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临床试验/CTRI/2024/11/077162
CTRI/2024/11/077162尚未招募3 期

Comparison of Non-Cultured Epidermal Cell Suspension (NCES) and 3D Bioprinting of Autologous Melanocytes for the Treatment of Vitiligo: A Pilot Study

Command Hospital Air Force Bangalore1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年12月10日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
20
试验地点
1
主要终点
Rate of repigmentation of vitiligo patches

研究概览

简要总结

This prospective pilot study is designed to evaluate and compare the efficacy of Non-Cultured Epidermal Cell Suspension (NCES) and 3D bioprinting of autologous melanocytes in the treatment of vitiligo, with repigmentation rate as the primary endpoint. A total of 32-34 stable vitiligo patches will be included, with each treatment arm receiving 16-17 patches. For NCES, a suspension of melanocytes from a thin skin biopsy will be applied to dermabraded patches. In the 3D bioprinting arm, melanocytes isolated from autologous skin will be mixed with hydroxymethyl cellulose (HMC) to create a bioink, which will then be printed into skin substitutes and applied to the prepared patches.

Patients will be followed monthly for six months, assessing repigmentation rates through clinical photographs, patient satisfaction on a Visual Analog Scale, and monitoring for any adverse events. It is hypothesized that 3D bioprinting will lead to higher repigmentation rates, improved patient satisfaction, and maintain a strong safety profile. The outcomes of this study are expected to provide insights into the potential of 3D bioprinting as a superior therapeutic alternative in vitiligo management, supporting its use in further clinical studies with larger sample sizes.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
All

入选标准

  • (a) Stable vitiligo for at least 12 months.
  • (b) Age between 18-45 years.
  • (c) Vitiligo patches located on accessible body areas (face, limbs, torso).
  • (d) No prior cellular transplantation on the selected patches.

排除标准

  • (a) Active vitiligo.
  • (b) Comorbid conditions such as diabetes or autoimmune diseases.
  • (c) Pregnancy or lactation.
  • (d) History of keloid or hypertrophic scar formation.

结局指标

主要结局

Rate of repigmentation of vitiligo patches

时间窗: over 3 to 4 months

次要结局

  • (a) Patient Satisfaction((b) Safety & Tolerability)

研究者

发起方
Command Hospital Air Force Bangalore
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Shrinivas Patil

Command Hospital Air Force Bangalore, Indian Air Force

研究点 (1)

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