ARDS
Conditions
Interventions
Stage 1: group 1:Aerosol inhalation hUCMSCs-Exos treatmen,Group 1: 3×10^9 particles
Stage 1: group 2:Aerosol inhalation hUCMSCs-Exos treatmen,Group 2: 1.2×10^10 particles
Stage 1: group 3:Aerosol inhalation hUCMSCs-Exos treatmen,Group 3: 4.8×10^10 particles
Stage 1: group 4:Aerosol inhalation hUCMSCs-Exos treatmen,Group 4: 9.6×10^10 particles
Stage 2: group 1:Aerosol inhalation hUCMSCs-Exos treatmen,Group 1: 3×10^9 particles or placebos
Stage 2: group 2:Aerosol inhalation hUCMSCs-Exos treatmen,Group 2: 1.2×10^10 particles or placebos
Stage 2 group 3:Aerosol inhalation hUCMSCs-Exos treatmen,Group 3: 4.8×10^10 particles or placebos
Stage 2: group 4:Aerosol inhalation hUCMSCs-Exos treatmen,Group 4: 9.6×10^10 particles or placebos
Sponsors
Shanghai East Hospital, School of Medicine, Tongji University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Admitted to the Intensive Care Department and diagnosed as a patient with ARDS (2012 Berlin criteria as the basis for diagnosis, in which stage 1 included mild to moderate ARDS patients and stage 2 included all ARDS patients). Diagnostic criteria for ARDS: Berlin criteria: a. known clinical manifestations of respiratory impairment or new/aggravated respiratory symptoms within one week of onset; b. Chest effects suggest reduced transmittance of both lungs, which cannot be completely explained by pulmonary fluid leakage, lobar/atelectasis, or sarcoidosis; c. Respiratory failure cannot be completely explained by heart failure or excessive fluid input, and when necessary, pulmonary edema due to increased hydrostatic pressure should be performed except cardiac ultrasound; d. Oxygenation state: mild 200mmHg=PaO2/FiO2=300mmHg; Moderate 100mmHg=PaO2/FiO2=200mmHg; Heavy PaO2/FiO2=100mmHg. 2) Age: 18-75 years old, male and female. 3) Patients who knew and voluntarily signed consent forms prior to this study.
Exclusion criteria
Exclusion criteria: 1) Pregnant or lactating women; 2) Patients with mental and cognitive disorders; 3) Patients with a suspected or clear history of alcohol and drug abuse; 4) Patients with a history of allergy to two or more drugs or foods; 5) Patients with tumor history; 6) Patients who have undergone cardiac surgery or have heart failure; 7) Patients taking immunosuppressants for a long time; 8) Patients who had a related lung disease (such as asthma, etc.) prior to this study and were using other preventive and therapeutic drugs; 9) Patients who have participated in other clinical trials within the last 3 months; 10) Patients deemed unsuitable for clinical trials for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stage 1: Key indicators: maximum tolerated dose, adverse events related to inhalation. ;Stage 2: changes in oxygenation index (PaO2/FiO2);Stage 2: inflammatory factors in alveolar lavage fluid.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Stage 2: Clinical outcomes: in-hospital all-cause mortality, length of stay, ICU time, rate and duration of mechanical ventilation, clinical signs and symptoms, changes in respiratory physiological measures including lung compliance and airway resistance, etc;Stage 2: clinical signs and symptoms;Stage 2: changes in respiratory physiological measures including lung compliance and airway resistance, etc; | — |
Countries
China
Contacts
Public ContactZhu Feng
Shanghai East Hospital, School of Medicine, Tongji University
Outcome results
None listed