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临床试验/NCT02149732
NCT02149732Available不适用

An Investigator-initiated Trial (IIT) on the Effect of Autologous Oral Mucosal Epithelial Sheet Transplantation in Corneal Limbal Deficiency Patients

Seoul National University Hospital2 个研究点 分布在 1 个国家开始时间: 2014年5月最近更新:
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

  1. patient with eye which has limbal stem cell deficiency and conjunctivalization of cornea
  2. patient who shows no improvement after limbal tissue or amniotic membrane transplantation, or who has difficulty in receiving long-term immunosuppressive treatment
  3. patient who agree this clinical trial
  4. patient with the eyes in which best corrected visual acuity is less than counting finger
  5. 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

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

申办方类型
Other
责任方
Sponsor

研究点 (2)

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