Phase 1 Study of Autologous Peripheral Hematopoietic Stem Cell Transplantation in Ischemic Stroke
试验速览
- 阶段
- 1 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change from Baseline in NIH-stroke scale (NIHSS) at 12 months
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of autologous peripheral hematopoietic stem cell transplantation in ischemic stroke.
详细描述
Stroke is among the main causes of mortality and disability of elderly population which still lack of efficient therapy. Stem sell transplantation provides a functional improvement after cerebral ischemia in rat models. Our study will recruit 40 ischemic stroke patients which will be divided into 2 groups (20 patients each): treatment group and control group. The former will be implanted with peripheral blood stem cell through anterior cerebral artery or middle cerebral artery (determined by the section of infarction) and receive convention stroke therapy. The latter only receive convention stroke therapy. The investigators expect that transplantation of the peripheral hematopoietic stem cell is safe and efficient to neurological recovery.
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
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 40~70
- •no consciousness disorders
- •internal carotid artery territory infarction
- •stroke happened < 1 year
- •with stable hemiplegia, but remain dependent in daily life
- •SSS(Scandinavian Stroke Scale) < 40
排除标准
- •pregnant women
- •can't tolerate the test because of other disease, such as heart failure, liver failure, renal failure, abnormal blood coagulation, AIDS, combine other tumor or special condition
研究组 & 干预措施
cell transplantation
The study group will not only be implanted with autologous hematopoietic stem cells, but also receive drug therapy.
干预措施: autologous hematopoiesis stem cell transplantation (Procedure)
cell transplantation
The study group will not only be implanted with autologous hematopoietic stem cells, but also receive drug therapy.
干预措施: Aspirin (Drug)
cell transplantation
The study group will not only be implanted with autologous hematopoietic stem cells, but also receive drug therapy.
干预措施: Warfarin (Drug)
cell transplantation
The study group will not only be implanted with autologous hematopoietic stem cells, but also receive drug therapy.
干预措施: Atorvastatin (Drug)
cell transplantation
The study group will not only be implanted with autologous hematopoietic stem cells, but also receive drug therapy.
干预措施: Edaravone (Drug)
Convention therapy
The control group just receive drug therapy.
干预措施: Aspirin (Drug)
Convention therapy
The control group just receive drug therapy.
干预措施: Warfarin (Drug)
Convention therapy
The control group just receive drug therapy.
干预措施: Atorvastatin (Drug)
Convention therapy
The control group just receive drug therapy.
干预措施: Edaravone (Drug)
结局指标
主要结局
Change from Baseline in NIH-stroke scale (NIHSS) at 12 months
时间窗: 1,3,6,12 months after cell transplantation
次要结局
- Barthel index(1,3,6,12 months after cell transplantation)
- perfusion magnetic resonance imaging scan(1,3,6,12 months after cell transplantation)
- Modified Rankin Scale(mRS)(3,6,12 months after cell transplantation)