Phase I Clinical Safety Study About Human Umbilical Cord Blood Monocyte in the Acute Ischemic Stroke
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- adverse events (AE)and serious adverse reaction(SAE)
研究概览
简要总结
The objective of the study is to determine the safely of Human Umbilical Cord Blood mononuclear cells by Intravenous injection in acute ischemic stroke patients.
详细描述
The study will use Umbilical Cord Blood cells (a special kind of cell that is believed to be a stem cell) isolated from UCB (blood obtained at birth from the umbilical cord blood of babies). StemCyte, a leading accredited UCB banking company with branches in the United States and Taiwan, will provide the units of UCB that match at least 4 out of 6 HLA (human leukocyte antigens) for transplantation. The HLA-matching is the same as that used to match cells and organs for transplantation so that the body does not reject the cells. Then cells injection by Intravenous in acute ischemic stroke patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The age of Subjects between 45 through 80 years.
- •Acute Ischemic Stroke.
- •National Institutes of Health Stroke Scale (NIHSS):6-18
- •Brain MRI shows the middle cerebral artery region (M1 and M2) of cerebral i infarction stroke patients.
- •Subjects have no midline shift or hemorrhagic transformation
排除标准
- •NIHSS score reduced more than 4 within after 24 hours.
- •Female are pregnant or lactating.
- •Subjects with impaired liver function, AIDS, cancer or other significant medical condition (including certifiable diseases, rare disease)
- •Subjects joined other clinical trails or received rt-PA therapy.
- •Immune dysfunction or receiving other immunosuppressive agents.
- •Subjects cannot have MRI test
- •Subjects' HLA typing results match less than 4 out of the 6 genotypes
结局指标
主要结局
adverse events (AE)and serious adverse reaction(SAE)
时间窗: after infusion 24, 48, 72 hours , 1 week or discharge , and 1, 3, 6 , 9, 12 months.
any AE or SAE (related or non-related) during the 12-month follow-up period
次要结局
- NIHSS(baseline, after infusion 24, 48, 72 hours, 1weeks or discharge, 1 3, 6, 9, 12months)
- Berg Balance score(baseline, after infusion 24, 48, 72 hours, 1weeks or discharge, 1 3, 6, 9, 12months)
- abdominal sonography-spleen(baseline, after infusion 24, 72 hours, 3, 12months)
- Brain Image(MRI)(baseline, after infusion 24 hours, 1, 6, 12months)
- Barthel Index(baseline, after infusion 24, 48, 72 hours, 1weeks or discharge, 1 3, 6, 9, 12months)
- cytokine family(baseline, after infusion 24, 48, 72 hours, 1 3, 6, 9, 12months)
- Blood examination(baseline, after infusion 24, 48, 72 hours, 1 3, 6, 9, 12months)
研究者
Shinn-Zong Lin
Hualien Tzu Chi Medical Center
Buddhist Tzu Chi General Hospital