Cardiopoietic stem cell therapy in ischaemic heart failure: long‐term clinical outcomes
Abstract Aims This study aims to explore long‐term clinical outcomes of cardiopoiesis‐guided stem cell therapy for ischaemic heart failure assessed in the Congestive Heart Failure Cardiopoietic Regenerative Therapy (CHART‐1) trial. Methods and results CHART‐1 is a multinational, randomized, and doub...
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| Format: | Article |
| Language: | English |
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Wiley
2020-12-01
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| Series: | ESC Heart Failure |
| Subjects: | |
| Online Access: | https://doi.org/10.1002/ehf2.13031 |
| _version_ | 1828855817865003008 |
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| author | Jozef Bartunek Andre Terzic Beth A. Davison Atta Behfar Ricardo Sanz‐Ruiz Wojciech Wojakowski Warren Sherman Guy R. Heyndrickx Marco Metra Gerasimos S. Filippatos Scott A. Waldman John R. Teerlink Timothy D. Henry Bernard J. Gersh Roger Hajjar Michal Tendera Stefanie Senger Gad Cotter Thomas J. Povsic William Wijns for the CHART Program |
| author_facet | Jozef Bartunek Andre Terzic Beth A. Davison Atta Behfar Ricardo Sanz‐Ruiz Wojciech Wojakowski Warren Sherman Guy R. Heyndrickx Marco Metra Gerasimos S. Filippatos Scott A. Waldman John R. Teerlink Timothy D. Henry Bernard J. Gersh Roger Hajjar Michal Tendera Stefanie Senger Gad Cotter Thomas J. Povsic William Wijns for the CHART Program |
| author_sort | Jozef Bartunek |
| collection | DOAJ |
| description | Abstract Aims This study aims to explore long‐term clinical outcomes of cardiopoiesis‐guided stem cell therapy for ischaemic heart failure assessed in the Congestive Heart Failure Cardiopoietic Regenerative Therapy (CHART‐1) trial. Methods and results CHART‐1 is a multinational, randomized, and double‐blind trial conducted in 39 centres in heart failure patients (n = 315) on standard‐of‐care therapy. The ‘active’ group received cardiopoietic stem cells delivered intramyocardially using a retention‐enhanced catheter. The ‘control’ group underwent patient‐level sham procedure. Patients were followed up to 104 weeks. In the entire study population, results of the primary hierarchical composite outcome were maintained neutral at Week 52 [Mann–Whitney estimator 0.52, 95% confidence interval (CI) 0.45–0.59, P = 0.51]. Landmark analyses suggested late clinical benefit in patients with significant left ventricular enlargement receiving adequate dosing. Specifically, beyond 100 days of follow‐up, patients with left ventricular end‐diastolic volume of 200–370 mL treated with ≤19 injections of cardiopoietic stem cells showed reduced risk of death or cardiovascular hospitalization (hazard ratio 0.38, 95% CI 0.16–0.91, P = 0.031) and cardiovascular death or heart failure hospitalization (hazard ratio 0.28, 95% CI 0.09–0.94, P = 0.040). Cardiopoietic stem cell therapy was well tolerated long term with no difference in safety readouts compared with sham at 2 years. Conclusions Longitudinal follow‐up documents that cardiopoietic stem cell therapy is overall safe, and post hoc analyses suggest benefit in an ischaemic heart failure subpopulation defined by advanced left ventricular enlargement on tolerable stem cell dosing. The long‐term clinical follow‐up thus offers guidance for future targeted trials. |
| first_indexed | 2024-12-13T01:01:47Z |
| format | Article |
| id | doaj.art-ade29cdc81994f4b9daed20367d13bfe |
| institution | Directory Open Access Journal |
| issn | 2055-5822 |
| language | English |
| last_indexed | 2024-12-13T01:01:47Z |
| publishDate | 2020-12-01 |
| publisher | Wiley |
| record_format | Article |
| series | ESC Heart Failure |
| spelling | doaj.art-ade29cdc81994f4b9daed20367d13bfe2022-12-22T00:04:39ZengWileyESC Heart Failure2055-58222020-12-01763345335410.1002/ehf2.13031Cardiopoietic stem cell therapy in ischaemic heart failure: long‐term clinical outcomesJozef Bartunek0Andre Terzic1Beth A. Davison2Atta Behfar3Ricardo Sanz‐Ruiz4Wojciech Wojakowski5Warren Sherman6Guy R. Heyndrickx7Marco Metra8Gerasimos S. Filippatos9Scott A. Waldman10John R. Teerlink11Timothy D. Henry12Bernard J. Gersh13Roger Hajjar14Michal Tendera15Stefanie Senger16Gad Cotter17Thomas J. Povsic18William Wijns19for the CHART ProgramCardiovascular Center OLV Hospital Moorselbaan 164 Aalst B‐9300 BelgiumCardiovascular Center OLV Hospital Moorselbaan 164 Aalst B‐9300 BelgiumMomentum Research, Inc. Durham NC USADepartment of Cardiovascular Medicine Mayo Clinic, Center for Regenerative Medicine 200 First Street SW Rochester MN 55905 USACardiology Department Hospital General