The object of this study is to observe the safety of umbilical cord mesenchymal stem cell therapy for acute respiratory distress syndrome, consisting with two phases.
The secondary objectives are to observe the preliminary efficacy of umbilical cord mesenchymal stem cell therapy for acute respiratory distress syndrome. Phase One is an open-label, dose-escalation clinical study. Following safety and tolerability conclusions from Phase One, and upon evaluation and approval by the data safety committee and ethics committee, conduct Phase Two study, which will be a randomized, double-blind, placebo-controlled study. Dosage selection will be based on the safest and most effective dosage determined from Phase One results.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
umbilical cord mesenchymal stem cell
non-cell-containing placebo
The safety of umbilical cord mesenchymal stem cell therapy for acute respiratory distress syndrome.
The 28-day mortality of patients receiving umbilical cord mesenchymal stem cell therapy
Time frame: The 1, 6, 24 hours; 3、7、14、21 days and 4, 12, 24, 36, 48 weeks after injection.
The efficacy of umbilical cord mesenchymal stem cell therapy for acute respiratory distress syndrome.
Oxygenation index situation change (PaO2/FiO2) of patients receiving umbilical cord mesenchymal stem cell therapy
Time frame: The 1, 6, 24 hours; 3、7、14、21 days and 4, 12, 24, 36, 48 weeks after injection.
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