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临床试验/NCT06619184
NCT06619184已完成不适用

Comparison of The Effectiveness Between Transplantation of Autologous Non-Cultured Extracted Hair Follicle Outer Root Sheath Cell Suspension and Mini Punch Graft in Non-Segmental Vitiligo

Universitas Padjadjaran2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2022年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
21
试验地点
2
主要终点
Appearance of repigmentation (AOR)

研究概览

简要总结

Vitiligo is an acquired pigmentation disorder due to loss of melanocytes characterized by depigmentation macules or patches. One type of this disease is nonsegmental vitiligo (NSV). Until now, there is no satisfactory treatment for vitiligo. Vitiligo therapies are medical therapy include topical and systemic therapy, phototherapy as well as surgery. Surgical treatment is indicated in stable vitiligo, which is not responding to medical treatment. This procedure consists of tissue grafting and cellular transplantation. Mini punch graft (MPG) is the most frequently performed tissue transplantation technique, while cellular transplantation from autologous noncultured extracted hair follicle outer root sheath cell suspension (NCEHFORSCS) containing melanocyte stem cells, is currently a promising option.

详细描述

Current NSV treatments can be considered suboptimal and leading to decreased patient's quality of life due to the emotional burden of therapy dissatisfaction. When a stable NSV is not responding to medical therapy, surgery may be a useful treatment approach. All surgical techniques in vitiligo treatment share the same principle: transferring autologous melanocytes from a donor to repopulate melanocytes in the depigmented area that lacks a reservoir or fails to activate melanocytes in the outer root sheath (ORS) of hair follicles. MPG as the most frequently performed tissue transplantation technique transferred the epidermal melanocyte to vitiligo lesion, while NCEHFORSCS provides melanocytes with better properties and contains melanocyte stem cells. The advantages of melanocytes from ORS compared to epidermal are the follicular melanocyte:keratinocyte ratio consists of one melanocyte for every five keratinocytes or 1:5 in the hair bulb, melanocytes are more dendritic, have larger melanosomes, and have the potential to produce more melanin pigment. Due to these properties, hair follicles can be a better source of melanocytes than epidermis in the delivery of cellular transplantation-based therapy for vitiligo therapy. Research comparing the effectiveness of the two procedures has never been conducted in Indonesia, even though the incidence of vitiligo is quite high and the success of therapy is still not optimal. So the purpose of this study is to compare the effectiveness of the two procedures in NSV patient.

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 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Non-Segmental Vitiligo patients
  • Minimal 1-year duration of stability
  • Age between 18-70 years
  • Having at least two vitiligo lesions for NCEHFORSCS transplantation and MPG procedure
  • The two vitiligo lesions to be treated must meet the following criteria:
  • Have similar size, minimum of 1 cm² and a maximum of 20 cm²
  • The distance between the two lesions at least 1 cm
  • Location of the lesions must have a relatively similar distribution of hair follicles
  • Not located on the palms, soles, or penis

排除标准

  • Active vitiligo
  • Mixed vitiligo
  • Presence of new lesions
  • History of hypertrophic scars and keloids
  • History of bleeding disorders
  • Other active autoimmune diseases
  • History of wound healing disorders

结局指标

主要结局

Appearance of repigmentation (AOR)

时间窗: 4 months

The first appearance of repigmentation in non-segmental vitiligo (NSV) lesions after NCEHFORSCS transplantation and MPG procedure evaluated by blind investigator using dermoscope at weeks 2, -4, -8, -12, and -16

Total number of repigmentation non-segmental vitiligo (NSV) lesions

时间窗: 4 months

Total number of NSV lesions that experienced repigmentation at the 16th week of observation

Extent area of repigmentation

时间窗: 4 months

The repigmentation area percentage level of non-segmental vitiligo (NSV) lesions after NCEHFORSCS transplantation and MPG procedure determine by blind investigator using the digital images. The scores were confirmed by objective measurement of the extent of repigmentation by a digital image analysis system ImageJ® as follow: No repigmentation (0%) Poor repigmentation (0,1-49%) Fair repigmentation (50-74%) Good repigmentation (75-89%) Excellent repigmentation (90-100%)

Color match

时间窗: 4 months

Color match between repigmentation of the lesions and surrounding skin assessed subjectively by a blind investigator using digital photography at week 16 as follows: No repigmentation color Lighter than peri lesion skin color Same as peri lesion skin color Darker than peri lesion skin color

次要结局

  • Complication(4 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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