[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624772":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":33,"centralContacts":38,"locations":44,"responsibleParty":62,"collaborators":23,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":66,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":23,"studyType":78,"phases":79,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":47,"whyStopped":23,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Changchun Tuohua Pharmaceutical Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Human Umbilical Cord Mesenchymal Stem Cells Injection","EXPERIMENTAL","single-dose",[13,14,15,16],"Biological: 1 vial containing a total of 5×10^7 cells","Biological: 2 vial containing a total of 1×10^8 cells","Biological: 3 vial containing a total of 1.5×10^8 cells","Biological: 4 vial containing a total of 2×10^8 cells",[18,24,27,30],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"BIOLOGICAL","1 vial containing a total of 5×10^7 cells","venous reinfusion",[9],null,{"type":19,"name":25,"description":21,"armGroupLabels":26,"otherNames":23},"2 vial containing a total of 1×10^8 cells",[9],{"type":19,"name":28,"description":21,"armGroupLabels":29,"otherNames":23},"3 vial containing a total of 1.5×10^8 cells",[9],{"type":19,"name":31,"description":21,"armGroupLabels":32,"otherNames":23},"4 vial containing a total of 2×10^8 cells",[9],[34],{"name":35,"affiliation":36,"role":37},"Zhiyong Peng","Zhongnan Hospital","PRINCIPAL_INVESTIGATOR",[39],{"name":40,"role":41,"phone":42,"phoneExt":23,"email":43},"Shi Cheng","CONTACT","+8618504341228","thswcs@163.com",[45],{"facility":46,"status":47,"city":48,"state":49,"zip":23,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Zhongnan Hospital of Wuhan University","RECRUITING","Wuhan","Hubei","China","CN",{"type":53,"coordinates":54},"Point",[55,56],114.26667,30.58333,{"lat":56,"lon":55},[59],{"name":35,"role":41,"phone":60,"phoneExt":23,"email":61},"+8627-67811807","pengzy5@hotmail.com",{"type":63,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR","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":76,"type":77},36,"ESTIMATED","INTERVENTIONAL",[80,81],"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.",[84],"Acute Respiratory Distress Syndrome",[86,70,87],"Acute respiratory distress syndrome","Human Umbilical Cord Mesenchymal Stem Cells","2026-02-09",{"date":90,"type":91},"2026-02-17","ACTUAL",{"date":93,"type":91},"2025-04-25",{"date":95,"type":77},"2028-12-31",{"name":5,"class":6},1]