EUCTR2009-013103-63-DE进行中（未招募）不适用
Pilot study investigating the effect of intra-coronary and intra-myocardial application of enriched CD133pos autologous bone marrow derived stem cells for improving left ventricular function in chronic ischemic cardiomyopathy - AlsterMACS
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 64
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 18 to 80 years old
- •of female and male gender
- •Patient has reduced ejection fraction as evaluated by routine clinical angiogramm,
- •echocardiography or MRI (=45%) due to ischemic heart disease
- •symptomatic heart failure NYHA = II on optimal therapy
- •coronary artery in the target region that can be used for cell infusion
- •Patient has been informed of the nature of the clinical trial and agrees to its provision and
- •has provided written informed consent
- •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
- •planned or performed CABG surgery or PCI within 4 weeks of study entry
- •recent myocardial infarction (< 6 months)
- •TIMI flow < II in the coronary artery selected for infusion
- •cardiogenic shock requiring mechanical ventilation or intra-aortic balloon pump
- •progressive tumor disease
- •primary disease of bone marrow including mal-function of components of the coagulation
- •women of child-bearing age premenopausal
- •LV wall thickness < 5mm at planned site of injection
- •ventricular wall thrombus
- •severe aortic valvular heart disease
- •severe atrial or ventricular tachycardia unresponsive to intravenous or oral drug therapy
- •aneurysm of the anterior wall
- •history of stroke
- •know diseases of the liver resulting in reduced plasmatic coagulation with spontaneous INR
- •patients with chronic infectious diseases (HBV, HCV, HIV)
- •patients taking part or have taken part in other clinical trials within the past 3 months
- •patients unable to provide informed consent
- •any other medical condition that the enrolling physician deems significant in representing a
- •potential hazard for the patient when participating in this study
研究者
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