Autologous Oral Mucosa With Amniotic Membrane Transplantation for Limbal Stem Cell Deficiency: Clinical and Immunohistochemical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 主要终点
- change in number of acute surgeries
研究概览
简要总结
PURPOSE: To report clinical and histochemical results of oral mucosa graft transplantation in eyes with limbal stem cell deficiency.
DESIGN: Prospective observational study.
METHODS: 32 eyes of 27 patients with limbal stem cell deficiency underwent direct oral mucosa graft transplantation with amniotic membrane transplantation with a mean follow-up of 19 months. Clinical course of the disease including emergency surgeries, planned curative procedures, conjunctival inflammation, acute inpatient treatment and best corrected visual acuity were assessed at 3 months postoperatively and at last follow up visit. The unneeded parts of oral mucosa graft were analyzed immunohistochemically with staining for mesenchymal stem cell markers and pericytes (CD 90, CD 146, CD 166, CD 31, CD 68, protein gene product).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •limbal stem cell deficiency at least in one eye
- •undergoing oral mucosa with amniotic membrane transplantation
- •obtained written informed consent
排除标准
- •no written informed consent
结局指标
主要结局
change in number of acute surgeries
时间窗: baseline, 3 months after oral mucosa transplantation; through study completion, an average of 19 months
change in days of acute inpatient treatment
时间窗: baseline, 3 months after oral mucosa transplantation; through study completion, an average of 19 months
次要结局
- change in number of curative surgical procedures after oral mucosa transplantation(baseline, 3 months after oral mucosa transplantation; through study completion, an average of 19 months)
- change in conjunctival inflammation(baseline, 3 months after oral mucosa transplantation; through study completion, an average of 19 months)
研究者
Katrin Engelmann
Head of Ophthalmology
Klinikum Chemnitz gGmbH