Universitario Gregorio Marañón and CIBERCV (Instituto de Salud Carlos III) Madrid SpainDepartment of Cardiology and Structural Heart Disease Medical University of Silesia Katowice PolandConsultant South Egremont MA USACardiovascular Center OLV Hospital Moorselbaan 164 Aalst B‐9300 BelgiumCardiology, Department of Medical and Surgical Specialties, Radiological Sciences, and Public Health University and Spedali Civili Brescia ItalyNational and Kapodistrian University of Athens, School of Medicine Attikon University Hospital Athens GreeceSidney Kimmel Medical College Thomas Jefferson University Philadelphia PA USASchool of Medicine University of California San Francisco San Francisco CA USAThe Carl Edyth Lindner Center for Research and Education at The Christ Hospital Cincinnati OH USADepartment of Cardiovascular Medicine Mayo Clinic, Center for Regenerative Medicine 200 First Street SW Rochester MN 55905 USAPhospholamban Foundation Amsterdam NetherlandsDepartment of Cardiology and Structural Heart Disease Medical University of Silesia Katowice PolandMomentum Research, Inc. Durham NC USAMomentum Research, Inc. Durham NC USADuke Clinical Research Institute and Duke University Medical Center Durham NC USAThe Lambe Institute for Translational Medicine and Curam National University of Ireland Galway and Saolta University Healthcare Group Galway IrelandAbstract Aims This study aims to explore long‐term clinical outcomes of cardiopoiesis‐guided stem cell therapy for ischaemic heart failure assessed in the Congestive Heart Failure Cardiopoietic Regenerative Therapy (CHART‐1) trial. Methods and results CHART‐1 is a multinational, randomized, and double‐blind trial conducted in 39 centres in heart failure patients (n = 315) on standard‐of‐care therapy. The ‘active’ group received cardiopoietic stem cells delivered intramyocardially using a retention‐enhanced catheter. The ‘control’ group underwent patient‐level sham procedure. Patients were followed up to 104 weeks. In the entire study population, results of the primary hierarchical composite outcome were maintained neutral at Week 52 [Mann–Whitney estimator 0.52, 95% confidence interval (CI) 0.45–0.59, P = 0.51]. Landmark analyses suggested late clinical benefit in patients with significant left ventricular enlargement receiving adequate dosing. Specifically, beyond 100 days of follow‐up, patients with left ventricular end‐diastolic volume of 200–370 mL treated with ≤19 injections of cardiopoietic stem cells showed reduced risk of death or cardiovascular hospitalization (hazard ratio 0.38, 95% CI 0.16–0.91, P = 0.031) and cardiovascular death or heart failure hospitalization (hazard ratio 0.28, 95% CI 0.09–0.94, P = 0.040). Cardiopoietic stem cell therapy was well tolerated long term with no difference in safety readouts compared with sham at 2 years. Conclusions Longitudinal follow‐up documents that cardiopoietic stem cell therapy is overall safe, and post hoc analyses suggest benefit in an ischaemic heart failure subpopulation defined by advanced left ventricular enlargement on tolerable stem cell dosing. The long‐term clinical follow‐up thus offers guidance for future targeted trials.https://doi.org/10.1002/ehf2.13031CardiopoiesisClinical trialHeart failureLongitudinalRegenerative medicineStem cell |
| spellingShingle | Jozef Bartunek Andre Terzic Beth A. Davison Atta Behfar Ricardo Sanz‐Ruiz Wojciech Wojakowski Warren Sherman Guy R. Heyndrickx Marco Metra Gerasimos S. Filippatos Scott A. Waldman John R. Teerlink Timothy D. Henry Bernard J. Gersh Roger Hajjar Michal Tendera Stefanie Senger Gad Cotter Thomas J. Povsic William Wijns for the CHART Program Cardiopoietic stem cell therapy in ischaemic heart failure: long‐term clinical outcomes ESC Heart Failure Cardiopoiesis Clinical trial Heart failure Longitudinal Regenerative medicine Stem cell |
| title | Cardiopoietic stem cell therapy in ischaemic heart failure: long‐term clinical outcomes |
| title_full | Cardiopoietic stem cell therapy in ischaemic heart failure: long‐term clinical outcomes |
| title_fullStr | Cardiopoietic stem cell therapy in ischaemic heart failure: long‐term clinical outcomes |
| title_full_unstemmed | Cardiopoietic stem cell therapy in ischaemic heart failure: long‐term clinical outcomes |
| title_short | Cardiopoietic stem cell therapy in ischaemic heart failure: long‐term clinical outcomes |
| title_sort | cardiopoietic stem cell therapy in ischaemic heart failure long term clinical outcomes |
| topic | Cardiopoiesis Clinical trial Heart failure Longitudinal Regenerative medicine Stem cell |
| url | https://doi.org/10.1002/ehf2.13031 |
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