acute respiratory distress syndrome (ARDS)
Conditions
Interventions
Experimental group:CAStem cell injection
Control group:Placebo
Sponsors
China-Japan Friendship Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >=18 years; 2. According to the Berlin definition in 2012, it is diagnosed as ARDS, and the specific diagnostic criteria are as follows (simultaneously meeting the following four criteria) : (1) Acute onset or worsening respiratory symptoms within one week; (2) Infiltration of both lungs could not be explained by pleural effusion or atelectasis nodules; (3) Explanations of respiratory failure, cardiac insufficiency or fluid overload; (4) The level of hypoxemia was divided by light to severe: mild: 200 mmHg=5 cm H2O. The mild ARDS group might adopt non-invasive ventilation. Moderate: 100 mmHg=5 cm H2O; Severe: PaO2/FiO2=5 cm H2O; 3. After the diagnosis of ARDS, standard ventilation Settings (tidal volume [VT] 4-8 mL/kg[ideal body weight], platform pressure (Pplat) =5 cm H2O and FiO2>=0.5) were used for ventilation for 24 hours; 4. Those who can receive experimental drugs within 72 hours of the first diagnosis of ARDS; 5. Voluntarily participate in the study, agree to comply with the requirements of the clinical trial protocol, and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. The researchers judged that the expected survival time was less than 48 hours; 2. Those who are receiving any form of extracorporeal life support such as ECMO or continuous kidney replacement therapy (CRRT); 3. Moderate and severe liver failure (Childs Pugh score >12); 4. Patients with grade III or IV pulmonary hypertension; 5. Patients with PaCO2>50 mm Hg or severe chronic respiratory diseases requiring home oxygen therapy; 6. Deep vein thrombosis or pulmonary embolism occurred within 3 months before signing the informed consent; 7. Patients with a history of malignant tumor or severe atypical hyperplasia without treatment; 8. Major trauma or surgery within 5 days before signing the informed consent, or planned or expected surgery within 72 hours after the infusion of the study drug; 9. Patients with active infectious diseases, including human immunodeficiency virus (HIV) antibody positive, active tuberculosis, syphilis and other active infectious diseases, and the researchers think that it is not suitable to participate in this study; 10. Body mass index (BMI) >=40 kg/m^2; 11. Those who have received cell therapy or organ transplantation in the past and are considered unsuitable for this study by the researchers; 12. Patients who are pregnant or breastfeeding or plan to become pregnant during the study, or patients of childbearing age who do not wish to use contraception throughout the study period; 13. Patients who were treated with other investigational agents within 28 days prior to the start of treatment, and the investigational agents are determined by the investigator to interfere with the evaluation of the safety and efficacy of the investigational agents; 14. The investigator believes that participation in the study is not in the best interest of the patient or other circumstances, such as poor compliance, are not suitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All-cause mortality rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Ventilator-free days;ICU-free days;Days without organ failure ;Change in lung injury score from baseline;Changes in RALE scores from baseline assessed by chest radiography;Change in PaO2/FiO2 from baseline and the number of days from baseline until the first PaO2/FiO2 reached > 300 mmHg (and mechanical ventilation was no longer required for at least 12 consecutive hours);Change in OI from baseline;Changes from baseline in SOFA score in sequential organ failure and APACHE? score in acute physiology and chronic health;Pulmonary function;Improvement of the Short Form Health Status Survey (SF-12);Improvement in distance on the 6-minute walk test (6MWT) for cardiopulmonary rehabilitation;Improvement in chest CT; | — |
Countries
China
Contacts
Public ContactJia Yi
Zephyrm Biotechnologies
Outcome results
None listed