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临床试验/NCT02864823
NCT02864823已完成不适用

Autologous Perichondrium Transplantation for Replacement of Stem Cells and Their Niche in the Treatment of Necrotizing Scleritis

Chung-Ang University Hosptial, Chung-Ang University College of Medicine1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2011年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
1
主要终点
Success Rate of Repair of Scleral Defects

研究概览

简要总结

Necrotizing scleritis with severe ischemia is refractory to conventional treatment because of avascular necrosis.

The investigators assessed the therapeutic efficacy and safety of autologous perichondrium transplantation in patients with severe ischemic necrotizing scleritis, and analyzed the therapeutic effects.

详细描述

Ischemic necrotizing scleritis patients who showed persistent and progressive scleral melting were included in this study.

Perichondrium tissue was harvested from the patient's ear cartilage and transplanted to reconstruct the scleral defect after the necrotic tissue removal.

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

性别
All
接受健康志愿者
否

入选标准

  • •impending perforation or perforation state of sclera;
  • •graft melting following previous surgery;
  • •bacterial or fungal infection of sclera or graft after previous surgery;
  • •discomfort due to protrusion of scleral calcification with ischemic necrosis
  • •broad avascular area larger than 10 mm in diameter

排除标准

  • •asymptomatic patients
  • •smaller scleral defect less than 10 mm in diameter
  • •shallow scleral defect

研究组 & 干预措施

Perichondrium

Experimental

Perichondrium Autografts

干预措施: Perichondrium Autografts (Procedure)

结局指标

主要结局

Success Rate of Repair of Scleral Defects

时间窗: Six months after reconstructive surgery

Success Rate of Repair of Scleral Defects

次要结局

  • Post-Operative Complications(Six months after reconstructive surgery)

研究者

发起方
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jae Chan Kim

Professor

Chung-Ang University Hosptial, Chung-Ang University College of Medicine

研究点 (1)

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