NCT04522986已完成1 期
An Exploratory Study of ADR-001 in Patients with Severe Pneumonia Caused by SARS-CoV-2 Infection
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Safety: Adverse Event
研究概览
简要总结
Safety and efficacy of ADR-001 are evaluated in Patients with Severe Pneumonia caused by SARS-CoV-2 infection.
详细描述
Patients with Severe Pneumonia caused by SARS-CoV-2 infection are enrolled to the study. Adipose-derived mesenchymal stem cells (AD-MSCs) are administered once a week, total four times intravenously. Safety and efficacy of AD-MSCs are evaluated for 12 weeks after first administer.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •SARS-CoV-2 infection is confirmed on antigen test or PCR test
- •Pulmonary infiltrative shadow is confirmed on chest X-ray test
- •Mechanical ventilation is being utilized, or Acute Respiratory Failure whose PaO2 is not being achieved to 80 mmHg in spite of High-flow oxygen therapy
排除标准
- •Continue treatment for Pneumonia before SARS-CoV-2 infection
- •SOFA score >= 15
- •Infection type on DIC diagnosis criteria >= 4
- •Deep Venous Thrombosis
研究组 & 干预措施
Mesenchymal stem cell
Experimental
4 times dose of Mesenchymal stem cell
干预措施: Mesenchymal stem cell (Biological)
结局指标
主要结局
Safety: Adverse Event
时间窗: 12 weeks
Adverse events which appear in subjects with ADR-001 treatment are evaluated.
次要结局
未报告次要终点
研究者
研究点 (1)
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