Bone Marrow-Derived Stem Cell Transfer in Acute Myocardial Infarctions
A Double-blind, Randomised, Controlled Study of Autologous Bone Marrow-Derived Stem Cell Transfer In Patients With ST-Segment Elevation Myocardial Infarction.
研究概览
详细说明
Despite early coronary reperfusion, salvage of ischemic myocardium is incomplete and loss of viable myocardium initiates a process of adverse left ventricular (LV) remodeling1, compromising clinical outcome.
Experimental data have suggested that autologous bone marrow-derived or circulating progenitor cells may be beneficial for LV function recovery, but underlying mechanisms are unclear and prominent cardiomyocyte transdifferentiation has only been reported under selected experimental conditions. Early non-randomized clinical investigations indicate feasibility, safety and enhanced functional recovery after autologous human bone marrow-derived stem cell (BMSC) infusion into the infarct-related artery. More recently, a randomized open study demonstrated improvement of LV systolic function but not of LV remodeling following BMSC transfer.
In the absence of trials, in which the control group reproduces the exact conditions of the cell transfer group, including bone marrow aspiration and a placebo intracoronary injection, the true benefit of cell transfer cannot be fully appreciated.
We, therefore, designed a randomized, double-blind, and placebo-controlled exploratory study to investigate the effect of autologous BMSC transfer on LV functional and structural recovery after myocardial infarction. In view of the exploratory nature of the study and to detect potential mechanisms for the biological effect, we also assessed myocardial perfusion and oxidative metabolism using serial 1-[11C]acetate positron emission tomography (PET).
研究类型
注册
阶段
- 阶段2
联系人和位置
学习地点
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Leuven、比利时、3000
- Department of Cardiology, University Hospital Gasthuisberg
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- patients with acute myocardial infarction with cumulative ST-segment elevation >=6mm, successful epicardial reperfusion after PCI and significant LV dysfunction
Exclusion Criteria:
- patients presenting within 2 hours of symptom onset (no dilution of any treatment effect from aborted infarctions)
- patients with prior coronary artery bypass grafting, pulmonary edema, cardiogenic shock or significant co-morbidities
学习计划
研究是如何设计的?
设计细节
- 分配:随机化
- 介入模型:单组作业
- 屏蔽:双倍的
研究衡量的是什么?
主要结果指标
结果测量 |
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increase in global LV ejection fraction fraction; evaluation by magnetic resonance (MRI) after 4 months
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次要结果测量
结果测量 |
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change in infarct size and regional LV function; evaluation by magnetic resonance (MRI) after 4 months
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change in myocardial perfusion and oxidative metabolism; investigated using serial 1-[11C]acetate positron emission tomography after 4 months
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合作者和调查者
调查人员
- 首席研究员:Stefan Janssens, MD, PhD、Department of Cardiology, University Hospital Gasthuisberg, Leuven, Belgium
- 研究主任:Frans Van de Werf, MD, PhD、Department of Cardiology, University Hospital Gasthuisberg, Leuven, Belgium
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
研究完成
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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