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The regulatory sciences for stem cell-based medicinal products

null

《医学前沿（英文）》 2014年第8卷第2期页码 190-200 doi: 10.1007/s11684-014-0323-5

摘要：

Over the past few years, several new achievements have been made from stem cell studies, many of which have moved up from preclinical stages to early, or from early to middle or late, stages thanks to relatively safe profile and preliminary evidence of effectiveness. Moreover, some stem cell-based products have been approved for marketing by different national regulatory authorities. However, many critical issues associated mainly with incomplete understanding of stem cell biology and the relevant risk factors, and lack of effective regulations still exist and need to be urgently addressed, especially in countries where establishment of appropriate regulatory system just commenced. More relevantly, the stem cell regulatory sciences need to be established or improved to more effectively evaluate quality, safety and efficacy of stem cell products, and for building up the appropriate regulatory framework. In this review, we summarize some new achievements in stem cell studies, especially the preclinical and clinical studies, the existing regulations, and the associated challenges, and we then propose some considerations for improving stem cell regulatory sciences with a goal of promoting the steadfast growth of the well-regulated stem cell therapies abreast of evolvement of stem cell sciences and technologies.

关键词： stem cell-based medicinal products (SCMPs) stem cell therapy (SCT) safety effectiveness standards guidelines regulatory science

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MAS-based production scheduling system for manufacturing cell-based workshop

CHU Hong-yan, CAO Quan-jun, FEI Ren-yuan

《机械工程前沿（英文）》 2006年第1卷第4期页码 375-380 doi: 10.1007/s11465-006-0043-x

摘要： The task of production scheduling is to determine the detailed machining path, time, machine tool, etc., for every work piece, according to the production objective and constraints. It is also an important part of the manufacturing system. In this paper, the manufacturing cell-based workshop is described and its scheduling system structure is established based on MAS (multi-agent system) technology. Through the negotiation and communication of each agent, the machining path is determined and the machining sequence and start time are calculated by GA (genetics algorithm). The communication among agents uses the CORBA (common object request broker architecture) technology of the OMG (Object Management Group). The CORBA-based architecture of the communication is designed and some interfaces for the communication are listed. For the genetics algorithm, chromosome coding, fitness function, parameters selection, and the basic genetics operation including selection, crossover and aberrance, are described. The scheduling system also can deal with some abnormal conditions, such as machine tool failure and urgent tasks. Finally, two scheduling examples are given.

关键词： negotiation selection multi-agent communication abnormal

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Challenges of NK cell-based immunotherapy in the new era

null

《医学前沿（英文）》 2018年第12卷第4期页码 440-450 doi: tzg@ustc.edu.cn

摘要：

Natural killer cells (NKs) have a great potential for cancer immunotherapy because they can rapidly and directly kill transformed cells in the absence of antigen presensitization. Various cellular sources, including peripheral blood mononuclear cells (PBMCs), stem cells, and NK cell lines, have been used for producing NK cells. In particular, NK cells that expanded from allogeneic PBMCs exhibit better efficacy than those that did not. However, considering the safety, activities, and reliability of the cell products, researchers must develop an optimal protocol for producing NK cells from PBMCs in the manufacture setting and clinical therapeutic regimen. In this review, the challenges on NK cell-based therapeutic approaches and clinical outcomes are discussed.

关键词： natural killer cells immunotherapy adoptive transfer genetic modification immune checkpoint inhibitor

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Static analysis of corrugated panels using homogenization models and a cell-based smoothed mindlin plate

Nhan NGUYEN-MINH, Nha TRAN-VAN, Thang BUI-XUAN, Trung NGUYEN-THOI

《结构与土木工程前沿（英文）》 2019年第13卷第2期页码 251-272 doi: 10.1007/s11709-017-0456-0

摘要： Homogenization is a promising approach to capture the behavior of complex structures like corrugated panels. It enables us to replace high-cost shell models with stiffness-equivalent orthotropic plate alternatives. Many homogenization models for corrugated panels of different shapes have been proposed. However, there is a lack of investigations for verifying their accuracy and reliability. In addition, in the recent trend of development of smoothed finite element methods, the cell-based smoothed three-node Mindlin plate element (CS-MIN3) based on the first-order shear deformation theory (FSDT) has been proposed and successfully applied to many analyses of plate and shell structures. Thus, this paper further extends the CS-MIN3 by integrating itself with homogenization models to give homogenization methods. In these methods, the equivalent extensional, bending, and transverse shear stiffness components which constitute the equivalent orthotropic plate models are represented in explicit analytical expressions. Using the results of ANSYS and ABAQUS shell simulations as references, some numerical examples are conducted to verify the accuracy and reliability of the homogenization methods for static analyses of trapezoidally and sinusoidally corrugated panels.

