中国组织工程与再生医学的最新研究进展

Recent development of tissue engineering and regenerative medicine in China

本文介绍了我国组织工程和再生医学方面的研究、标准制定以及管理方面的最新进展。我国的组织工程在国家的大力支持下在基础研究方面取得了很大的成绩,研究的重点主要是组织工程皮肤、软骨、骨、肌腱、角膜、血管、微囊化细胞等。目前西安第四军医大学组织工程研究中心研究的组织工程皮肤最为显著,已经获得国家食品药品监督管理局医疗器械产品注册证,其他的组织工程医疗产品尚处于研发和临床前研究阶段。组织工程质量标准研究主要从种子细胞、材料支架和组织工程产品三个方面进行控制。在组织工程质量标准制定方面完成了8个组织工程医疗产品的相关标准,其他多个标准正在起草研究中,标准的研究为组织工程的产业化发展起到了很好的作用,也为组织工程的管理提供了技术支持。

This paper described the recent development of tissue engineering and regenerative medicine related with scientific research,drafting standards and regulation in China.Significant advances have been made in the past decade in tissue engineering and regenerative medicine under the support by the national finance in China.The tissue engineering research mainly involve in the tissue engineered skin,cartilage,bone,cornea,blood vessel and encapsulated cells etc.The tissue engineered skin developed by Shaanxi Aierfu Activitissue Engineering Co.,Ltd has been approved by the State Food and Drug Administration（SFDA） for marketing.Other tissue engineered products are in the stage of laboratory research and preclinical test.The investigations for the quality control of the tissue engineering products mainly focus on the seeding cells,material scaffold and final products.We have finished 8 standards related with tissue engineering products.The drafting standards provided the technical support for the regulation of tissue engineering medical products