Phase II Study of Autologous Peripheral Blood CD34 Stem Cell Implantation in Chronic Stroke Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- NIH-stroke scale (NIHSS)
研究概览
简要总结
The objective of the study is to determine the efficacy of brain transplants of CD34+ stem cells obtained from peripheral blood of patients in the treatment of chronic stroke patients.
详细描述
30 patients are divided into 2 groups, one treatment group and one control group.Treatment group will be implanted with peripheral blood stem cell and receive convention stroke therapy ,and control group only receive convention stroke therapy. We expect that transplantation of the peripheral blood CD34+ cells has the potential of significant benefit to neurological recovery. In a previous phase I clinical trial, we have shown that transplantation of CD34+ cells obtained from the peripheral blood of the chronic stroke patients was safe and beneficial for neurological recovery. We expect this trial can further prove the efficacy of this treatment method.
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
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 35-70 chronic stroke adult patient,
- •with stroke history of more than 6 months, less than 60 months，
- •with stable hemiplegia condition, and
- •NIHSS (NIH Stroke Scale) score is between 9-20.
排除标准
- •patients aged less than 35 or more than 70,
- •hemorrhage stroke or MRI show the occlusion is not in the middle cerebral artery territory，NIHSS is not in the range of 9-20,
- •pregnant women,
- •impaired liver function, abnormal blood coagulation, AIDS, combine other tumor or special condition.
研究组 & 干预措施
PBSC Treatment
Patients in PBSC treatment will receive brain implant of autologous peripheral blood stem cell(CD34+) plus convention stroke treatment that include rehabilitation and antiplatelet medication
干预措施: Intercerebral implantation of Autulogous Stem Cells (Procedure)
Control
Control group receive conventional stroke treatment that include rehabilitation and antiplatelet medication
干预措施: convention therapy (Drug)
结局指标
主要结局
NIH-stroke scale (NIHSS)
时间窗: 1, 2, 4, 12 weeks, and confirmed at 6 and 12 months
次要结局
- European stroke scale (ESS)(1, 2, 4, 12 weeks, and confirmed at 6 and 12 months)
- European stroke motor subscale (EMS)(1, 2, 4, 12 weeks, and confirmed at 6 and 12 months)
- Barthel index and Mini-Mental State Examination (MMSE)(1, 2, 4, 12 weeks, and confirmed at 6 and 12 months)
- Magnetic resonance imaging (MRI) and computed tomography (CT) scans(1, 2, 4, 12 weeks, and confirmed at 6 and 12 months)