Acute Respiratory Distress Syndrome
Conditions
Interventions
Phase 1: hMSC-Exos low dose group:7 times aerosol inhalation of hMSC-Exos (2*10^8 particles at Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7)
Phase 1: hMSC-Exos medium dose group:7 times aerosol inhalation of hMSC-Exos (8*10^8 particles at Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7)
Phase 1: hMSC-Exos high dose group:7 times aerosol inhalation of hMSC-Exos (16*10^8 particles at Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7)
Phase 2: hMSC-Exos dosage 1 group:basic treatment and 7 times aerosol inhalation of hMSC-Exos (a quarter of MTD/day at Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7)
Phase 2: hMSC-Exos dosage 2 group:basic treatment and 7 times aerosol inhalation of hMSC-Exos (MTD/day at Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7)
Phase 2: control group:basic treatment and 7 times aerosol inhalation of normal saline (at Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7)
Sponsors
Ruijin Hospital affiliated Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. The subjects themselves or their family members voluntarily participate in this study and sign the informed consent form; 2. Aged 18-70 years, male or female; 3. Definitely diagnosed as acute respiratory distress syndrome (ARDS) (according to the Berlin definition and diagnostic criteria of ARDS); 4. Course of disease < 96 hours after diagnosis; 5. Chest X-ray showed bilateral infiltration with pulmonary edema; 6. No clinical manifestations of left ventricular hypertension, or pulmonary artery wedge pressure (PAOP) <= 18mmHg.
Exclusion criteria
Exclusion criteria: 1. Patients with severe allergic constitution; 2. Moderate to severe liver failure (children Pugh score > 12); 3. Patients with severe chronic respiratory diseases, PaCO2 > 50mmhg, and need home oxygen therapy; 4. Severe trauma occurred within 14 days before screening; 5. History of malignant tumor (patients with skin basal cell carcinoma in the past can be included); 6. They are undergoing hemodialysis or peritoneal dialysis; 7. The patients who had deep venous thrombosis or pulmonary embolism within 90 days; 8. Acute myocardial infarction occurred within 30 days; 9. Neuromuscular diseases that result in impaired natural ventilation include, but are not limited to, C5 or higher spinal cord injury, amyotrophic lateral sclerosis, Guillain Barre syndrome, and myasthenia gravis; 10. Obesity (BMI > 28); 11. Lung transplantation; 12. Bone marrow transplantation; 13. Active immunosuppression is defined as receiving immunosuppressive drugs or having a medical condition associated with immunodeficiency. These included: 1) HIV (AIDS or CD4 40mg/day): 4) absolute neutrophil count < 500 / mm3; Short term systemic steroid therapy (intravenous or oral) for less than 1 week, topical steroid for skin diseases; 14. Patients undergoing extracorporeal circulation support (ECMO) or high frequency oscillatory ventilation; 15. They were not willing to receive lung protective ventilation (minimum tidal volume 6ml / kg pbw) or liquid management treatment; 16. Have a history of epilepsy, need continuous anticonvulsant therapy, or have received anticonvulsant therapy in the past 3 years; 17. The estimated survival time was less than 30 days; 18. Hepatitis B, hepatitis C, AIDS, syphilis patients; 19. Women of childbearing age are pregnant, lactating or pregnant within one year; 20. Those who could not understand the study protocol; according to the judgment of the researchers, there were other situations in which the patients were not suitable to participate in the study (for example, there were factors to reduce the follow-up compliance, and the patients did not receive relevant supportive treatment, etc.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse reaction; | — |
Secondary
| Measure | Time frame |
|---|---|
| 28-day and 60-day mortality;The number of days that survivors were offline for mechanical ventilation;The number of days the survivor was out of ICU;Murray lung injury score;PaO2/FiO2;SOFA score and Apach II score;Incidence of treatment emergent adverse event in 60 days;Pathogen; | — |
Countries
China
Contacts
Public ContactJieming Qu
Ruijin Hospital affiliated Shanghai Jiao Tong University School of Medicine
Outcome results
None listed