[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100555614":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":11,"centralContacts":11,"locations":23,"responsibleParty":42,"collaborators":46,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":52,"sex":58,"minAge":59,"maxAge":11,"enrollmentInfo":60,"targetDuration":11,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":11,"overallStatus":26,"whyStopped":11,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},{"fullName":5,"class":6},"Instituto De Investigación Sanitaria Puerta De Hierro-Segovia De Arana","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment group","EXPERIMENTAL",null,[13],"Biological: Mesenchymal stem cells",{"label":15,"type":16,"description":11,"interventionNames":11},"Control","NO_INTERVENTION",[18],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":11},"BIOLOGICAL","Mesenchymal stem cells","Endobronchial administration of 10⁶ MSCs\u002Fkg in each transplanted lung, 4 weeks apart.",[9],[24],{"facility":25,"status":26,"city":27,"state":11,"zip":11,"country":28,"countryCode":29,"cosmosGeoPoint":30,"geoPoint":35,"contacts":36},"Hospital Universitario Puerta de Hierro Majadahonda","RECRUITING","Madrid","Spain","ES",{"type":31,"coordinates":32},"Point",[33,34],-3.70256,40.4165,{"lat":34,"lon":33},[37],{"name":38,"role":39,"phone":40,"phoneExt":11,"email":41},"David Gomez de Antonio, PhD","CONTACT","+341916623","dgavm@yahoo.es",{"type":43,"investigatorFullName":44,"investigatorTitle":45,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","David Gomez de Antonio","Head of Research Group",[47],{"name":48,"class":49},"Ministerio de Ciencia e Innovación, Spain","OTHER_GOV","100555614","phase-1-safety-of-endobronchial-mesenchymal-stromal-cells-in-the-treatment-of-chronic-lung-allograft-dysfunction-100555614",false,"NCT06514378","Safety of Endobronchial Mesenchymal Stromal Cells in the Treatment of Chronic Lung Allograft Dysfunction","An Open Label, Randomised, Controlled Clinical Trial to Asses the Safety of Endobronchial Administration of Allogneic Mesenchymal Stromal Cells in Patients With Lung Trasplant Chronic Rejection: Endosclad Study.","ENDOSCLAD","Inclusion Criteria:\n\nPatients should have signed written informed consent. Adult patients ≥18 years of age at the time of enrolment Patients recipients of a uni or bipulmonary transplant An established diagnosis of BOS ≧ 0p (FEV1≤90% and \u002F or FEF 25-75% ≤ of the baseline value with no other justifying cause) in the last 6 months.\n\nExclusion Criteria:\n\n* History of lobar transplantation History of heart-lung transplantation Active infection at the time of inclusion. Active Acute Rejection not treated at the time of inclusion. Oncological history (except cutaneous basal cell or carcinoma in situ) Systemic autoimmune diseases. Active HIV \u002F HBV \u002F HCV infection (confirmed by serology or PCR) Proximal airway stenosis Pregnancy Performance status 3 or 4 (confined to bed or chair for more than 50% of waking hours, able only to perform some self-care activities) Estimated survival less than 3 months. Known hypersensitivity to components used in the production of allogeneic MSCs. Any circumstance that, in the opinion of the investigator, compromises the patient's ability to participate in the clinical trial.","ALL","18 Years",{"count":61,"type":62},12,"ESTIMATED","INTERVENTIONAL",[65],"PHASE1","Lung transplantation is the only therapeutic alternative for more and more patients with respiratory diseases in their most advanced stages.\n\nThe most limiting factor to achieve long term survival si chronic lung allograft dysfunction, a multifactorial disease without an effective treatment.\n\nThe immunomodulatory capacity of mesenchymal stem cells enables them to be a potential therapeutic agent for this condition.\n\nThe objective of this study is to assess the safety of endobronchial administration of allogeneic MSCs in patients with chroniclung allograft dysfunction.",[68,69],"Chronic Lung Disease","Lung Transplant Rejection","2024-07-25",{"date":72,"type":73},"2024-07-26","ACTUAL",{"date":75,"type":73},"2023-09-19",{"date":77,"type":62},"2026-03-31",{"name":5,"class":6},1]