跳至主要内容
临床试验/NCT01244776
NCT01244776Unknown不适用

Transplantation of Acellular Corneal Matrix to Treat Corneal Ulcer

Shaanxi Aierfu Activtissue Engineering1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2010年4月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
1
主要终点
Rejection evaluation

研究概览

简要总结

This study is to develop a lamellar keratoplasty method for corneal ulcer using acellular corneal matrix (ACM) and to make an analysis among patients for its therapeutic effect.

详细描述

Infections, chemical injury, and other diseases result in acute or chronic corneal ulcer, which may damage corneal stroma and may lead to permanent corneal scars and blindness. Corneal transplantation is standard method for corneal ulcer, but severe shortage of donor corneas limits its application. Acellular porcine corneal matrix is similar to the native cornea, especially with the biological property and microstructure. Recently, this matrix has been proved to be safe when transplanted to animal subjects and will not be rejected by the recipient. In animal lamellar keratoplasty experiments, acellular corneal matrix showed that they can integrate into the corneal wound bed and help reconstruction of the lamellar integrity of corneal stroma. This study will investigate its healing effect on human corneal ulcer. It will provide a potential corneal substitute for this disease.

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

  • Patients aged between 18 and 75 yrs.
  • Corneal ulcer.
  • Informed consent.

排除标准

  • Corneal perforation.
  • Other ocular diseases.
  • The presence of systemic connective tissue diseases
  • Severe allergic constitution
  • Pregnancy
  • The presence of chronic disease, such as significant cardiovascular illness
  • The patients who received clinical experiments for other medicine or medical devices within 3 months prior to the transplantation.
  • Any patient that is not suitable for recruitment, in the judgment of the investigator.

结局指标

主要结局

Rejection evaluation

时间窗: 30 days following transplantation

次要结局

  • Corneal wound healing(90 days following transplantation)

研究者

发起方
Shaanxi Aierfu Activtissue Engineering
申办方类型
Industry

研究点 (1)

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