Safety and Tolerance of Umbilical Cord Mesenchymal Stem Cells in Patients With Acute Respiratory Distress Syndrome
Acute Respiratory Distress Syndrome
About this trial
This is an interventional treatment trial for Acute Respiratory Distress Syndrome focused on measuring Human Umbilical Cord Mesenchymal Stem Cells, Acute Respiratory Distress Syndrome
Eligibility Criteria
Inclusion Criteria: 18-75 years old (including the threshold), male or female A definite diagnosis of mild to moderate acute respiratory distress syndrome (ARDS) (according to the ARDS Berlin definition and diagnostic criteria) ARDS onset ≤ 5 days 100 mmHg < PaO2/FiO2 ≤ 300 mmHg Bilateral pulmonary infiltrates on chest radiograph or chest CT Rule out other causes of pulmonary oedema, such as cardiogenic pulmonary oedema and pulmonary oedema due to fluid overload Have no plans to have children within 2 weeks before screening and 3 months after the end of the trial, and agree to use effective non-pharmacological contraception during the trial Patients voluntarily signed an informed consent form and were willing to co-operate with the trial process Exclusion Criteria: Hypersensitivity to known components of the drug (the main component of this product is human umbilical cord mesenchymal stem cells, excipients include dimethyl sulfoxide, human albumin, compound electrolyte injection), the presence of a history of allergy to gentamicin or other history of severe allergy Patients requiring treatment for any malignancy within 2 years prior to administration (except non-melanoma skin cancer) Lung transplant patients Patients with malignant haematological diseases Persons who have had a cardiovascular event within 3 months prior to dosing (e.g., unstable angina, congestive heart failure, myocardial infarction within the last 12 months, haemodynamic instability or known left ventricular ejection fraction (LVEF) <40% or clinically significant rhythm or conduction abnormalities) A history of deep vein thrombosis or pulmonary embolism during the Screening Period that, in the judgement of the Investigator, may be triggered or increase risk by receiving MSC transplantation therapy A breastfeeding female or a female with a positive blood pregnancy test result during the Screening Period History of immunodeficiency and/or autoimmune disease such as systemic lupus erythematosus (SLE), or other congenital immunodeficiency disease, idiopathic IgA deficiency. Laboratory tests at screening meet any of the following: Albuminous transaminase (AST) or albuminous transaminase (ALT) > 5 x ULN (non-hepatic sources are excluded; Serum creatinine > 1.5 x ULN or glomerular filtration rate < 60 mL/min/1.74 m2; Activated partial thromboplastin time (APTT) > 2.5 x ULN or prothrombin time; (PT) > 2.5 x ULN (not receiving anticoagulation) Positive infectious diseases (HBsAg, HCV, HIV-1, syphilis, active tuberculosis) Currently receiving extracorporeal life support (ECLS) such as continuous haemodialysis (CRRT) and carbon dioxide removal (ECCO2R), or high frequency oscillatory ventilation (HFOV) Presence of any other irreversible condition or symptom for which the subject has an expected survival of <3 months Combined WHO Class III or IV pulmonary hypertension Patients who refuse lung protective ventilation and fluid management Participation in other clinical trials or studies within 3 months prior to administration Persons with prior stem cell therapy Any other condition that, in the judgement of the investigator, makes participation in this trial inappropriate, such as a condition in which the study is not in the subject's current best interest (e.g., detrimental to health)
Sites / Locations
Arms of the Study
Arm 1
Experimental
Human Umbilical Cord Mesenchymal Stem Cells
The trial was divided into three dose groups: Low-dose group: 1000000 cells/kg Medium-dose group: 2000000 cells/kg High-does group: 4000000 cells/kg