Human Umbilical-Cord-Derived Mesenchymal Stem Cell Therapy in Paraquat Poisoning Induced Lung Injury

Study Overview
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Brief Summary
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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
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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.

Official Title
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Safety and Efficacy of Human Umbilical-Cord-derived Mesenchymal Stem Cell Transplantation in Paraquat Poisoning Induced Lung Injury

Conditions
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Paraquat Poisoning, Lung Injury

Intervention / Treatment
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* Biological: UCMSC group
* Other: Control group(Normal saline)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: UCMSC group<br>Human umbilical cord MSCs are administrated to patients by intravenous injection | Biological: UCMSC group<br>* Human umbilical cord MSCs are transplanted by intravenous injection(5×10^5/kg) ，once a day,a total of three times.<br>|
| Other: Control group(Normal saline)<br>Patients will receive normal saline at the same time points as that in experimental group. | Other: Control group(Normal saline)<br>* Normal saline in same volume as MSCs are transplanted to patients.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety will be determined by the assessment of major adverse events. | 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. | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The efficacy of UC-MSC treatment was measured clinical evaluation. | The efficacy of UC-MSC treatment was measured clinical evaluation defined as wheezing, coughing and other symptoms improved than before. | 2 months | 
| The efficacy of UC-MSC treatment was measured by chest computerized tomography. | 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). | 2 months | 
| The efficacy of UC-MSC treatment was monitored by pulmonary function. | The pulmonary function efficacy of UC-MSC treatment was measured by arterial blood gas analysis (oxygenation index). | 2 months | 
| The efficacy of UC-MSC treatment was measured by lab Indicators. | The efficacy of UC-MSC treatment was measured by lab Indicators defined as blood cell analysis, markers of inflammation (C-reactive protein). | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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paraquat poisoning, lung injury, stem cell therapy, human umbilical cord mesenchymal stem cell, phase 1/2 clinical study, allogeneic stem cell transplantation