NCT02283879Unknown1 期
Human Umbilical Cord Mesenchymal Stem Cell Therapy for Patients With Cerebral Hemorrhage
Shenzhen Hornetcorn Bio-technology Company, LTD1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2015年3月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Safety evaluation through vital signs, the results of clinical lab tests and adverse events (AEs)
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of human umbilical cord mesenchymal stem cell(hUC-MSC) for cerebral hemorrhage sequela.
详细描述
Human umbilical cord mesenchymal stem cells exhibit the potential to differentiate into neural cells, which have been confirmed in in vivo and in vitro experiments. There have been few clinical reports describing umbilical cord mesenchymal stem cells for treatment of cerebral hemorrhage.
To investigate the effects of hUC-MSC treatment for cerebral hemorrhage sequela, 20 patients with cerebral hemorrhage will be enrolled and receive 4 times of hUC-MSC transplantation.
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 40-70 intracerebral hemorrhage patient
- •With stroke history of more than 3 months, less than 60 months
- •National Institutes of Health stroke scale(NIHSS) 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
- •History of neurological disease, head injury or psychiatric disorder;
- •Pregnant women;
- •Impaired liver function, abnormal blood coagulation, AIDS, HIV, combine other tumor or special condition;
- •Progressive apoplexy;
- •With malignant tumors.
结局指标
主要结局
Safety evaluation through vital signs, the results of clinical lab tests and adverse events (AEs)
时间窗: 12 months
次要结局
- Improvement of infarct size measured by brain MRI(before the transplant and 1, 6, 12 months after transplantation)
- National Institutes of Health stroke scale(NIHSS) score(before the transplant and after the transplant 1, 2 and 3 months)
- Modified Barthel index(before and 1, 3, 6 and 12 months after transplantation)
研究者
研究点 (1)
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