关键词： homogenization corrugated panel asymptotic analysis smoothed finite element method (S-FEM) cell-based smoothed three-node Mindlin plate element (CS-MIN3)

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An extended cell-based smoothed discrete shear gap method (XCS-FEM-DSG3) for free vibration analysis

M. H. NGUYEN-THOI,L. Le-ANH,V. Ho-HUU,H. Dang-TRUNG,T. NGUYEN-THOI

《结构与土木工程前沿（英文）》 2015年第9卷第4期页码 341-358 doi: 10.1007/s11709-015-0302-1

摘要： A cell-based smoothed discrete shear gap method (CS-FEM-DSG3) was recently proposed and proven to be robust for free vibration analyses of Reissner-Mindlin shell. The method improves significantly the accuracy of the solution due to softening effect of the cell-based strain smoothing technique. In addition, due to using only three-node triangular elements generated automatically, the CS-FEM-DSG3 can be applied flexibly for arbitrary complicated geometric domains. However so far, the CS-FEM-DSG3 has been only developed for analyzing intact structures without possessing internal cracks. The paper hence tries to extend the CS-FEM-DSG3 for free vibration analysis of cracked Reissner-Mindlin shells by integrating the original CS-FEM-DSG3 with discontinuous and crack−tip singular enrichment functions of the extended finite element method (XFEM) to give a so-called extended cell-based smoothed discrete shear gap method (XCS-FEM-DSG3). The accuracy and reliability of the novel XCS-FEM-DSG3 for free vibration analysis of cracked Reissner-Mindlin shells are investigated through solving three numerical examples and comparing with commercial software ANSYS.

关键词： cracked Reissner-Mindlin shell free vibration analysis cell-based smoothed discrete shear gap method (CS-FEM-DSG3) extended cell-based smoothed discrete shear gap method (XCS-FEM-DSG3) smoothed finite element methods (SFEM)

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The unregulated commercialization of stem cell treatments: a global perspective

Douglas Sipp

《医学前沿（英文）》 2011年第5卷第4期页码 348-355 doi: 10.1007/s11684-011-0150-x

摘要： Research into the biological properties and clinical potential of stem cells has spurred strong public investment, industry development, media coverage, and patient interest in recent years. To date, however, few clinical applications of demonstrated safety and efficacy have been developed with the exception of uses of hematopoietic stem cells in the treatment of diseases of the blood and immune systems. This lack of an evidence basis notwithstanding, hundreds of companies and private clinics around the world now sell putative stem cell treatments for an enormously broad range of medical and quality-of-life conditions. This represents a major challenge for legitimate scientists working in the field, for authorities seeking to protect their constituencies, and for patients and consumers targeted by such companies’ marketing strategies. In this review, I provide an overview of the global industry in pseudomedical stem cell treatments, with an investigation of claims in a single disease area (amyotrophic lateral sclerosis), and make recommendations for the introduction and enforcement of appropriate regulatory responses to this problem.

关键词： stem cell tourism medical ethics stem cell policy and regulation alternative medicine

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Therapeutic potential of stem cell in liver regeneration

null

《医学前沿（英文）》 2011年第5卷第1期页码 26-32 doi: 10.1007/s11684-011-0107-0

摘要：

Liver transplantation is the only life-saving procedure for patients with end-stage liver disease. However, its potential benefits are hampered by many disadvantages, such as the relative shortage of donors, operative risks, and high costs. These issues have prompted the search for new alternative therapies for irreversible liver disease. Stem cell therapy, with the ability for self-renewal and potential for multilineage differentiation, is a promising alternative approach. Several studies have demonstrated that transplantation of hepatic stem/progenitor cells or hepatocyte-like cells derived from multipotent stem cells leads to donor cell-mediated repopulation of the liver and improved survival rates in experimental models of liver disease. However, a registered clinical application based on stem cell technology will take at least an additional 5 to 10 years because of some limitations; e.g. the lack of suitable cell sources and risk of teratoma formation. This review summarizes the general understanding of the therapeutic potentials of stem cells in liver disease, including the sources, mechanisms, and delivery methods of hepatic stem cells in liver regeneration, and discusses some challenges for their therapeutic application.

