ABSTRACT
Objective:According to the regulatory requirement in China, double filing system including institutional filing and project filing is mandated for conducting stem cell clinical research at medical institutions. Thus, the organization and implementation of stem cell clinical research is different from traditional drug clinical trials. Based on the analysis of the main roles and responsibilities of stem cell clinical research, this article explores countermeasures to promote the legal and regulatory development of stem cell clinical research.Methods:This study sorts out and analyzes the changes in the main roles and responsibilities of stem cell clinical research in the context of double filing system, and conducts analysis on the main-role construction of stem cell clinical research.Results:Combining the institutional practical experience of conducting and managing stem cell clinical research, three key issues are proposed to promote stem cell clinical research, which including the construction of quality inspection platform, optimizing institutional setting and talent training.Conclusions:It is recommended to strengthen the construction of the main roles and responsibilities of stem cell clinical research, which has important practical significance for promoting stem cell clinical research and accelerating the clinical translation and application of stem cells.
ABSTRACT
Objective This study aims to analyze and investigate the major factors that affecting stem cell clinical research,explore corresponding countermeasures,to further promote the clinical research and translational application of stem cells.Methods Comprehensive investigation were conducted to analyze and summarize the the most recent basic research of stem cells,standardization of stem cell preparation sources,human personnel,clinical research and supporting systems.Results The slow progress of stem cell clinical research could attribute to several factors,including sluggish frontier basic research of stem cells;lack of high-quality,clear-source,and controllable samples for stem cell research institutes,lack of standard operation codes,professional consensus,guidelines in multi-center clinical research and stem cell research,and unsound supporting system of stem cell clinical research.Conclusions Based on the analysis and summaries,combined with the practice and exploration of the author in past decade.Our recommendations include:focus on human major diseases,strive to make breakthroughs in key scientific problems of stem cell and translational research,establish a national stem cell resource bank,and conduct multi-center stem cell clinical research.Besides,increase the effort in personnel training in various related fields,establish a scientific system and mechanism for the supervision of stem cell clinical research,accelerate the clinical research and translation of stem cells,and finally contribute to the "Healthy China 2030" national strategy to provide better service to public.