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.
Male or female patients aged 18 to 80 years (inclusive).
Diagnosis of moderate or severe Acute Respiratory Distress Syndrome (ARDS) according to A New Global Definition of Acute Respiratory Distress Syndrome, with an infectious etiology.
No improvement after 24 hours of conventional clinical treatment (defined as a persistent PaO₂/FiO₂ ratio ≤200 mmHg or a decrease from >200 mmHg to ≤200 mmHg after 24 hours of conventional supportive therapy; for severe ARDS, this assessment period may be shortened to 8 hours).
Ability to fully understand the nature of the study and voluntarily provide written informed consent.
Patients with ARDS caused by COVID-19 infection.
Patients currently suffering from hepatitis B, hepatitis C, active or latent tuberculosis, AIDS, syphilis, immunodeficiency disorders, or other immune system diseases.
Presence of severe cardiovascular diseases at screening, including:Cardiac function classification of NYHA class III or higher.Uncontrolled myocarditis or valvular disease.Malignant arrhythmia requiring pharmacological treatment.
Abnormal liver or renal function at screening meeting any of the following criteria:ALT or AST ≥ 5 × ULN, or total bilirubin ≥ 3 × ULN.Serum creatinine ≥ 3 × ULN, or patients currently undergoing renal replacement therapy (CRRT).
Single group
1 vial containing a total of 5×10^7 cells
Biological/Vaccinevenous reinfusion
2 vial containing a total of 1×10^8 cells
Biological/Vaccinevenous reinfusion
3 vial containing a total of 1.5×10^8 cells
Biological/Vaccinevenous reinfusion
4 vial containing a total of 2×10^8 cells
Biological/Vaccinevenous reinfusion
DLT incidence rate
Safety Indicator
Maximum Tolerated Dose
Safety Indicator
Any adverse events related to MSCs therapy
Safety Indicato
Incidence of Clinically Significant Changes in Vital Signs from Baseline
Safety Indicato
Incidence of clinically significant changes in laboratory tests from baseline
Safety Indicato
male/female tumor marker positive rate
Safety Indicato
all-cause mortality
Efficacy Endpoint
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