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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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Traumatic rib fractures are the most common injury in thoracic trauma. Previously，the patients with traumatic rib fractures were mostly treated non-surgically，of which 50%，especially those combined with flail chest presented chronic pain or chest wall deformities and over 30% had long-term disabilities，being unable to retain a full-time job. In the past two decades，thanks to the development of internal fixation material technology，the surgical treatment of rib fractures has achieved good outcomes. However，there are still some problems in clinical treatment，including inconsistency in surgical treatment and quality control in medical services. The current consensuses on the management of regional traumatic rib fractures published at home and abroad mainly focus on the guidance of the overall treatment decisions and plans，and relevant clinical guidelines abroad lacks progress in surgical treatment of rib fractures in recent years. Therefore，the Chinese Society of Traumatology affiliated to Chinese Medical Association and Chinese College of Trauma Surgeons affiliated to Chinese Medical Doctor Association，in conjunction with national multidisciplinary experts，formulate the Chinese Consensus for Surgical Treatment of Traumatic Rib Fractures（2021）following the principle of evidence-based medicine，scientific nature and practicality. This expert consensus puts forward some clear，applicable，and graded recommendations from aspects of preoperative imaging evaluation，surgical indications，timing of surgery，surgical methods，rib fracture sites for surgical fixation，internal fixation methods and material selections，treatment of combined injuries in rib fractures，in order to provide references for surgical treatment of traumatic rib fractures.
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Objective:To establish a reasonable and effective formative evaluation system based on the characteristics of practical teaching of medical laboratory to evaluate the effect of practical teaching and improve the quality and level of teaching.Methods:A survey and research method was used to screen the elements needed for the formative evaluation system, so as to construct the framework and evaluation indicators of the practice teaching of this specialty. The students from Batch 2016 were scored before and after implementing formative evaluation, and the results were statistically analyzed by paired t test with SPSS 20.0 software. Results:The survey results of a total of 30 teachers (experts) and 121 students in this major were counted. According to the practical characteristics of this major, the evaluation system included two first-level indicators, five second-level indicators, and corresponding third-level and fourth-level indicators. After statistical analysis, students' learning interest, practical ability, self-learning ability, team assistance ability and knowledge development ability were all significantly improved after the implementation of formative evaluation ( P<0.01- P<0.05), and students' enthusiasm for class also increased ( P<0.05). Conclusion:It proves that the constructed formative evaluation system conforms to the characteristics of practical teaching of medical laboratory, which helps to improve the effect of practical teaching and lays a foundation for its application in the practical teaching of this professional course.
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Objective:The hemolytic prediction model of the axial flow impeller blood pump is carried out by using a computational fluid dynamics(CFD) multiphase flow model.Methods:The hydrodynamic performance of the pump and the flow field in the pump, and the shear stress distribution are analyzed. A hemolytic prediction model based on the shear stress is built based on the calculation results. Hemolysis tests in vitro were performed 6 times with fresh bovine blood. At each time, the flow of the ventricular assist device(VAD) is 5 L/min and the outflow tract pressure is 100 mmHg(13.3kPa). According to the tests, the plasma free hemoglobin(FHB) content and the hematocrit(HCT) are measured every half hour. At the end of each experiment Normal Index of Hemolysis(NIH) is calculated.Results:The average of NIH is 0.0055 g/100L, almost identical with that obtained from the hemolytic prediction model.Conclusion:Multiphase flow model can be used for quantitative predictions of the hemolytic behavior of a VAD. This method can be applied in the selection stage of a blood pump.
