本文研究目的为汇总我国医疗器械组织工程类产品研究和发展情况。研究方法为概括、总结我国医疗器械组织工程类产品的组成、产品种类、发展现状及相关管理方式、产品注册相关指导文件。研究结果为组织工程医疗产品主要由种子细胞、支架材料和有利于细胞的微环境组成。国内已有皮肤、心血管、骨和软骨以及神经组织等产品上市或在审。其中,皮肤产品的研究最早、研究成果和转化成果最多。为适应国内实际情况,国内监管部门也在积极制定医疗器械组织工程产品注册申报及监管协调机制,并面向社会征求相关意见。研究结论为医疗器械组织工程产品打破了传统治疗方法具有的供体少或供皮区不足、免疫排斥、成活率低等局限性,在治疗组织、器官缺损或功能性丧失方面具有潜在优势,为临床治疗提供了新的方向;相信随着技术的发展进步、国内监管部门以及社会各方面的努力,组织工程医疗产品将进一步造福人类社会。
<<Objective:Summarize the research and development of tissue engineering products for medical devices in China. Methods:Summarize the composition,types,research progress,related management methods and guidance documents for products registration of tissue engineering products for medical devices in China. Results:These tissue engineering products for medical devices mainly consist of seed cells,scaffold materials and cell-friendly microenvironment. Some of tissue engineering products such as skin,cardiovascular,bone and cartilage,and nerve tissue,are already available on the market or under review. Tissue engineering skin is one of the earliest products to be studied,with the most research results and products. In order to adapt to the actual situation in China,the domestic regulatory authorities have been also actively carrying out a mechanism for the registration of medical devices and for the coordination mechanism of supervision,and seeking relevant opinions from the public. Conclusion:The tissue engineering products for medical devices can break the limitation of the traditional therapy,such as shortage of donors and skin supply,immune rejection and low survival rate,and have potential advantages in the treatment of tissue and organ with the functional loss,and seeking relevant opinions from the public. With the development of technology,the efforts of domestic regulatory authorities and society,the tissue engineering products for medical devices will benefit human society further.
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