E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with acute ST-elevated myocardial infarction treated with primary percutaneous coronary intervention |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10000891 |
E.1.2 | Term | Acute myocardial infarction |
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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 |
1. To determione the safety of intra-coronary infusion of enriched CD133+, bone-marrow-derived, autologous progenitor cells in patients 5-10 days after acute percuteneous coronary revascularization for ST-segment elevation myocardial infarction (STEMI).
2. To determine whether intra-coronary infusion of enriched CD133+, bone-marrow-derived, autologous progenitor cells i patients 5-10 days after percuteneous coronary revascularization for STEMI imporves left ventricular thickening in akinetic/hypokinetic segments. |
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E.2.2 | Secondary objectives of the trial |
See protocol page 6 and 7 and § 20, page 21-23. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Primary coronary intervention (PCI) for acute ST elevated myocardial infarction between 2-24 hours after onset of chest pain. 2. ST-segment elevation >= 2mm in >= 3 adjacent leads. 3. Presence of severe hypokinesia and/or akinesia in >=2 adjacent segments on echocardiogram at 48-72 hours after primary PCI. 4. Age between 20 and 70 years. |
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E.4 | Principal exclusion criteria |
1. Pregnant or lactating. 2. Prior history of myocardial infarction before the index event. 3. Decompensated congestive heart failure. 4. Pre-exisiting LV dysfunction. 5. Cardiomyopathy. 6. Previous cardiac surgery. 7. Congenital heart disorder. 8. Paroxysmal atrial fibrillation or history of verntricular arrhythmias. 10. Presence of pacemaker or defibrillator. 12. contraindication to bone marrow aspiration. 15. 3-vessel coronary artery disease necessitating intervention within 4 months. 16. Immune compromise including HIV, HBV, HCV infection.
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E.5 End points |
E.5.1 | Primary end point(s) |
Safety: Comparison of progression in coronary atheroscelosis burden proximal and distal to the stented segment of the infarct-related artery in treated and control groups.
Efficacy: Comparison of chanegs in myocardial thickening in non-viable akinetic / hypokinetic wall segments as determined by cardiac MRS in treated and control groups. |
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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 | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
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) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | No |
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 | No |
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 | No |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 2 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
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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24 month FU after the inclusion of the patient in 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 | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 5 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |