NCT04524962终止1 期
Phase I/IIA Study of Descartes-30 in Acute Respiratory Distress Syndrome
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- To Assess the Safety of Descartes-30 in Patients With Moderate-to-severe ARDS.
研究概览
简要总结
Emergency study to test the safety of Descartes-30 cells in patients with moderate-to-severe acute respiratory distress syndrome (ARDS) AND COVID-19
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
- •Patients must be 18 years of age or older at the time of enrollment
- •Patient maintains a diagnosis of moderate or severe ARDS according to the Berlin definition of ARDS
排除标准
- •Patient is currently enrolled into another therapeutic clinical trial with an experimental therapy that has not received marketing approval by U.S. FDA.
- •Patient is in moribund state with expected survival <24 hours.
研究组 & 干预措施
Descartes 30
Experimental
干预措施: Descartes 30 (Biological)
结局指标
主要结局
To Assess the Safety of Descartes-30 in Patients With Moderate-to-severe ARDS.
时间窗: 3 months
Safety will be determined principally by assessment of adverse events (AEs) and serious adverse events (SAEs).
次要结局
未报告次要终点
研究者
研究点 (2)
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