Human umbilical cord mesenchymal stem cell injection for moderate to severe ARDS

Inclusion Criteria:

* 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.
* Willingness to comply with all study procedures and demonstrate good compliance during the study period.
* Agreement to participate in long-term follow-up.

Exclusion Criteria:

* 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).
* Patients receiving extracorporeal membrane oxygenation (ECMO) therapy at the time of screening.
* Severe hematological abnormalities at screening, including: hemorrhagic manifestations, PTA ≤ 40% (or INR ≥ 2.0), severe anemia (Hb \< 60 g/L), moderate or severe thrombocytopenia (PLT \< 50 × 10\^9/L), disseminated intravascular coagulation (DIC), leukemia, or other hematological abnormalities deemed ineligible for the study.
* Severe end-stage respiratory diseases at screening.
* Pulmonary hypertension with a pulmonary artery pressure \> 70 mmHg.
* History of deep vein thrombosis or pulmonary embolism within the 6 months prior to enrollment.
* Patients post lung transplantation.
* Presence of severe cardiopulmonary malformations at screening.
* Severe psychiatric disorders.
* Patients who are pregnant (positive pregnancy test), breastfeeding, or have a pregnancy plan, are unwilling to practice contraception during the study and for 12 months after the infusion, or are of childbearing potential and unwilling to use effective contraception.
* Use of high-dose corticosteroids equivalent to methylprednisolone \> 240 mg/day within 3 days prior to enrollment, or long-term irregular use of systemic corticosteroids for other diseases, which, in the investigator's judgment, may affect efficacy evaluation.
* Allergy to any component of the Human Umbilical Cord Mesenchymal Stem Cell Injection (e.g., human albumin), or a history of severe allergies deemed by the investigator as unsuitable for participation.
* Concurrent participation in another interventional clinical trial, or participation in another interventional clinical trial within the 3 months prior to screening.
* History or current diagnosis of malignancy, or pathological confirmation of precancerous lesions.
* Any other condition that, in the investigator's judgment, would lead to premature termination of the study, such as non-adherence to the protocol, concurrent severe illnesses requiring combined treatment, significant laboratory abnormalities, or social/family factors that could compromise the patient's safety or data collection.