The Use of Magnetic Resonance Imaging and Superparamagnetic Particles of Iron Oxide in Cardiovascular Disease - a Pilot Study in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Change in signal intensity in the region of interest on MRI scanning
研究概览
简要总结
The ability to label specific cells and image their natural movements in vivo would allow researchers to investigate the mechanisms of disease progression. In addition, cell-based therapy, especially stem cell therapy, requires non-invasive monitoring of transplanted cells to follow their bio-distribution and biological function. Because of recent interest in stem cell treatment, several methods have been investigated for in vivo cell tracking. The investigators propose to assess whether the magnetic resonance imaging (MRI) contrast agent Endorem (superparamagnetic particles of iron oxide) can be used to label cells for in vivo tracking using MRI. The investigators will use 20 healthy human volunteers to:
- Assess the feasibility of imaging Endorem-labelled cells in vivo
- Compare the distribution of Endorem-labelled cells with that of intravenous injection of Endorem
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers
- •Age >18 years
排除标准
- •Pregnancy
- •Contraindication to MRI scanning (detected by safety questionnaire) including severe claustrophobia
- •Inability or refusal to give informed consent
- •Renal or hepatic dysfunction
- •HIV/hepatitis B/ hepatitis C/ HTLV/ syphilis
- •Intercurrent illness
- •Blood dyscrasias
研究组 & 干预措施
Administration of labelled cells
MRI scanning before and after administration of iron-labelled cells
干预措施: Administration of autologous Endorem-labelled mononuclear cells intravenously (Biological)
Administration of Endorem
MRI scanning before and after intravenous administration of Endorem
干预措施: Administration of Endorem (Drug)
结局指标
主要结局
Change in signal intensity in the region of interest on MRI scanning
时间窗: 0 hours, 24 hours, 48 hours, 5-7 days
次要结局
未报告次要终点