\\n\\n
More than half of the publishers listed alongside IntechOpen (18 out of 30) are Social Science and Humanities publishers. IntechOpen is an exception to this as a leader in not only Open Access content but Open Access content across all scientific disciplines, including Physical Sciences, Engineering and Technology, Health Sciences, Life Science, and Social Sciences and Humanities.
\\n\\nOur breakdown of titles published demonstrates this with 47% PET, 31% HS, 18% LS, and 4% SSH books published.
\\n\\n“Even though ItechOpen has shown the potential of sci-tech books using an OA approach,” other publishers “have shown little interest in OA books.”
\\n\\nAdditionally, each book published by IntechOpen contains original content and research findings.
\\n\\nWe are honored to be among such prestigious publishers and we hope to continue to spearhead that growth in our quest to promote Open Access as a true pioneer in OA book publishing.
\\n\\n\\n\\n
\\n"}]',published:!0,mainMedia:null},components:[{type:"htmlEditorComponent",content:'
Simba Information has released its Open Access Book Publishing 2020 - 2024 report and has again identified IntechOpen as the world’s largest Open Access book publisher by title count.
\n\nSimba Information is a leading provider for market intelligence and forecasts in the media and publishing industry. The report, published every year, provides an overview and financial outlook for the global professional e-book publishing market.
\n\nIntechOpen, De Gruyter, and Frontiers are the largest OA book publishers by title count, with IntechOpen coming in at first place with 5,101 OA books published, a good 1,782 titles ahead of the nearest competitor.
\n\nSince the first Open Access Book Publishing report published in 2016, IntechOpen has held the top stop each year.
\n\n\n\nMore than half of the publishers listed alongside IntechOpen (18 out of 30) are Social Science and Humanities publishers. IntechOpen is an exception to this as a leader in not only Open Access content but Open Access content across all scientific disciplines, including Physical Sciences, Engineering and Technology, Health Sciences, Life Science, and Social Sciences and Humanities.
\n\nOur breakdown of titles published demonstrates this with 47% PET, 31% HS, 18% LS, and 4% SSH books published.
\n\n“Even though ItechOpen has shown the potential of sci-tech books using an OA approach,” other publishers “have shown little interest in OA books.”
\n\nAdditionally, each book published by IntechOpen contains original content and research findings.
\n\nWe are honored to be among such prestigious publishers and we hope to continue to spearhead that growth in our quest to promote Open Access as a true pioneer in OA book publishing.
\n\n\n\n
\n'}],latestNews:[{slug:"intechopen-signs-new-contract-with-cepiec-china-for-distribution-of-open-access-books-20210319",title:"IntechOpen Signs New Contract with CEPIEC, China for Distribution of Open Access Books"},{slug:"150-million-downloads-and-counting-20210316",title:"150 Million Downloads and Counting"},{slug:"intechopen-secures-indefinite-content-preservation-with-clockss-20210309",title:"IntechOpen Secures Indefinite Content Preservation with CLOCKSS"},{slug:"intechopen-expands-to-all-global-amazon-channels-with-full-catalog-of-books-20210308",title:"IntechOpen Expands to All Global Amazon Channels with Full Catalog of Books"},{slug:"stanford-university-identifies-top-2-scientists-over-1-000-are-intechopen-authors-and-editors-20210122",title:"Stanford University Identifies Top 2% Scientists, Over 1,000 are IntechOpen Authors and Editors"},{slug:"intechopen-authors-included-in-the-highly-cited-researchers-list-for-2020-20210121",title:"IntechOpen Authors Included in the Highly Cited Researchers List for 2020"},{slug:"intechopen-maintains-position-as-the-world-s-largest-oa-book-publisher-20201218",title:"IntechOpen Maintains Position as the World’s Largest OA Book Publisher"},{slug:"all-intechopen-books-available-on-perlego-20201215",title:"All IntechOpen Books Available on Perlego"}]},book:{item:{type:"book",id:"5903",leadTitle:null,fullTitle:"Principles and Applications in Nuclear Engineering - Radiation Effects, Thermal Hydraulics, Radionuclide Migration in the Environment",title:"Principles and Applications in Nuclear Engineering",subtitle:"Radiation Effects, Thermal Hydraulics, Radionuclide Migration in the Environment",reviewType:"peer-reviewed",abstract:"Nuclear engineering could be viewed as the engineering field that ensures optimum and sustainable technological applications of natural and induced radioactive materials in different industrial sectors. 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\r\n\tPlants are dependent on temperature, light, moisture, and carbon dioxide to produce grains and other plant products to satisfy basic human needs. Climate change is very likely to affect food security at the global, regional, and local levels. Climate change can disrupt food availability, reduce access to food, and affect food quality. Increases in temperature, changes in precipitation patterns, changes in extreme weather events, and reductions in water availability may all result in reduced agricultural productivity. To meet the food demands of the ever-increasing global population, new technologies and management practices are being adopted to boost yield and maintain productivity under both normal and adverse conditions.
