[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100579343":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":29,"centralContacts":34,"locations":39,"responsibleParty":53,"collaborators":28,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":28,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":28,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":28,"overallStatus":74,"whyStopped":28,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Shanghai IxCell Biotechnology Co., LTD","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"hMSCs 5.0×10^7","EXPERIMENTAL","Human umbilical cord mesenchymal stem cells（hMSCs）5.0×10\\^7 cells",[13],"Biological: MSC",{"label":15,"type":10,"description":16,"interventionNames":17},"hMSCs 10.0×10^7","Human umbilical cord mesenchymal stem cells（hMSCs）10.0×10\\^7 cells",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"hMSCs 20.0×10^7","Human umbilical cord mesenchymal stem cells（hMSCs）20.0×10\\^7 cells",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"BIOLOGICAL","MSC","a single injection dose i.v.",[15,19,9],null,[30],{"name":31,"affiliation":32,"role":33},"tao Ren, Doctor","Shanghai 6th People's Hospital","PRINCIPAL_INVESTIGATOR",[35],{"name":31,"role":36,"phone":37,"phoneExt":28,"email":38},"CONTACT","021-64369181","rentao305@163.com",[40],{"facility":41,"status":28,"city":42,"state":28,"zip":28,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Shanghai Sixth People's Hospital","Shanghai","China","CN",{"type":46,"coordinates":47},"Point",[48,49],121.45806,31.22222,{"lat":49,"lon":48},[52],{"name":31,"role":36,"phone":28,"phoneExt":28,"email":28},{"type":54,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100579343","phase-1-clinical-trial-of-human-umbilical-cord-mesenchymal-stem-cells-ixcell-huc-msc-p-in-the-treatment-of-ctd-ild-100579343",false,"NCT06823063","Clinical Trial of Human Umbilical Cord Mesenchymal Stem Cells (IxCell hUC-MSC-P) in the Treatment of CTD-ILD","A Phase I Clinical Trial to Evaluate the Safety and Tolerability of a Single Dose of Human Umbilical Cord Mesenchymal Stem Cell Injection (IxCell hUC-MSC-P) in Patients With Connective Tissue Disease-associated Interstitial Lung Disease","Inclusion Criteria:\n\n1. Both sexes, aged 18-80 years;\n2. SSc diagnosed according to the 2013 American College of Rheumatology and European League Against Rheumatism (ACR\u002FEULA) criteria:\n3. Pulmonary fibrosis ≥10% was confirmed by high-resolution chest computed tomography (HRCT);\n4. The diffusion capacity for carbon monoxide (DLco) was 30%-89% of the expected value, and progression of interstitial lung disease was found. Progression was confirmed if one of the following criteria was met:\n\n   1. A decline of 10% or more in the percentage of predicted forced vital capacity (FVC%p) within 24 months (significant decline in ventilatory function) despite treatment;\n   2. A decline of ≥5% in FVC%p + a decline of ≥15% in DLco (a decline in ventilation function + a decline in diffusion capacity) within 24 months despite treatment;\n   3. Within 24 months, high resolution CT (HRCT) showed worsening of pulmonary fibrosis + ≥5% decline in FVC%p (deterioration of lung imaging + decline in ventilatory function), despite treatment.\n   4. Despite the treatment, 24 months reduced FVC % p + 5% or higher clinical symptoms (reduced ventilation function + symptoms);\n   5. Worsening of pulmonary fibrosis on HRCT + worsening of clinical symptoms (worsening of lung imaging + worsening of symptoms) within 24 months despite treatment;\n5. Forced Vital Capacity (FVC) was greater than 40% of expected vital capacity;\n6. The patient was able to complete the 6-Minute Walk Test (6MWT);\n7. Be able to understand and complete pulmonary function test procedures.\n8. Fully informed experiment purposes, methods, and possible uncomfortable, willing to medicine and follow-up inspection on time, according to the requirements of plan agreed to participate in trials, and sign the informed consent.\n\nExclusion Criteria:\n\n1. The patients were diagnosed with other lung diseases other than SSc-ILD, such as COPD, lung abscess, lung cancer and other types of connective tissue disease-related interstitial lung disease.\n2. Have obvious acute lung infection requiring anti-infection treatment (treatment of 4 weeks prior to the start of the respiratory tract infection and systemic infection);\n3. History of severe pulmonary hypertension, including right heart failure, cardiac intubation, and parenteral administration of prostaglandin analogues;\n4. History of myocardial infarction or angina pectoris within 6 months before enrollment;\n5. Patients with 3 or more fingertip ulcers when signing the informed consent form or unable to accurately observe fingertip ulcers due to other reasons of the hand;\n6. Allergic to any component of the medication;\n7. Life expectancy of less than 1 year due to diseases other than SSc;\n8. Planned surgical procedures during the trial;\n9. Has a history of scleroderma kidney crisis;\n10. Patients who had used glucocorticoids within 2 weeks before enrollment but could not maintain the dosage ≤10mg\u002F d equivalent prednisone;\n11. Patients who had used methotrexate within 2 months before enrollment, or failed to maintain a stable dosage while using other immunosuppressants;\n12. Into groups of 2 months before used anti fibrosis drug (such as pyrazole ketone, dani, cloth, etc.);\n13. Patients treated with rituximab, tocilizumab and mesenchymal stem cells within 2 months before enrollment;\n14. Patients with other systemic diseases and organ dysfunction (ALT\\>1.5 times upper limit of normal; Cr\\>1.5 times upper limit of normal; LVEF≤40%; Other progressive or uncontrolled diseases);\n15. Active hepatitis, tuberculosis, HIV infection;\n16. Patients with malignant tumors or a history of cancer;\n17. Pregnant or lactating women or those who have recently planned to have children and cannot take effective contraceptive measures;\n18. People with a history of alcohol or drug abuse;\n19. Enrolled in another drug trial within 3 months before enrollment;\n20. Unable to complete all assessors;\n21. And anyone who was deemed by the investigator to be ineligible for inclusion.","ALL","18 Years","80 Years",{"count":66,"type":67},18,"ESTIMATED","INTERVENTIONAL",[70],"PHASE1","To evaluate the safety and tolerability of IxCell hUC-MSC-P in the treatment of patients with connective tissue disease-related interstitial lung disease.\n\nTo evaluate the efficacy, pharmacokinetics and immunogenicity of IxCell hUC-MSC-P in the treatment of connective tissue disease-associated interstitial lung disease (CTD-ILD).",[73],"CTD-ILD","NOT_YET_RECRUITING","2025-02-12",{"date":77,"type":78},"2025-02-14","ACTUAL",{"date":80,"type":67},"2025-04-01",{"date":82,"type":67},"2026-12-31",{"name":5,"class":6},1]