Autologous Bone Marrow Mesenchymal Stem Cell Transplantation for Treatment of Chronic Stroke
试验速览
- 阶段
- 1 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change from baseline in NIH Stroke Scale at 12 months
研究概览
简要总结
Stroke is one of the leading causes of disability in the world, and stem cell - transplantation provides a promising approach for rehabilitation. The main objective of this study is to evaluate the efficacy of the intracerebral injection of autologous bone marrow mesenchymal stem cells in patients with chronic stroke.
详细描述
For many stroke survivors, the best hope is a lengthy program of rehabilitation, followed by a life-long process of clinical support. However, even with rehabilitation therapy, 50% to 95% of stroke survivors remain impaired. There is thus a great need for new therapeutic developments for patients with disability after stroke, which is largely unexplored. Regenerative cell-based therapies offer long-term hope for many patients with stroke, as stem cells might be possible for dead or injured neural cells to be replaced after acute stroke. 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 stroke. The neurological outcome will be determined after transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 ischemia stroke or intracerebral hemorrhage patient
- •With stroke history of more than 3 months, less than 60 months
- •With stable hemiplegia condition
- •NIHSS (NIH stroke scale) score of 7 or more points
- •Patient is stable (normal respiration, afebrile, BP less than mean arterial pressure of 125 mm of Hg, fasting blood sugar <7 mg, and normal urea/electrolytes for at least 48 hours.)
排除标准
- •Patients aged less than 40 or more than 70
- •Lacunar infarction
- •History of neurological disease, head injury or psychiatric disorder with disablity
- •Pregnant women
- •Impaired liver function, abnormal blood coagulation, AIDS, HIV, combine other tumor or special condition
- •Inaccessibility for follow up
- •Unwillingness to provide written informed consent
结局指标
主要结局
Change from baseline in NIH Stroke Scale at 12 months
时间窗: 1, 6 and 12 months
次要结局
- Improvement of infarct size measured by brain MRI(1,6 and 12 months after transplantation)
研究者
Qichuan Zhuge
Department of Neurosurgery
Wenzhou Medical University