E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Acute myocardial infarction (LVEF<45%) ICD10: I21.9 |
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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 |
Effect of the BMNC on heart function (LVEF) measured via echocardiography
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E.2.2 | Secondary objectives of the trial |
Regeneration Second global function measured via MRI and MFI |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients at ages > 18 years and < 80 years • of female and male gender • with early LVDF determined by echocardiography (LVEF < 45 %; > 250 median BNP level ) after timely (at maximum 6 hours after the onset of symptoms) successful PCI (balloon + stent with reflow in the culprit artery territory) of an AMI in the proximal LAD territory or a hemodynamically relevant stenosis of another coronary artery (LCX, RCA) • conventional therapy according to the ESC guidelines for heart failure • BMI >20 kg/ m2 und <35kg/m2 • after signed informed consent prior to cell treatment are enrolled |
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E.4 | Principal exclusion criteria |
Patients with AMI/PCI elder than 21 days; • with left ventricular dysfunction due to other reasons than ischemic cardiomyopathy, e.g. hypertension • with relevant valvular disease; • Aneurysma of the anterior myocardial wall or myocardial wall thickness of < 5 mm, • with overt heart failure, other than ischemic cardiomyopathy, myocardial wall thickness of < 10 mm, and relevant valvular disease; • scheduled for thrombolysis or coronary artery bypass graft (CABG) surgery; • with history of multivessel disease, coronary revascularization - by percutaneous tech-niques and bypass surgery - and cardiac transplantation; • with history of stroke and/or transient ischemic attack (TIA); • with history of thromboembolic event (e.g. phlebothrombosis, pulmonary embolism), bleeding disorders and known disease of the coagulation system; • with extensive hypercholesterinemia; • with diabetes mellitus Type I•, diabetic retinopathy• (5 % of DM-2) and diabetic neph-ropathy (34 % of DM-2) ; • with extensive deviations of baseline laboratory values and significant findings at physical examination which in the opinion of the investigator may worsen under treatment; • with systemic disease – (e.g. known or suspected anaphylaxia, intolerance against X-ray contrast agent and antibiotics, pre-malignant and malignant disease) or in bad condition (Karnofsky-Index below 70%); • pregnant women and women of childbearing potential who have not had a negative preg-nancy test within 48 hours before treatment; • with any disease or condition that seriously compromises the function of other body sys-tems than the heart and/or might interfere with conduct of the study and interpretation of the results; • patients with a positive blood culture as well as a chronic or acute HIV-, HBV-, HCV-infection; • patients who take part in other clinical trials at the same time; • as well as those unable to provide informed consent may not be recruited |
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E.5 End points |
E.5.1 | Primary end point(s) |
To assess the efficacy of intramyocardial BMNC cell therapy concerning left ventricular ejection fraction as measured by echocardiography |
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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 | No |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
The control group consists of patients with the same caracteristics but not included in the trial |
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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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
The control group consists of patients with the same caracteristics but not included in the trial |
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E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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 | 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 | No |
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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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 | |