VitiligoNCT07187882
Autologous Non-cultured Epidermal Cell Suspension Transplantation in the Treatment of Vitiligo
A study testing Autologous Non-cultured Epidermal Cell Suspension transplantation in people with Vitiligo, run by Peking University People's Hospital at 1 site in China.
Trial summary
To observe the long-term efficacy and safety of autologous non cultured epidermal cell suspension transplantation in the treatment of vitiligo, analyze the correlation between cell density, type, and postoperative efficacy and prognosis, and providing a basis for clinical application. Read more about this study
- Who is it for?
- Ages 8 to 65 years
- Conditions the study is for
- Vitiligo
- What is being tested?
- Autologous Non-cultured Epidermal Cell Suspension transplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 25 Apr 2024to 31 Dec 2025
- Phase
- Interventional
- 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 8 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients diagnosed as vitiligo, according to the "Vitiligo Diagnosis and Treatment Consensus (2021 edition)
- Segmental and unclassified vitiligo stable for 6 months, Non-segmental vitiligo stable for 1 year and resistant to medication and phototherapy
- BSA≥5%
- Sign the informed consent and be willing to undergo surgical treatment
- 8-65 years old, both genders
Who cannot join
- Severe visceral or infectious disease not suitable for surgical treatment
- Tendency toward keloid formation
- Coagulation defects
- Unable to complete follow-up on time
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, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Xiaolan Ding, M.D., +861088325472, lancyding@126.com
About this study
To observe the long-term efficacy and safety of autologous non cultured epidermal cell suspension transplantation in the treatment of vitiligo, analyze the correlation between cell density, type, and postoperative efficacy and prognosis, and providing a basis for clinical application.
Read the detailed description
- Patient recruitment Inclusion criteria:
- Patients diagnosed as vitiligo, according to the "Vitiligo Diagnosis and Treatment Consensus (2021 edition)
- Segmental and unclassified vitiligo stable for 6 months, Non-segmental vitiligo stable for 1 year and resistant to medication and phototherapy
- BSA≥5%
- Sign the informed consent and be willing to undergo surgical treatment
- 8-65 years old, both genders Exclusion criteria:
- Severe visceral or infectious disease not suitable for surgical treatment 2) Tendency toward keloid formation 3) Coagulation defects 4) Unable to complete follow-up on time 2. Non-cultured epidermal cell suspension transplantation procedure
- Thin split thickness skin grafts of about one-tenth of the recipient area were taken from the donor site(anterolateral thigh)after aseptic precautions.
- The suspension for non-cultured epidermal cell suspension transplantation was prepared by the cell sorting kit (Primcell, Jiangsu Repatec Life Science Co.,Ltd).
- The recipient site was cleaned with 75% alcohol and anesthetized by applying topical compound lidocaine cream for 45 to 60 minutes. Then the recipient skin was uniformly dermabraded using an electrical dermabrader set at 10,000 to 20,000 rpm until punctate bleeding points appeared. Dermabrasion was performed 0.5 mm beyond the margin of the recipient area to minimize the perigraft halo of depigmentation.
- The cell suspension was applied onto the dermabraded recipient area. The recipient site was then fixed firmly with 4 layers of dressing. From the inner to the outer layer, these dressings were: non adherent wound dressing , paraffin-embedded gauze, dry gauze, and elastic bandage. The dressings were removed 10 days after transplantation.
- Postoperative Follow-Up All patients returned to the hospital for follow-up examinations at 2 weeks, 1month, 2 months, 3 months, 4 months, 5 months and 6 months after transplantation.
The repigmentation was graded based on the percentage of the area of repigmentation as poor (less than 25%), good (26%-50%), very good (51%-75%), or excellent (more than 75%).
The melanin index (MI) and erythema index (EI) of the recipient sites were measured using a Mexameter MX18 (Courage 1Khazaka Electronic GmbH, Koln, Germany). The relative MI (RMI) and relative EI (REI) were calculated as the ratio of the MI or EI of the recipient sites relative to the symmetrical control skin region.
