[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626868":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":34,"locations":35,"responsibleParty":62,"collaborators":64,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":70,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":34,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":34,"overallStatus":38,"whyStopped":34,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"RSUP Persahabatan","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Umbilical Cord Mesenchymal Stem Cells Group","EXPERIMENTAL","Participants receive intravenous infusion of umbilical cord-derived mesenchymal stem cells (1 million cells\u002Fkg body weight) on Day 1 and Day 21, in addition to standard COPD therapy.",[13],"Genetic: Umbilical Cord Mesenchymal Stem Cells",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo Group","PLACEBO_COMPARATOR","Participants receive intravenous infusion of 100 mL normal saline (placebo) on Day 1 and Day 21, in addition to standard COPD therapy.",[19],"Drug: Normal saline placebo",[21,29],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"GENETIC","Umbilical Cord Mesenchymal Stem Cells","Umbilical cord mesenchymal stem cells provided by PT Prostem (GMP-certified facility), diluted in 100 mL normal saline, administered intravenously at 20 mL\u002Fhour.",[9],[27,28],"UC-MSCs","Mesenchymal Stromal Cells from Umbilical Cord",{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DRUG","Normal saline placebo","100 mL normal saline administered intravenously at 20 mL\u002Fhour, matching appearance and administration schedule of active intervention.",[15],null,[36],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Persahabatan Hospital","RECRUITING","Jakarta","Jakarta Special Capital Region","13230","Indonesia","ID",{"type":45,"coordinates":46},"Point",[47,48],106.84513,-6.21462,{"lat":48,"lon":47},[51,56,60],{"name":52,"role":53,"phone":54,"phoneExt":34,"email":55},"Heidy Agustin, Pulmonologist","CONTACT","+62 816-1147-386","heidy_agst@yahoo.com",{"name":57,"role":53,"phone":58,"phoneExt":34,"email":59},"Triya Damayanti, Pulmonologist","+62 812-9463-3437","tria_94@yahoo.com",{"name":57,"role":61,"phone":34,"phoneExt":34,"email":34},"PRINCIPAL_INVESTIGATOR",{"type":63,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR",[65],{"name":66,"class":67},"PT. Prodia Stem Cell Indonesia","INDUSTRY","100626868","phase-2-umbilical-cord-mesenchymal-stem-cells-as-adjuvant-therapy-in-group-e-copd-patients-100626868",false,"NCT07441226","Umbilical Cord Mesenchymal Stem Cells as Adjuvant Therapy in Group E COPD Patients","A Randomized, Double-Blind, Controlled Trial of Umbilical Cord Mesenchymal Stem Cells as Adjuvant Therapy in Group E COPD Patients","UCMSC-COPD","Inclusion Criteria:\n\n* Adults aged 40 to 75 years.\n* Diagnosed with Group E Chronic Obstructive Pulmonary Disease (COPD) according to GOLD 2023 criteria.\n* Receiving triple inhalation therapy (long-acting beta-agonist, inhaled corticosteroid, long-acting muscarinic antagonist) for at least 6 months prior to enrollment.\n* Clinically stable for at least 2 weeks prior to enrollment.\n* Provided written informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Current smoker or stopped smoking less than 6 months prior to screening.\n* Acute exacerbation of COPD within 2 weeks prior to enrollment.\n* Diagnosis of pulmonary diseases other than COPD, including tuberculosis, pulmonary embolism, pneumothorax, multiple bullae, asthma, interstitial lung disease, or lung cancer.\n* History of tuberculosis within the past 10 years.\n* Active infection (including HIV positive).\n* Malignancy of any type.\n* Severe cardiac disease, including congestive heart failure classified as NYHA class III or IV, significant arrhythmias, valvular heart disease, cardiomyopathy, or congenital heart disease.\n* Severe hepatic dysfunction (SGOT, SGPT, or bilirubin levels \\>2 times upper limit of normal).\n* Severe renal dysfunction (serum creatinine \\>1.5 times upper limit of normal).\n* Pregnant or breastfeeding.\n* Comorbid conditions that may affect survival (e.g., advanced diabetes mellitus with HbA1c \\>7%, recent myocardial infarction, unstable angina, liver cirrhosis, acute glomerulonephritis).\n* Leukopenia (white blood cell count \\\u003C4×10⁹\u002FL) or agranulocytosis (white blood cell count \\\u003C1.5×10⁹\u002FL or neutrophils \\\u003C0.5×10⁹\u002FL).\n* History of psychiatric illness, epilepsy, or other central nervous system disorders.\n* History of alcohol or drug abuse.\n* Participation in another clinical trial within 3 months prior to enrollment.\n* Poor adherence to prior medical care or expected difficulty completing the study protocol.\n* Inability to perform spirometry maneuvers.\n* Life expectancy less than 6 months due to comorbid conditions.\n* Use of immunosuppressive therapy within 8 months prior to screening.","ALL","40 Years","75 Years",{"count":80,"type":81},20,"ESTIMATED","INTERVENTIONAL",[84],"PHASE2","This study aims to evaluate the efficacy and safety of allogeneic human UC-MSC to treat stage E Chronic Obstructive Pulmonary Disease (COPD).\n\nAll participants in this study already receive standard treatment for COPD, which includes triple inhaled medications with LABA, LAMA and ICS.\n\nWe hypothesize that UC-MSCs will improve COPD management. UC-MSCs are prepared in a certified laboratory and given intravenously. For 12 months from day 0, all patients will be observed for comprehensive safety evaluation, pulmonary function testing (PFT), quality of life indicators including questionnaires, 6-min walk test (6MWT), and inflammation biomarkers.",[87],"Chronic Obstructive Pulmonary Disease (COPD)","2026-02-24",{"date":90,"type":91},"2026-02-27","ACTUAL",{"date":93,"type":91},"2025-08-08",{"date":95,"type":81},"2028-01",{"name":5,"class":6},1]