Immune Modulation by Stem Cell Derived Exosomes in Critically Ill COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Cytokine profile in supernatants
研究概览
简要总结
Following whole blood stimulation with mesenchymal stem cell derived exosomes, immune phenotype, cytokine release and mRNA expression patterns from critically ill patients with COVID-19 will be determined.
详细描述
Critically ill patients with COVID-19 may develop lung failure and require extracorporal oxygenation due to hyperinflammation and progressive lung fibrosis. The anti-inflammatory and immune modulatory function of mesenchymal stem cells will be investigated by whole blood stimulation experiments using stem cell derived exosomes. Exosome preparations have been characterized by miRNA and protein expression patterns and suggest their tissue regenerative capacity.
The hypothesis of the present study is that mesenchymal stem cell derived exosomes attenuate inflammation and support anti-fibrotic pathways.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Critically ill COVID-19 patients with lung dysfunction
- •COVID-19 WHO severity degree >= 4, ARDS (WHO Definition 13 March 2020)
- •Body weight > 50 kg
- •Informed consent
排除标准
- •Pregnant or breast feeding women
结局指标
主要结局
Cytokine profile in supernatants
时间窗: 24 hours, 1 year
Quantification of pro- and anti-inflammatory biomarkers after 24 hours of whole blood culture
次要结局
- Immune phenotyping(1 year)
- Genetic predisposition to hyperinflammation(1 year)
研究者
Manfred Weiss
Professor, MD, MBA, Clinical Professor
University of Ulm