{"id":"3fd3642eb5e4","type":"article","url":"https://hartvaat.nl/2017/03/01/cardiopoietische-celtherapie-bij-gevorderd-ischemisch-hartfalen-c-cure-39-weeksr/","title":"Cardiopoietische celtherapie bij gevorderd ischemisch hartfalen: C-CURE 39-weeksresultaten","title_en":"Cardiopoietic cell therapy for advanced ischaemic heart failure: results at 39 weeks of the prospective, randomized, double blind, sham-controlled CHART-1 clinical trial.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":["acuut-hartfalen","emperor-trials","step-hfpef"],"journal":"European heart journal","doi":"10.1093/eurheartj/ehw543","source_url":"https://doi.org/10.1093/eurheartj/ehw543","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"],"significance":6,"published":"2017-03-01","source_date":"2017-03-01","image":"","kennis":[],"congress":"","summary_en":"The C-CURE trial of cardiopoietic stem cell therapy in advanced ischemic heart failure showed preliminary efficacy signals at 39 weeks, though the improvement in functional capacity requires confirmation in larger trials.","created":"2026-07-03T10:26:35Z","updated":"2026-07-03T18:38:31Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Resultaten na 39 weken van de prospectieve gerandomiseerde dubbelblinde C-CURE-trial naar cardiopoietische celtherapie bij gevorderd ischemisch hartfalen.","abstract_original":"AIMS: 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. METHODS AND RESULTS: This multinational, randomized, double-blind, sham-controlled study was conducted in 39 hospitals. Patients with symptomatic ischaemic 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. CONCLUSION: 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."}