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

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: Xijing Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Vitiligo
• Mesenchymal Stem Cells
• Exosomes

Interventions

Type	Name	Description
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	Oral Prednisone	Oral administration of prednisone at 0.5 mg/kg daily for 4 weeks followed by gradual tapering, for patients with progressive vitiligo.
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.
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.

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-11-01
• Completion: 2028-03-01
• First posted: 2026-04-09
• Last updated: 2026-04-09

Locations

1 site across 1 country: China