Safety and Efficacy of Melanocyte-keratinocyte Transplantation in the Treatment of Vitiligo
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- effectiveness of MKTP in treating vitiligo
研究概览
简要总结
In vitiligo, the melanocytes are lost from the skin in certain areas. One treatment for vitiligo takes the melanocytes from areas of normal skin and places them on areas of that same person's body which have lost their color. This is called the melanocyte-keratinocyte transplantation procedure (MKTP). This procedure has been used successfully in over 3000 cases in India and Saudi Arabia. The purpose of this study is to see if it is effective when performed at the investigators' institution.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be at least 18 years old
- •Have a diagnosis of vitiligo with no news lesions or growth of old lesions in the past 6 months
- •Be able to understand the requirements of the study, the risks involved, and be able to sign the informed consent form
- •Agree to follow and undergo all study-related procedures
排除标准
- •Female patients who are breastfeeding, pregnant, or planning to become pregnant
- •Patients with a history of developing vitiligo or keloids at sites of trauma
- •Patients self-reported as having HIV or Hepatitis C
- •Patients self-reported as having uncontrolled Diabetes Mellitus
- •The investigator feels the patient should not participate in the study for any reason
研究组 & 干预措施
MKTP treatment
subject will undergo MKTP
干预措施: Melanocyte-keratinocyte transplantation procedure (MKTP) (Procedure)
结局指标
主要结局
effectiveness of MKTP in treating vitiligo
时间窗: 6 months
Assessed by percent repigmentation (excellent= 100%-95%, good= 94%-65%, fair= 64%-25%, poor= 24%-0%).
次要结局
- safety of MKTP in treating vitiligo(6 months)
研究者
Iltefat Hamzavi
Dermatologist
Henry Ford Health System