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临床试验/EUCTR2006-000281-36-GB
EUCTR2006-000281-36-GB进行中(未招募)1 期

A Phase I/II safety and tolerability study following autologous infusion of adult haematopoietic cells to patients with acute total anterior circulation ischaemic stroke

Imperial College London0 个研究点目标入组 10 人开始时间: 2006年4月10日最近更新:

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
10

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

入选标准

  • Symptoms and signs of clinically definite acute stroke
  • Time of onset is known & treatment can be started within 7 days of onset
  • CT or MRI brain scanning has reliably excluded both intracranial haemorrhage and structural brain lesions which can mimic stroke (e.g. cerebral tumour)
  • The stroke is severe and conforming to total anterior circulation phenotype (weakness, homonymous hemianopia and focal cognitive deficit (e.g. aphasia) or reduction in consciousness.
  • An age range of 30 to 80 years of age
  • 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

  • Known defect of clotting or platelet function
  • Haematological causes of stroke
  • Severe co-morbidity
  • Hepatic or renal dysfuction
  • Patients with evidence of life-threatening infection (e.g. HIV) or life-threatening illness (e.g. advanced cancer)
  • Patient should be excluded if blood glucose <3.0 or >20.0mmol/L
  • Patient was already dependent in activities of daily living before the present stroke.
  • Patients who have been included in any other clinical trial within the previous month
  • Patients who are unavailable for follow-up (e.g. no fixed home address)

研究者

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