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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

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...

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Autores principales: 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
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5381596/
https://www.ncbi.nlm.nih.gov/pubmed/28025189
http://dx.doi.org/10.1093/eurheartj/ehw543
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author 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
author_facet 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
author_sort Bartunek, Jozef
collection PubMed
description 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.
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spelling pubmed-53815962017-04-10 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 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 Eur Heart J Fast-Track Clinical Research 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. Oxford University Press 2017-03-01 2016-12-20 /pmc/articles/PMC5381596/ /pubmed/28025189 http://dx.doi.org/10.1093/eurheartj/ehw543 Text en © The Author 2016. Published by Oxford University Press on behalf of the European Society of Cardiology. http://creativecommons.org/licenses/by-nc/4.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com
spellingShingle Fast-Track Clinical Research
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
Cardiopoietic cell therapy for advanced ischaemic heart failure: results at 39 weeks of the prospective, randomized, double blind, sham-controlled CHART-1 clinical trial
title Cardiopoietic cell therapy for advanced ischaemic heart failure: results at 39 weeks of the prospective, randomized, double blind, sham-controlled CHART-1 clinical trial
title_full Cardiopoietic cell therapy for advanced ischaemic heart failure: results at 39 weeks of the prospective, randomized, double blind, sham-controlled CHART-1 clinical trial
title_fullStr Cardiopoietic cell therapy for advanced ischaemic heart failure: results at 39 weeks of the prospective, randomized, double blind, sham-controlled CHART-1 clinical trial
title_full_unstemmed Cardiopoietic cell therapy for advanced ischaemic heart failure: results at 39 weeks of the prospective, randomized, double blind, sham-controlled CHART-1 clinical trial
title_short Cardiopoietic cell therapy for advanced ischaemic heart failure: results at 39 weeks of the prospective, randomized, double blind, sham-controlled CHART-1 clinical trial
title_sort cardiopoietic cell therapy for advanced ischaemic heart failure: results at 39 weeks of the prospective, randomized, double blind, sham-controlled chart-1 clinical trial
topic Fast-Track Clinical Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5381596/
https://www.ncbi.nlm.nih.gov/pubmed/28025189
http://dx.doi.org/10.1093/eurheartj/ehw543
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