Preclinical evaluation of the safety and effectiveness of a new bioartificial cornea  

作　　者：Yansha Hao Jingting Zhou Ju Tan Feng Xiang Zhongliang Qin Jun Yao Gang Li Mingcan Yang Lingqin Zeng Wen Zeng Chuhong Zhu 

机构地区：[1]Department of Anatomy,Engineering Research Center for Organ Intelligent Biological Manufacturing of Chongqing,key Lab for Biomechanics and Tissue Engineering of Chongqing,Third Military Medical University,Chongqing,400038,China [2]Engineering Research Center of Tissue and Organ Regeneration and Manufacturing,Ministry of Education,Chongqing,400038,China [3]State Key Laboratory of Traum1,Burnand Combined Injury,Chongqing,China [4]Department of Cell Biology,Third Military Army Medical University,Chongqing,400038,China [5]Hong Chang Biotechnology Co.,Ltd,Guangzhou,510700,China [6]Zhong Zhi Yi Gu Research Institute,Chongqing Jiukang Medical Research Institute Co.,Ltd.,.China

出　　处：《Bioactive Materials》2023年第11期265-278,共14页生物活性材料（英文）

基　　金：National Science Fund for Distinguished Young Scholars(No.31625011);the National Key Research and Development Program(No.2016YFC1101100).

摘　　要：Cross-linking agents are frequently used to restore corneal properties after decellularization,and it is especially important to select an appropriate method to avoid excessive cross-linking.In addition,how to promote wound healing and how to improve scar formation require further investigation.To ensure the safety and efficacy of animal-derived products,we designed bioartificial corneas(BACs)according to the criteria for Class III medical devices.Our BACs do not require cross-linking agents and increase mechanical strength via self-cross-linking of aldehyde-modified hyaluronic acid(AHA)and carboxymethyl chitosan(CMC)on the surface of decellularized porcine corneas(DPCs).The results showed that the BACs had good biocompatibility and transparency,and the modification enhanced their antibacterial and anti-inflammatory properties in vitro.Preclinical animal studies showed that the BACs can rapidly regenerate the epithelium and restore vision within a month.After 3 months,the BACs were gradually filled with epithelial,stromal,and neuronal cells,and after 6 months,their transparency and histology were almost normal.In addition,side effects such as corneal neovascularization,conjunctival hyperemia,and ciliary body hyperemia rarely occur in vivo.Therefore,these BACs show promise for clinical application for the treatment of infectious corneal ulcers and as a temporary covering for corneal perforations to achieve the more time.

关 键 词：DECELLULARIZATION Bioartificial cornea Cross-linking BIOCOMPATIBILITY TRANSPARENCY 

分 类 号：R318[医药卫生—生物医学工程] TB3[医药卫生—基础医学]