EUCTR2008-004625-42-DE进行中（未招募）不适用
Percutaneous Intramyocardial Cell Therapy After Acute Myocardial Infarction using Bone Marrow Mononuclear Cells</full-title-trial - Alster Stem Cell
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 25
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •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
研究者
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