Repeated application of bone marrow-derived stem cells to treat chronicpost-infarction heart failure
- Conditions
- 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-IIIand with open vessel / bypass sullpying the previously infarcted areaTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2011-000595-33-NL
- Lead Sponsor
- Goethe University Frankfurt
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 676
• 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
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
• Non-ischemic cardiomyopathy
• Necessity for revascularization in other vessel than the infarct vessel
at the time of study therapy
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• 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Improve mortality in patients with symptomatic chronic post-infarction heart failure under full dose conventional medical and device treatment<br>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 Outcome Measures
Name Time Method