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临床试验/NCT07187882
NCT07187882招募中不适用

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

Peking University People's Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年4月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
1
主要终点
Repigmentation rate

研究概览

简要总结

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.

详细描述

1. Patient recruitment Inclusion criteria:

  1. Patients diagnosed as vitiligo, according to the "Vitiligo Diagnosis and Treatment Consensus (2021 edition)
  2. Segmental and unclassified vitiligo stable for 6 months, Non-segmental vitiligo stable for 1 year and resistant to medication and phototherapy
  3. BSA≥5%
  4. Sign the informed consent and be willing to undergo surgical treatment
  5. 8-65 years old, both genders Exclusion criteria:

1) 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

  1. Thin split thickness skin grafts of about one-tenth of the recipient area were taken from the donor site(anterolateral thigh)after aseptic precautions.
  2. The suspension for non-cultured epidermal cell suspension transplantation was prepared by the cell sorting kit (Primcell, Jiangsu Repatec Life Science Co.,Ltd).
  3. 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.
  4. 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.

3. 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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
8 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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
  • •Sign the informed consent and be willing to undergo surgical treatment
  • •8-65 years old, both genders

排除标准

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

研究组 & 干预措施

NCES

Experimental

干预措施: Autologous Non-cultured Epidermal Cell Suspension transplantation (Procedure)

结局指标

主要结局

Repigmentation rate

时间窗: 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%).

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ding Xiaolan

Associate Professor

Peking University People's Hospital

研究点 (1)

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