Study of Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes in Vitiligo
hUMSCs-Exo-VIT
A Single-Center, Randomized, Controlled Trial of Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes for the Treatment of Vitiligo
1 other identifier
interventional
96
1 country
1
Brief Summary
This study evaluates whether exosomes derived from human umbilical cord mesenchymal stem cells (hUMSCs-Exo) are safe and effective for treating vitiligo in adults. Vitiligo 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. This 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). For progressive vitiligo, participants are randomly assigned to either: Experimental 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 For stable vitiligo, participants are randomly assigned to either: Experimental 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. This 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 1, 2026
CompletedStudy Start
First participant enrolled
April 1, 2026
CompletedFirst Posted
Study publicly available on registry
April 9, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2028
April 9, 2026
March 1, 2026
1.6 years
April 1, 2026
April 1, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
VASI 50 Response Rate at Week 24
Proportion of participants achieving at least 50% improvement in Vitiligo Area Scoring Index (VASI) from baseline to week 24. VASI is calculated by summing the product of body surface area affected and degree of depigmentation across all body regions. VASI 50 response is defined as (baseline VASI - week 24 VASI) / baseline VASI × 100% ≥ 50%.
Baseline to 24 weeks
Secondary Outcomes (1)
Percent Change in VASI From Baseline
Baseline, weeks 4, 8, 12, 16, and 24
Study Arms (4)
Progressive Stage Experimental Group
EXPERIMENTALPatients 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.
Progressive Stage Control Group
ACTIVE COMPARATORPatients in progressive stage receive oral prednisone 0.5 mg/kg daily for 4 weeks followed by gradual tapering, combined with topical tacrolimus ointment and NB-UVB phototherapy.
Stable Stage Experimental Group
EXPERIMENTALPatients 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.
Stable Stage Control Group
ACTIVE COMPARATORPatients in stable stage receive topical tacrolimus ointment combined with NB-UVB phototherapy, following the routine clinical regimen.
Interventions
Oral administration of prednisone at 0.5 mg/kg daily for 4 weeks followed by gradual tapering, for patients with progressive vitiligo.
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.
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.
Topical application of tacrolimus ointment, twice daily, as a combined treatment for all participants.
Narrow-band ultraviolet B phototherapy, administered 3 times weekly, as a combined treatment for all participants.
Eligibility Criteria
You may qualify if:
- Clinically diagnosed non-segmental vitiligo
- 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)
- Total body surface area (BSA) of vitiligo lesions between 1% and 30%
- Age 18 to 65 years, male or female
- Willing to participate and provide written informed consent
You may not qualify if:
- Pregnancy or breastfeeding
- Known allergy to mesenchymal stem cells or exosome components
- Severe cardiac, hepatic, or renal dysfunction, or severe immunocompromised status
- For progressive vitiligo: use of systemic immunosuppressants, corticosteroids, phototherapy, or photochemotherapy within the past 3 months
- For stable vitiligo: use of phototherapy, topical immunosuppressants, or corticosteroids within the past 1 month
- Concurrent autoimmune diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis, psoriasis) or severe infectious diseases
- History of malignancy or hematologic disorders
- History of psychiatric disorders or inability to comply with study procedures
- Any other condition that, in the investigator's judgment, may increase the risk to the participant or interfere with the conduct of the trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xijing Hospitallead
Study Sites (1)
Xijing Hospital, The First Affiliated Hospital of Air Force Medical University
Xi'an, Shaanxi, 710032, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- The study is an open-label trial due to the nature of the cellular exosome intervention, which makes blinding of participants, investigators, and outcome assessors infeasible
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 1, 2026
First Posted
April 9, 2026
Study Start
April 1, 2026
Primary Completion (Estimated)
November 1, 2027
Study Completion (Estimated)
March 1, 2028
Last Updated
April 9, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share