Comparison of Non-Cultured Epidermal Cell Suspension (NCES) and 3D Bioprinting of Autologous Melanocytes for the Treatment of Vitiligo: A Pilot Study
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
Dr Shrinivas Patil
Command Hospital Air Force Bangalore, Indian Air Force
