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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
40
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.
Department of poisoning and treatment,Affiliated Hospital to Academy of Military Medical Sciences
Beijing, China
RECRUITINGSafety 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.
Time frame: 2 months
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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 2 months
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