy (CHART-1) trial aimed to validate cardiopoiesis-based biotherapy in a larger heart failure cohort. This multinational, randomized, double-blind, sham-controlled study was conducted in 39 hospitals. Patients with symptomatic ischemic heart failure on guideline-directed therapy (n = 484) were screened; n = 348 underwent bone marrow harvest and mesenchymal stem cell expansion. Those achieving > 24 million mesenchymal stem cells (n = 315) were randomized to cardiopoietic cells delivered endomyocardially with a retention-enhanced catheter (n = 157) or sham procedure (n = 158). Procedures were performed as randomized in 271 patients (n = 120 cardiopoietic cells, n = 151 sham). The primary efficacy endpoint was a Finkelstein-Schoenfeld hierarchical composite (all-cause mortality, worsening heart failure, Minnesota Living with Heart Failure Questionnaire score, 6-min walk distance, left ventricular end-systolic volume, and ejection fraction) at 39 weeks. The primary outcome was neutral (Mann-Whitney estimator 0.54, 95% confidence interval [CI] 0.47-0.61 [value > 0.5 favours cell treatment], P = 0.27). Exploratory analyses suggested a benefit of cell treatment on the primary composite in patients with baseline left ventricular end-diastolic volume 200-370 mL (60% of patients) (Mann-Whitney estimator 0.61, 95% CI 0.52-0.70, P = 0.015). No difference was observed in serious adverse events. One (0.9%) cardiopoietic cell patient and 9 (5.4%) sham patients experienced aborted or sudden cardiac death. The primary endpoint was neutral, with safety demonstrated across the cohort. Further evaluation of cardiopoietic cell therapy in patients with elevated end-diastolic volume is warranted. |
X Demographics
Geographical breakdown
Country | Count | As % |
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United Kingdom | 2 | 40% |
United States | 1 | 20% |
Unknown | 2 | 40% |
Demographic breakdown
Type | Count | As % |
---|---|---|
Members of the public | 3 | 60% |
Practitioners (doctors, other healthcare professionals) | 1 | 20% |
Scientists | 1 | 20% |
Mendeley readers
Geographical breakdown
Country | Count | As % |
---|---|---|
Chile | 1 | <1% |
United States | 1 | <1% |
Poland | 1 | <1% |
Unknown | 194 | 98% |
Demographic breakdown
Readers by professional status | Count | As % |
---|---|---|
Student > Master | 24 | 12% |
Student > Ph. D. Student | 23 | 12% |
Researcher | 22 | 11% |
Student > Bachelor | 19 | 10% |
Professor | 15 | 8% |
Other | 45 | 23% |
Unknown | 49 | 25% |
Readers by discipline | Count | As % |
---|---|---|
Medicine and Dentistry | 78 | 40% |
Biochemistry, Genetics and Molecular Biology | 15 | 8% |
Agricultural and Biological Sciences | 9 | 5% |
Nursing and Health Professions | 8 | 4% |
Pharmacology, Toxicology and Pharmaceutical Science | 7 | 4% |
Other | 18 | 9% |
Unknown | 62 | 31% |