NCT00845117已完成不适用
Cultivated Stem Cell Transplantation for the Treatment of Limbal Stem Cell Deficiency
Veerle Van Gerwen2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2008年7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
- 21
- 试验地点
- 2
- 主要终点
- Visual Acuity
研究概览
简要总结
The purpose of this study is to determine whether cultivated stem cell transplantation is effective for the treatment of patients wtih corneal stem cell deficiency.
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
- •Patients suffering from LSCD IIa and IIb. Those suffering from IIc may be included once inflammation has subsided and cornea can be staged as IIb.
- •Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
- •Women of child-bearing potential should use adequate contraception prior to study entry and for the duration of study participation
排除标准
- •Subjects who are pregnant or lactating
- •Subjects who have sensitivity to drugs that provide local anesthesia
- •Subjects suffering from active infection of the external eye
- •Medical conditions that prohibit the use of systemic immunosuppression (in cases of allogenic transplantation)
研究组 & 干预措施
Limbal Stem Cell Transplant
Experimental
The cornea is debrided of all superficial fibrovascular tissue and the cultivated stem cell graft is glued onto the cornea.
干预措施: Cultivated limbal stem cell graft transplantation (Procedure)
结局指标
主要结局
Visual Acuity
时间窗: Just before surgery and upto 1 years after surgery
Vascularization
时间窗: Just before surgery and upto 1 years after surgery
Epithelialization
时间窗: Just before surgery and upto 1 years after surgery
Conjunctivalization
时间窗: Just before surgery and upto 1 years after surgery
次要结局
- Prolonged subsequent corneal graft survival time(1 year post corneal transplant)
研究者
Veerle Van Gerwen
Prof. Dr. Marie-Jose Tassignon
University Hospital, Antwerp
研究点 (2)
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