Human Umbilical-Cord-Derived Mesenchymal Stem Cell Therapy in Paraquat Poisoning Induced Lung Injury
- Conditions
- Paraquat PoisoningLung Injury
- Interventions
- Other: Control group(Normal saline)Biological: UCMSC group
- Registration Number
- NCT02444858
- Lead Sponsor
- Affiliated Hospital to Academy of Military Medical Sciences
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group(Normal saline) Control group(Normal saline) Patients will receive normal saline at the same time points as that in experimental group. UCMSC group UCMSC group Human umbilical cord MSCs are administrated to patients by intravenous injection
- Primary Outcome Measures
Name Time Method Safety will be determined by the assessment of major adverse events. 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.
- Secondary Outcome Measures
Name Time Method The efficacy of UC-MSC treatment was measured by chest computerized tomography. 2 months The efficacy of UC-MSC treatment was quantified by the differences between the two groups and from baseline to 2 months, as measured by chest computerized tomography(CT).
The efficacy of UC-MSC treatment was measured clinical evaluation. 2 months The efficacy of UC-MSC treatment was measured clinical evaluation defined as wheezing, coughing and other symptoms improved than before.
The efficacy of UC-MSC treatment was measured by lab Indicators. 2 months The efficacy of UC-MSC treatment was measured by lab Indicators defined as blood cell analysis, markers of inflammation (C-reactive protein).
The efficacy of UC-MSC treatment was monitored by pulmonary function. 2 months The pulmonary function efficacy of UC-MSC treatment was measured by arterial blood gas analysis (oxygenation index).
Trial Locations
- Locations (1)
Department of poisoning and treatment,Affiliated Hospital to Academy of Military Medical Sciences
🇨🇳Beijing, China