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临床试验/NCT01169935
NCT01169935已完成不适用

In Vivo Tracking of Magnetically-labelled Human Mononuclear Cells Using MRI Scanning

University of Edinburgh1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2010年7月最近更新:
适应症
干预措施
相关药物

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

Treatment of a wide range of diseases using stem cells and other types of cell appears promising. Following administration of cells it is often not clear where exactly the cells have gone and how many of them have reached the target site. This has been one of the challenges of developing these treatment options further. We have developed a method of labelling human cells with a magnetic resonance imaging (MRI) "contrast agent" which contains tiny iron filings. Following intravenous administration it is possible to see where the iron-labelled cells have gone using MRI scanning. We would like to do is to demonstrate that these cells behave normally and migrate to a site of inflammation. We plan to induce an area of inflammation in the forearm of healthy volunteers using the Mantoux test (a test of immunity against tuberculosis) before giving the labelled cells intravenously. After the Mantoux test we will give these volunteers iron-labelled cells and do MRI scans of their forearm to determine whether these cells can be seen accumulating in the target site.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy male or female volunteers age 18 to 65 years
  • Previous vaccine for tuberculosis more than 5 years ago

排除标准

  • pregnancy / breast feeding
  • Contra-indication to MRI scanning
  • Inability or refusal to give informed consent
  • Renal failure (eGFR <25mL/min) or hepatic dysfunction (Child's B or C)
  • HIV/hepatitis B/hepatitis C/HTLV/syphilis
  • Active malignant disease
  • Blood dyscrasia
  • High risk of allergy to protamine sulphate (fish allergy, infertile men, vasectomy)
  • Known history of tuberculosis infection.
  • History of prolonged residence (> 6 months) in a region or country with a high prevalence of tuberculosis.
  • Previous Mantoux reaction of 15mm of greater.

研究组 & 干预措施

Administration of Intra-dermal SPIO

Experimental

MRI scanning before and after intra-dermal injection of SPIO.

干预措施: Administration of intra-dermal Endorem (Drug)

Mantoux, Venesection, Labelled cells

Experimental

Mantoux test then MRI scanning before and after administration of iron-labelled cells obtained by venesection.

干预措施: Mantoux test (Biological)

Mantoux, Venesection, Labelled cells

Experimental

Mantoux test then MRI scanning before and after administration of iron-labelled cells obtained by venesection.

干预措施: Autologous Endorem-labelled mononuclear cells (Biological)

Mantoux, Apheresis, Labelled cells

Experimental

Mantoux test then MRI scanning before and after administration of iron-labelled cells obtained by apheresis.

干预措施: Mantoux test (Biological)

Mantoux, Apheresis, Labelled cells

Experimental

Mantoux test then MRI scanning before and after administration of iron-labelled cells obtained by apheresis.

干预措施: Autologous Endorem-labelled mononuclear cells (Biological)

Mantoux, Administration of Endorem

Experimental

Mantoux test then MRI scanning before and after administration of Endorem.

干预措施: Mantoux test (Biological)

Mantoux, Administration of Endorem

Experimental

Mantoux test then MRI scanning before and after administration of Endorem.

干预措施: Administration of Endorem (Drug)

Mantoux only

Experimental

Mantoux test then serial MRI scanning.

干预措施: Mantoux test (Biological)

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, 3 - 5 days

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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