RT Journal Article
T1 Cardiopoietic cell therapy for advanced ischaemic heart failure: results at 39 weeks of the prospective, randomized, double blind, sham-controlled CHART-1 clinical trial.
A1 Bartunek, Jozef
A1 Terzic, Andre
A1 Davison, Beth A
A1 Filippatos, Gerasimos S
A1 Radovanovic, Slavica
A1 Beleslin, Branko
A1 Merkely, Bela
A1 Musialek, Piotr
A1 Wojakowski, Wojciech
A1 Andreka, Peter
A1 Horvath, Ivan G
A1 Katz, Amos
A1 Dolatabadi, Dariouch
A1 El Nakadi, Badih
A1 Arandjelovic, Aleksandra
A1 Edes, Istvan
A1 Seferovic, Petar M
A1 Obradovic, Slobodan
A1 Vanderheyden, Marc
A1 Jagic, Nikola
A1 Petrov, Ivo
A1 Atar, Shaul
A1 Halabi, Majdi
A1 Gelev, Valeri L
A1 Shochat, Michael K
A1 Kasprzak, Jaroslaw D
A1 Sanz-Ruiz, Ricardo
A1 Heyndrickx, Guy R
A1 Nyolczas, Noémi
A1 Legrand, Victor
A1 Guédès, Antoine
A1 Heyse, Alex
A1 Moccetti, Tiziano
A1 Fernandez-Aviles, Francisco
A1 Jimenez-Quevedo, Pilar
A1 Bayes-Genis, Antoni
A1 Hernandez-Garcia, Jose Maria
A1 Ribichini, Flavio
A1 Gruchala, Marcin
A1 Waldman, Scott A
A1 Teerlink, John R
A1 Gersh, Bernard J
A1 Povsic, Thomas J
A1 Henry, Timothy D
A1 Metra, Marco
A1 Hajjar, Roger J
A1 Tendera, Michal
A1 Behfar, Atta
A1 Alexandre, Bertrand
A1 Seron, Aymeric
A1 Stough, Wendy Gattis
A1 Sherman, Warren
A1 Cotter, Gad
A1 Wijns, William
A1 CHART Program, 
K1 Cardiopoiesis
K1 Cardiovascular disease
K1 Disease severity
K1 Marker
K1 Precision medicine
K1 Regenerative medicine
K1 Stem cell
K1 Target population
AB 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 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. 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.
YR 2017
FD 2017
LK http://hdl.handle.net/10668/10715
UL http://hdl.handle.net/10668/10715
LA en
DS RISalud
RD Apr 7, 2025