Treatment of Human Cord Blood Mononuclear Cell for Delayed Encephalopathy After Carbon Monoxide Poisoning
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change From Baseline in Mini-Mental State Examination (MMSE)
研究概览
简要总结
The effects and safety of Human cord blood mononuclear cell for delayed encephalopathy after carbon monoxide poisoning
详细描述
To evaluate the effect and mechanism of human cord blood mononuclear cell transplantation for delayed encephalopathy after carbon monoxide poisoning
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Investigator)
入排标准
- 年龄范围
- 35 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •35-60 years old.
- •No serious infection, chronic diseases, diabetes and tuberculosis.
- •Written informed consents were obtained from all subjects.
- •Symptomatic Delayed Encephalopathy After Carbon Monoxide Poisoning.
排除标准
- •The heart, liver, kidney and other viscera serious organic disease.
- •Allergic constitution, clotting disorders, autoimmune diseases and tumors.
- •Pregnancy.
- •Moribund patient.
- •History of prior brain injury.
- •History of central nervous system disease.
研究组 & 干预措施
intervention group
Human Cord Blood Mononuclear Cell will be slowly infusion three times,at one days, 30 days,at 60days.
干预措施: Human cord blood mononuclear cell (Biological)
control group
hyperbaric oxygen
干预措施: hyperbaric oxygen (Other)
intervention group
Human Cord Blood Mononuclear Cell will be slowly infusion three times,at one days, 30 days,at 60days.
干预措施: hyperbaric oxygen (Other)
结局指标
主要结局
Change From Baseline in Mini-Mental State Examination (MMSE)
时间窗: Baseline, 4, 8, 12 and 24 weeks
次要结局
- Chang from baseline in head CT(Baseline, 6 and 12 months)
- Serum levels of IL-2,IL-4,IL-6,IL-10,TNF,IFN-γ，IL-17A，IL-8，IL-12p70，MIG，MCP-1(ng/ul)(Baseline,1 and 2 months)
- Cerebrospinal levels of IL-2,IL-4,IL-6,IL-10,TNF,IFN-γ，IL-17A，IL-8，IL-12p70，MIG，MCP-1(ng/ul)(Baseline, 1 and 2 months)
- Change From Baseline in Activities of Daily Living (ADL)(Baseline, 4, 8, 12 and 24 weeks)
研究者
Chen shuangfeng
Central Laboratory Director
Liaocheng People's Hospital