Phase I-II, Randomized, Intraindividually Placebo Controlled Clinical Trial, to Evaluate the Efficacy of Autologous Melanocyte Transplantion on Amniotic Membrane as a Substrate for Patients With Stable Vitiligo.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Efficacy of Autologous Melanocyte Transplantion on Amniotic Membrane as a Substrate for Patients With Stable Vitiligo
研究概览
简要总结
Vitiligo is an acquired skin disease that significantly impacts the quality of life of patients. Medical treatment of vitiligo includes the use of melanocyte transplantation but the results are variable.
This single center, single blind clinical trial comparing another treatment and also no treatment was designed to assess the efficacy of autologous monocyte transplantation in monolayers on a substrate of amniotic membrane for the treatment of stable vitiligo. Patients will receive the two interventions, melanocyte suspension and monolayer on amniotic membrane and will provide an untreated area as a control.
详细描述
Main Objective:
The main objective is to assess the efficacy of autologous transplantation of monocytes in monolayers grown on a biological substrate of amniotic membrane in the treatment of stable vitiligo. Using a system of digital imaging analysis the percentage of re-pigmentation obtained will be studied after 3, 6 and 9 months of treatment.
Secondary Objectives:
To demonstrate differences in efficacy (as measured by the percentage of re-pigmentation) of each of the 2 techniques used: pure melanocytes in suspension and amniotic membrane with melanocytes in monolayers.
To assess how rapidly epithelialization occurs and the cosmetic result in the short and long term of the areas treated with each of the techniques.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must voluntarily provide informed consent before any of the tests included in the trial which do not form part of standard treatment can be performed.
- •Mentally stable patients, suffering from piebaldism, vitiligo of metameric distribution, focal or generalized vitiligo which has remained stable for at least one year without de-pigmentation or spontaneous re-pigmentation after standard medical treatment.
- •A minimum hypopigmented area to treat of 100 cm2 (at least 30 cm2 for each of the therapeutic options).
- •For women of child-bearing age, a negative pregnancy test.
排除标准
- •Women who are pregnant or breast-feeding.
- •Positive results in any of the blood tests given
- •Concomitant serious illness.
- •Patients who have received any agent currently the focus of research in the 30 days prior to their inclusion.
- •Patients currently participating in another clinical trial or receiving any other agent currently the focus of research.
结局指标
主要结局
Efficacy of Autologous Melanocyte Transplantion on Amniotic Membrane as a Substrate for Patients With Stable Vitiligo
时间窗: six months
次要结局
未报告次要终点