Autologous ex Vivo Conjunctival Epithelial Cell Expansion for Ocular Surface
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Complications
研究概览
简要总结
To evaluate the use of cultivated conjunctival epithelial equivalents for the treatment of ocular diseases
详细描述
Ex-vivo autologous conjunctiva expansion on human amniotic membrane (HAM), followed by clinical transplantation surgery
Preparation of HAM. Human amniotic membrane (HAM) prepared for human use will be obtained from the Singapore Eye Bank. HAM will be rapidly thawed in a 37oC water bath, and washed with phosphate buffered saline. The amniotic epithelium will be removed using a combination of Dispase digestion and mechanical scraping. Complete removal of the amniotic epithelial cells will be confirmed by microscopy. The HAM is then placed on a culture plate, with the basement-membrane side up, and incubated with DMEM at 37oC in an atmosphere of 5% CO2 and 95% air overnight before use.
Ex-vivo expansion of conjunctival cells on HAM. A forniceal conjunctival biopsy will be performed in patients undergoing pterygium surgery. The tissue will be cultured on the HAM either as a cell suspension or as explants, with the methods described above. The media is changed every 2 days and the culture is maintained for 2-3 weeks. The cells will form a confluent sheet and begin to stratify and differentiate. The tissue will then be raised to an air-liquid interface to promote differentiation.
Histological analysis. The conjunctival epithelial cell sheets on the amniotic membrane will be examined by light microscopy. Samples of the tissue will be fixed and processed with the use of standard histological procedures and stained with H&E and PAS reagents. Electron microscopic examination will be carried for the tissue. The sections will also be subjected to immunohistochemical analysis for cytokeratin markers.
Clinical Transplantation of cultivated conjunctival epithelial cells on HAM
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with ocular surface disorders, e.g. primary pterygium, scheduled for elective surgical excision
- •Indications for surgery will be the presence of ocular surface symptoms in the affected eye, loss of visual acuity from visual axis obscuration or irregular astigmatism, or cosmesis.
- •Only one eye of a patient will be eligible for study entry.
- •Patients who are adult males and females who are aged 21 or older, and are considered mentally sound
- •Patients who are willing to undergo long-term follow-up, as outlined in this protocol
- •Patients who have signed an informed consent form that has been approved by the SNEC Ethics Committee.
排除标准
- •Patients less than 21 years of age
- •Patients who are incapable, either by law or of mental state, of giving consent in their own right
- •Patients who are either unable or unwilling to keep scheduled appointments and adhere to the other aspects of the protocol
- •Patients who are pregnant or breastfeeding
- •Patients with a history of drug allergy
- •Patients who have received an investigational drug within 28 days preceding surgery
- •Patients with intraocular pressure over 21 mmHg or history of ocular hypertension or glaucoma
- •Patients who are documented to be steroid responders
结局指标
主要结局
Complications
Epithelialisation
Graft integrity
Resolution of inflammation
Visual acuity
次要结局
- Degree of scarring