VitiligoPhase 1/2hUMSCs-Exo-VITNCT07519031
Study of Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes in Vitiligo
A Phase 1/2 study testing Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes (hUC-MSC-Exos) Intravenous Infusion, Oral Prednisone and Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes (hUC-MSC-Exos) Local Injection in people with Vitiligo and Mesenchymal Stem Cells, run by Xijing Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Vitiligo, Mesenchymal Stem Cells, Exosomes
- What is being tested?
- Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes (hUC-MSC-Exos) Intravenous Infusion, Oral Prednisone and Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes (hUC-MSC-Exos) Local Injection
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- Apr 2026to Mar 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Xijing Hospital, The First Affiliated Hospital of Air Force Medical University
Xi'an, Shaanxi, 710032
Zhe Jian, +86-15332332587, jason21-26@163.com
About this study
Official title: 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.
Read more
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
- Being tested
- Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes (hUC-MSC-Exos) Intravenous Infusion, Oral Prednisone, Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes (hUC-MSC-Exos) Local Injection, Topical Tacrolimus Ointment, Narrow-Band Ultraviolet B (NB-UVB) Phototherapy
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes (hUC-MSC-Exos) Intravenous InfusionBiological
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 PrednisoneDrug
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 InjectionBiological
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 OintmentDrug
Topical application of tacrolimus ointment, twice daily, as a combined treatment for all participants.
Narrow-Band Ultraviolet B (NB-UVB) PhototherapyProcedure or surgery
Narrow-band ultraviolet B phototherapy, administered 3 times weekly, as a combined treatment for all participants.
| Study group | Role | What they receive |
|---|---|---|
| Progressive Stage Experimental Group | Experimental | 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. Receives: Biological: Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes (hUC-MSC-Exos) Intravenous Infusion; Drug: Topical Tacrolimus Ointment; Procedure: Narrow-Band Ultraviolet B (NB-UVB) Phototherapy |
| Progressive Stage Control Group | Active comparator | 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. Receives: Drug: Oral Prednisone; Drug: Topical Tacrolimus Ointment; Procedure: Narrow-Band Ultraviolet B (NB-UVB) Phototherapy |
| Stable Stage Experimental Group | Experimental | 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. Receives: Biological: Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes (hUC-MSC-Exos) Local Injection; Drug: Topical Tacrolimus Ointment; Procedure: Narrow-Band Ultraviolet B (NB-UVB) Phototherapy |
| Stable Stage Control Group | Active comparator | Patients in stable stage receive topical tacrolimus ointment combined with NB-UVB phototherapy, following the routine clinical regimen. Receives: Drug: Topical Tacrolimus Ointment; Procedure: Narrow-Band Ultraviolet B (NB-UVB) Phototherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: Baseline to 24 weeks
Secondary outcomes (1)
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.
Measured: Baseline, weeks 4, 8, 12, 16, and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study startApr 2026 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VitiligoStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07519031
- Sponsor's protocol ID
- XJPF-LCY-V20260331
- Acronym
- hUMSCs-Exo-VIT
- Status last verified
- Mar 2026
- First submitted
- 1 Apr 2026
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Randomized, Controlled Trial of Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes for the Treatment of Vitiligo
- ClinicalTrials.gov ID
- NCT07519031
- Acronym / sponsor ID
- hUMSCs-Exo-VIT / XJPF-LCY-V20260331
- Conditions
- Vitiligo, Mesenchymal Stem Cells, Exosomes
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 9 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Progressive Stage Experimental Group | Experimental | Biological: Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes (hUC-MSC-Exos) Intravenous Infusion, Drug: Topical Tacrolimus Ointment, Procedure: Narrow-Band Ultraviolet B (NB-UVB) PhototherapyPatients 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 comparator | Drug: Oral Prednisone, Drug: Topical Tacrolimus Ointment, Procedure: Narrow-Band Ultraviolet B (NB-UVB) PhototherapyPatients 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 | Experimental | Biological: Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes (hUC-MSC-Exos) Local Injection, Drug: Topical Tacrolimus Ointment, Procedure: Narrow-Band Ultraviolet B (NB-UVB) PhototherapyPatients 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 comparator | Drug: Topical Tacrolimus Ointment, Procedure: Narrow-Band Ultraviolet B (NB-UVB) PhototherapyPatients in stable stage receive topical tacrolimus ointment combined with NB-UVB phototherapy, following the routine clinical regimen. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes (hUC-MSC-Exos) Intravenous InfusionIntravenous 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. | Biological | Progressive Stage Experimental Group |
| Oral PrednisoneOral administration of prednisone at 0.5 mg/kg daily for 4 weeks followed by gradual tapering, for patients with progressive vitiligo. | Drug | Progressive Stage Control Group |
| Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes (hUC-MSC-Exos) Local InjectionLocal 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. | Biological | Stable Stage Experimental Group |
| Topical Tacrolimus OintmentTopical application of tacrolimus ointment, twice daily, as a combined treatment for all participants. | Drug | Progressive Stage Control Group, Progressive Stage Experimental Group, Stable Stage Control Group, Stable Stage Experimental Group |
| Narrow-Band Ultraviolet B (NB-UVB) PhototherapyNarrow-band ultraviolet B phototherapy, administered 3 times weekly, as a combined treatment for all participants. | Procedure or surgery | Progressive Stage Control Group, Progressive Stage Experimental Group, Stable Stage Control Group, Stable Stage Experimental Group |
Primary outcome
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%.
1 secondary outcome
Percent Change in VASI From Baseline
Time frame: Baseline, weeks 4, 8, 12, 16, and 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes (hUC-MSC-Exos) Intravenous Infusion, Oral Prednisone and Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes (hUC-MSC-Exos) Local Injection in people with Vitiligo and Mesenchymal Stem Cells, run by Xijing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhe Jian (+86-15332332587, jason21-26@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VASI 50 Response Rate at Week 24 (time frame: Baseline to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.