# Cardiopoietische celtherapie bij gevorderd ischemisch hartfalen: C-CURE 39-weeksresultaten

*geplaatst 2017-03-01 · Hartfalen · European heart journal · doi 10.1093/eurheartj/ehw543 · https://hartvaat.nl/2017/03/01/cardiopoietische-celtherapie-bij-gevorderd-ischemisch-hartfalen-c-cure-39-weeksr/*

Resultaten na 39 weken van de prospectieve gerandomiseerde dubbelblinde C-CURE-trial naar cardiopoietische celtherapie bij gevorderd ischemisch hartfalen.

## English: Cardiopoietic cell therapy for advanced ischaemic heart failure: results at 39 weeks of the prospective, randomized, double blind, sham-controlled CHART-1 clinical trial.

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.

## Abstract (original, from the publication)

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.

Auteurs: 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

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Bron: European heart journal, https://doi.org/10.1093/eurheartj/ehw543. Bijgewerkt 2026-07-03T18:38:31Z. 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.