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Objective:To explore the ethical issues arising from stem cell research in China and propose countermeasures to regulate stem cell research.Methods:This article analyzed the ethical issues arising from stem cells in terms of regulatory systems, source channels, production processes, storage industries, and translational applications.Results:Combining the current ethical situation of stem cell research and the practical exploration of the authors' unit, we proposed countermeasures to address the ethical issues of stem cell research in five aspects, including forming a scientific and effective stem cell ethical regulatory system, building an open and transparent stem cell traceability mechanism, creating a GMP-compliant stem cell production platform, selecting a legal and compliant stem cell storage institution, and conducting ethical stem cell clinical research.Conclusions:It is of great practical significance to strengthen the ethical construction of stem cell research and regulate stem cell transformation research to promote the healthy development of the stem cell industry.
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Objective:To study and analyze the problems and challenges of stem cell clinical research quality control, and explore possible strategies to strengthen the quality control of stem cell clinical research.Methods:Analyze the problems of the stem cell clinical research quality control system, and summarize the factors that affect the quality control of stem cell clinical research.Results:In view of the current status analysis of stem cell clinical research quality control, it is recommended to promote stem cells from following five aspects: strengthening and improving the capacity building of clinical research institutions, establishing stem cell clinical quality control system, strengthening the quality control of stem cell preparations, strengthening the team-building of stem cell clinical research investigators, and establishing a stem cell clinical research data platform.Conclusions:Strengthening the quality control of stem cell clinical research is of great significance for accelerating the clinical research and transformational application of stem cells.
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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.
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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.
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Objective:To establish a three-level clinical grade human umbilical cord mesenchymal stem cells (hUC-MSCs) bank, including seed cell bank (SCB), master cell bank (MCB) and working cell bank (WCB), and provide hUC-MSCs with controllable quality for clinical research and application.Methods:247 human umbilical cord tissues were isolated, cultured, amplified, subcultured and frozen in GMP laboratory, and the biological characteristics, safety and stability of hUC-MSCs were tested in accordance with the requirements of relevant quality management control specifications.Results:247 strains of hUC-MSCs were isolated and prepared. The prepared hUC-MSCs have good purity and homogeneity without tumorigenicity, show good differentiation ability in biological efficacy, and have strong immunosuppressive effect in the process of co-culture with immune cells. These cells have passed the quality check of National Institute for Food and Drug Control. In this study, a three-level hUC-MSCs bank was established, and it was included into the National Stem Cell Translational Resource Center.Conclusions:A three-level clinical hUC-MSCs bank was successfully established and preliminarily applied to clinical research, which effectively promoted the standardized development of clinical stem cell resource bank and the clinical transformation and application of stem cells in China.
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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.
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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.
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Objective To discuss the feasibility of computerized tomography (CT) calibration technique for the quantification of the hepatic fat content in vivo . Methods Eleven healthy volunteers, 53 patients with fatty liver, 10 cases of chronic hepatitis B and 10 cases of liver cirrhosis were tested with CT calibration test tubes. Test tubes contained solutions with Terbutyl alcohol, which CT scan density (CTD) is close to fat tissue, and 18.5% glucose solution which CTD is almost identical to normal liver. Variable Terbutyl concentrations of 10%, 20%, 30% and 40%, which stands for various fat content in liver, were used to measure patients with variable degrees of steatosis under CT scan. Results There was a negative linear correlation ( r = -0.982 , P
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Objective To study how ConA actives macrophages in vivo to produce cytotoxic effectors and its phagocytic functions,and cytotoxicity. Methods ConA was intraperitoneally injected(ip). Cock red blood cells(cRBC) were used to evaluate MΦ phagocytic activity,and S180 cells as target cells to analyze MΦ dependent cytotoxicity(MTC).Nitric oxide(NO),TNF-α and IL-1 levels of MΦ cultural supernatant were measured using griess reagent,L929 cells MTT method and thymocytes proliferation test respectively. Results ConA could promote MΦ to phagocytize cRBC and kill S180 cells,enhance the production of such factors as NO,TNF-α and IL-1 by MΦ. There was significant difference compared with PBS control group(P＜0.01). Conclusions ConA could stimulate MΦ to produce effectors, which mediate immune regulation of ConA to MΦ.