Acute Respiratory Distress Syndrome
Conditions
Interventions
Experimental Group:This study adopts a 3+3 dose-escalation design. Eligible subjects will be sequentially assigned to three dose groups (low, medium, and high) according to the order of enrollment. On
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Sign the informed consent form and be able to complete the trial according to the protocol. 2. Age 18-65 years, male or female. 3. Body weight >=50 kg. 4. Meet the diagnostic criteria for ARDS. The diagnostic criteria for ARDS are as follows: (1) Acute onset: New or worsening respiratory symptoms within one week after a known clinical insult (including acute pancreatitis, pneumonia, sepsis, aspiration, trauma, etc.); (2) Imaging: Bilateral opacities (patchy or consolidated) not fully explained by pleural effusion, atelectasis, or nodules; (3) Origin of pulmonary edema: Respiratory failure not fully explained by heart failure or fluid overload; (4) Impaired oxygenation: PaO2/FiO2 =5 cmH2O. 5. Time from first meeting the ARDS diagnostic criteria to enrollment =24 hours. 7. The patient or legal representative is able to sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Previous treatment with erythrocyte membrane formulations and known allergy to any of their components. 2. Coagulation dysfunction, active bleeding or thrombosis requiring hemostatic or anticoagulant therapy. 3. Pregnancy, lactation, or women of childbearing potential not using effective contraception. 4. Uncontrolled severe systemic diseases (e.g., central nervous system, cardiovascular system, hematologic system, digestive system, endocrine system, urogenital system, immune system, etc.) or psychiatric disorders. 5. Underlying diseases that may interfere with accurate assessment of oxygenation status, including severe chronic lung disease (e.g., COPD, idiopathic pulmonary fibrosis, cystic fibrosis) and other specific pulmonary conditions (e.g., cardiogenic pulmonary edema, diffuse alveolar hemorrhage, acute eosinophilic pneumonia, acute interstitial pneumonia). 6. Inability to complete required examinations due to objective conditions, such as severe pneumothorax, massive pleural effusion, or inability to obtain arterial blood gas or chest imaging. 7. Severe cardiovascular or cerebrovascular events within the past 6 months: heart failure (NYHA class III-IV), myocardial infarction, unstable angina, severe arrhythmia, cerebral infarction, or intracerebral hemorrhage. 8. Hepatic or renal dysfunction: AST/ALT > 2.5× upper limit of normal (ULN); serum creatinine > 1.5 mg/dL (male) or > 1.4 mg/dL (female). 9. Active infectious diseases such as HIV infection, syphilis, or active pulmonary tuberculosis. 10. Severe autoimmune disease. 11. Any cause of leukopenia (WBC < 3 × 10^9/L) or granulocytopenia (absolute neutrophil count < 0.5 × 10^9/L). 12. Any other medical or non-medical factor that, in the investigator's judgment, may compromise study safety, accuracy of study results, or the subject's ability to complete the entire study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Adverse Events (AEs);Incidence of Serious Adverse Events (SAEs); | — |
Secondary
| Measure | Time frame |
|---|---|
| Ventilator-free days within 28 days;ICU length of stay;Total hospital length of stay;ICU mortality;In-hospital mortality;Arterial blood gas parameters (pH, PaO2, PaCO2, Lac, PaO2/FiO2, etc.);Respiratory mechanics parameters (respiratory rate, FiO2, PEEP, peak pressure, plateau pressure, compliance);Lung Ultrasound Score (LUS);Chest CT;6-minute walk test distance;mMRC dyspnea scale score;St. George's Respiratory Questionnaire (SGRQ) score;Levels of inflammatory markers ;Alveolar injury markers;Optimal dose of YMN-V112 formulation for ARDS treatment;Routine blood test;Biochemical indexes;Urination and defecation routine; | — |
Countries
China
Contacts
Public ContactXiaodong Jin/Yuquan Wei
West China Hospital, Sichuan University
Outcome results
None listed