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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.

  • Author(s): Bartunek, Jozef
  • Terzic, Andre
  • Davison, Beth A
  • Filippatos, Gerasimos S
  • Radovanovic, Slavica
  • Beleslin, Branko
  • Merkely, Bela
  • Musialek, Piotr
  • Wojakowski, Wojciech
  • Andreka, Peter
  • Horvath, Ivan G
  • Katz, Amos
  • Dolatabadi, Dariouch
  • El Nakadi, Badih
  • Arandjelovic, Aleksandra
  • Edes, Istvan
  • Seferovic, Petar M
  • Obradovic, Slobodan
  • Vanderheyden, Marc
  • Jagic, Nikola
  • Petrov, Ivo
  • Atar, Shaul
  • Halabi, Majdi
  • Gelev, Valeri L
  • Shochat, Michael K
  • Kasprzak, Jaroslaw D
  • Sanz-Ruiz, Ricardo
  • Heyndrickx, Guy R
  • Nyolczas, Noémi
  • Legrand, Victor
  • Guédès, Antoine
  • Heyse, Alex
  • Moccetti, Tiziano
  • Fernandez-Aviles, Francisco
  • Jimenez-Quevedo, Pilar
  • Bayes-Genis, Antoni
  • Hernandez-Garcia, Jose Maria
  • Ribichini, Flavio
  • Gruchala, Marcin
  • Waldman, Scott A
  • Teerlink, John R
  • Gersh, Bernard J
  • Povsic, Thomas J
  • Henry, Timothy D
  • Metra, Marco
  • Hajjar, Roger J
  • Tendera, Michal
  • Behfar, Atta
  • Alexandre, Bertrand
  • Seron, Aymeric
  • Stough, Wendy Gattis
  • Sherman, Warren
  • Cotter, Gad
  • Wijns, William
  • CHART Program
  • et al.


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.


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.

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