NCT02149732Available不适用
An Investigator-initiated Trial (IIT) on the Effect of Autologous Oral Mucosal Epithelial Sheet Transplantation in Corneal Limbal Deficiency Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- Available
- 试验地点
- 2
研究概览
简要总结
To investigate the effect of ocular surface reconstruction and assess the safety in cultivated oral mucosal epithelial cell sheet transplantation (COMET) regarding patients with cicatricial change of ocular surface.
详细描述
Interventional study for treatment of patients with cicatricial change of ocular surface.
Single Group: (Limbal stem cell deficiency group)
Treatment: After cultivating autologous Oral mucosal epithelial cell sheet, the sheet will be transplanted to the ocular surface of the patients
Inclusion criteria
- patient with eye which has limbal stem cell deficiency and conjunctivalization of cornea
- patient who shows no improvement after limbal tissue or amniotic membrane transplantation, or who has difficulty in receiving long-term immunosuppressive treatment
- patient who agree this clinical trial
- patient with the eyes in which best corrected visual acuity is less than counting finger
- patient who is older than sixteen year old
研究设计
- 研究类型
- Expanded Access
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
- •patient with eye which has limbal stem cell deficiency and conjunctivalization of cornea
- •patient who shows no improvement after limbal tissue or amniotic membrane transplantation, or who has difficulty in receiving long-term immunosuppressive treatment
- •patient who agree this clinical trial
- •patient with the eyes in which best corrected visual acuity is less than counting finger
- •patient who is older than sixteen year old
排除标准
- •patient who has relevant corneal transparency
- •patient who is on the pregnancy or has a plan of pregnancy within 1 year
- •patient who has corneal infection
- •patient who has diagnosis of HBV, HCV, HIV, syphilis
- •patinet who has past medial history of antinal, myocardial infarction, heart failure, arrhythmia, brain stroke, cerebrovascular disease
- •patient who has malignancy
- •patient who shows hypersensitivity to bovine protein.
研究者
研究点 (2)
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