Primary Objective: To evaluate the safety and tolerability of human umbilical cord mesenchymal stem cell injection in the treatment of moderate/severe acute respiratory distress syndrome.Secondary Objectives: To explore the efficacy and appropriate dosage of human umbilical cord mesenchymal stem cell injection in the treatment of moderate/severe acute respiratory distress syndrome.Exploratory Objective: To explore the immunogenicity and pharmacokinetic/pharmacodynamic (PK/PD) characteristics of a single dose of human umbilical cord mesenchymal stem cell injection in patients with moderate/severe acute respiratory distress syndrome.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
venous reinfusion
venous reinfusion
venous reinfusion
venous reinfusion
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
RECRUITINGDLT incidence rate
Safety Indicator
Time frame: within 28 days after administration
Maximum Tolerated Dose
Safety Indicator
Time frame: Periprocedural
Any adverse events related to MSCs therapy
Safety Indicato
Time frame: within 28 days after administration
Incidence of Clinically Significant Changes in Vital Signs from Baseline
Safety Indicato
Time frame: within 28 days after administration
Incidence of clinically significant changes in laboratory tests from baseline
Safety Indicato
Time frame: within 28 days after administration
male/female tumor marker positive rate
Safety Indicato
Time frame: within 28 days after administration
all-cause mortality
Efficacy Endpoint
Time frame: within 28 days after administration
Time of non-mechanical ventilation (days)
Efficacy Endpoint
Time frame: within 28 days after administration
Non-intensive care time (days)
Efficacy Endpoint
Time frame: within 28 days after administration
Time without organ failure (days)
Efficacy Endpoint
Time frame: within 28 days after administration
PaO2/FiO2 varies from baseline
Efficacy Endpoint
Time frame: 24 hours, 3, 7, 14, 28 days after infusion of test drug
Arterial blood gas analysis (pH, PaO _ 2, PaCO _ 2, Lac) changed from baseline
Efficacy Endpoint
Time frame: 24 hours, 3, 7, 14, 28 days after infusion of test drug
Lung injury score changes from baseline
The minimum score is 0, and the maximum score is 4. A higher score indicates a more severe condition. Efficacy Endpoint
Time frame: Days 7, 14, 28
Sequential organ failure score changes from baseline
Minimum score 0, maximum score 24. The higher the score, the worse the prognosis Efficacy Endpoint
Time frame: Days 3, 7, 14, 28
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