本课题选用温州医科大学构建的组织工程化视神经产品,为保证产品临床安全和有效,针对该产品的技术和工艺控制关键点,选用先进的分析手段,建立组织工程化视神经修复产品安全性评价系统平台。本课题主要从其理化性能测试、生物学评价入手,建立完善视神经支架材料体内、体外降解评价方法,并建立组织工程化视神经再生微管降解产物的分析方法并验证。对降解产物的毒性进行风险评估。
This topic selects the tissue-engineered optic nerve product constructed by Wenzhou Medical College. In order to ensure the clinical safety and effectiveness of the product, according to the key points of technology and process control of the product, advanced analysis methods are selected to establish the safety evaluation system platform of tissue-engineered optic nerve repair products. This subject mainly starts with its physical and chemical performance test and biological evaluation, establishes and improves the evaluation method of degradation of optic nerve scaffold materials in vivo and in vitro, and establishes and verifies the analysis method of degradation products of tissue-engineered optic nerve regeneration microtubules. Risk assessment of the toxicity of degradation products.