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临床试验/NCT02720146
NCT02720146Unknown不适用

The Effect of Platelet Lysate on Corneal Epithelial Wound healing---the Collection of Human Serum From Volunteers

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2016年5月最近更新:
适应症

试验速览

阶段
不适用
入组人数
10
试验地点
1
主要终点
The purpose of this project is to collect the human serum as a control group,

研究概览

简要总结

"Poor corneal epithelialization problem" can be found in a lot of ocular surface disorders, including limbal insufficiency, dry eye, chemical burn and neurotrophic disorders. Delayed corneal epithelialization under any circumstances can lead to corneal infection, corneal melting, corneal opacity, pain or blurred vision. It is thus important to develop pharmacological methods to promote corneal epithelial wound healing in those patients. Previously, various epitheliotrophic growth factors, autologous serum, cord blood serum, etc. have been proved to be effective in promoting corneal epithelial wound healing. However, those topical agents have the drawbacks including the difficulties during preparation, expensive price, non-standardized quality and the risk of contamination during preparation. It will be clinically important to find other blood derivatives which are effective, convenient for use, stable in quality and being cheap.

During the recent few years, various" platelet related blood derivatives" have been proved to contain a lot of epitheliotrophic growth factors, and can promote wound healing. Among those products, "platelet lysate" has the benefits of being commercially available. It can avoid the complicated producing procedure, and has stable quality. Although platelet lysate has been widely used in various medical fields, especially in culturing mesenchymal stem cells, its potential in promoting corneal epithelial wound healing has not been proven. The purpose of this project is to explore the possibility of using platelet lysate to treat patients with poor corneal epithelialization problem, and compare its epitheliotrophic ability with other blood derivatives. The cultured human corneal epithelial cell line will be used for all experiments, and will be cultured with media containing different blood products: (1) control group without blood derivatives, (2) fetal bovine serum, (3) human serum, (4) platelet lysate commercial product-UltraGro, (5)platelet lysate commercial product---PlatMax. MTS assay will be used to measure proliferation ability. "Scratch-induced directional wounding assay" and "Boyden chamber chemotaxis assa" will be used to measure cell migration. Scanning electron microscopy, transmission electron microscopy, transepithelial electric resistance (TEER) and immunohistochemistry with junctional proteins will be used to measure cellular differentiation. Through these experiments, the investigator aim to understand whether platelet lysate can replace other blood derivatives, and be used for treating patients with corneal epithelialization problem.

Beside, current medications in dry eye are all manufactured, transported and used in the form of liquid form. However, it is more disturbing in transporting, commercializing, storing and the limitation of expiration date for current medications compared with powder form medications. Therefore, improving the convenience of utilizing and storage without at the expense of the efficacy of blood-derivatives has become a critical issue. Our study also aimed at trying to produce platelet-related derivatives (including platelet lysate) and human serum into the form of dry powder and resuspended it with preservative-free artificial tears. The investigator would compare the epitheliotrophic ability of the liquid form of blood derivatives and the powder form of blood derivatives.

Since human serum is needed for comparison , the investigator proposed this IRB to collect human serum from healthy volunteers。

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

The purpose of this project is to collect the human serum as a control group,

时间窗: 1 year

The purpose of this project is to collect the human serum as a control group, and to explore the possibility of using "platelet lysate" to treat patients with poor corneal epithelialization problem, and compare its epitheliotrophic ability with other blood derivatives. Besides, the investigator would also compared the efficacy of dry powder of platelet lysate and other blood derivatives. The cultured human corneal epithelial cell line will be used for all experiments, and will be cultured with media containing different blood products: 1. control group without blood derivatives, 2. fetal bovine serum, 3. human peripheral blood serum 4. platelet lysate commercial product-UltraGro 5. platelet lysate commercial product---PlatMax. 6. the dry powder of human peripheral blood serum resuspended with artificial tear The investigator will evaluate the effects of these blood derivatives.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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