Study of Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes in Vitiligo
Key facts
- Where
- Xi'an, ChinaSee the site
- Phase
- Phase 1/2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07519031, who can take part
Where in China
- Xijing Hospital (The First Affiliated Hospital of Air Force Medical University)Xi'an, ChinaContact: Zhe JianNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Xijing Hospital
- Trial code
- NCT07519031
- Record updated
- 9 April 2026
- Original description
This study evaluates whether exosomes derived from human umbilical cord mesenchymal stem cells (hUMSCs-Exo) are safe and effective for treating vitiligo in adults.Read full original descriptionShow less
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.
Inclusion: 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: 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; Known allergy to mesenchymal stem cells or exosome components; Severe cardiac, hepatic, or renal dysfunction, or severe immunocompromised status; 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; Pregnancy or breastfeeding.