[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632849":3},{"organization":4,"armGroups":7,"interventions":31,"overallOfficials":37,"centralContacts":56,"locations":62,"responsibleParty":78,"collaborators":37,"id":80,"slug":37,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":81,"sex":87,"minAge":88,"maxAge":89,"enrollmentInfo":90,"targetDuration":37,"studyType":93,"phases":94,"briefSummary":97,"conditions":98,"keywords":37,"overallStatus":102,"whyStopped":37,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"Xijing Hospital","OTHER",[8,16,22,27],{"label":9,"type":10,"description":11,"interventionNames":12},"Progressive Stage Experimental Group","EXPERIMENTAL","Patients in progressive stage receive intravenous infusion of human umbilical cord mesenchymal stem cell-derived exosomes (hUC-MSC-Exos) at a fixed dose of 2×10¹¹ particles per infusion, administered once every 2 weeks for a total of 5 infusions, combined with topical tacrolimus ointment and NB-UVB phototherapy.",[13,14,15],"Biological: Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes (hUC-MSC-Exos) Intravenous Infusion","Drug: Topical Tacrolimus Ointment","Procedure: Narrow-Band Ultraviolet B (NB-UVB) Phototherapy",{"label":17,"type":18,"description":19,"interventionNames":20},"Progressive Stage Control Group","ACTIVE_COMPARATOR","Patients in progressive stage receive oral prednisone 0.5 mg\u002Fkg daily for 4 weeks followed by gradual tapering, combined with topical tacrolimus ointment and NB-UVB phototherapy.",[21,14,15],"Drug: Oral Prednisone",{"label":23,"type":10,"description":24,"interventionNames":25},"Stable Stage Experimental Group","Patients in stable stage receive local injection of human umbilical cord mesenchymal stem cell-derived exosomes (hUC-MSC-Exos) at a fixed dose of 1×10¹⁰ particles per cm² of lesion area per infusion, administered once every 2 weeks for a total of 5 infusions, combined with topical tacrolimus ointment and NB-UVB phototherapy.",[26,14,15],"Biological: Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes (hUC-MSC-Exos) Local Injection",{"label":28,"type":18,"description":29,"interventionNames":30},"Stable Stage Control Group","Patients in stable stage receive topical tacrolimus ointment combined with NB-UVB phototherapy, following the routine clinical regimen.",[14,15],[32,38,43,47,51],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"BIOLOGICAL","Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes (hUC-MSC-Exos) Intravenous Infusion","Intravenous infusion of human umbilical cord mesenchymal stem cell-derived exosomes at a fixed dose of 2×10¹¹ particles per infusion, administered once every 2 weeks for a total of 5 infusions, for patients with progressive vitiligo.",[9],null,{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":37},"DRUG","Oral Prednisone","Oral administration of prednisone at 0.5 mg\u002Fkg daily for 4 weeks followed by gradual tapering, for patients with progressive vitiligo.",[17],{"type":33,"name":44,"description":45,"armGroupLabels":46,"otherNames":37},"Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes (hUC-MSC-Exos) Local Injection","Local injection of human umbilical cord mesenchymal stem cell-derived exosomes at a fixed dose of 1×10¹⁰ particles per cm² of lesion area per infusion, administered once every 2 weeks for a total of 5 infusions, for patients with stable vitiligo.",[23],{"type":39,"name":48,"description":49,"armGroupLabels":50,"otherNames":37},"Topical Tacrolimus Ointment","Topical application of tacrolimus ointment, twice daily, as a combined treatment for all participants.",[17,9,28,23],{"type":52,"name":53,"description":54,"armGroupLabels":55,"otherNames":37},"PROCEDURE","Narrow-Band Ultraviolet B (NB-UVB) Phototherapy","Narrow-band ultraviolet B phototherapy, administered 3 times weekly, as a combined treatment for all participants.",[17,9,28,23],[57],{"name":58,"role":59,"phone":60,"phoneExt":37,"email":61},"Zhe Jian","CONTACT","+86-15332332587","jason21-26@163.com",[63],{"facility":64,"status":37,"city":65,"state":66,"zip":67,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":75,"contacts":76},"Xijing