- Laboratory Tests The cell number and vitality of the suspension was determined by an automatic intelligent cell counter. The flow cytometry was used to analyze the cell types.
- Conditions
- Vitiligo
- Being tested
- Autologous Non-cultured Epidermal Cell Suspension transplantation
- Keywords
- non cultured epidermal cell suspension, vitiligo, autologous
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Non-cultured Epidermal Cell Suspension transplantationProcedure or surgery
- Thin split thickness skin grafts were taken from the donor site (anterolateral thigh) after application of topical anaesthesia under complete aseptic precautions.
- The cell suspension was prepared by the cell sorting kit (Primcell, Jiangsu Repatec Life Science Co.,Ltd).
- Then the recipient skin was uniformly dermabraded using an electrical dermabrader set at 10,000 to 20,000 rpm until punctate bleeding points appeared.
- The cell suspension was applied onto the dermabraded recipient area.
- The recipient site was then fixed firmly with dressings and elastic bandage. The dressings were removed 10 days after transplantation.
| Study group | Role | What they receive |
|---|---|---|
| NCES | Experimental | Not described Receives: Procedure: Autologous Non-cultured Epidermal Cell Suspension transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Repigmentation rate
The repigmentation rate depends on the percentage of repigmentation area /recipient area*100%. The extent of repigmentation was devided as poor (less than 25%), good (26%-50%), very good (51%-75%), or excellent (more than75%).
Measured: 2 weeks, 1month, 2 months, 3 months, 4 months, 5 months and 6 months after transplantation
Secondary outcomes (2)
Relative Melanin Index
The melanin index (MI) of the recipient sites were measured using a Mexameter MX18 (Courage 1Khazaka Electronic GmbH, Koln, Germany). The relative MI (RMI) and were calculated as the ratio of the MI of the recipient sites relative to the symmetrical control skin region
Measured: 2 weeks, 1month, 2 months, 3 months, 4 months, 5 months and 6 months after transplantation
Relative erythema index
The erythema index (EI) of the recipient sites were measured using a Mexameter MX18 (Courage 1Khazaka Electronic GmbH, Koln, Germany). The relative EI (REI) were calculated as the ratio of the EI of the recipient sites relative to the symmetrical control skin region
Measured: 2 weeks, 1month, 2 months, 3 months, 4 months, 5 months and 6 months after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study start25 Apr 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (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.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ding Xiaolan, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07187882
- Sponsor's protocol ID
- RDL2023-04
- Status last verified
- Sep 2025
- First submitted
- 16 Sep 2025
- Last updated
- 23 Sep 2025
- 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 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Non-cultured Epidermal Cell Suspension Transplantation in the Treatment of Vitiligo
- ClinicalTrials.gov ID
- NCT07187882
- Acronym / sponsor ID
- RDL2023-04
- Conditions
- Vitiligo
- Keywords
- non cultured epidermal cell suspension, vitiligo, autologous
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 25 Apr 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 23 Sep 2025 (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.
To observe the long-term efficacy and safety of autologous non cultured epidermal cell suspension transplantation in the treatment of vitiligo, analyze the correlation between cell density, type, and postoperative efficacy and prognosis, and providing a basis for clinical application.
Detailed description
- Patient recruitment Inclusion criteria:
- Patients diagnosed as vitiligo, according to the "Vitiligo Diagnosis and Treatment Consensus (2021 edition)
- Segmental and unclassified vitiligo stable for 6 months, Non-segmental vitiligo stable for 1 year and resistant to medication and phototherapy
- BSA≥5%
- Sign the informed consent and be willing to undergo surgical treatment
- 8-65 years old, both genders Exclusion criteria:
- Severe visceral or infectious disease not suitable for surgical treatment 2) Tendency toward keloid formation 3) Coagulation defects 4) Unable to complete follow-up on time 2. Non-cultured epidermal cell suspension transplantation procedure
- Thin split thickness skin grafts of about one-tenth of the recipient area were taken from the donor site(anterolateral thigh)after aseptic precautions.
- The suspension for non-cultured epidermal cell suspension transplantation was prepared by the cell sorting kit (Primcell, Jiangsu Repatec Life Science Co.,Ltd).
