NCT03291366Unknown1 期
Intrathecal Injection of Mesenchymal Stem Cells in Central Nervous System injury2017
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 30
- 主要终点
- life quality score
研究概览
简要总结
Central nervous system (CNS) injury leads to morbidity in patients, which has few good rehabilitation measures. Mesenchymal stem cells seem to have regenerative and tissue-repairing capabilities. The investigators design this study to infuse mesenchymal stem cells (MSCs) intrathecally to CNS injury patients, and observe the safety and efficacy by recording the change of nervous system scores, trying to prove the effect of MSC in rehabilitate CNS injury.
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
- 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
- 否
入选标准
- •CNS injury > 3 months
- •age > 18 years
- •willing to give consent
- •stable vital signs
- •absence of active infectcion
排除标准
- •any contradiction to intrathecal infusion
- •age < 18 years
- •CNS injury < 3 months
- •CNS injury > 3 years
研究组 & 干预措施
MSC
Experimental
infusion of aUCMSC and conventional therapy
干预措施: conventional treatment (Drug)
MSC
Experimental
infusion of aUCMSC and conventional therapy
干预措施: UCMSCC (Drug)
conventional
Active Comparator
conventional therapy
干预措施: conventional treatment (Drug)
结局指标
主要结局
life quality score
时间窗: 1y
次要结局
- adverse events(1y)
研究者
Jianming Tan
Professor
Fuzhou General Hospital
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