摘要
近年来国内外以干细胞为主的细胞治疗研究发展迅速,在治疗退行性疾病、缺血性心脑血管疾病、肝硬化及糖尿病等领域已开展了多项临床试验研究,但作为新型治疗性产品,干细胞产品在治疗的安全性和有效性方面还存在若干风险因素。本文对常见的干细胞种类、特性以及与临床应用相关的内在和外在风险因素进行了综述,旨在以现有的理论和技术条件,探讨治疗性干细胞产品基本的质量控制要求和策略。
A fast growth has recently been achieved in development of stemcell-based medicinal products（SCMPs）,which are undergoing tests in a variety of clinical trials for treating different diseases,such as degenerative diseases,ischemic cardiovascular diseases,liver cirrhosis and diabetes.However,as an emerging promising biotherapeutical product,the SCMP-related risks do exist and can cause failure or even severe adverse responses in the SCMP-based therapies.To help develop a general guideline to ensure the quality of SCMPs for both safety and efficacy in treatments,we summarize some recent achievements in understanding both the intrinsic and extrinsic risk factors in association with types,characteristics and intended use of different SCMPs in this paper.
出处
《中国生物制品学杂志》
CAS
CSCD
2013年第5期736-739,共4页
Chinese Journal of Biologicals
关键词
干细胞
治疗
风险
质量控制
Stem cells
Therapy
Risk
Quality control
