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:From the perspective of medical institutions and enterprises, based on the current situation in China, starting from the breakthrough the bottleneck of industrial development, discuss possible measures to promote the industrialization of stem cells.Methods:The factors that affect the stem cell industrialization were studied by sorting and analyzing the current stem cell industrialization policy and environment, current situation and existing problems, etc.Results:From the perspective of medical institutions and enterprises, combined with the connotation and characteristics of the stem cell industry and the author's experience and practice during the past 10 years, it is recommended to consider the promotion of the industrialization of stem cells comprehensively from the three levels that including " three transformations" , " three doubles" and " three integrations" .Conclusions:Integrate and play the role of medical institutions as the main body of stem cell clinical research and enterprises as the main body of stem cell industrialization, strengthen the multi-stakeholder cooperation among government, industry, academia, research and funding agencies, accelerate the development, transformation and application of stem cell products and derivative products.Promoting the coordinated development of the upstream, midstream, downstream and related supporting industries of the stem cell industry is of great practical significance for seizing a new round of industrial translation and historical development opportunities in the biomedical field, seizing the commanding heights of the international stem cell industry, and helping the country's major development strategy.
ABSTRACT
Objective:This study aims to analyze and summarize the current status and existing problems of stem cell research, and explore possible measures to strengthen the translation of scientific and technological achievements for stem cell in China.Methods:To study and analyze the current status of stem cell planning and policy, basic research, clinical research and clinical trials, as well as drug development, summarize the factors that affect the translation of stem cell scientific and technological achievements.Results:Combined with the practice and exploration of author in recent ten years, it is suggested to promote the translation and clinical application of scientific and technological achievements for stem cell from six aspects, including regulatory policy, resource collection, clinical research, the collaboration of institutes and enterprises, project incubation as well as risk prevention and control.Conclusions:Strengthening translation and clinical application of scientific and technological achievements for stem cell could not only meet the needs of Chinese economic and social development, but also contribute to the "Healthy China 2030" national strategy. It is of great practical significance to speed up the translation from a follower to a leader in stem cell industry globally, improve the core competitiveness and seize the commanding heights of the stem cell industry in the word.