The Effect of in Vivo Cultured Limbal Stem Cells in the Treatment of Unilateral Corneal Stem Cell Damage
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 主要终点
- Limbal defect size
研究概览
简要总结
Corneal epithelial cells and limbal stem cells (LSC) are located in the limbus basal epithelium that are necessary for repair of corneal. About patients with deficient or absence of this area has been proposed various treatments such as limbal stem cell transplantation.
This study is a prospective clinical trial to compare the improvement of limbal stem cell deficiency (LSCD) in vivo by using of Amniotic Membrane Extract Eye Drop (AMEED).
详细描述
The cornea is the eye anterior portion which its refractive power and transparent is essential for normal vision.
The damaged cornea surface can reduce vision and leads to blindness, ultimately. Corneal epithelial and some times, limbal stem cell (LSC) are involved in corneal injuries. Limbal stem cells (LSC) are necessary for repair and reconstruction of corneal that reduction of these cells occurs by various causes including congenital causes, eye inflammatory diseases and burns. For cornea stem cell damages or limbal stem cell deficiency (LSCD), cornea becomes conjunctivalization. LSCD may involve one eye (unilateral) or two eyes (bilateral).
Due to autologous transplantation problems in patients with unilateral LSCD and recent successes to resolve this problem, it seems that transplantation of cultured corneal stem cells on amniotic membrane is other way in treatment of unilateral LSCD. It is called ex vivo.
Amniotic membrane can modulate corneal epithelium healing by promoting re-epithelialization and migration of limbal stem cell while suppressing stromal inflammation, angiogenesis and scarring. It is well accepted that amniotic membrane transplantation (AMT) as a temporary patch normally dissolves within 2 weeks. Consequent reapplication of membrane is difficult for the patient. On the other hand, in ex vivo, corneal tissue from healthy eye must be transported to laboratory for cell culture on AM that is required equipment. There is, also, a risk of cell infection and transmission that is very important issue. However, in infected cells, re-biopsy of the healthy eye is required that is uncomfortable and difficult for the patient. Other studies have been reported that amniotic membrane extract (AME) has same characteristics and features.
We previously have reported an effective potential of AMEED in limbal stem cell proliferation in vitro and also rabbit corneal epithelium healing in vivo.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with unilateral chemical burn (grade III to up); estimation of chemical burns amount and classification was according to Dua.
- •Without Age limitation
排除标准
- •Lack of timely referral of patients for examinations
- •Simultaneous use of other drugs that cause impairment of the data
结局指标
主要结局
Limbal defect size
时间窗: 12 months
The measurement of limbal defect size by microscope 12 months after corneal surgery
Corneal epithelial integrity
时间窗: 12 months
The measurement of Corneal epithelial integrity by microscope 12 months after corneal surgery
Corneal epithelial stability
时间窗: 12 months
The measurement of Corneal epithelial stability by microscope 12 months after corneal surgery
次要结局
- Best spectacle corrected visual activity(12 months)
- Transparency(12 months)
- Vascularization(12 months)