NCT01470573已完成2 期
Regenerative Medicine in Ocular Surface: Application of Cell Therapy for Ocular Surface Repair Using Progenitor Autologous Cells of Sclerocorneal Limbus Amplified ex Vivo
Fundacion Clinic per a la Recerca Biomédica6 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2011年11月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 6
- 主要终点
- Visual Acuity
研究概览
简要总结
Progenitor limbo sclerocorneal cells have properties of proliferation and differentiation to corneal and conjunctival epithelium. This cells can be isolated and ex vivo expanded using cell culture technics that could permit the biological replacement of damaged ocular surface.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •principal Inclusion Criteria:
- •Serious unilateral limbic insufficiency
- •Normal ophthalmological clinical examination in the opposite eye (biopsied eye)
排除标准
- •serious disorders in palpebral dynamics
- •bilateral limbic insufficiency, immunological, systemic or local illness like toxical epidermic necrosis or pemphigoid
- •breastfeeding or pregnancy
- •positive serology of HIV, VLTH, HVC, HVB, CMV, Trypanosoma Cruzi or Treponema Pallidum
结局指标
主要结局
Visual Acuity
时间窗: 6 months
visual acuity improvement
次要结局
- Improvement in appearance of ocular surface(6 months)
- lack of scar tissue in ocular surface(6 months)
- decrease of preexisting corneal vascularization(6 months)
- Improvement of corneal transparency(6 months)
- absence or decrease of corneal conjunctivalization(6 months)
- adverse events(6 months)
研究者
Sara Varea
Clinical Research Manager
Fundacion Clinic per a la Recerca Biomédica
研究点 (6)
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