Transplantation of Tissue Cultured Human Amniotic Epithelial Cells Onto Damaged Ocular Surfaces
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 4
- 主要终点
- Ocular surface healing
研究概览
简要总结
To investigate the effect of using tissue cultured human amniotic epithelial cells to re-establish severely damaged ocular surfaces. Specifically, to determine the efficacy of transplanted tissue cultured amniotic epithelial cells on persistent corneal epithelial defect, a potential visual threaten ocular disorder.
详细描述
Ocular surface diseases and injury caused by chemicals, result in chronic ulceration, and may never be able to be healed normally, and may lead to permanent vision loss. Standard medical treatments often fail. Histologically and somehow functionally, human amniotic cells are similar to ocular surface cells, and these cells have been shown to be safe to be transplanted to another subject and will not be rejected by the recipient. In animal studies, amniotic cells demonstrated that they can re-establish the integrity of ocular surface in more than 30% of recipients without apparent toxic side effects. This study will investigate this novel strategy for its effect on human ocular surface disorder. It will provide a potential alternative therapy for this difficult and devastating disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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 88 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients with corneal epithelial defects and ulcers that have persisted for 4 weeks or longer, regardless of their cause. These patients will have received traditional medical therapy, including correcting the underlying causes, suppressing inflammation, and augmenting the tissue healing processes, but the epithelial defects have persisted.
排除标准
- •Patients who are pregnant or under age 18 will be excluded.
- •Placentas will not be used if the following problems are present:
- •If the mother has an infection at the time of her baby's birth;
- •If the mother has a high risk of developing infection due to intravenous drug use or other factors;
- •If the mother has diabetes, arthritis, or raised blood pressure;
- •If the baby is unhealthy;
- •If there is evidence of infection of the womb (uterus) and afterbirth (placenta) at the time of delivery.
结局指标
主要结局
Ocular surface healing
时间窗: 30 days following initiation of treatment
次要结局
未报告次要终点
研究者
James McCulley
Chairman - Department of Ophthalmology
University of Texas Southwestern Medical Center