Study of Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes in Vitiligo (hUMSCs-Exo-VIT)

April 1, 2026 updated by: Xijing Hospital

A Single-Center, Randomized, Controlled Trial of Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes for the Treatment of Vitiligo

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

96

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Xijing Hospital, The First Affiliated Hospital of Air Force Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Progressive Stage Experimental Group
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.
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.
Drug: Topical Tacrolimus Ointment
Topical application of tacrolimus ointment, twice daily, as a combined treatment for all participants.
Procedure: Narrow-Band Ultraviolet B (NB-UVB) Phototherapy
Narrow-band ultraviolet B phototherapy, administered 3 times weekly, as a combined treatment for all participants.
Active Comparator: Progressive Stage Control Group
Patients 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.
Drug: Topical Tacrolimus Ointment
Topical application of tacrolimus ointment, twice daily, as a combined treatment for all participants.
Procedure: Narrow-Band Ultraviolet B (NB-UVB) Phototherapy
Narrow-band ultraviolet B phototherapy, administered 3 times weekly, as a combined treatment for all participants.
Drug: Oral Prednisone
Oral administration of prednisone at 0.5 mg/kg daily for 4 weeks followed by gradual tapering, for patients with progressive vitiligo.
Experimental: 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.
Drug: Topical Tacrolimus Ointment
Topical application of tacrolimus ointment, twice daily, as a combined treatment for all participants.
Procedure: Narrow-Band Ultraviolet B (NB-UVB) Phototherapy
Narrow-band ultraviolet B phototherapy, administered 3 times weekly, as a combined treatment for all participants.
Biological: 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.
Active Comparator: Stable Stage Control Group
Patients in stable stage receive topical tacrolimus ointment combined with NB-UVB phototherapy, following the routine clinical regimen.
Drug: Topical Tacrolimus Ointment
Topical application of tacrolimus ointment, twice daily, as a combined treatment for all participants.
Procedure: Narrow-Band Ultraviolet B (NB-UVB) Phototherapy
Narrow-band ultraviolet B phototherapy, administered 3 times weekly, as a combined treatment for all participants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VASI 50 Response Rate at Week 24
Time Frame: Baseline to 24 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change in VASI From Baseline
Time Frame: Baseline, weeks 4, 8, 12, 16, and 24
Percent change in Vitiligo Area Scoring Index (VASI) from baseline to each follow-up time point. VASI is calculated by summing the product of body surface area affected and degree of depigmentation. Negative values indicate improvement.
Baseline, weeks 4, 8, 12, 16, and 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xijing Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

March 1, 2028

Study Registration Dates

First Submitted

April 1, 2026

First Submitted That Met QC Criteria

April 1, 2026

First Posted (Actual)

April 9, 2026

Study Record Updates

Last Update Posted (Actual)

April 9, 2026

Last Update Submitted That Met QC Criteria

April 1, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XJPF-LCY-V20260331

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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