acute respiratory distress syndrome (ARDS)
Conditions
Interventions
Intervention group:mesenchymal stem cells (umbilical cord)
Sponsors
China-Japan Friendship Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Age: 18~70 years old (including the threshold), regardless of gender; (2) Patients with ARDS caused by moderate and severe infection (except for patients with ARDS caused by trauma) who meet the diagnostic criteria of ARDS (Berlin definition) (moderate and severe, i.e. PaO2/FiO2 = 200mmHg and PEEP = 5cmH2O); (3) Patients who need or are undergoing invasive mechanical ventilation; (4) Chest imaging (chest CT or X-ray) showed bilateral infiltrating shadows; (5) There is no clinical evidence of bilateral lung infiltration due to heart failure or fluid overload; (6) The time from the first meeting of the ARDS diagnostic criteria (Berlin definition) to the enrollment is not more than 96 hours; (7) All subjects and their partners have no family planning within 6 months from screening to the end of the trial and agree to take effective non-drug contraceptive measures during the trial; (8) Volunteer to participate in clinical research, understand and sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Those who are known to be allergic to products of bovine origin or to any component of the test drug; (2) Those who have a history of drug abuse or drug abuse within 6 months before screening; (3) Those who have participated in clinical trials of other drugs and accepted the administration of investigational drugs within 3 months before screening; (4) Solid and blood malignant tumors, except for early malignant tumors that have undergone radical treatment for more than 5 years, and low-grade malignant tumors, such as thyroid papillary carcinoma and skin basal cell carcinoma, which have been removed by surgery, have been confirmed by the comprehensive evaluation of the researchers to meet the inclusion criteria; (5) Cardiogenic pulmonary edema; (6) In addition to the respiratory system, more than 3 other organs or systems fail; (7) Previous organ transplant recipients; (8) Within 3 months before screening, cardiovascular system diseases meet any of the following criteria: a) Serious arrhythmia requiring drug treatment and the researcher judged that the risk of participating in clinical trials was greater than that of beneficiaries; b) Myocardial infarction and severe/unstable angina pectoris occurred within 3 months before administration; (9) Select those who have deep venous thrombosis or pulmonary thrombosis or other thromboembolism events that the researcher thinks are not suitable to participate in this study within 3 months before screening; Or being treated with thrombolysis due to high risk of thrombosis; (10) Moderate to severe liver failure (using Child-Pugh criteria>12 points, see Appendix 4 for details); (11) Breastfeeding women or women with positive blood pregnancy test results during screening period; (12) Patients with thoracic deformity (such as funnel chest); (13) Active infection, including human immunodeficiency virus (HIV) antibody positive, hepatitis B surface antigen (HBsAg) positive, hepatitis C antibody (HCV) positive, and active pulmonary tuberculosis; (14) Currently receiving extracorporeal life support (ECLS) or high-frequency oscillatory ventilation (HFOV); (15) Brain hernia; (16) The researcher believes that there are other serious life-threatening complications (such as severe heart failure, WHO grade III or IV pulmonary hypertension), or mental diseases, or a history of laboratory abnormalities that may interfere with the evaluation of this study; (17) Any other circumstances judged by the researcher to be unsuitable for participation in this study, such as the condition that the study is not in the best interests of the subject at present (such as damage to health).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events;Dose limited toxicity (DLT); | — |
Secondary
| Measure | Time frame |
|---|---|
| 28-day mortality risk after MSCs infusion;Total time without mechanical ventilation within 28 days after MSCs infusion;Oxygenation index (OI) change;Changes in lung injury score (LIS);Changes in ventilator-related parameters [positive end-expiratory pressure (PEEP); airway platform pressure (Pplat);Static lung compliance (Cs);Pharmacokinetics;Anti-drug antibody (ADA);Laboratory index;Maximum tolerant dose (MTD); | — |
Countries
China
Contacts
Public ContactZhan Qingyuan
China-Japan Friendship Hospital
Outcome results
None listed