A Phase 1/2 interventional study of Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes (hUC-MSC-Exos) Intravenous Infusion and Oral Prednisone in Vitiligo, Mesenchymal Stem Cells and Exosomes, sponsored by Xijing Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-04-09.
Sponsored by Xijing Hospital · Phase 1/2, Interventional, and Treatment
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.
343 studies on the registry are indexed under Vitiligo; 96 are open to participants now.
This study's planned enrollment of 96 is above the median of 36 across 265 interventional studies indexed under Vitiligo.
Browse Vitiligo studies →Xijing Hospital is the lead sponsor of 474 studies on the registry; 159 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 · Drug: Topical Tacrolimus Ointment · Procedure: Narrow-Band Ultraviolet B (NB-UVB) Phototherapy
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: Oral Prednisone · Drug: Topical Tacrolimus Ointment · Procedure: Narrow-Band Ultraviolet B (NB-UVB) Phototherapy
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.
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
Patients in stable stage receive topical tacrolimus ointment combined with NB-UVB phototherapy, following the routine clinical regimen.
Drug: Topical Tacrolimus Ointment · Procedure: Narrow-Band Ultraviolet B (NB-UVB) Phototherapy
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 administration of prednisone at 0.5 mg/kg daily for 4 weeks followed by gradual tapering, for patients with progressive vitiligo.
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 application of tacrolimus ointment, twice daily, as a combined treatment for all participants.
Narrow-band ultraviolet B phototherapy, administered 3 times weekly, as a combined treatment for all participants.
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
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
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Apr 2026; primary completion for Nov 2027, 19 months later.
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This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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