中文摘要：

近年来以非造血干细胞为主的干细胞基础理论及临床应用研究发展迅猛,并为解决许多疑难性临床问题带来了新希望。与干细胞研究相适应的干细胞产业,在传统再生医学基础上,也迅速发展成为深入影响包括传统再生医学在内的新的健康医药产业。而与干细胞研究及干细胞产业相关的监管科学,也在国家监管机构及干细胞研发机构共同努力下不断发展。本文概述了目前国际上干细胞研究、产业发展及监管科学现状,包括近年来我国在推动干细胞监管方面所做的努力,以期通过有效的干细胞监管科学的发展促进干细胞研究及其产业规范有序地向前发展。

英文摘要：

Over the past few years, both basic research and clinical studies for non-hematopoietic stem cells have been growing dramatically and brought new promises for solving a number of difficult clinical problems. The fast growth of stem cell studies has been accompanied by the quick development of stem cell industry, which is a new branch of the regenerative medicine and actually is increasingly influencing both current and traditional medical specialties, including the traditional regenerative medicine itself. Meanwhile, the regulatory sciences for supporting stem cell studies and industries are forming with the ioint efforts of national regulatory authorities and research institutions of the field. This article briefly summarizes recent achievements in stem cell clinical studies and stem cell industry, as well as the associated regulations, including the efforts made by Chinese stem cell regulatory society. It is expected that, with the effective regulations in place in the future, both stem cell product and the associated industry will move forward in a much healthierway.