[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100591960":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":11,"locations":11,"responsibleParty":20,"collaborators":11,"id":24,"slug":25,"hasResults":26,"nctId":27,"briefTitle":28,"officialTitle":28,"acronym":11,"eligibilityCriteria":29,"healthyVolunteers":26,"sex":30,"minAge":31,"maxAge":32,"enrollmentInfo":33,"targetDuration":11,"studyType":36,"phases":37,"briefSummary":39,"conditions":40,"keywords":11,"overallStatus":42,"whyStopped":11,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":11},{"fullName":5,"class":6},"Ruijin Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Bronchiectasis patients","EXPERIMENTAL",null,[13],"Biological: REGEND001 Autologous Basal Layer Stem Cell Suspension",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"BIOLOGICAL","REGEND001 Autologous Basal Layer Stem Cell Suspension","REGEND001 Autologous Basal Layer Stem Cell Suspension is an innovative cell therapy product designed for chronic structural lung diseases, such as bronchiectasis. This treatment involves harvesting regenerative stem cells (expressing KRT5\u002FP63 markers) from the patient's own bronchial basal layer via fiberoptic bronchoscopy. After isolation, purification, and ex vivo expansion, the cells are administered as a suspension through bronchoscopic infusion into damaged lung segments.",[9],{"type":21,"investigatorFullName":22,"investigatorTitle":23,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Jieming QU","Professor","100591960","phase-1-regend001-autologous-basal-layer-stem-cell-transplantation-for-bronchiectasis-a-translational-application-study-100591960",false,"NCT06987214","REGEND001 Autologous Basal Layer Stem Cell Transplantation for Bronchiectasis: A Translational Application Study","Inclusion Criteria:\n\n1. Age 25-80 years.\n2. Confirmed diagnosis of bronchiectasis.\n3. FEV1 ≥35% predicted; DLCO ≥30% and \\\u003C80% predicted.\n\nExclusion Criteria:\n\n1. Pregnancy, lactation, or plans for pregnancy within 1 year.\n2. Active malignancy or history of malignancy.\n3. Positive serology for HIV, HBV, HCV, or syphilis.","ALL","25 Years","80 Years",{"count":34,"type":35},10,"ESTIMATED","INTERVENTIONAL",[38],"PHASE1","This clinical trial aims to evaluate the safety and efficacy of REGEND001, an autologous basal layer stem cell transplantation therapy, in patients with chronic structural lung disease (bronchiectasis). The treatment involves harvesting bronchial basal layer stem cells from the patient, expanding them ex vivo, and reintroducing them via bronchoscopic infusion to repair damaged lung tissue.",[41],"Bronchiectasis Adult","NOT_YET_RECRUITING","2025-05-22",{"date":45,"type":46},"2025-05-23","ACTUAL",{"date":48,"type":35},"2025-06-30",{"date":50,"type":35},"2026-05-30",{"name":5,"class":6}]