Allogeneic Cord Blood in the Treatment of Neurological Diseases in Adults
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 发起方
- 入组人数
- 80
- 主要终点
- Changes in modified Rankin Scale (mRS)
研究概览
简要总结
This open label trial is conducted to investigate the efficacy and safety of allogeneic umbilical cord blood therapy for adult patients with neurological diseases.
详细描述
Neurological diseases such as stroke or spinal cord injuries are very common etiologies causing disability in developed countries. Cord blood possess various stem and progenitor cells, as well as their secreted regenerative factors, and is known to repair injured brain. The investigators clinical research aims to determine the safety and efficacy of allogeneic Umbilical Cord Blood for adult patients with neurological diseases such as stroke and spinal cord injury.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ischemic or hemorrhagic stroke (onset < 24 months), or
- •Spinal cord injury (onset < 24 months)
排除标准
- •Raised intracranial pressure
- •Malignant cancer
- •Renal failure
- •Severe pulmonary dysfunction
研究组 & 干预措施
Allogeneic cord blood therapy
Allogeneic cord blood therapy
干预措施: Allogeneic cord blood treatment (Biological)
结局指标
主要结局
Changes in modified Rankin Scale (mRS)
时间窗: 1 month - 3 months - 6 months - 12 months
modified Rankin Scale (mRS) from 1 - 5 whereby 1 is best (no significant disability) and 5 is worst (severe disability); The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability.
次要结局
- Monitoring Adverse Events(1 month - 3 months - 6 months - 12 months)