Treatment of Patients With Inflammatory-dystrophic Diseases of the Cornea Using Autologous Limbal Stem Cells (Corneal Epithelial Stem Cells) or Adipose-derived Mesenchymal Stem Cells
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Number of cured patients
研究概览
简要总结
Treatment of patients with inflammatory-dystrophic diseases of the cornea using autologous limbal stem cells (corneal epithelial stem cells) or adipose-derived mesenchymal stem cells
详细描述
In order to treat inflammatory and dystrophic diseases of the cornea perilimbal injections of cultured autologous stem cells are performed. Corneal (limbal) epithelial stem cells (LSC) or mesenchymal stem cells derived from adipose tissue (ADSC) are mixed with sodium hyaluronate 1%
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •inflammatory-dystrophic diseases of the cornea:
- •Epithelial defects of the cornea, ulcerative keratitis of various etiology, resistant to standard methods of treatment
- •Dystrophic diseases of the cornea, accompanied by edema
- •Burns of the cornea
- •Neurotrophic forms of keratitis
- •Persistent post-traumatic, postoperative, contusion keratitis and keratopathy
排除标准
- •Viral hepatitis B and C, HIV, tubeculosis and other chronic viral and bacterial infections.
- •Cancer or leukemia
- •Any diseases in the stage of decompensation.
- •Mental disorders.
- •Anomalies of eye refraction
研究组 & 干预措施
mesenchymal stem cells
Patients with inflammatory-dystrophic diseases of the cornea receiving standard treatment plus adipose-derived mesenchymal stem cells
干预措施: mesenchymal stem cells (Biological)
结局指标
主要结局
Number of cured patients
时间窗: 2 month
Number of patients cured
Number of patients with treatment-related adverse events
时间窗: 4 weeks
MSC/LSC application related adverse events assessed by blood count, liver and function tests
次要结局
未报告次要终点