Autologous Cell Suspension Grafting Using ReCell in Vitiligo and Piebaldism Patients: a Randomized Controlled Pilot Study
试验速览
- 阶段
- 4 期
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- degree of repigmentation
研究概览
简要总结
Autologous epidermal cell suspension grafting is an effective method of surgical treatment in vitiligo, which is suitable for treating larger areas with better cosmetic results as compared to other grafting methods. The ReCell Autologous Cell Harvesting Device (Avita Medical Europe Limited, Cambridge, UK) is an autologous cell harvesting device which, compared to other forms of autologous epidermal cell suspension grafting, is easier in use showing similar results. Furthermore, the ReCell device needs no laboratory facilities. Therefore, it is promising for patients with large vitiligo and piebaldism lesions.
Objectives: Primary: to asses the efficacy and safety of autologous epidermal cell suspension grafting with the ReCell device after CO2 laser abrasion compared to CO2 laser abrasion alone and no treatment, in patients with piebaldism and stable vitiligo. Secondary: to assess the practical aspects and patients satisfaction of autologous epidermal cell suspension grafting with the ReCell device.
Study design: Prospective observer blinded randomized controlled pilot study. Study population: 10 patients ≥ 18 years with stable segmental vitiligo or piebaldism who are under treatment at the Netherlands Institute for Pigment Disorders (NIPD) at the Academic Medical Centre University of Amsterdam.
Methods: Three depigmented regions on the trunk or proximal extremities will be randomly allocated to; CO2 laser abrasion + ReCell autologous cell suspension grafting, or CO2 laser abrasion, or no treatment. After the transplantation, UV-treatment according to the standard treatment protocol of the NIPD will be started on all sites and continued for 3 months. Three and six months after grafting, the percentage of repigmentation of the lesions will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient with piebaldism
- •Patients with segmental vitiligo,stable since 12 months without systemic therapy or topical therapy as defined by the absence of new lesions and/or enlargement of existing lesions
- •with at least three depigmented skin lesions on the proximal extremities or trunk larger than 3x3 cm or one lesion of at least 9x3 cm
- •willing and able to give written informed consent
排除标准
- •UV therapy or systemic immunosuppressive treatment during the last 12 months
- •Local treatment of vitiligo during the last 12 months
- •Vitiligo lesions with follicular or non-follicular repigmentation
- •Skin type I
- •Recurrent HSV skin infections
- •Hypertrophic scars
- •Cardial insufficiency
- •Patients with a history of hypersensitivity to (UVB or UVA) light and/or allergy to local anesthesia.
- •Patients who are pregnant or breast-feeding
- •Patients not competent to understand the procedures involved
- •Patients with atypical nevi
- •Patients with a personal history of melanoma or non-melanoma skin cancer
结局指标
主要结局
degree of repigmentation
时间窗: 6 months
Objective assessment of the degree of repigmentation 6 months after autologous epidermal cell suspension grafting. Assessment will be done by standardized photographs and a digital image analysis system.
次要结局
- Visual assessment of side effects per treatment region(6 months)
- General outcome assessed by the patient(6 months)
研究者
Lisa Komen
Drs.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)