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临床试验/NCT02510651
NCT02510651已完成1 期

Effect of Procedural-Related Variables on Melanocyte-Keratinocyte Suspension Transplantation in Non-Segmental Stable Vitiligo: A Clinical and Immunohistochemical Study

Cairo University0 个研究点目标入组 40 人开始时间: 2010年1月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
40
主要终点
The number of patients with satisfactory response after the surgical procedure for vitiligo.

研究概览

简要总结

ORSHFS grafts yielded lower cell counts than NCECS but the M-K ratio and resultant repigmentation did not show significant difference with better healing of the donor site. Compared to cryoblebs, CO2 gave more homogenous pigmentation. The acral sites showed better results using combination of donor NCECS and recipient cryoblebs.

详细描述

Background: Melanocyte-keratinocyte suspension (M-K susp) is gaining popularity for vitiligo treatment. Few studies have addressed procedure-related variables.

Objective

To assess the effect of different M-K susp procedure-related variables on the clinical outcome in stable vitiligo.

Methods: This retrospective study included 40 cases with stable non-segmental vitiligo treated by M-K susp followed by narrow band- ultraviolet B phototherapy twice weekly. Donor site was either a skin graft in non-cultured epidermal cell suspension (NCECS) (34 cases) or hair follicle unit in Outer Root Sheath Hair Follicle Suspension (ORSHFS) (6 cases). Recipient site was prepared by either cryoblebbing (24 cases) or carbon dioxide (CO2)laser resurfacing (16 cases). Cell counts and viability were recorded in the cell suspensions, and tissue melanocytes and keratinocytes were examined by Melan A and Cytokeratin respectively. Assessment of repigmentation was done 18 months after the procedure.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Stable non-segmental vitiligo

排除标准

  • Active vitiligo

结局指标

主要结局

The number of patients with satisfactory response after the surgical procedure for vitiligo.

时间窗: one year

次要结局

未报告次要终点

研究者

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

Dalia Abdel Halim

Assisstant professorof dermatology

Cairo University

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