Heart Failure
Conditions
Keywords
heart failure, old myocardial infarction, bone marrow-derived mononuclear cells, chronic, ischemic
Brief summary
Single or repeated application of autologous bone marrow-derived stem cells to treat chronic post-infarction heart failure
Detailed description
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.
Interventions
BIOLOGICALintracoronary infusion of autologous bone marrow-derived cells
Intracoronary infusion into open vessel / bypass supplying previous (\> 3 months) infarct area
Sponsors
Johann Wolfgang Goethe University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Previous myocardial infarction at least 3 months ago, open infarct vessel or bypass * Left ventricular ejection fraction (LVEF) ≤ 45% on echocardiography * Stable chronic heart failure NYHA class II to III under constant (4 weeks) evidence-based optimal medical treatment * age 18 - 80 years * written informed consent * women of childbearing age: negative pregnancy test; effective contraception for the first 8 months in the trial
Exclusion criteria
* Non-ischemic cardiomyopathy * Necessity for revascularization in other vessel than the infarct vessel at the time of study therapy * Hemodynamic relevant severe valvular disease with indication for operative / interventional revision * Heart failure with preserved ejection fraction (diastolic heart failure), LVEF \> 45% * Unstable Angina * Severe peripheral artery occlusive disease (≥ Fontaine stadium III) * Active infection (C-reactive protein \> 10 mg/dl), chronic active hepatitis; any chronic inflammatory disease, HIV infection * Neoplastic disease without documented remission in the last 5 years * Stroke ≤ 3 months * Impaired renal function (Serum creatinine \> 2,5 mg/dl) at the time of study inclusion * Relevant liver disease (GOT \> 2x upper normal limit, spontaneous INR \> 1,5). * Diseases of hematopoetic system, anemia (Hemoglobin \< 8.5 mg/dl), thrombocytopenia \< 100.000/µl) * Splenomegaly * Allergy or intolerance of clopidogrel, prasugrel, ticagrelor, heparin, bivalirudin * History of bleeding disorder * gastrointestinal bleeding ≤ 3 months * major surgery or trauma ≤ 3 months * Uncontrolled hypertension * Pregnancy, lactation period * mental retardation * previous cardiac cell therapy within last 12 months * Participation in another clinical trial ≤ 30 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mortality at 2 years after inclusion into the study | 2 years | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Morbidity at 2 and 5 years after inclusion into the study | 2 years and 5 years | 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 |
Countries
Germany
Outcome results
None listed