Transplantation of Autologous Oral Mucosal Epithelial Stem Cell Sheet for Treating Limbal Stem Cell Deficiency Disease
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 7
- 主要终点
- The area of reepithelialization of corneal epithelium
研究概览
简要总结
The aim of this trials investigates the therapeutic effects of application autologous oral mucosal epithelial cell sheets in the treatment of limbal stem cell deficiency disease.
详细描述
A number of external factors can result in limbal stem cell deficiency(LSCD), causing pain, pathological corneal epithelium regeneration, inflammation reaction and seriously visual loss. For patients with unilaterally damaged eye, transplantation of limbal tissue from the healthy eye can be used in the past years in the risk of inducing limbal stem cell damaged in the healthy eye. While graft of human leukocyte antigen matched allogenic limbal stem cells require immune suppressive medications, it can cause side effects in the body. Over the past 10 years, the clinical trials of application of cultured autologous oral mucosal epithelial cell sheet to treat LSCD have been emerged as a promising strategy in many countries. However, little study has been reported in China. This study investigates the therapeutic effects of application autologous oral mucosal epithelial cell sheets in the treatment of limbal stem cell deficiency disease in China.
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
- •Male or female aged>=18 years old
- •Normal intraocular pressure
- •Normal Eyelid
- •No cataract and retinal disease
- •No ulcers and tumor in the mouth
排除标准
- •Severe Systemic infection
- •History of acute phase of ocular and oral inflammation
- •History of hyper sensibility or allergy to antibiotics or serum
- •Women who are or may be pregnant
- •Patients with infectious diseases
- •Patients with other complications
结局指标
主要结局
The area of reepithelialization of corneal epithelium
时间窗: 3 months
The preoperative status of the eye will be recorded on the basis of clinical drawings and pre-and post-operative photographs. These pictures will be sent to two corneal experts in order to evaluate the results. Judgement criterion: the results will be tested with a slit lamp: Normal: no epithelial loss; Mild: the area of epithelial loss \<1/3; Moderate: the area of epithelial loss \>1/3 \<2/3; Severe: the area of epithelial loss\> 2/3
次要结局
- Improvement of best correct visual acuity(one year)
- Decrease of corneal neovascularization(one year)