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
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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