Lung Injury, Paraquat Poisoning
Conditions
Keywords
paraquat poisoning, lung injury, stem cell therapy, human umbilical cord mesenchymal stem cell, phase 1/2 clinical study, allogeneic stem cell transplantation
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.
Interventions
BIOLOGICALUCMSC group
Human umbilical cord MSCs are transplanted by intravenous injection(5×10\^5/kg) ，once a day,a total of three times.
Normal saline in same volume as MSCs are transplanted to patients.
Sponsors
Ivy Institute of Stem Cells Co. Ltd
Affiliated Hospital to Academy of Military Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
15 Years to 60 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 monitored by pulmonary function. | 2 months | The pulmonary function efficacy of UC-MSC treatment was measured by arterial blood gas analysis (oxygenation index). |
| 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). |
Countries
China
Contacts
Primary ContactZewu Qiu, M.D.
Outcome results
None listed