The goal of this clinical trial is to evaluate the safety and tolerability of multiple doses of human umbilical cord mesenchymal stem cell injection in patients with Mild to Moderate Acute Respiratory Distress Syndrome (ARDS), and to further explore the efficacy, pharmacodynamic profile and appropriate dose of administration to provide a basis for the use of safer and more effective treatments for patients with Mild to Moderate Acute Respiratory Distress Syndrome (ARDS).
Participants are required to sign an informed consent form and, after undergoing a series of tests and meeting the protocol's entry and exclusion criteria, are assigned to a dose group for intravenous infusion of human umbilical cord mesenchymal stem cells. Each subject will receive three infusions.
18-75 years old (including the threshold), male or female
A definite diagnosis of mild to moderate acute respiratory distress syndrome (ARDS) (according to the ARDS Berlin definition and diagnostic criteria)
ARDS onset ≤ 5 days
100 mmHg < PaO2/FiO2 ≤ 300 mmHg
Hypersensitivity to known components of the drug (the main component of this product is human umbilical cord mesenchymal stem cells, excipients include dimethyl sulfoxide, human albumin, compound electrolyte injection), the presence of a history of allergy to gentamicin or other history of severe allergy
Patients requiring treatment for any malignancy within 2 years prior to administration (except non-melanoma skin cancer)
Lung transplant patients
Patients with malignant haematological diseases
Sequential
Human Umbilical Cord Mesenchymal Stem Cells
Biological/VaccineThe stem cell infusion route is peripheral intravenous infusion. All subjects received experimental drugs and conventional treatment during the study period.
Adverse Event (AE)
Adverse events that occurred during the trials
Serious Adverse Event (SAE)
Serious adverse events that occurred during the trial
Maximum Tolerated Dose (MTD)
Maximum Tolerated Dose
Oxygenation index
To observe the improvement in oxygenation index (P/F) from baseline
Chest routine scan
To explore the improvement in lung imaging (calculation of lung exudate area)
Intubation rate
To explore the rate of intubation in subjects within 28 days after infusion
Length of hospitalisation
Length of stay in hospital within 28 days
Interferon-γ (IFN-γ）
The concentration of IFN-γ in blood
Interleukin-1β （IL-1β）
The concentration of IL-1β in blood
Interleukin-6 （IL-6）
The concentration of IL-6 in blood
Interleukin-8 （IL-8）
The concentration of IL-8 in blood
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