Autologous Non-cultured Epidermal Cell Suspension Transplantation in the Treatment of Vitiligo

NCT07187882 | Recruiting

• 1 other identifier: RDL2023-04
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Vitiligo

Keywords

non cultured epidermal cell suspension; vitiligo; autologous

Outcome Measures

Primary Outcomes (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%).

  2 weeks, 1month, 2 months, 3 months, 4 months, 5 months and 6 months after transplantation

Secondary Outcomes (2)

• Relative Melanin Index

  2 weeks, 1month, 2 months, 3 months, 4 months, 5 months and 6 months after transplantation

• Relative erythema index

  2 weeks, 1month, 2 months, 3 months, 4 months, 5 months and 6 months after transplantation

Study Arms (1)

NCES

EXPERIMENTAL

Procedure: Autologous Non-cultured Epidermal Cell Suspension transplantation

Interventions

Autologous Non-cultured Epidermal Cell Suspension transplantation PROCEDURE

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.

NCES

Eligibility Criteria

• Age: 8 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years old, both genders

You may not qualify if:

• Severe visceral or infectious disease not suitable for surgical treatment
• Tendency toward keloid formation
• Coagulation defects
• Unable to complete follow-up on time

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

MeSH Terms

Conditions

Vitiligo

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: September 23, 2025
• Study Start: April 25, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)