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Fibrotic remodeling is an adverse consequence of immune response-driven phenotypic modulation of cardiac cells following myocardial infarction (MI). MicroRNA-146b (miR-146b) is an active regulator of immunomodulation, but its function in the cardiac inflammatory cascade and its clinical implication in fibrotic remodeling following MI remain largely unknown. Herein, miR-146b-5p was found to be upregulated in the infarcted myocardium of mice and the serum of myocardial ischemia patients. Gain- and loss-of-function experiments demonstrated that miR-146b-5p was a hypoxia-induced regulator that governed the pro-fibrotic phenotype transition of cardiac cells. Overexpression of miR-146b-5p activated fibroblast proliferation, migration, and fibroblast-to-myofibroblast transition, impaired endothelial cell function and stress survival, and disturbed macrophage paracrine signaling. Interestingly, the opposite effects were observed when miR-146b-5p expression was inhibited. Luciferase assays and rescue studies demonstrated that the miR-146b-5p target genes mediating the above phenotypic modulations included interleukin 1 receptor associated kinase 1 (IRAK1) and carcinoembryonic antigen related cell adhesion molecule 1 (CEACAM1). Local delivery of a miR-146b-5p antagomir significantly reduced fibrosis and cell death, and upregulated capillary and reparative macrophages in the infarcted myocardium to restore cardiac remodeling and function in both mouse and porcine MI models. Local inhibition of miR-146b-5p may represent a novel therapeutic approach to treat cardiac fibrotic remodeling and dysfunction following MI.
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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:To analyze the CT manifestations of the 2019 novel coronavirus pneumonia (NCP) combined with severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS) literature review, and to summarize the characteristics of CT imaging, so as to improve the ability of rapid and accurate diagnosis.Methods:CT manifestations of two confirmed cases of NCP were reported, meanwhile the literatures on SARS and MERS imaging performance were reviewed and summarized.Results:The two cases of NCP were both in acute stage, the CT imaging showed multiple and scattered ground-glass opacity (GGO) in both lungs, which is similar to the CT performance of SARS and MERS in acute stage.Conclusions:The CT features of 2019 novel coronavirus pneumonia are similar to SARS and MERS. It has certain characteristics and changes rapidly with the course of the disease. In the acute stage, GGO and paving stone sign were the main manifestations. In the acute phase, GGO and crazy paving are the main manifestations. In the progress stage, the interlobular septal thickening and consolidation appeared. During the absorption period, the lesions disappeared or fibrosis was left behind, with lung structure distortion and bronchiectasis. Lymphadenopathy and hydrothorax were rare.
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Objective@#To analyze the CT manifestations of the 2019 novel coronavirus pneumonia (NCP) combined with severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS) literature review, and to summarize the characteristics of CT imaging, so as to improve the ability of rapid and accurate diagnosis.@*Methods@#CT manifestations of two confirmed cases of NCP were reported, meanwhile the literatures on SARS and MERS imaging performance were reviewed and summarized.@*Results@#The two cases of NCP were both in acute stage, the CT imaging showed multiple and scattered ground-glass opacity (GGO) in both lungs, which is similar to the CT performance of SARS and MERS in acute stage.@*Conclusions@#The CT features of 2019 novel coronavirus pneumonia are similar to SARS and MERS. It has certain characteristics and changes rapidly with the course of the disease. In the acute stage, GGO and paving stone sign were the main manifestations. In the acute phase, GGO and crazy paving are the main manifestations. In the progress stage, the interlobular septal thickening and consolidation appeared. During the absorption period, the lesions disappeared or fibrosis was left behind, with lung structure distortion and bronchiectasis. Lymphadenopathy and hydrothorax were rare.
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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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Simultaneous PET/MR imaging is a novel multimodality imaging approach that can assess disease activity together with assessment of cardiac anatomy, function, and tissue composition during a single scan. Cardiac PET/MR imaging has the potential in the diagnosis and assessment of myocardial ischemia, viability, inflammation, cardiac sarcoidosis, cardiac amyloidosis, cardiac tumors and atherosclerotic plaque imaging. This review summarizes the most promising applications of PET/MR in the cardiovascular field. The combination of various radiotracers and multi-parametric imaging with PET/MR will have a bright future in the research of cardiovascular diseases.
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Objective To study the superiority of severe multiple trauma treatment model based on damage control strategy. Methods In the intergrated injury first-aid mode, the intensive care unit-guided damage control strategy was used to treat severe multiple trauma. Results A total of 789 severe multiple damage patients were treated with damage control strategies in our hospital from December 2018 to December 2018. Sixty-nine patients died and the survival rate was 91.25％. Conclusions The intensive care unit-guided trauma control strategy has a satisfactory clinical effect in the treatment of patients with severe multiple trauma.