\r\n\r\n\tThis book highlights state-of-the-art research and practices for adaptation to climate change in food production systems. The main topics covered include production technologies, management practices, and stress tolerance of agronomic plants in a single source, current scientific understanding of observed and projected climate change impacts on agronomic plant production and quality, modeling of autonomous and planned adaptation, and development of early warning and/or support systems for climate-related decision-making.
",isbn:"978-1-83881-062-7",printIsbn:"978-1-83881-055-9",pdfIsbn:"978-1-83881-063-4",doi:null,price:0,priceEur:0,priceUsd:0,slug:null,numberOfPages:0,isOpenForSubmission:!1,hash:"e4d0b0a5b0d55843e704d38d55206b91",bookSignature:"Dr. Shah Fahad, Dr. Shah Saud, Prof. Yajun Chen, Dr. Chao Wu and Dr. Depeng Wang",publishedDate:null,coverURL:"https://cdn.intechopen.com/books/images_new/10363.jpg",keywords:"Climate, Growth Characteristics, Physiological Attributes, Wheat, Rice, Maize, Cotton, Cereals, Growth Regulators, Cereal Plants, Abiotic Stress, Water Availability",numberOfDownloads:2992,numberOfWosCitations:0,numberOfCrossrefCitations:3,numberOfDimensionsCitations:6,numberOfTotalCitations:9,isAvailableForWebshopOrdering:!0,dateEndFirstStepPublish:"May 26th 2020",dateEndSecondStepPublish:"June 16th 2020",dateEndThirdStepPublish:"August 15th 2020",dateEndFourthStepPublish:"November 3rd 2020",dateEndFifthStepPublish:"January 2nd 2021",remainingDaysToSecondStep:"10 months",secondStepPassed:!0,currentStepOfPublishingProcess:5,editedByType:null,kuFlag:!1,biosketch:"Dr. Fahad is an editor and reviewer for more than 10 peer-reviewed international journals and was a recipient of the Publons Peer Review Award 2019, also he has been honored by different authorities for his outstanding performance in different fields like research and education and received the Young Rice Scientist Award in 2014 and Distinguish Ph.D. Scholar of Huazhong Agricultural University in 2015.",coeditorOneBiosketch:null,coeditorTwoBiosketch:null,coeditorThreeBiosketch:null,coeditorFourBiosketch:null,coeditorFiveBiosketch:null,editors:[{id:"194771",title:"Dr.",name:"Shah",middleName:null,surname:"Fahad",slug:"shah-fahad",fullName:"Shah Fahad",profilePictureURL:"https://mts.intechopen.com/storage/users/194771/images/system/194771.jpeg",biography:"Dr. Shah Fahad is currently working as Assistant professor in Agriculture department, the University of Swabi, Khyber Pakhtunkhwa Pakistan. He studied in Pakistan at Agricultural University Khyber Pakhtunkhwa and Quiad-I-Azam University Islamabad where he successfully completed two degrees: a BSC (HONS) in Agronomy and Mphil. In Plant Physiology. As a scholar he continued for another degree, in graduate studies at Huazhong Agricultural University Wuhan, China pursuing Ph.D. in Agronomy which was achieved with honors in 2015. Mr. Shah Fahad did his Post Doctorate at Huazhong Agricultural University in 2017. He is a contributor to many international journals with focuses on global warming and their influences on rice crop attributes in his articles. He is a member of the Editorial Board and a Critic of ten international journals.",institutionString:"University of Swabi",position:null,outsideEditionCount:0,totalCites:0,totalAuthoredChapters:"1",totalChapterViews:"0",totalEditedBooks:"1",institution:{name:"University of Swabi",institutionURL:null,country:{name:"Pakistan"}}}],coeditorOne:{id:"320321",title:"Dr.",name:"Shah",middleName:null,surname:"Saud",slug:"shah-saud",fullName:"Shah Saud",profilePictureURL:"https://mts.intechopen.com/storage/users/320321/images/system/320321.jpg",biography:"The co-editor\\'s short CV, as specified on the book preparation formDr. Shah Saud is currently working as a Post Doctorate researcher at the Northeast Agricultural University, Harbin, China. He received his PhD in 2017 from the Northeast Agricultural University, Harbin, China. He has completed several national and international research projects. Dr. Shah Saud has published 135 articles