Mesenchymal Stromal Cell Therapy for Severe Covid-19 Infection
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- To evaluate the safety of intravenous infusion of MSC in patients with severe to critical COVID-19 pneumonia
研究概览
简要总结
The overall objective of the study is to evaluate the safety and efficacy of MSC therapy combined with best supportive care in hospitalized patients with COVID-19.
详细描述
This study is a monocentric prospective phase I/II clinical trial, aiming at evaluating the safety and efficacy of 3 intravenous administrations of BM-MSC in 20 patients with severe to critical COVID-19 pneumonia.
After signed informed consent, patients will receive 3 infusions of (1.5)-3.0 x106/kg BM-MSC (from the same donor) at 3-4 days interval, in addition to the standard of care for COVID-19 disease.
The trial will be open for inclusion for 2 years after initiation. Each patient will be followed for 90 days after inclusion. The total study duration will thus be 2 years and 90 days.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
To evaluate the safety of intravenous infusion of MSC in patients with severe to critical COVID-19 pneumonia
时间窗: Day 28
To assess the infusional toxicity
To evaluate the efficacy of intravenous infusion of MSC in patients with severe to critical COVID-19 pneumonia
时间窗: Day 28
Group A (patients not under mechanical ventilation): to determine the pourcentage of patients requiring mechanical ventilation
次要结局
- To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy)(Day 90)