Ocular Surface Reconstruction With Cultivated Autologus Mucosal Epithelial Transplantation.
试验速览
- 阶段
- 2 期
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Ocular surface clinical and pathological status(signs of limbal deficiency and immunopathological markers)after the surgery
研究概览
简要总结
The purpose of this study is to elucidate the appropriate condition of developing cultivated autologous oral mucosal epithelial graft and evaluate the surgical outcome of transplantation of the cultivated cells in the patients.
详细描述
Ocular surface damage caused by severe ocular surface diseases. 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. Ocular surface reconstruction with cultivated autologous mucosal epithelial transplantation is served to improve the surgical results of ocular surface reconstruction and decrease the use of 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
- •Bilateral limbal stem cell deficiency proved by specific clinical features and impression cytology
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 clinical and pathological status(signs of limbal deficiency and immunopathological markers)after the surgery
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