NCT04366323已完成1 期
Phase I / II Clinical Trial, Multicenter, Randomized and Controlled, to Assess the Safety and Efficacy of Intravenous Administration of Allogeneic Adult Mesenchymal Stem Cells of Expanded Adipose Tissue in Patients With Severe Pneumonia Due to COVID-19
Andalusian Network for Design and Translation of Advanced Therapies6 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2020年4月27日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 6
- 主要终点
- Safety of the administration of allogeneic mesenchymal stem cells derived from adipose tissue assessed by Adverse Event Rate
研究概览
简要总结
Phase I/II clinical trial to evaluate the safety and efficacy of Allogenic Adipose Tissue-Derived Mesenchymal Stem Cells Expanded in patients with severe COVID-19 pneumonia
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Pneumonia, severe or critical, caused by COVID-19 infection
- •Life expectancy > 48 hours.
- •Commitment to use a contraceptive method of proven efficacy in both men and women during the duration of the clinical trial.
排除标准
- •Coinfection with other viruses or bacteria (HIV, tuberculosis, influenza virus, adenovirus or other respiratory infections, active infection by HBV or C).
- •History of multiple allergies, including allergy to Penicillin or other Blactams.
- •Pregnant and lactating women.
- •Patients with malignant tumors or hemopathies or any state of immunosuppression considered as severe.
- •Patients with autoimmune diseases.
- •Chronic heart failure with ejection fraction less than 30%.
- •Any other condition for which, in the opinion of the main investigator, the subject is considered not to be in compliance with the study.
研究组 & 干预措施
Experimental
Experimental
干预措施: ALLOGENEIC AND EXPANDED ADIPOSE TISSUE-DERIVED MESENCHYMAL STEM CELLS (Drug)
结局指标
主要结局
Safety of the administration of allogeneic mesenchymal stem cells derived from adipose tissue assessed by Adverse Event Rate
时间窗: 12 months
Efficacy of the administration of allogeneic mesenchymal stem cells derived from adipose tissue assessed by Survival Rate
时间窗: 28 days
次要结局
未报告次要终点
研究者
研究点 (6)
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