Autologous Bone Marrow Mesenchymal Stem Cell Transplantation for Chronic Ischemic Stroke
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change from baseline in Fugl-Meyer Scale at 12 months
研究概览
简要总结
Stroke is a frequently occurring and common diseases in nervous system,and most of the survivors will remain disorders of motor,sensory and cognition function.Stem cell transplantation provides a promising approach for rehabilitation. The main objective of this study is to evaluate the efficacy and safy of the transplantation of autologous bone marrow mesenchymal stem cells in patients with chronic stroke.
详细描述
Stroke is a frequently occurring and common diseases in nervous system,and most of the survivors will remain disorders of motor,sensory and cognition function.It will brought heavy burden to patients themselves,their family and society.Drugs,rehabilitation excise and hyperbaric oxygen will improve functions after acute stroke.However,in the chronic ischemic stroke,there was few methods to improve the functions.In recently research,stem cell will be a new methods to improve the neural function after through differentiate to nervous cells and secrete some neurotrophic factors to repair the damage. In this study, the investigators will assess the safety and feasibility of intracerebral transplantation of autologous bone marrow mesenchymal stem cells in patients with chronic ischemic stroke. The neurological outcome will be determined after transplantation.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-80 chronic ischemia stroke or patients
- •With stroke history of more than 6 months, less than 60 months
- •NIHSS (NIH stroke scale) score of 7 or more points
- •Internal carotid artery territory infarction measured by MRI
- •Can be hospitalized and signed informed consent
- •With fewer effect by traditional post-stroke treatments or rehabilitations
排除标准
- •Lacunar infarction
- •Recurrent thrombotic diseases less than 6 months
- •Hemorrhage stroke,brain tumor or MRI show the occlusion is not in the middle cerebral artery territory
- •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
- •Penicillin anaphylaxis or some other drugs allergy
- •Autoimmune disease
- •Inaccessibility for follow up
结局指标
主要结局
Change from baseline in Fugl-Meyer Scale at 12 months
时间窗: 1,3,6 and 12 months
次要结局
- Change from baseline in NIH Stroke Scale at 12 months(1,3,6 and 12 months)
- Change from baseline in Barthel Index at 12 months(1,3,6 and 12 months)
- Change from baseline in SSS at 12 months(1,3,6 and 12 months)
- Change from baseline in mRS at 12 months(1,3,6 and 12 months)
- Improvement of vision measured by brain visual examination(1,6 and 12 months)
研究者
Xiaodan Jiang
Zhujiang Hospital,Southern Medical University, China
Southern Medical University, China