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The pathogenesis of liver failure is extremely complex. In recent years, the role of chemokines in viral hepatitis has been widely concerned. A large number of studies have confirmed that the abnormal expression of chemokines is closely related to the process of viral hepatitis and other types of hepatitis. Interferon-inducible protein-10 (IP-10) is a good indicator of the specificity and sensitivity of inflammatory liver injury. In this paper, IP-10 in different types of liver injury in the pathogenesis of research progress were reviewed to provide valuable indicators for clinical diagnosis, treatment strategy and prognosis evaluation of liver injury.
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Objective To detect the consistency of EGFR mutations in pleural effusion in terminal non-small cell lung cancer(NSCLC)patients by amplification refractory mutation system- polymeric chain reaction (ARMS-PCR).Methods Pleural effusion from 44 cases with advanced NSCLC were collected.DNA was extract-ed from a part of pleural effusion,and EGFR gene18,19,20,and 2 l exons mutations were detected by ARMS-PCR amplification. The left part of pleural effusion was used for the pathological microscopic examination of the embedding and to evaluate the feasibility of pleural effusion direct detection.Part of the case results were compared with tissue or pleural effusion at the same time. Results The mutation rate of EGFR detection in pleural effusion was 54.5%,including 19-del(50.0%)and 21-L858R(50.0%);75.0% of pleural effusion sediment was morpho-logically diagnosed with adenocarcinoma and EGFR mutation rate was 27.3% in pleural effusion with no tumor cell. The consistent rate was 72.7% in 22 cases of pleural effusion and tissue and that was 50.0% in 16 cases of pleural effusion and plasma.The comparison between pleural effusion and organizations and plasma test results was statisti-cally significant(P < 0.05).(P < 0.05).Conclusions EGFR gene mutation rate in pleural effusion is lower than that in tumor tissue specimens in terminal NSCLC patients and tumor tissue is still the best test specimens.
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Objective To detect serum antinuclear antibody (ANA) with enzyme-linked immunosorbent (ELISA) and linear immunoblot technique (LIA) and to evaluate and compare the performance of two methods in auxiliary diagnosis of systemic lupus erythematosus (SLE). Methods ANA detected by both ELISA and LIA of 597 cases were collected in the last two years. The results were retrospective analyzed. The sensitivity, specificity, accuracy, positive predictive value, negative predictive value, and the consistency of the two methods were compared and analyzed. Results The sensitivity of ELISA and LIA was 79.3% and 86.6% respectively for SLE patients; specificity 81.7% and 77.3%; accuracy 81.4% and 78.6%, positive predictive value 40.9%, and 37.8%;negative predictive value 96.1% and 97.3% respectively. No significant difference was found between the two methods (P > 0.05). The results showed that the coincidence rate was 81.4%, and the Kappa test 0.55. The Kappa test of the two methods in SLE group was 0.403. Conclusion No statistical significance is found in the comparison of ELISA method and LIA method to detect ANA for the diagnosis of SLE and the combination of two kinds of detection method has important application value.
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Sepsis remains the leading cause of death in intensive care unit.The pathogenesis of sepsis is extremely complex.Immune dysfunction plays an important role in the occurrence and development of sepsis.Many mechanisms are responsible for sepsis induced immune-suppression,including apoptotic depletion of immune cells,increased T regulatory and myeloid-derived suppressor cells,and cellular exhaustion.The article provided a brief review on the advance of immunologic mechanisms underlying sepsis.
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Sepsis is a life-threatening organ dysfunction caused by dysregulated host responses to infection. Despite decades of research, it remains the leading cause of death in intensive care units (ICUs). None of the current treatment, including antibiotics, organ protection and liquid resuscitation, is specifically effective for sepsis. Immunosuppression is one of the currently accepted pathogenesis and immunotherapy is one of the hot spot of current sepsis research. Immune related treatments include restricting the release of pathogen toxin and its removal, controlling the excessive inflammatory reaction and apoptosis inhibition, etc. Numerous pre-clinical studies using immunomodulatory agents such as interleukin-7 (IL-7), anti-programmed cell death-1 (PD-1) antibody and others, have demonstrated reversal of T cell dysfunction and improved survival resulting from reviewing recent advances in immunotherapy of sepsis. Therefore, immunotherapy may be a new way of sepsis treatment.