关键词： stem cell liver disease regenerative medicine

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Stem cell niches and endogenous electric fields in tissue repair

null

《医学前沿（英文）》 2011年第5卷第1期页码 40-44 doi: 10.1007/s11684-011-0108-z

摘要：

Adult stem cells are responsible for homeostasis and repair of many tissues. Endogenous adult stem cells reside in certain regions of organs, known as the stem cell niche, which is recognized to have an important role in regulating tissue maintenance and repair. In wound healing and tissue repair, stem cells are mobilized and recruited to the site of wound, and participate in the repair process. Many regulatory factors are involved in the stem cell-based repair process, including stem cell niches and endogenous wound electric fields, which are present at wound tissues and proved to be important in guiding wound healing. Here we briefly review the role of stem cell niches and endogenous electric fields in tissue repair, and hypothesize that endogenous electric fields become part of stem cell niche in the wound site.

关键词： stem cell stem cell niche electric field tissue repair

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Transcriptomics and proteomics in stem cell research

null

《医学前沿（英文）》 2014年第8卷第4期页码 433-444 doi: 10.1007/s11684-014-0336-0

摘要：

Stem cells are capable of self-renewal and differentiation, and the processes regulating these events are among the most comprehensively investigated topics in life sciences. In particular, the molecular mechanisms of the self-renewal, proliferation, and differentiation of stem cells have been extensively examined. Multi-omics integrative analysis, such as transcriptomics combined with proteomics, is one of the most promising approaches to the systemic investigation of stem cell biology. We reviewed the available information on stem cells by examining published results using transcriptomic and proteomic characterization of the different stem cell processes. Comprehensive understanding of these important processes can only be achieved using a systemic methodology, and employing such method will strengthen the study on stem cell biology and promote the clinical applications of stem cells.

关键词： embryonic stem cells transcriptomics proteomics

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Advancement of human leukocyte antigen-partially matched related hematopoietic stem cell transplantation

null

《医学前沿（英文）》 2013年第7卷第3期页码 306-315 doi: 10.1007/s11684-013-0279-x

摘要：

Allogeneic hematopoietic stem cell transplantation (HSCT) is one of the most effective options for hematological malignancies, and human leukocyte antigen-partially matched related donors (PMRDs) are a valuable option for HSCT. Several protocols (with or without ex vivo T-cell depletion (TCD)) have been established worldwide. TCD including CD34⁺positive selection and CD3/CD19 depletion has successfully overcome the human leukocyte antigen disparity. However, TCD is associated with prolonged immune deficiencies, increased risks of infectious complications, and high transplantation-related mortality. PMRD HSCT without ex vivo TCD is well developed, and numerous patients have benefitted from it. Here, we review the literature on PMRD HSCT.

关键词： partially matched related donor hematopoietic stem cell transplantation allogeneic

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Cannabidiol prevents depressive-like behaviors through the modulation of neural stem cell differentiation

《医学前沿（英文）》 2022年第16卷第2期页码 227-239 doi: 10.1007/s11684-021-0896-8

摘要： Chronic stress impairs radial neural stem cell (rNSC) differentiation and adult hippocampal neurogenesis (AHN), whereas promoting AHN can increase stress resilience against depression. Therefore, investigating the mechanism of neural differentiation and AHN is of great importance for developing antidepressant drugs. The nonpsychoactive phytocannabinoid cannabidiol (CBD) has been shown to be effective against depression. However, whether CBD can modulate rNSC differentiation and hippocampal neurogenesis is unknown. Here, by using the chronic restraint stress (CRS) mouse model, we showed that hippocampal rNSCs mostly differentiated into astrocytes under stress conditions. Moreover, transcriptome analysis revealed that the FoxO signaling pathway was involved in the regulation of this process. The administration of CBD rescued depressive-like symptoms in CRS mice and prevented rNSCs overactivation and differentiation into astrocyte, which was partly mediated by the modulation of the FoxO signaling pathway. These results revealed a previously unknown neural mechanism for neural differentiation and AHN in depression and provided mechanistic insights into the antidepressive effects of CBD.

