[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Changchun Tuohua Pharmaceutical Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":45},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":5},"100624772","phase-1-a-clinical-trial-of-human-umbilical-cord-mesenchymal-stem-cell-injection-for-the-treatment-of-severe-acute-respiratory-distress-syndrome-100624772",false,"NCT07413978","A Clinical Trial of Human Umbilical Cord Mesenchymal Stem Cell Injection for the Treatment of Severe Acute Respiratory Distress Syndrome","A Phase I-II, Open-label, Single-arm, Dose-escalation Clinical Trial to Evaluate the Safety and Tolerability of Human Umbilical Cord Mesenchymal Stem Cell Injection in the Treatment of Moderate to Severe Acute Respiratory Distress Syndrome","ARDS","Inclusion Criteria:\n\n* Male or female patients aged 18 to 80 years (inclusive).\n* Diagnosis of moderate or severe Acute Respiratory Distress Syndrome (ARDS) according to A New Global Definition of Acute Respiratory Distress Syndrome, with an infectious etiology.\n* No improvement after 24 hours of conventional clinical treatment (defined as a persistent PaO₂\u002FFiO₂ ratio ≤200 mmHg or a decrease from \\>200 mmHg to ≤200 mmHg after 24 hours of conventional supportive therapy; for severe ARDS, this assessment period may be shortened to 8 hours).\n* Ability to fully understand the nature of the study and voluntarily provide written informed consent.\n* Willingness to comply with all study procedures and demonstrate good compliance during the study period.\n* Agreement to participate in long-term follow-up.\n\nExclusion Criteria:\n\n* Patients with ARDS caused by COVID-19 infection.\n* Patients currently suffering from hepatitis B, hepatitis C, active or latent tuberculosis, AIDS, syphilis, immunodeficiency disorders, or other immune system diseases.\n* Presence of severe cardiovascular diseases at screening, including:Cardiac function classification of NYHA class III or higher.Uncontrolled myocarditis or valvular disease.Malignant arrhythmia requiring pharmacological treatment.\n* Abnormal liver or renal function at screening meeting any of the following criteria:ALT or AST ≥ 5 × ULN, or total bilirubin ≥ 3 × ULN.Serum creatinine ≥ 3 × ULN, or patients currently undergoing renal replacement therapy (CRRT).\n* Patients receiving extracorporeal membrane oxygenation (ECMO) therapy at the time of screening.\n* Severe hematological abnormalities at screening, including: hemorrhagic manifestations, PTA ≤ 40% (or INR ≥ 2.0), severe anemia (Hb \\\u003C 60 g\u002FL), moderate or severe thrombocytopenia (PLT \\\u003C 50 × 10\\^9\u002FL), disseminated intravascular coagulation (DIC), leukemia, or other hematological abnormalities deemed ineligible for the study.\n* Severe end-stage respiratory diseases at screening.\n* Pulmonary hypertension with a pulmonary artery pressure \\> 70 mmHg.\n* History of deep vein thrombosis or pulmonary embolism within the 6 months prior to enrollment.\n* Patients post lung transplantation.\n* Presence of severe cardiopulmonary malformations at screening.\n* Severe psychiatric disorders.\n* Patients who are pregnant (positive pregnancy test), breastfeeding, or have a pregnancy plan, are unwilling to practice contraception during the study and for 12 months after the infusion, or are of childbearing potential and unwilling to use effective contraception.\n* Use of high-dose corticosteroids equivalent to methylprednisolone \\> 240 mg\u002Fday within 3 days prior to enrollment, or long-term irregular use of systemic corticosteroids for other diseases, which, in the investigator's judgment, may affect efficacy evaluation.\n* Allergy to any component of the Human Umbilical Cord Mesenchymal Stem Cell Injection (e.g., human albumin), or a history of severe allergies deemed by the investigator as unsuitable for participation.\n* Concurrent participation in another interventional clinical trial, or participation in another interventional clinical trial within the 3 months prior to screening.\n* History or current diagnosis of malignancy, or pathological confirmation of precancerous lesions.\n* Any other condition that, in the investigator's judgment, would lead to premature termination of the study, such as non-adherence to the protocol, concurrent severe illnesses requiring combined treatment, significant laboratory abnormalities, or social\u002Ffamily factors that could compromise the patient's safety or data collection.","ALL","18 Years","80 Years",{"count":21,"type":22},36,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","Primary Objective: To evaluate the safety and tolerability of human umbilical cord mesenchymal stem cell injection in the treatment of moderate\u002Fsevere acute respiratory distress syndrome.Secondary Objectives: To explore the efficacy and appropriate dosage of human umbilical cord mesenchymal stem cell injection in the treatment of moderate\u002Fsevere acute respiratory distress syndrome.Exploratory Objective: To explore the immunogenicity and pharmacokinetic\u002Fpharmacodynamic (PK\u002FPD) characteristics of a single dose of human umbilical cord mesenchymal stem cell injection in patients with moderate\u002Fsevere acute respiratory distress syndrome.",[29],"Acute Respiratory Distress Syndrome",[31,15,32],"Acute respiratory distress syndrome","Human Umbilical Cord Mesenchymal Stem Cells","RECRUITING","2026-02-09",{"date":36,"type":37},"2026-02-17","ACTUAL",{"date":39,"type":37},"2025-04-25",{"date":41,"type":22},"2028-12-31",{"name":43,"class":44},"Changchun Tuohua Pharmaceutical Co., Ltd.","INDUSTRY",""]