Study of Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes in Vitiligo

ConditionsVitiligo Mesenchymal Stem Cells Exosomes

Trial statusNot yet recruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexAll

Age18-65

SponsorXijing Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes (hUC-MSC-Exos) Intravenous Infusion
Biological/Vaccine
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.
Oral Prednisone
Drug
Oral administration of prednisone at 0.5 mg/kg daily for 4 weeks followed by gradual tapering, for patients with progressive vitiligo.
Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes (hUC-MSC-Exos) Local Injection
Biological/Vaccine
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.
Topical Tacrolimus Ointment
Drug
Topical application of tacrolimus ointment, twice daily, as a combined treatment for all participants.
Narrow-Band Ultraviolet B (NB-UVB) Phototherapy
Procedure/Surgery
Narrow-band ultraviolet B phototherapy, administered 3 times weekly, as a combined treatment for all participants.

Treatment groups

96 Participants

are divided into 4 treatment groups

Group A: Progressive Stage Experimental GroupExperimental treatment 3 interventions

Group B: Progressive Stage Control GroupActive comparator 3 interventions

Group C: Stable Stage Experimental GroupExperimental treatment 3 interventions

Group D: Stable Stage Control GroupActive comparator 2 interventions

Trial outcomes

Primary outcomes

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%.

Time frame

Baseline to 24 weeks

Secondary outcomes

Percent Change in VASI From Baseline

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.

Time frame

Baseline, weeks 4, 8, 12, 16, and 24

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xijing Hospital

Lead sponsor

Source ClinicalTrials.gov

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