摘要
用于移植治疗的细胞主要有肝细胞、胰岛细胞、树突状细胞、细胞因子诱导的杀伤细胞、淋巴因子激活的杀伤细胞、胚胎干细胞、造血干细胞、间充质干细胞等,每种细胞都有不同的生物学特性。在临床应用前,要严格按照国家食品药品监督管理局的有关规定,研究特定细胞制剂的生物学特性、药理学、毒理学等,进行动物和临床试验,确定适应症、禁忌症,评估有效性和安全性。正式获得国家食品药品监督管理局许可后,再进行相关临床研究和应用。
The cells used for cell transplantation therapy mainly consist of hepatoeyte, islet cells, dendritic cells, cytokine-induced killer cells, lymphokine activated killer cells, embryonic stem cells, hemopoietic stem cells, and mesenehymal stem cells, etc. Every cell kind has different biological characteristics. Before clinic application, according to the related documents of State Food and Drug Administration, the specific cell agent is studied on its biological characteristics, pharmacology, and toxicology, etc. Animal experiments and clinical tests are carried on to assure its indications and contraindieations for assessment of safety and efficacity. After a license has been obtained from State Food and Drug Administration, the related clinical researches and applications can be carried on.
出处
《中国生物工程杂志》
CAS
CSCD
北大核心
2013年第9期119-125,共7页
China Biotechnology
关键词
细胞移植治疗
体细胞
干细胞
Cell transplantation therapy Somatic cell Stem cell
