[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100588864":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":23,"locations":29,"responsibleParty":63,"collaborators":11,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":71,"acronym":11,"eligibilityCriteria":72,"healthyVolunteers":69,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":11,"studyType":79,"phases":80,"briefSummary":83,"conditions":84,"keywords":11,"overallStatus":32,"whyStopped":11,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Ruijin Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"COPD patients","EXPERIMENTAL",null,[13],"Biological: P63+ lung progenitors",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","P63+ lung progenitors","1. Patient Screening and Cell Collection:\n\n   Eligible patients will undergo sample collection at the study center or authorized tertiary hospitals. The operator will collect samples via bronchial brushing from three healthy segments of the patient's 3-5 level bronchi. The samples will be transported to a cooperative production facility for isolation and preparation. The cell preparation cycle is approximately 4-8 weeks. Patients will bear the costs of this process.\n2. Transplantation Therapy:\n\n   Transplantation therapy will be conducted at Ruijin Hainan Hospital. The cell preparation will be administered via fiberoptic bronchoscopy to each lung segment, with one dose per patient. After infusion, patients are advised to remain hospitalized for 24-48 hours for observation.\n3. Post-Treatment Follow-Up:\n\nPatients are advised to return for examination and evaluation at 4 and 24 weeks post-treatment.",[9],[21,22],"Lung progenitors","Airway basal stem cells",[24],{"name":25,"role":26,"phone":27,"phoneExt":11,"email":28},"Jiayang Yan","CONTACT","+8619821839207","yjy19960816@163.com",[30,49],{"facility":31,"status":32,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Ruijin Hospital Hainan Branch, Shanghai Jiao Tong University School of Medicine","RECRUITING","Qionghai","Hainan","571437","China","CN",{"type":39,"coordinates":40},"Point",[41,42],110.46417,19.2425,{"lat":42,"lon":41},[45],{"name":46,"role":26,"phone":47,"phoneExt":11,"email":48},"Wen Su","0898-62621907","sw11831@rjh.com",{"facility":50,"status":32,"city":51,"state":52,"zip":53,"country":36,"countryCode":37,"cosmosGeoPoint":54,"geoPoint":58,"contacts":59},"Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine","Shanghai","Shanghai Municipality","200025",{"type":39,"coordinates":55},[56,57],121.45806,31.22222,{"lat":57,"lon":56},[60],{"name":61,"role":26,"phone":62,"phoneExt":11,"email":28},"Jiayang Yan, Ph.D","86-21-64370045",{"type":64,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Jieming QU","Professor","100588864","phase-1-regend001-autologous-basal-layer-stem-cell-transplantation-for-chronic-obstructive-pulmonary-disease-copd-a-translational-application-study-100588864",false,"NCT06946953","REGEND001 Autologous Basal Layer Stem Cell Transplantation for Chronic Obstructive Pulmonary Disease (COPD): A Translational Application Study","Inclusion Criteria:\n\n1. Diagnosed with COPD according to the 2021 Global Initiative for Chronic Obstructive Lung Disease (GOLD);\n2. Post-bronchodilator FEV1\u002FFVC \\\u003C70%;\n3. DLCO ≥20% and \\\u003C80% of predicted value.\n\nExclusion Criteria:\n\n1. Pregnant, breastfeeding, or planning to become pregnant within 1 year after treatment (or male participants planning for their spouse to become pregnant);\n2. Positive for syphilis (TP-Ab), HIV, hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibodies;\n3. Current or past history of malignancy.","ALL","40 Years","80 Years",{"count":77,"type":78},20,"ESTIMATED","INTERVENTIONAL",[81,82],"PHASE1","PHASE2","This clinical trial aims to evaluate the safety and efficacy of REGEND001, an autologous bronchial basal cell therapy, for the treatment of Chronic Obstructive Pulmonary Disease (COPD). COPD is a chronic respiratory condition characterized by persistent airflow limitation and impaired lung function, leading to significant morbidity and mortality worldwide. Current treatments primarily focus on symptom management and have limited impact on disease progression or survival. This study proposes a novel approach using autologous bronchial basal cells, which have demonstrated the potential to repair damaged lung tissue and improve lung function in preclinical studies. The therapy involves the collection of bronchial basal cells via bronchial brushing, followed by their expansion and reintroduction into the patient's lungs via bronchoscopic infusion. The primary objective is to assess the improvement in lung diffusion capacity (DLCO), with secondary endpoints including changes in lung ventilation function (FEV1, FVC) and quality of life (CAT score). The study will also monitor safety, including the incidence of adverse events. Eligible participants are COPD patients aged 40-80 with moderate to severe disease. The trial includes a screening phase, cell collection, transplantation, and follow-up assessments at 4 and 24 weeks post-treatment. This study represents a promising advancement in regenerative medicine for COPD, offering a potential therapeutic option that addresses the underlying structural damage in the lungs.",[85],"Chronic Obstructive Pulmonary Disease (COPD)","2026-07-18",{"date":88,"type":89},"2026-07-21","ACTUAL",{"date":91,"type":89},"2025-03-23",{"date":93,"type":78},"2029-12-31",{"name":5,"class":6},2]