Safety and Efficacy of Human Umbilical-Cord-derived Mesenchymal Stem Cell Transplantation in Paraquat Poisoning Induced Lung Injury
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Safety will be determined by the assessment of major adverse events.
研究概览
简要总结
Phase I-II Clinical Trial-Safety and efficacy of umbilical-cord-derived mesenchymal stem cell (UC-MSC) in patients with paraquat poisoning induced lung injury, randomized,single blind, controlled prospective study.
详细描述
Phase I-II Clinical Trial-Safety and efficacy of umbilical-cord-derived mesenchymal stem cell (UC-MSC) in patients with paraquat poisoning induced lung injury,randomized, single blind, controlled prospective study.
Forty patients will be selected and randomized into two groups: the first group of 20 patients will receive three-time injection of UC-MSC and the remaining 20 patients will comprise the control group.
Every patient will maintain their standard treatment of paraquat poisoning, with maximum tolerated dosage without side effects.
The day of last infusion will be considered day zero. From that moment, followup will be divided into 2 d,7 d,14 d, 28 d and 2 m.
Clinical results will be analyzed after completion of 2 months of followup.
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
- Single (Participant)
入排标准
- 年龄范围
- 15 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 15 and 60 y(including 15y)
- •A history of ingestion paraquat, and hospitalization within 96 hours after paraquat poisoning
- •No previous organic disease history of serious heart, liver, kidney and lung, etc;
- •Patients with moderate poisoning (oral dose of 20-40mg of PQ ion/kg of body weight)
- •Patient or his legal agent signed informed consent voluntarily
- •Capable of good communication with researchers and follow the entire test requirements
排除标准
- •Refused to sign informed consent
- •Elderly high-risk patients
- •Socially and mentally disabilities
- •Hepatitis B, hepatitis C, HIV and tuberculosis patients
- •Pregnant or perinatal women
- •Severe organ failure patients
- •Patients participated in clinical trials of other drugs within 3 months
- •Other circumstances not suitable to the trial(mixed toxicants poisoning)
结局指标
主要结局
Safety will be determined by the assessment of major adverse events.
时间窗: 2 months
Safety will be determined by the assessment of major adverse events defined as trial-related death,required hospitalization or prolonged hospitalization time, persistent or significant loss of organ function，other serious adverse events.
次要结局
- The efficacy of UC-MSC treatment was measured by chest computerized tomography.(2 months)
- The efficacy of UC-MSC treatment was measured clinical evaluation.(2 months)
- The efficacy of UC-MSC treatment was measured by lab Indicators.(2 months)
- The efficacy of UC-MSC treatment was monitored by pulmonary function.(2 months)