EUCTR2010-024409-11-GB进行中（未招募）1 期
Pilot Clinical Assessment of Ex Vivo Expanded Corneal Limbal Stem Cell Transplantation in Patients with Severe Ocular Surface Disease (OSD) Arising from Limbal Stem Cell Deficiency
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Adult patients, of either sex, with bilateral corneal blindness due to limbal stem cell deficiency
- •- Visual acuity less than 3/60 in the better eye
- •- Severe, debilitating corneal disease with extremely low chance of successful outcome with limbal and corneal graft surgery
- •- Functioning retina indicated by light perception and ultra-sonographic examination to exclude retinal detachment
- •- Normal intra-ocular pressure
- •- Schirmer’s test at least 50% normal values
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Inability to give informed, comprehending consent
- •- Unfitness for local or general anaesthesia
- •- Inability to self-administer medication
- •- Inability to tolerate immunosuppressive therapy
- •- Severe dry eyes
- •- Patients with corneal anaesthesia
- •- Patients with severe lid deformities
- •- Patients with uncontrolled glaucoma or drainage procedures
研究者
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