Single or repeated application of autologous bone marrow-derived stem cells to treat chronic post-infarction heart failure
Improve mortality and morbidity in patients with symptomatic chronic post-infarction heart failure under full dose conventional medical and device treatment including resynchronization therapy, by single versus repeated intracoronary infusion of autologous bone marrow-derived mononuclear cells.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
81
Intracoronary infusion into open vessel / bypass supplying previous (\> 3 months) infarct area
Zentralklinik Bad Berka
Bad Berka, Germany
Goethe University Frankfurt
Frankfurt, Germany
Klinikum Fulda
Fulda, Germany
Universitätsklinikum Mainz
Mainz, Germany
Mortality at 2 years after inclusion into the study
2-year observed mortality is significantly lower in patients receiving 2 repeated intracoronary applications of autologous bone marrow-derived cells (t2c001) compared to patients receiving 1 intracoronary application of autologous bone marrow-derived cells (t2c001)
Time frame: 2 years
Morbidity at 2 and 5 years after inclusion into the study
Efficacy endpoints: Comparison between the 2 treatment groups at 2-year and 5-year follow-up * Cardiac mortality, cardiovascular mortality * Rehospitalisation for heart failure * Ischemic cardiac events (STEMI, NSTEMI, ACS) * Coronary revascularisations (PCI / CABG) * Heart transplantation, Assist-device implantation * New resynchronization therapy, ICD implantation * NYHA-Status, NT-proBNP serum levels * Minnesota Living with Heart Failure Questionnaire Safety endpoints: bleeding events, all in-hospital events (during hospitalization for BMC therapy), life-threatening arrhythmias, new malignancies
Time frame: 2 years and 5 years
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Krankenhaus Hetzelstift
Neustadt, Germany
Zentralklinikum Suhl
Suhl, Germany