NCT02095444Unknown1 期
Phase1 Study of Recombinant Stem Cells That Repair Lung Injury in H7N9 Infected Patients
S-Evans Biosciences Co., Ltd.1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2014年3月最近更新:
适应症
干预措施
相关药物
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
- The degree of lung injury
研究概览
简要总结
The purpose of this study is to determine whether human menstrual blood-derived stem cells are effective in the treatment of infection of H7N9 virus caused acute lung injury.
详细描述
- recruiting volunteers of H7N9 infection: age > 18; patients signed with the informed consent; APACHE II > 20 score
- patients infused with menstrual blood progenitor cells infusion dose: 1~10×10*7 cells/kg infusion frequency: 2 times a week, 2 weeks for infusion
- test items and standard spirits lifted; pulmonary function improved; lung image injury improved
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
- 是
入选标准
- •Clinical diagnosis of H7N9 infection
- •must be critical injured for lung tissues
排除标准
- •cancer diseases
- •pregnancy
- •mental disorder
- •allergic constitution
- •severe inflammation
研究组 & 干预措施
Menstrual blood stem cells
Experimental
1x10*7 cells/kg, IV(in the vein) twice a week. Number of course for two weeks.
干预措施: Menstrual blood stem cells (Drug)
结局指标
主要结局
The degree of lung injury
时间窗: 14 days
次要结局
未报告次要终点
研究者
研究点 (1)
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