and chapters related to horticulture, climate change, landscaping, plant physiology and environmental stresses with Springer, Elsevier, and Wiley, etc. According to Scopus®, Dr. Shah Saud publications have received roughly 3200 citations with an h-index of 29. He is an editor and reviewer for more than 23 peer-reviewed international journals.",institutionString:"Northeast Agricultural University",position:null,outsideEditionCount:0,totalCites:0,totalAuthoredChapters:"0",totalChapterViews:"0",totalEditedBooks:"0",institution:{name:"Northeast Agricultural University",institutionURL:null,country:{name:"China"}}},coeditorTwo:{id:"320323",title:"Prof.",name:"Yajun",middleName:null,surname:"Chen",slug:"yajun-chen",fullName:"Yajun Chen",profilePictureURL:"https://mts.intechopen.com/storage/users/320323/images/system/320323.jpg",biography:"Dr. Yajun Chen has completed a Ph.D. in 2005 in the field of Crop Cultivation and Farming System from Northeast Agricultural University, Harbin, China. Later, she completed her postdoctoral research in the field of biology in Northeast forestry university, Harbin, China. Currently, she is a professor working in Horticulture College of Northeast Agricultural University. Over the course of a dozen years, she had studied in Australia (2003-2004), the United States (2010-2011) and Norway (2015-2016) as a visiting scholar that was funded by the Chinese government. Her research work encompasses ornamental plant adverse physiology and ecology, coping with ecological environment adaptation and restoration of garden plants. Dr. Yajun Chen has published over 110 research papers in peer-reviewed journals in her field at home and abroad. She as a chief editor has edited more than 20 books on important aspects of local flora, turf and flower culture, plant stress physiology. She has also trained more than 80 masters and 5 PhDs in these fields. Her outstanding work was recognized and won 8 awards for scientific and technological progress in Heilongjiang province, China. Dr. Yajun Chen has won 2 international and 13 national projects.",institutionString:"Northeast Agricultural University",position:null,outsideEditionCount:0,totalCites:0,totalAuthoredChapters:"0",totalChapterViews:"0",totalEditedBooks:"0",institution:{name:"Northeast Agricultural University",institutionURL:null,country:{name:"China"}}},coeditorThree:{id:"320324",title:"Dr.",name:"Chao",middleName:null,surname:"Wu",slug:"chao-wu",fullName:"Chao Wu",profilePictureURL:"https://mts.intechopen.com/storage/users/320324/images/system/320324.jpg",biography:"Dr. Chao Wu engages in the field crop cultivation and physiology, and plant phenomics. He has completed his Ph.D during 2013-2016 from Huazhong Agricultural University, Wuhan, China, and completed his post Ph.D during 2017-2019 from Nanjing Agricultural University, Nanjing, China. Now, he is associate research fellow in Guangxi Institute of Botany, Guangxi Zhuang Autonomous Region and the Chinese Academy of Sciences, Guilin, China. He chairs a Natural Science Foundation of Jiangsu Province, and two Postdoctoral Science Foundation researches, and focus mainly on physiological mechanisms of abiotic-stress tolerance (heat, drought) in crops and medicinal plants. He has published over 20 papers in international journals, such as field crops research, the crop journal, and frontiers in plant science.",institutionString:"Guangxi Institute of Botany",position:null,outsideEditionCount:0,totalCites:0,totalAuthoredChapters:"0",totalChapterViews:"0",totalEditedBooks:"0",institution:{name:"Guangxi Institute of Botany",institutionURL:null,country:{name:"China"}}},coeditorFour:{id:"320325",title:"Dr.",name:"Depeng",middleName:null,surname:"Wang",slug:"depeng-wang",fullName:"Depeng Wang",profilePictureURL:"https://mts.intechopen.com/storage/users/320325/images/system/320325.jpg",biography:"Dr. Depeng Wang has completed Ph.D. in 2016 in the field of Agronomy and Crop Physiology from Huazhong Agriculture University, Wuhan, China. Presently he is serving as a professor in College of Life