A Proof of Concept Study for the DNA Repair Driven by the Mesenchymal Stem Cells in Critical COVID-19 Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Expression of PARP1 gene as indicator of base excision repair
研究概览
简要总结
Our aim in this study is to determine the positive effect of stem cell therapy applied on critically ill patients with coronavirus infection on DNA repair genes.
Patients diagnosed with COVID-19 infection are divided into two equal (n:30) groups. Group-1(n/15): Patients in critically ill condition receiving conventional therapy, Group-2 (n/15): Patients in critically ill condition receiving conventional therapy and systemically transplanted MSCs. The DNA repair pathway will be examined as 11 genes in 5 different parts. Investigated parameters:
- Base excision repair
- Nucleotide excision repair
- Recombinational repair
- Mismatch repair
- Direct reversal Investigated parameters: broad biochemical analysis, apoptosis, clinical outcome, and mortality rates.
详细描述
Our aim in this study is to determine the positive effect of stem cell therapy applied on critically ill patients with coronavirus infection on DNA repair genes.
Patients diagnosed with COVID-19 infection are divided into two equal (n:30) groups. Group-1(n/15): Patients in critically ill condition receiving conventional therapy, Group-2 (n/15): Patients in critically ill condition receiving conventional therapy and systemically transplanted MSCs. The DNA repair pathway will be examined as 11 genes in 5 different parts. Investigated parameters:
- Base excision repair
- Nucleotide excision repair
- Recombinational repair
- Mismatch repair
- Direct reversal Investigated parameters: broad biochemical analysis, apoptosis, clinical outcome, and mortality rates.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •40-65 years old male/female.
- •Obtaining informed consent from him or his legal relative.
- •Confirmed COVID-19 related severe ARDS cases.
排除标准
- •pregnant, malignant tumours, the ones who has confirmed co-infection; history of using long-term immunosuppressive agents
结局指标
主要结局
Expression of PARP1 gene as indicator of base excision repair
时间窗: 6 months
Expression of PARP1 gene as indicator of base excision repair
Expression of genes ATM, RAD51, RAD52 and WRN as indicator of Recombinational repair
时间窗: 6 months
Expression of genes ATM, RAD51, RAD52 and WRN as indicator of Recombinational repair
Expression of genes RAD23B and ERCC1 as indicator of Nucleotide excision repair
时间窗: 6 months
Expression of genes RAD23B and ERCC1as indicator of Nucleotide excision repair
Expression of genes MLH1, MSH2 and MSH6as indicator of Mismatch repair
时间窗: 6 months
Expression of genes MLH1, MSH2 and MSH6 as indicator of Mismatch repair
次要结局
未报告次要终点