关键词： cannabidiol depression radial neural stem cells neurogenesis

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In vivo imaging of hematopoietic stem cell development in the zebrafish

Panpan Zhang, Feng Liu

《医学前沿（英文）》 2011年第5卷第3期页码 239-247 doi: 10.1007/s11684-011-0123-0

摘要： imaging is crucial for developmental biology and can further help to follow cell development/differentiation in normal and pathological conditions. Recent advances in optical imaging techniques has facilitated tracing of the developmental dynamics of a specific organ, tissue, or even a single cell. The zebrafish is an excellent model for imaging of hematopoiesis due to its transparent embryo at early stage; moreover, different zebrafish hematopoietic stem cells (HSCs) transgenic lines have been demonstrated as very useful tools for illustrating the details of the HSC developmental process. In this review, we summarize recent studies related to the non-invasive imaging of HSC transgenics, to show that zebrafish transgenic lines are powerful tools for developmental biology and disease. At the end of the review, the perspective and some open questions in this field will be discussed.

关键词： hematopoietic stem cell hematopoiesis in vivo imaging transgenics zebrafish

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Mutant DNA methylation regulators endow hematopoietic stem cells with the preleukemic stem cell property

null

《医学前沿（英文）》 2015年第9卷第4期页码 412-420 doi: 10.1007/s11684-015-0423-x

摘要：

Genetic mutations are considered to drive the development of acute myeloid leukemia (AML). With the rapid progress in sequencing technologies, many newly reported genes that are recurrently mutated in AML have been found to govern the initiation and relapse of AML. These findings suggest the need to distinguish the driver mutations, especially the most primitive single mutation, from the subsequent passenger mutations. Recent research on DNA methyltransferase 3A (DNMT3A) mutations provides the first proof-of-principle investigation on the identification of preleukemic stem cells (pre-LSCs) in AML patients. Although DNMT3A mutations alone may only transform hematopoietic stem cells into pre-LSCs without causing the full-blown leukemia, the function of this driver mutation appear to persist from AML initiation up to relapse. Therefore, identifying and targeting preleukemic mutations, such as DNMT3A mutations, in AML is a promising strategy for treatment and reduction of relapse risk.

关键词： preleukemic stem cell acute myeloid leukemia relapse DNMT3A

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Stem cell gene therapy: the risks of insertional mutagenesis and approaches to minimize genotoxicity

Chuanfeng Wu, Cynthia E. Dunbar

《医学前沿（英文）》 2011年第5卷第4期页码 356-371 doi: 10.1007/s11684-011-0159-1

摘要： Virus-based vectors are widely used in hematopoietic stem cell (HSC) gene therapy, and have the ability to integrate permanently into genomic DNA, thus driving long-term expression of corrective genes in all hematopoietic lineages. To date, HSC gene therapy has been successfully employed in the clinic for improving clinical outcomes in small numbers of patients with X-linked severe combined immunodeficiency (SCID-X1), adenosine deaminase deficiency (ADA-SCID), adrenoleukodystrophy (ALD), thalassemia, chronic granulomatous disease (CGD), and Wiskott-Aldrich syndrome (WAS). However, adverse events were observed during some of these HSC gene therapy clinical trials, linked to insertional activation of proto-oncogenes by integrated proviral vectors leading to clonal expansion and eventual development of leukemia. Numerous studies have been performed to understand the molecular basis of vector-mediated genotoxicity, with the aim of developing safer vectors and lower-risk gene therapy protocols. This review will summarize current information on the mechanisms of insertional mutagenesis in hematopoietic stem and progenitor cells due to integrating gene transfer vectors, discuss the available assays for predicting genotoxicity and mapping vector integration sites, and introduce newly-developed approaches for minimizing genotoxicity as a way to further move HSC gene therapy forward into broader clinical application.

关键词： gene therapy hematopoietic stem cells insertional mutagenesis genotoxicity induced pluripotent stem cell

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The stem cell and tissue engineering research in Chinese ophthalmology

GE Jian, LIU Jingbo

《医学前沿（英文）》 2007年第1卷第1期页码 6-10 doi: 10.1007/s11684-007-0002-x

摘要： Much has been considerably developed recently in the ophthalmic research of stem cell (SC) and tissue engineering (TE). They have become closer to the clinical practice, standardized and observable. Leading edge research of SC and TE on the ocular surface reconstruction, neuroregeneration and protection, and natural animal model has become increasingly available. However, challenges remain on the way, especially on the aspects of function reconstruction and specific differentiation. This paper reviews the new developments in this area with an intention of identifying research priorities for the future.

关键词： available observable neuroregeneration protection function reconstruction