Efficacy of Cultivated Corneal Epithelial Stem Cell for Ocular Surface Reconstruction
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Ocular surface status (signs of limbal deficiency and immunopathological markers)
研究概览
简要总结
The purpose of this study is to elucidate the appropriate condition of developing cultivated corneal epithelial graft and evaluate the surgical outcome of transplantation of the cultivated corneal epithelial stem cell in the patients.
详细描述
Ocular surface damage caused by severe ocular surface diseases, particularly thermal and chemical burn or Stevens-Johnson syndrome result in corneal epithelial defect, corneal vascularization, corneal conjunctivalization and loss of transparency. Corneal limbal stem cell transplantation has been demonstrated to improve the outcome of ocular surface reconstruction. However, the conventional management of allograft limbal transplantation generally has unsatisfactory outcome because of high risk of rejection and requires long-life immunosuppressive medications.
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
- •Unilateral/Bilateral limbal stem cell deficiency proved by specific clinical features and impression cytology result
排除标准
- •Age under 18
- •Active ocular infection, Severe dry eye, Uncontrolled glaucoma
- •Immunocompromised host
- •Pregnancy
结局指标
主要结局
Ocular surface status (signs of limbal deficiency and immunopathological markers)
时间窗: Three years
次要结局
未报告次要终点
研究者
Pinnita Prabhasawat
Associate Professor
Mahidol University