Safety and Feasibility of Autologous M2 Macrophage Transplantation in Treatment of Non-Acute Stroke Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- The number of patients with severe adverse events
研究概览
简要总结
The purpose of this study is to determine whether M2 macrophages are safe and feasible in the treatment of non-acute stroke patients
详细描述
Our primary hypothesis is that autologous M2 macrophage transplantation via intrathecal introduction is feasible and safe after non-acute stroke. Our secondary hypothesis is that autologous M2 macrophage transplantation is associated with improved neurological outcome after non-acute stroke
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Computed tomography confirmed ischemic or hemorrhagic stroke
- •Duration since stroke onset more than 3 and less than 12 months
- •Age between 18 and 75 years old
- •Persistent neurological deficits more than 4 points in NIHSS stroke scale
- •Signed informed consent
排除标准
- •The history of previous stroke
- •Thrombophilias or primary hematological diseases
- •Malignancy
- •Hepatic or renal dysfunctions
- •Hemodynamic or respiratory instability
- •Autoimmune disease
- •HIV or uncontrolled bacterial, fungal, or viral infections
- •Pregnancy
- •Participation in other clinical trials
研究组 & 干预措施
M2 macrophages
M2 macrophage introduction
干预措施: M2 macrophage introduction (Other)
结局指标
主要结局
The number of patients with severe adverse events
时间窗: 1-3 days, 6 months
Occurence of severe adverse events including mortality, neurological worsening and seizures
次要结局
- Improvement in modified Rankin scale(1-3 days, 6 months)
- Improvement of functional outcome in National Institutes of Health Stroke Scale (NIHSS)(1-3 days, 6 months)
- Improvement in Barthel Index(1-3 days, 6 months)
研究者
Ekaterina Y. Shevela
Senior Researcher, Laboratory of Cellular Therapy, Research Institute of Clinical Immunology
Siberian Branch of the Russian Academy of Medical Sciences