[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100623401":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":45,"collaborators":47,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":55,"acronym":20,"eligibilityCriteria":56,"healthyVolunteers":53,"sex":57,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":20,"studyType":63,"phases":64,"briefSummary":67,"conditions":68,"keywords":70,"overallStatus":30,"whyStopped":20,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"PT. Prodia Stem Cell Indonesia","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"UC-MSC treatment group","EXPERIMENTAL","Participants will receive a single intra-renal injection of UC-MSCs (1 × 10⁶ cells\u002Fkg BW), followed by a 12-month monitoring period for safety and renal function outcomes.",[13],"Biological: Umbilical Cord Mesenchymal Stem Cells",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","Umbilical Cord Mesenchymal Stem Cells","This intervention consists of a single intra-renal injection of allogeneic umbilical cord-derived mesenchymal stem cells (UC-MSCs) administered under imaging guidance. The dose administered is 1 × 10⁶ cells per kilogram of body weight.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Metalia Puspitasari, MD","CONTACT","+628116110283","puspitasarimetalia@gmail.com",[28],{"facility":29,"status":30,"city":31,"state":20,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Dr. Sardjito General Hospital","RECRUITING","Yogyakarta","55284","Indonesia","ID",{"type":36,"coordinates":37},"Point",[38,39],110.36472,-7.80139,{"lat":39,"lon":38},[42,43],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},{"name":23,"role":44,"phone":20,"phoneExt":20,"email":20},"PRINCIPAL_INVESTIGATOR",{"type":46,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[48],{"name":49,"class":50},"Dr. Sardjito General Hospital, Yogyakarta, Indonesia","UNKNOWN","100623401","phase-1-safety-and-efficacy-of-allogeneic-umbilical-cord-mesenchymal-stem-cell-therapy-in-diabetic-nephropathy-patients-a-clinical-trial-100623401",false,"NCT07396155","Safety and Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cell Therapy in Diabetic Nephropathy Patients: A Clinical Trial","Inclusion Criteria:\n\n* Diagnosed with Type 2 Diabetes Mellitus (T2DM)\n* Aged between 40 and 65 years\n* Diagnosed with chronic kidney disease (CKD) stage III or IV, defined as estimated GFR (eGFR) between 15-60 mL\u002Fmin\u002F1.73 m² (using CKD-EPI formula)\n* Renal biopsy showing diabetic nephropathy type IIa-IV\n* Presence of proteinuria, with urine albumin-to-creatinine ratio (UACR) between 30-3000 mg\u002Fg (spot morning urine sample)\n* Controlled diabetes, defined as HbA1c \\\u003C10.0% during screening\n* Blood pressure within the range of: Systolic 100-160 mmHg, Diastolic 60-100 mmHg\n* On stable standard therapy for diabetic nephropathy (e.g. ACE inhibitors or ARBs) for at least 12 weeks prior to screening\n* Willing to provide written informed consent and comply with all study procedures until completion\n\nExclusion Criteria:\n\n* Active malignancy or history of cancer\n* Active liver disease or abnormal liver function (ALT or AST ≥2× upper limit of normal)\n* Hemoglobin \\\u003C8 g\u002FdL or platelet count \\\u003C100,000\u002FµL\n* Serious or unstable cerebrovascular or cardiovascular conditions within the last 6 months\n* Positive pregnancy test or currently breastfeeding (for women of reproductive age)\n* Currently receiving immunosuppressive therapy equivalent to ≥20 mg\u002Fday prednisone\n* History of participation in other stem cell research or therapy studies","ALL","30 Years","65 Years",{"count":61,"type":62},10,"ESTIMATED","INTERVENTIONAL",[65,66],"PHASE1","PHASE2","The goal of this clinical trial is to evaluate the safety and efficacy of a single intra-renal injection of allogeneic umbilical cord-derived mesenchymal stem cells (UC-MSCs) in adults with diabetic nephropathy aged 40 to 65 years. The primary questions the study aims to answer are:\n\n1. Is UC-MSC therapy safe and well-tolerated when administered intra-renally in patients with diabetic nephropathy?\n2. Does UC-MSC therapy improve kidney function and modulate inflammatory markers over a 12-month follow-up-period?\n\nThis is a single-arm, open-label, prospective clinical trial. Participants will receive a one-time intra-renal injection of UC-MSC at a dose of 1 x 10⁶ cells\u002Fkg body weight.\n\nParticipants will attend scheduled follow-up visits at 1, 3, 6, 9, and 12 months post-injections for evaluation of:\n\n1. Renal function (eGFR, serum creatinine, and urine albumin-creatinine ratio)\n2. Inflammatory markers (TNF-α, IL-10)\n3. Safety outcomes including early and late adverse events\n\nThe results will be compared to baseline measurements to assess changes after the intervention.\n\nIf there is a comparison group: Researchers will compare \\[arm information\\] to see if \\[insert effects\\].\n\nParticipants will \\[describe the main tasks participants will be asked to do, interventions they'll be given and use bullets if it is more than 2 items\\].",[69],"Diabetic Nephropathy Type 2",[71,72,73,74,75,76,77,78,79,80,81],"Umbilical Cord Mesenchymal Stem Cell","Diabetic Nephropathy","Kidney Disease","Intra-renal Injection","TNF-alpha","IL-10","Glomerular Filtration Rate","eGFR","Regenerative Medicine","Mesenchymal Stem Cells","UC-MSC","2026-02-03",{"date":84,"type":85},"2026-02-09","ACTUAL",{"date":87,"type":62},"2026-07-01",{"date":89,"type":62},"2027-10",{"name":5,"class":6},1]