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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
  • Peking University People's Hospital

    Beijing, Beijing Municipality, 100044

    Xiaolan Ding, M.D., +861088325472, lancyding@126.com

    Recruiting

Other trials in China

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
  1. Patient recruitment Inclusion criteria:
  2. Patients diagnosed as vitiligo, according to the "Vitiligo Diagnosis and Treatment Consensus (2021 edition)
  3. Segmental and unclassified vitiligo stable for 6 months, Non-segmental vitiligo stable for 1 year and resistant to medication and phototherapy
  4. BSA≥5%
  5. Sign the informed consent and be willing to undergo surgical treatment
  6. 8-65 years old, both genders Exclusion criteria:
  7. 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
  8. Thin split thickness skin grafts of about one-tenth of the recipient area were taken from the donor site(anterolateral thigh)after aseptic precautions.
  9. The suspension for non-cultured epidermal cell suspension transplantation was prepared by the cell sorting kit (Primcell, Jiangsu Repatec Life Science Co.,Ltd).
  10. 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.
  11. 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.
  12. 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.

  1. 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

    1. 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.
Study groups in NCT07187882
Study groupRoleWhat they receive
NCESExperimentalNot 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.

  1. 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)
  1. 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

  2. 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.

  1. First posted23 Sep 2025
  2. Study start25 Apr 2024
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

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)
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

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.

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