Hospital, The First Affiliated Hospital of Air Force Medical University","Xi'an","Shaanxi","710032","China","CN",{"type":71,"coordinates":72},"Point",[73,74],108.92861,34.25833,{"lat":74,"lon":73},[77],{"name":58,"role":59,"phone":60,"phoneExt":37,"email":61},{"type":79,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"SPONSOR","100632849",false,"NCT07519031","Study of Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes in Vitiligo","A Single-Center, Randomized, Controlled Trial of Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes for the Treatment of Vitiligo","hUMSCs-Exo-VIT","Inclusion Criteria:\n\n* Clinically diagnosed non-segmental vitiligo\n* Progressive vitiligo: new lesions or enlargement of existing lesions within the past 3 months (VIDA score ≥ 3); Stable vitiligo: no new lesions or enlargement of existing lesions within the past 1 year (VIDA score = 0)\n* Total body surface area (BSA) of vitiligo lesions between 1% and 30%\n* Age 18 to 65 years, male or female\n* Willing to participate and provide written informed consent\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding\n* Known allergy to mesenchymal stem cells or exosome components\n* Severe cardiac, hepatic, or renal dysfunction, or severe immunocompromised status\n* For progressive vitiligo: use of systemic immunosuppressants, corticosteroids, phototherapy, or photochemotherapy within the past 3 months\n* For stable vitiligo: use of phototherapy, topical immunosuppressants, or corticosteroids within the past 1 month\n* Concurrent autoimmune diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis, psoriasis) or severe infectious diseases\n* History of malignancy or hematologic disorders\n* History of psychiatric disorders or inability to comply with study procedures\n* Any other condition that, in the investigator's judgment, may increase the risk to the participant or interfere with the conduct of the trial","ALL","18 Years","65 Years",{"count":91,"type":92},96,"ESTIMATED","INTERVENTIONAL",[95,96],"PHASE1","PHASE2","This study evaluates whether exosomes derived from human umbilical cord mesenchymal stem cells (hUMSCs-Exo) are safe and effective for treating vitiligo in adults.\n\nVitiligo is a skin condition that causes white patches due to loss of pigment-producing cells. Current treatments have limitations, especially for patients with active disease who require oral steroids with significant side effects.\n\nThis study is a single-center, randomized, controlled trial enrolling 96 adults aged 18 to 65 years with non-segmental vitiligo. Participants are divided into two groups based on disease activity: progressive vitiligo (new patches appearing or existing patches expanding in the past 3 months) and stable vitiligo (no changes in the past year).\n\nFor progressive vitiligo, participants are randomly assigned to either:\n\nExperimental group: hUMSCs-Exo given by intravenous infusion every 2 weeks for 5 sessions, plus tacrolimus ointment and narrowband UVB light therapy, or Control group: oral prednisone (a standard steroid treatment) plus tacrolimus ointment and narrowband UVB light therapy\n\nFor stable vitiligo, participants are randomly assigned to either:\n\nExperimental group: hUMSCs-Exo given by local injection into the white patches every 2 weeks for 5 sessions, plus tacrolimus ointment and narrowband UVB light therapy, or Control group: tacrolimus ointment plus narrowband UVB light therapy alone The treatment period lasts 12 weeks, with follow-up visits continuing to 24 weeks. The main outcome measures include improvement in skin repigmentation measured by the Vitiligo Area Scoring Index (VASI), changes in quality of life, and safety monitoring throughout the study.\n\nThis study aims to establish a standardized approach for using hUMSCs-Exo in vitiligo treatment and to explore how exosomes may work by reducing oxidative stress and regulating immune responses.",[99,100,101],"Vitiligo","Mesenchymal Stem Cells","Exosomes","NOT_YET_RECRUITING","2026-04-01",{"date":105,"type":106},"2026-04-09","ACTUAL",{"date":108,"type":92},"2026-04",{"date":110,"type":92},"2028-03",{"name":5,"class":6},1]