EUCTR2019-002688-89-ES进行中（未招募）1 期
Phase 1/2 clinical study to assess the feasibility, safety, tolerability and preliminary efficacy of the administration of HCR040, a drug whose active substance is HC016, allogeneic adipose-derived adult mesenchymal stem cells expanded and pulsed with H2O2, in patients with acute respiratory distress syndrome. (included patients COVID-19)
Histocell S.L.0 个研究点目标入组 26 人开始时间: 2019年7月26日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 26
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •–Men and women = 18 years
- •–Patients with criteria of moderate to severe ARDS according to the Berlin Conference.
- •–Patients with invasive mechanical ventilation
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 26
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •–Participation in a previous clinical study within 28 days prior to the ARDS situation.
- •–Administration of a previous cell therapy product in the 5 years prior to this ARDS clinical situation.
- •–Inability to obtain Informed Consent.
研究者
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