[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611385":3},{"organization":4,"outcomesModule":7,"designInfo":37,"detailedDescription":43,"studyPopulation":36,"armGroups":44,"interventions":50,"overallOfficials":36,"centralContacts":54,"locations":60,"responsibleParty":79,"collaborators":81,"id":85,"slug":36,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":36,"eligibilityCriteria":90,"healthyVolunteers":86,"sex":91,"minAge":92,"maxAge":93,"enrollmentInfo":94,"targetDuration":36,"studyType":97,"phases":98,"briefSummary":100,"conditions":101,"keywords":103,"overallStatus":63,"whyStopped":36,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"Regend Therapeutics","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":36},[9,13],{"measure":10,"description":11,"timeFrame":12},"Change in clinical symptoms","Cough, wheezing, respiratory rate are included in clinical symptomes. Both status and frequency would be evaluated.","12 and 24 weeks after treatment",{"measure":14,"description":15,"timeFrame":16},"Changes in oxygen therapy","Oxygen saturation (SpO₂), oxygen therapy settings, and daily duration of oxygen therapy would be evaluated.","24 weeks after treatment",[18,21,24,27,30,33],{"measure":19,"description":20,"timeFrame":16},"Changes in general condition","Rate of weight gain, time of independent activity are evaluated as general condition.",{"measure":22,"description":23,"timeFrame":12},"Change in lung diffusing capacity for carbon monoxide (DLCO) from baseline","DLCO is a measure of the conductance of CO across the alveolar-capillary membrane and its binding with hemoglobin.",{"measure":25,"description":26,"timeFrame":12},"Change in forced expiratory volume in one second (FEV1) from baseline","FEV1 is the volume of breath exhaled with effort in one second.",{"measure":28,"description":29,"timeFrame":12},"Change in forced vital capacity (FVC) from baseline","FVC is the full amount of air that can be exhaled with effort in a complete breath",{"measure":31,"description":32,"timeFrame":16},"Change in high resolution computed tomography (HRCT) from baseline","HRCT scan is a type of CT scan that shows detailed pictures of lungs",{"measure":34,"description":35,"timeFrame":16},"Bronchiolitis Obliterans (BO) exacerbation","Frequency and severity of events will be evaluated",null,{"allocation":38,"interventionModel":39,"interventionModelDescription":36,"primaryPurpose":40,"observationalModel":36,"timePerspective":36,"maskingInfo":41},"NA","SINGLE_GROUP","TREATMENT",{"masking":42,"maskingDescription":36,"whoMasked":36},"NONE","The study is co-sponsored by Regend Therapeutics and Shanghai Children's Hospital.",[45],{"label":46,"type":47,"description":36,"interventionNames":48},"Airway Basal Stem Cells","EXPERIMENTAL",[49],"Biological: Airway Basal Stem Cells",[51],{"type":52,"name":46,"description":46,"armGroupLabels":53,"otherNames":36},"BIOLOGICAL",[46],[55],{"name":56,"role":57,"phone":58,"phoneExt":36,"email":59},"Liling Qian, Professor and Chief Physician","CONTACT","086-021-62474880","qianliling@shchildren.com.cn",[61],{"facility":62,"status":63,"city":64,"state":36,"zip":65,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":73,"contacts":74},"Shanghai Children's Hospital, School of Medicine, Shanghai Jiao Tong University","RECRUITING","Shanghai","200000","China","CN",{"type":69,"coordinates":70},"Point",[71,72],121.45806,31.22222,{"lat":72,"lon":71},[75],{"name":76,"role":57,"phone":77,"phoneExt":36,"email":78},"Lei He","086-021-52976581","hl@shchildren.com.cn",{"type":80,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR",[82],{"name":83,"class":84},"Shanghai Children's Hospital","OTHER","100611385",false,"NCT07239895","Treatment of Pediatric Bronchiolitis Obliterans by Airway Basal Stem Cells","Exploratory Study of Airway Basal Stem Cells on Treatment of Pediatric Bronchiolitis Obliterans","Inclusion Criteria:\n\n* Males and females, aged between 28 days and 18 years;\n* Diagnosed with bronchiolitis obliterans according to the guidelines;\n* Meeting at least one of the following: FEV1 \\\u003C 55% of predicted value; requiring continuous assisted mechanical ventilation or oxygen therapy;\n* None of acute infections within the past four weeks;\n* Tolerating bronchoscopy;\n* The child and\u002For parent(s) provide informed consent, and are able to understand and adhere to scheduled visits, treatments, laboratory tests, and other study procedures.\n\nExclusion Criteria:\n\n* Subjects with bronchiolitis obliterans syndrome (BOS) who are on a current cGVHD treatment regimen at screening.\n* At the time of screening, subject who is positive in each of treponema pallidum antibody (TP-Ab), human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody test. Hepatitis B virus carriers with stable current condition can be enrolled. Cured hepatitis C patients with negative result in HCV ribonucleic acid (RNA) test can be enrolled as well.\n* Subject who is assessed to have major lung diseases other than BO by investigators at screening or who has other severe systemic diseases within 6 months prior to screening and is considered to be unsuitable for this study by investigators.\n* Presence of severe coagulation dysfunction at screening and may compromise the safety of bronchoscopy in the investigator's judgment.\n* Subjects requiring long-term maintenance anticoagulant therapy or antiplatelet aggregation therapy, and for whom, in the investigator's assessment, the medication cannot be discontinued within a week prior to cell collection and infusion.\n* Subjects with suicide risk or a history of psychiatric disorders at screening.\n* Participation in another interventional clinical study within 3 months prior to screening.\n* Poor compliance, making him or her difficult to complete the study.\n* Subjects who is considered to be unsuitable for this study in in the opinion of the investigator.","ALL","28 Days","18 Years",{"count":95,"type":96},12,"ESTIMATED","INTERVENTIONAL",[99],"EARLY_PHASE1","Bronchiolitis obliterans (BO) is a chronic lung disease which was initiated with injury of the bronchiolar epithelium and resulted in nonuniform luminal obliteration or narrowing. Among children, the most common form of BO is post-infectious BO with a lack of treatment guidelines or standard therapy. In this study, an open, single-armed study is performed to preliminarily evaluate the safety and efficacy of airway basal stem cells on treatment of pediatric BO.",[102],"Pediatric Bronchiolitis Obliterans",[46,104,105,106],"Bronchiolitis obliterans","Bronchiolar Epithelium","Pedatric Bronchiolitis Obliterans","2026-01-12",{"date":109,"type":110},"2026-01-14","ACTUAL",{"date":112,"type":110},"2025-11-11",{"date":114,"type":96},"2027-11",{"name":5,"class":6},1]