Science, Linyi University, Linyi, China. He is the principal investigator of Crop Genetic Improvement, Physiology & Ecology Center in Linyi University. His current research focus on crop ecology and physiology, agronomy. Such as the key characteristics associated with high yielding crop, the effect of temperature on crop grain yield and solar radiation utilization, morphological plasticity to agronomic manipulation in leaf dispersion and orientation, optimal integrated crop management practices for maximizing crop grain yield. Dr. Depeng Wang has published over 36 papers in reputed journals. He has edited 1 book and witten 4 book chapters on important aspects of crop physiology, environmental stress, and crop quality formation. According to Google Scholar Citation, his publications have received about 100 citations. He is a reviewer for 5 peer-reviewed international journals. Dr. Depeng Wang is a provincial crop expert in green, high quality and efficient technology, has participated 6 National projects with more than 4 million research fundings.",institutionString:"Linyi University",position:null,outsideEditionCount:0,totalCites:0,totalAuthoredChapters:"0",totalChapterViews:"0",totalEditedBooks:"0",institution:{name:"Linyi University",institutionURL:null,country:{name:"China"}}},coeditorFive:null,topics:[{id:"5",title:"Agricultural and Biological Sciences",slug:"agricultural-and-biological-sciences"}],chapters:[{id:"73771",title:"Morphophysiological Traits, Biochemical Characteristic and Productivity of Wheat under Water and Nitrogen-Colimitation: Pathways to Improve Water and N Uptake",slug:"morphophysiological-traits-biochemical-characteristic-and-productivity-of-wheat-under-water-and-nitr",totalDownloads:121,totalCrossrefCites:0,authors:[null]},{id:"73824",title:"Advances in Developing Multigene Abiotic and Biotic Stress-Tolerant Rice 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Their capacity for self-proliferation and multilineage potential is promising for induction of regenerative cells without a natural capacity for self-renewal. In 2014, a groundbreaking advance in iPSC research occurred when iPSC-derived sheets of retinal pigment epithelium were transplanted to a patient with age-related macular degeneration, the first report of iPSC treatment in humans [3]. Since then, explosive expansion clinical iPSC treatment of patients with otherwise intractable diseases has been expected. However, expanding the clinical use of iPSCs requires a well-defined quality standard. Generating clinical-grade iPSCs for regenerative treatments presents many challenges, and concerns over safe iPSC use must be solved promptly. For instance, ensuring that culture conditions are not exposed to risk of contamination by predictable or unpredictable agents requires a great deal of investment in terms of cost and equipment. In addition, the most clinically applicable method of generating and selecting a suitable iPSC line is under debate. Furthermore, although the construction of iPSC banks for allo-transplantation has progressed [4], generating sufficient qualified cell lines for clinical use requires several years to cover a large segment of the population. In this chapter, we discuss the current issues for expanding the clinical applications of human iPSCs.
\nIn regard to the standardization of human pluripotent stem cells, a consensus for using embryonic stem cells (ESCs) was previously announced by the International Stem Cell Banking Initiative (ISCBI) contributors and the Ethics Working Party of the International Stem Cell Forum [5]. This consensus defined general principles for human ESC banking and described quality control processes for human ESC lines. Although many of these criteria can be applied to iPSCs, standardization of iPSC lines for clinical application is not fully established because there exist various iPSC generation methods and differences between iPSC lines. The tumorigenic and differentiation properties of iPSC lines are not identical, even for those generated by the same procedure [6]. