E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with coronary artery disease, suffering from a large myocardial infarction. The loss of viable myocardium initiates a process of adverse left ventricular (LV) remodeling leading to chamber dilatation and contractile dysfunction in many patients. Intracoronary bone marrow cell transfer may represent - for the first time - a therapeutic strategy to enhance LV functional recovery after AMI (our current medical and interventional strategies are only able to limit the damage). |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Hypothesis 1: Use of a low amount of BMCs (low dose, 40 mL) for intracoronary therapy improves LV ejection fraction after AMI at 6 months as compared to a blinded control group receiving an intracoronary placebo infusion.
Hypothesis 2: The efficacy of irradiated bone marrow cells for intracoronary therapy is superior to no intracoronary bone marrow cell application in a control group concerning improvement of left ventricular ejection fraction after AMI at 6 months. Furthermore, the effect is similar compared to non-irradiated cells. |
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E.2.2 | Secondary objectives of the trial |
Influence of intracoronary BMC therapy on clinical endpoints: - Major adverse cardiac events (death, recurrent AMI, target vessel revascularization, hospitaliza-tion with heart failure) - Physical capacity as assessed by cardiopulmonary exercise testing - Quality of life as assessed by the Minnesota Living with Heart Failure Questionnaire Influence of intracoronary BMC therapy on parameters of LV remodeling and function in the setting of a multicenter trial: - LV end-diastolic and end-systolic volume indices (as determined by MRI) - Infarct size (MRI); LV mass (MRI); Regional LV function (MRI) - Diastolic LV function (Doppler echocardiography)
Influence of intracoronary BMC therapy on LV ejection fraction at 18 months as determined by MRI
Influence of intracoronary bone marrow cell therapy on serum and bone marrow markers of inflammation and angiogenesis
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Patients with a first ST-segment elevation myocardial infarction, successful percutaneous coronary intervention (PCI) with stent implantation of the infarct-related artery, hypokinesia or akinesia involving equal to or more than 2/3 of the left ventricular anteroseptal, lateral, and/or inferior wall, as revealed by angiography performed immediately after PCI. And time from symptom onset to reperfusion of >3 hours and baseline LVEF <57% as assessed by MRI. Or time from symptom onset to reperfusion 1,5 to 3 hours with LVEF <52% on MRI.
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E.4 | Principal exclusion criteria |
Multivessel coronary artery disease requiring repeat PCI or coronary bypass grafting, pulmonary edema or cardiogenic shock (Killip classes III and IV), advanced renal or hepatic disease, pregnancy, documented terminal illness or cancer, pacemaker or ICD. Reinfarction in the myocardial circulatory bed of a documented previous myocardial infarction.
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E.5 End points |
E.5.1 | Primary end point(s) |
Global left ventricular ejection fraction (LVEF) change from baseline (prior to cell transfer) to 6 month follow-up will be the prespecified, primary endpoint of the BOOST-2 trial. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | Yes |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
low/high dose; irradiated/non-irradiated |
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E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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last visit of the last subject undergoing the trial |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 6 |