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


ABSTRACT:

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.

SUBMITTER: Bartunek J 

PROVIDER: S-EPMC5381596 | biostudies-literature | 2017 Mar

REPOSITORIES: biostudies-literature

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

Bartunek Jozef J   Terzic Andre A   Davison Beth A BA   Filippatos Gerasimos S GS   Radovanovic Slavica S   Beleslin Branko B   Merkely Bela B   Musialek Piotr P   Wojakowski Wojciech W   Andreka Peter P   Horvath Ivan G IG   Katz Amos A   Dolatabadi Dariouch D   El Nakadi Badih B   Arandjelovic Aleksandra A   Edes Istvan I   Seferovic Petar M PM   Obradovic Slobodan S   Vanderheyden Marc M   Jagic Nikola N   Petrov Ivo I   Atar Shaul S   Halabi Majdi M   Gelev Valeri L VL   Shochat Michael K MK   Kasprzak Jaroslaw D JD   Sanz-Ruiz Ricardo R   Heyndrickx Guy R GR   Nyolczas Noémi N   Legrand Victor V   Guédès Antoine A   Heyse Alex A   Moccetti Tiziano T   Fernandez-Aviles Francisco F   Jimenez-Quevedo Pilar P   Bayes-Genis Antoni A   Hernandez-Garcia Jose Maria JM   Ribichini Flavio F   Gruchala Marcin M   Waldman Scott A SA   Teerlink John R JR   Gersh Bernard J BJ   Povsic Thomas J TJ   Henry Timothy D TD   Metra Marco M   Hajjar Roger J RJ   Tendera Michal M   Behfar Atta A   Alexandre Bertrand B   Seron Aymeric A   Stough Wendy Gattis WG   Sherman Warren W   Cotter Gad G   Wijns William W  

European heart journal 20170301 9


<h4>Aims</h4>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.<h4>Methods and results</h4>This multinational, randomized, double-blind, sham-controlled study was conducted in 39 hospitals. Patients with symptomatic ischaemic heart failure on guideline-di  ...[more]

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