Study on the Safety and Efficacy of Allogeneic Mesenchymal Stem Cell Implantation Combined With Bypass Grafting in Patients With Coronary Artery Disease and Ischemic Cardiomyopathy.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- iMP-related adverse events
研究概览
简要总结
The aim of the present study is to investigate safety and efficacy of intramyocardial implantation of a novel mesenchymal precursor cell type (iMP) in patients with ischemic cardiomyopathy at the time of coronary artery bypass grafting.
详细描述
This study aims to investigates in situ cardiac regeneration utilizing precision delivery of a novel mesenchymal precursor cell type (iMP) during coronary artery bypass surgery (CABG) in patients with ischemic cardiomyopathy (LVEF < 40 %). Preoperative scintigraphy imaging (SPECT) will be used to identify hibernating myocardium not suitable for conventional myocardial revascularization for iMP implantation. iMP cells will be implanted intramyocardially in predefined viable peri-infarct areas that show poor perfusion, which could not be grafted due to poor target vessel quality. Postoperatively, SPECT will be used to identify changes in scar area.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from 18 to 75 years
- •Severe coronary artery disease amenable to surgical revascularization according to current guidelines
- •History of acute myocardial infarction at least 14 days previously
- •Left ventricular ejection fraction (LVEF) ≤ 40% as assessed with echocardiography
- •Distinct area of dyskinetic or akinetic left ventricular myocardium corresponding with the infarct localization
- •Patient's informed consent obtained
排除标准
- •Emergency operation
- •Debilitating chronic disease (eg. malignancy or terminal renal failure)
- •Concomitant valve surgery
- •Previous cardiac surgery
- •Malignant ventricular arrhythmias
- •Haematologic disease
- •Woman in reproductive age
- •Severe psychiatric illness
研究组 & 干预措施
Stem cells implantation
Patients with severe coronary artery disease and chronic ischemic cardiomyopathy with a LVEF ≤40% who are scheduled for elective CABG according to accepted guidelines. Additional criteria include the following: age <75 years, history of myocardial infarction (not less than 14 days before the procedure), LVEF ≤40 % assessed with echocardiography, and a distinct area of dyskinetic or akinetic left ventricular myocardium corresponding with the infarct localization.
干预措施: Intramyocardial implantation of of a novel mesenchymal precursor cell type (iMP). (Procedure)
结局指标
主要结局
iMP-related adverse events
时间窗: 12 months
Major adverse cardiac and cerebrovascular events including death, postoperative myocardial infarction, need for revascularization, stroke, hospitalization for worsening heart failure, myocardial rupture, infectious myocarditis, or sustained ventricular arrhythmias.
Hypersensitivity
时间窗: 12 months
Hypersensitivity reaction (fever, urticaria, hemolytic anemia, hypotension, immune thrombocytopenia)
次要结局
- Change in quality of life(12 months)
- LVEF(12 months)
- Scar reduction(12 months)
研究者
Kyriakos Anastasiadis
Professor Kyriakos Anastasiadis
AHEPA University Hospital