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In recent years, basic scientific research and clinical studies on mesenchymal stem cell-derived exosome (MSC-Exo) have developed rapidly. MSC-Exo has shown good anti-tumor effects in preclinical and clinical studies. However, due to its diverse sources and functions, MSC-Exo therapy still faces many ethical issues in clinical conversion and application, including the unclear tumor types and mechanisms of action applicable to MSC-Exo, the risk/benefit issues in the process of clinical research, the lack of safety/effectiveness evaluation standards, lax access standards, and the incomplete regulatory systems. The technical guidelines and regulatory policies related to the clinical transformation and application of stem cell therapy are constantly improving. Therefore, to effectively avoid ethical risks, regulate the research and treatment related to the clinical transformation and application of MSC-Exo therapy, and improve the safety and efficacy of MSC-Exo therapy in tumor therapy, it is proposed to deepen clinical research on the relationship between MSC-Exo and tumor regulation, strengthen the risk/benefit analysis, supervise and improve the professional quality of researcher, deeply root in the principle of subjects not to be harmed, construct and perfect the relevant regulatory system, and improve the reviewing ability of the ethics committee, so as to promote the rapid clinical transformation of MSC-Exo and bring good news to cancer patients.
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Objective:By analyzing the development purpose and goals, status quo and achievements, characteristics, and problems identified of Shandong Provincial Clinical Research Center, tailored measurements and suggestions are put forward in this paper, to serve for better development of Shandong Provincial Clinical Research Center, and construct a more efficient clinical research transformation platform.Methods:Carrying out statistical analysis of the annual reports of the first two batches of 12 Shandong Provincial Clinical Research Centers to identify similarities and uniqueness; Benchmarking with the construction goals of Shandong Provincial Clinical Research Centers to figure out achievements and space for improvement; SWOT analysis was conducted to analyze opportunities and challenges, and experiences were summarized.Results:After two years’ construction, the centers have remarkable achievement by facilitating resources, establishing research platforms, and setting up collaborative research networks. However, common problems are still existed, such as: weak innovation foundation, insufficient attention from supporting institutions, lacking of compound talents in clinical research, peak discipline should be developed at provincial centers to promote the capacity building, and the ability to promote innovation at local level also needs to be improved.Conclusions:The construction of Shandong Provincial Clinical Research Center is facing a great deal of opportunities and challenges. By boosting attention of the supporting institution, enhancing continuing investment, implementing annual evaluation system, guiding the outstanding provincial centers to apply for national centers, and strengthening the achievement transfer and promotion, the construction of the provincial centers will be improved, and further enhance the clinical research capacity at provincial level.
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BACKGROUND: With the in-depth investigation of stem cells and better understanding of kidney ischemia/reperfusion injury, stem cell therapy for renal ischemia/reperfusion injury in animal experiments have been developed extensively, and have achieved certain advance. Therefore, it is necessary to conduct a systematic evaluation to explore the specific efficacy of stem cell therapy for renal ischemia/reperfusion injury. OBJECTIVE: To systematically evaluate the effects of stem cells on the function and structure of the kidney and the immune function of the body and the feasibility of transformation into clinical practice based on the animal experiments. METHODS: Databases of PubMed, Web of Science, Embase, CNKI, VIP and WanFang were searched by computer, and the search time was limited before May 2019. The literature was screened independently by two researchers, and the data were extracted. SYRCLE animal experiment bias risk assessment tool was used to evaluate the methodological quality of the study, and the evidence quality was evaluated using CERQual tool.
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@#Efficient and safe delivery of drugs, proteins or genes to the targeted sites has been the focus of pharmaceutical research. Inorganic nanomaterials are ideal materials for drug delivery systems due to their good stability, excellent biocompatibility and high drug loading capacity.Inorganic nanomaterials are ideal materials for drug delivery systems due to their good stability, high biocompatibility and excellent drug loading capacity. In this review, we started with reported researches and clinical trials to discuss the researches and clinical transformation of these inorganic nanoparticles in application of drug delivery, including carbon nanomaterials, silica nanoparticles, calcium nanomaterials, gold nanoparticles, magnetic nanoparticles, upconversion nanoparticles and quantum dots, providing theoretical reference for application of inorganic drug delivery carriers in the development of new drugs, looking to the prospects of inorganic nanomaterials in clinical application.
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To date, the pathogenesis of inflammatory bowel disease (IBD) is not fully understood.The study of microRNAs (miRNAs) provides a new opportunity for IBD research.miRNAs play an important role in cellular functions including cell differentiation, proliferation, signal transduction and apoptosis.Some studies discover that miRNAs have a role in gut immunity, intestinal mucosa and gut microbiota.It is likely that miRNAs play a role in the development of IBD.So it''s necessary to study further about the relationship between miRNAs and IBD.This review describes the current research of miRNAs in the pathogenesis of IBD and their application in the diagnosis and therapy of IBD.
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Objective: To investigate the effects of low level gallium aluminum arsenide (GaAlAs) laser irradiation on proliferation, cytokine secretion and adipogenic differentiation of cultured human adipose tissue-derived stem cells (hADSCs), and to find a safe and effective method for improving clinical treatment effect of ADSC. Methods: The cultured hADSCs from human adipose tissue were treated by using 650nm GaAlAs laser irradiation at a single of 2, 4 and 8J/cm2 respectively. Cell proliferation was quantified by MTT assay, cytokine secretion was determined by ELISA, and adipogenic differentiation was examined by oil red staining respectively. In addition, the expression profiles of putative hADSC surface markers were determined by real-time PCR. Results: MTT assay showed that treatment with GaAlAs laser irradiation at 4J/cm2 and 8J/cm2 (especially 4J/cm2) markedly promoted ADSCs proliferation from day 4 to day 6 after irradiation, when compared with the unirradiated group (P<0.05). ELISA results showed that the concentrations of VEGF, PDGF and TGF-˜ in culture supernatant were 287.5±15.2pg/ml, 36.0±0.7ng/ml, and 292.6±10.5pg/ml when hADSCs were exposed to 4J/cm2 GaAlAs laser, and they were significantly higher than those of unirradiated group (145.3±21.6pg/ml, 26.7±0.6ng/ml and 130.6±6.0pg/ml, respectively, P<0.05). Quantitative PCR showed that the mRNA expression levels of cell surface marker CD13, CD29, CD44 and CD90 in hADSCs exposed to 4J/cm2 GaAlAs laser were 1.19, 22.05, 4.38 and 7.22 fold of those in unirradiated group (P<0.05). And the oil red staining revealed that GaAlAs laser irradiation could markedly accelerate the adipogenic differentiation of hADSCs (P<0.05). Conclusions: Low energy laser irradiation is a simple, safe and effective method, which can enhance the proliferation, cytokine secretion and adipogenic differentiation of ADSCs, may help to improve the therapeutic effect of ADSCs by clinical transformation application.
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Due to practical and ethical concerns associated with human experiments, animal models have been essential in cancer research.Vast resources are expended during the development of new cancer therapeutics, and selection of optimal in vivo models should improve this process.Genetically engineered mouse models ( GEMM) of cancer have progressively improved in technical sophistication and, accurately recapitulating the human cognate condition, have provided opportunities to accelerate the development of cancer drugs.In this article we consider the different types of animal models used for predicting the results of clinical trials of cancer drugs, and discuss the strengths and weaknesses of each in this regard.In addition, the methods of predicting in vivo models and clinical translation are discussed.