Abstract:Stem cells have brought hopes for solving major medical difficulties， and a number of clinical studies on stem cell therapy have been conducted and some of them showed， to some extent， efficacy. As a type of stem cell therapeutic products， stem cell-based medicinal products shall be strictly manipulated and managed during preparation and application. Since we are still at the starting stage of clinical translation of stem cells， relevant policies and regulations in our country need further detailing. Utilizing stem cell bank to standardize the preparation and application of stem cell-based medicinal products has become international mainstream trends. Supported by the Strategic Priority Research Program of Chinese Academy of Sciences， Beijing stem cell bank has established the first clinical grade stem cell bank and clinical grade stem cell lines， obtained a series of Quality Inspection Reports issued by the National Institutes for Food and Drug Control， and carried out several clinical studies with stem cells. Moreover， Beijing stem cell bank participated in the formulation of a number of policies and regulations related to stem cells. In this paper， based on the research progress of Beijing stem cell bank， we will review the management of clinical-grade stem cell-based medicinal products and the construction of clinical-grade stem cell bank， hoping to make some contributions to the healthy development of stem cell research in our country.