- The recipient site was cleaned with 75% alcohol and anesthetized by applying topical compound lidocaine cream for 45 to 60 minutes. Then the recipient skin was uniformly dermabraded using an electrical dermabrader set at 10,000 to 20,000 rpm until punctate bleeding points appeared. Dermabrasion was performed 0.5 mm beyond the margin of the recipient area to minimize the perigraft halo of depigmentation.
- The cell suspension was applied onto the dermabraded recipient area. The recipient site was then fixed firmly with 4 layers of dressing. From the inner to the outer layer, these dressings were: non adherent wound dressing , paraffin-embedded gauze, dry gauze, and elastic bandage. The dressings were removed 10 days after transplantation.
- Postoperative Follow-Up All patients returned to the hospital for follow-up examinations at 2 weeks, 1month, 2 months, 3 months, 4 months, 5 months and 6 months after transplantation.
The repigmentation was graded based on the percentage of the area of repigmentation as poor (less than 25%), good (26%-50%), very good (51%-75%), or excellent (more than 75%).
The melanin index (MI) and erythema index (EI) of the recipient sites were measured using a Mexameter MX18 (Courage 1Khazaka Electronic GmbH, Koln, Germany). The relative MI (RMI) and relative EI (REI) were calculated as the ratio of the MI or EI of the recipient sites relative to the symmetrical control skin region.
- Laboratory Tests The cell number and vitality of the suspension was determined by an automatic intelligent cell counter. The flow cytometry was used to analyze the cell types.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NCES | Experimental | Procedure: Autologous Non-cultured Epidermal Cell Suspension transplantation |
Who may qualify
- Ages
- 8 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients diagnosed as vitiligo, according to the "Vitiligo Diagnosis and Treatment Consensus (2021 edition)
- Segmental and unclassified vitiligo stable for 6 months, Non-segmental vitiligo stable for 1 year and resistant to medication and phototherapy
- BSA≥5%
- Sign the informed consent and be willing to undergo surgical treatment
- 8-65 years old, both genders
Key exclusion criteria (4 listed)
- Severe visceral or infectious disease not suitable for surgical treatment
- Tendency toward keloid formation
- Coagulation defects
- Unable to complete follow-up on time
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 |
|---|---|---|
| Autologous Non-cultured Epidermal Cell Suspension transplantation1. Thin split thickness skin grafts were taken from the donor site (anterolateral thigh) after application of topical anaesthesia under complete aseptic precautions. 2. The cell suspension was prepared by the cell sorting kit (Primcell, Jiangsu Repatec Life Science Co.,Ltd). 3. Then the recipient skin was uniformly dermabraded using an electrical dermabrader set at 10,000 to 20,000 rpm until punctate bleeding points appeared. 4. The cell suspension was applied onto the dermabraded recipient area. 5. The recipient site was then fixed firmly with dressings and elastic bandage. The dressings were removed 10 days after transplantation. | Procedure or surgery | NCES |
Primary outcome
Repigmentation rate
Time frame: 2 weeks, 1month, 2 months, 3 months, 4 months, 5 months and 6 months after transplantation
The repigmentation rate depends on the percentage of repigmentation area /recipient area*100%. The extent of repigmentation was devided as poor (less than 25%), good (26%-50%), very good (51%-75%), or excellent (more than75%).
2 secondary outcomes
Relative Melanin Index
Time frame: 2 weeks, 1month, 2 months, 3 months, 4 months, 5 months and 6 months after transplantation
Relative erythema index
Time frame: 2 weeks, 1month, 2 months, 3 months, 4 months, 5 months and 6 months after transplantation
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 23 Sep 2025.
- 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 study testing Autologous Non-cultured Epidermal Cell Suspension transplantation in people with Vitiligo, run by Peking University People's 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 4 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: looking for participants now, as of the sponsor's last update on 23 Sep 2025. 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Repigmentation rate (time frame: 2 weeks, 1month, 2 months, 3 months, 4 months, 5 months and 6 months after transplantation). 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 23 Sep 2025.