ABCB5 as a Prognostic Marker in Survival of Cultivated Limbal Stem Cell Transplantation Expanded in Vitro on Amniotic Membrane in Patients With Limbal Stem Cell Deficiency.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Objective clinical evaluation
研究概览
简要总结
In this study the prognostic value of ABCB5 in survival of the limbal stem cell transplantation expanded in vitro on amniotic membrane for corneal surface reconstruction in patients with limbal stem cell deficiency will be analyzed.
详细描述
There are several diseases that cause the cornea to lose its clarity and directly affects the vision of the individual, therefore, the use of limbal stem cells has been having increasing acceptance in the field of medical therapy. An open clinical study is running with patients with limbal stem cell deficiency, performing a limbal stem cell transplantation expanded in vitro on amniotic membrane and the value of ABCB5 as a prognostic factor in the survival of transplant will be determined. The corneal surface status will be the primary endpoint.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Bilateral limbal stem cell deficiency of any etiology.
- •Corneal impression cytology positive for goblet cells.
- •Ocular ultrasound results within normal parameters.
- •Agree to participate in the study and sign the informed consent.
排除标准
- •1. Active immunological diseases.
结局指标
主要结局
Objective clinical evaluation
时间窗: 12 months
A grading system from 0 to 4 using photographs taken with slit lamp, will be used to determine by two independent examiners the degree of corneal transparency and superficial vascularization.
次要结局
- Quality of life questionnaire(12 months)
- Corneal cells morphology(12 months)
- Visual acuity(12 months)