Comparative Study of the Use of Trypsin Versus Dispase in Melanocyte-Keratinocyte Transplantation for the Treatment of Vitiligo
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Pigmentation
研究概览
简要总结
Previous studies have evaluated the transplantation of pigment cells (melanocytes)and skin cells (keratinocytes) for the treatment of vitiligo. This procedure is known as MKTP (Melanocyte Keratinocyte Transplantation Procedure). Multiple studies have found this procedure to be both safe and effective for the treatment of vitiligo. The majority of these studies utilized trypsin to help isolate melanocytes and keratinocytes. Trypsin is enzyme that helps to separate the different layers of skin. However, some cell biologists believe that the enzyme dispase (which can be used to separate the epidermis from the dermis) is less toxic to cells of the epidermis and can result in a greater number of viable melanocytes and keratinocytes for transplantation.
This study will look at the repigmentation rates of MKTP using trypsin to isolate cells, versus MKTP using dispase to isolate cells.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Will perform cell separation using either diaspase or trypsin
入排标准
- 年龄范围
- 18 Years 至 65 Years（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 generalized vitiligo-vitiligo affecting both sides of the body on one or more areas of the body (extremities, trunk, etc.)
- •Have stable vitiligo, defined as no new lesion development (or expansion of existing lesions) in the 6 months prior to proposed procedure date
- •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 self-reported to be lactating, pregnant, or planning to become pregnant
- •Patients with a history of developing vitiligo or hypertrophic scars 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
- •Patients with acral vitiligo, defined as significant involvement of the fingers and/or toes
- •Patients with focal or segmental vitiligo, defined as vitiligo affecting only one area of the body on only one side of the body
- •Patients with vitiligo affecting greater than 30% of their body surface area
结局指标
主要结局
Pigmentation
时间窗: 6 months
Investigator will assess amount of pigmentation at site of procedure.
次要结局
未报告次要终点
研究者
Iltefat Hamzavi
Senior Staff Physician
Henry Ford Health System