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Cardiopoietic cell therapy for advanced ischemic heart failure : results at 39 weeks of the prospective, randomized, double blind, sham-controlled CHART-1 clinical trial
- Source :
- Repositorio Institucional de la Consejería de Sanidad de la Comunidad de Madrid, Consejería de Sanidad de la Comunidad de Madrid, European Heart Journal, r-IGTP. Repositorio Institucional de Producción Científica del Instituto de Investigación Germans Trias i Pujol, instname, European heart journal, vol 38, iss 9, Dipòsit Digital de Documents de la UAB, Universitat Autònoma de Barcelona
- Publication Year :
- 2017
-
Abstract
- Altres ajuts: This work was supported by Celyad, SA (Mont-Saint-Guibert, Belgium). Celyad has received research grants from the Walloon Region (Belgium, DG06 funding). 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.
- Subjects :
- 0301 basic medicine
Male
Cardiopoiesis
Cardiovascular disease
Disease severity
Marker
Precision medicine
Regenerative medicine
Stem cell
Target population
Adult
Aged
Double-Blind Method
Female
Heart Failure
Humans
Mesenchymal Stem Cell Transplantation
Middle Aged
Myocardial Ischemia
Prospective Studies
Treatment Outcome
Young Adult
Cardiology and Cardiovascular Medicine
Cell- and Tissue-Based Therapy
mesenchymal stem-cells
030204 cardiovascular system & hematology
Cardiorespiratory Medicine and Haematology
outcomes
Fast-Track Clinical Research
Sudden cardiac death
0302 clinical medicine
Ischemia
cardiovascular disease
Clinical endpoint
target population
CHART Program
Ejection fraction
bone-marrow
Heart Failure/Cardiomyopathy
3. Good health
Cohort
Cardiology
Fast Track
disease severity
delivery
medicine.medical_specialty
precision medicine
Clinical Sciences
regenerative medicine
03 medical and health sciences
cardiopoiesis
Internal medicine
medicine
Adverse effect
marker
disease
business.industry
medicine.disease
mortality
Confidence interval
Clinical trial
stem cell
Editor's Choice
030104 developmental biology
predictors
Cardiovascular System & Hematology
Heart failure
business
Subjects
Details
- Language :
- English
- ISSN :
- 15229645
- Database :
- OpenAIRE
- Journal :
- Repositorio Institucional de la Consejería de Sanidad de la Comunidad de Madrid, Consejería de Sanidad de la Comunidad de Madrid, European Heart Journal, r-IGTP. Repositorio Institucional de Producción Científica del Instituto de Investigación Germans Trias i Pujol, instname, European heart journal, vol 38, iss 9, Dipòsit Digital de Documents de la UAB, Universitat Autònoma de Barcelona
- Accession number :
- edsair.doi.dedup.....bd476f209e3b7147f64f775093581130