An Early Phase 1 interventional study of human induced pluripotent stem cell derived exosomes （GD-iExo-003） and a placebo of exosomes derived from human induced pluripotent stem cell for injection in Stable Vitiligo, sponsored by Second Affiliated Hospital of Wannan Medical College. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-02-06.
Sponsored by Second Affiliated Hospital of Wannan Medical College · Early Phase 1, Interventional, and Treatment
Evaluate the efficacy of induced pluripotent stem cell-derived exosomes (iPSC-Exos) for the treatment of stable vitiligo
This study aims to evaluate the efficacy and safety of iPSC-Exos in the treatment of localized stable vitiligo. iPSC-Exos have been found to possess the ability to promote cell survival, proliferation, and repair, potentially improving skin pigmentation in vitiligo patients by modulating the survival and function of melanocytes.
This study will consist of 2 parts, with part 1 being a dose-escalation study and part 2 being an expanded safety study based on part 1 findings.
A traditional 3+3 dose escalation design will be implemented in part 1. Cohort 1: receive 1×10\^8 particles per time; cohort 2: 3×10\^8 particles per time and cohort 3: 9×10\^8 particles per time.
In part 2, 20 subjects will be randomized in a 1:1 ratio [exosome (n=10) or exosome placebo (n=10)]. The dose level will be determined by Data Safety Monitoring Board based on part 1.
343 studies on the registry are indexed under Vitiligo; 96 are open to participants now.
This study's planned enrollment of 29 is below the median of 36 across 265 interventional studies indexed under Vitiligo.
Browse Vitiligo studies →This is the only study on the registry with Second Affiliated Hospital of Wannan Medical College as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
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.
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.
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.
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.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
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.
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.
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.
group1-low-dose group, 3 patients will receive doses of GD-iExo-003 at 1×10\^8 particles per 4 square centimeters of lesion area in 100 μL. group2-mid-dose group, 3 patients will receive doses of GD-iExo-003 at 3×10\^8 particles per 4 square centimeters of lesion area in 100 μL. group3-high-dose group, 3 patients will receive doses of GD-iExo-003 at 9×10\^8 particles per 4 square centimeters of lesion area in 100 μL. The administration method is microneedle injection, with each injection being 100 ul. Once every 2 weeks, for a total treatment duration of 3 months, with an additional follow-up period of 6 months
Drug: human induced pluripotent stem cell derived exosomes （GD-iExo-003）
Patients in this arm will be given a placebo. The administration method is microneedle injection, with each injection being 100 ul. Once every 2 weeks, for a total treatment duration of 3 months, with an additional follow-up period of 6 months.
Drug: a placebo of exosomes derived from human induced pluripotent stem cell for injection
human induced pluripotent stem cell derived exosomes （GD-iExo-003）
a placebo of exosomes derived from human induced pluripotent stem cell for injection
adverse events as assessed by CTCAE
all potentially treated subjects to assess the safety
Time frame: Screening and 1 day, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks, 14 weeks，18 weeks，22 weeks，24 weeks after the first injection
Local Adverse Reactions
Changes in the lesions at the site of the white patches after treatment, such as erythema, blisters, erosion, scaling, pigmentation, Koebner phenomenon, etc
Time frame: Screening and 1 day, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks, 14 weeks，18 weeks，22 weeks，24 weeks after the first injection
Systemic Adverse Reactions
blood tests to check liver function indicators-Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST)-and kidney function indicators-Creatinine (Cr), Blood Urea Nitrogen (BUN)
Time frame: Screening and 1 day, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks, 14 weeks，18 weeks，22 weeks，24 weeks after the first injection
Changes in the area of white patches
Using the grid counting method to calculate the area of white patches
Time frame: Screening and 1 day, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks, 14 weeks，18 weeks，22 weeks，24 weeks after the first injection
Vitiligo Area Scoring Index (VASI) change
VASI = Number of Hand Palm Units × Percentage of Depigmentation, with VASI values ranging from 0 to 100. One palm area is divided into 32 finger-joint units, where the palm center area accounts for 18 finger-joint units representing 0.54%, and one finger-joint unit represents 0.03%. VASI Improvement Rate = (VASI score before treatment - VASI score after treatment) / VASI score before treatment × 100%. VASI50 is defined as an improvement in the VASI score of ≥50% from baseline; VASI75 is defined as an improvement in the VASI score of ≥75% from baseline.
Time frame: Screening and 1 day, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks, 14 weeks，18 weeks，22 weeks，24 weeks after the first injection
Vitiligo Noticeability Scale (VNS) change
This questionnaire includes assessments of appearance noticeability and psychosocial impact, with higher scores indicating a greater level of impact.
Time frame: Screening and 1 day, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks, 14 weeks，18 weeks，22 weeks，24 weeks after the first injection
Dermatology Life Quality Index (DLQI) change
The questionnaire contains 10 questions, with each option scored from 0 to 3. If a question is not relevant, it is also scored as 0. The score range is from 0 to 30, with higher scores indicating a greater impact on the quality of life.
Time frame: Screening and 1 day, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks, 14 weeks，18 weeks，22 weeks，24 weeks after the first injection
Plan to share: No — The study will not share individual participant data to other researchers.
No publications or documents are linked to this record.
Start is estimated for Feb 2025; primary completion for Nov 2026, 21 months later.
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This study is not yet recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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