Chronic post-infarction heart failure due to an at least 3 months old myocardial infarction, treated with optimal medication according to the evidence-based guidelines, in NYHA stadium II-III
Conditions
Interventions
Product Name: t2c001
Product Code: t2c001
Pharmaceutical Form:
Current Sponsor code: t2c001-DS
Other descriptive name: Bone marrow-derived progenitor cells
Concentration unit: Munit million units
Con
Sponsors
Goethe University Frankfurt
Eligibility
Sex/Gender
All
Inclusion criteria
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 and expected to survive > 1 year • Written informed consent • Women of childbearing age: negative pregnancy test; effective contraception for the first 8 months in the trial Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 176 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 500
Exclusion criteria
Exclusion criteria: • Non-ischemic cardiomyopathy • Foreseeable 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), any chronic inflammatory disease • Neoplastic disease without documented remission in the last 5 years • Stroke = 3 months • Impaired renal function (Serum creatinine > 2,5 mg/dl or eGRF (MDRD) =30l/ min) 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 g/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 |
|---|---|
| Main Objective: Improve mortality in patients with symptomatic chronic post-infarction heart failure under full dose conventional medical and device treatment including resynchronization therapy frequently by intracoronary infusion of autologous bone marrow-derived mononuclear cells.;Secondary Objective: Improve morbidity in patients with symptomatic chronic post-infarction heart failure under full dose conventional medical and device treatment including resynchronization therapy frequently by intracoronary infusion of autologous bone marrow-derived mononuclear cells. ;Primary end point(s): 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);Timepoint(s) of evaluation of this end point: 2 years after inclusion into the trial | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy endpoints: - In patients receiving 2 repeated intracoronary applications of autologous bone marrow-derived cells (t2c001), the observed mortality is significantly lower than the SHFM-predicted mortality at 2-year follow-up 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 Prespecified combined clinical endpoints: o Death and rehospitalisation for heart failure o Cardiac Death and rehospitalisation for heart failure o Cardiac and Cardiovascular Death and rehospitalisation for heart failure o Death and myocardial infarction o Death and myocardial infarction and rehospitalisation for heart failure o Death and any cardiovascular event Safety endpoints: - All in-hospital events (during hospitalization for cell therapy) - Life-threatening arrhythmias (sustained ventricular tachycardia; ventricular fibrillation and cardiopulmonary resuscitation) - Any new malignant disease - Bleeding events - Safety of intracoronary application of autologous bone marrow-derived cells (t2c001) (procedural complications, adverse events at 30 days, SAEs at 4 months after each cell application) ;Timepoint(s) of evaluation of this end point: 2 years after inclusion into the trial | — |
Countries
Germany, Netherlands
Contacts
Public ContactCardiology
Goethe University
Outcome results
None listed