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临床试验/NCT00736307
NCT00736307已完成1 期

Transplantation of Ex-Vivo Expanded Human Limbal Epithelial Stem Cells (LSC) on Amniotic Membrane (AM) for Limbal Stem Cell Deficiency (LSCD)

Royan Institute4 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2007年10月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
10
试验地点
4
主要终点
Snellen visual acuity

研究概览

简要总结

The purpose of this study is to evaluate the efficacy, safety, and long term outcomes of ex vivo cultured limbal stem cell on amniotic membrane transplantation for corneal surface reconstruction in cases of partial and sever limbal stem cell deficiency.

详细描述

Ocular surface is composed of corneal and conjunctival epithelial cells. Normal cornea is essential for normal vision. Defects in renewal and repair of ocular surface as a result of limbal stem cell deficiency are now known to cause varying ocular surface morbidity including persistent photophobia, repeated and persistent surface breakdown and overt conjunctivalisation of the cornea. Restoring ocular health in these eyes has traditionally been frustrating. Ex vivo cultured limbal epithelial stem cells have been used successfully to treat limbal stem cell deficiency. Ex-vivo limbal stem cell allograft transplantation is achieved by harvesting limbal corneal tissue from donor eyes (either matched living relatives or cadaveric donors). The donor stem cells are obtained by excising a small area of the conjunctiva at the limbus and are a minor procedure. The tissue so obtained is then grown in tissue culture and once the cells have multiplied sufficiently, small sheets are transplanted on to the affected eye(s), backed with an amniotic membrane. The surgery is undertaken under either local or general anesthesia.

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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient with unilateral limbal stem cell insufficiency and totally corneal vascularization
  • Presence of Goblet cells on the cornea
  • Minimum tear was about 5 mm
  • Minimum duration of deficiency was 3 years
  • Vision was Light Perception

排除标准

  • Systemic disease affecting both eyes such as Stevens-Johnson syndrome

结局指标

主要结局

Snellen visual acuity

时间窗: 6 months

corneal epithelial integrity and stability

时间窗: 6 months

次要结局

  • Impression cytology(12 months)
  • Extent of retarding recurrent neovascularisation(12 months)

研究者

申办方类型
Other Gov

研究点 (4)

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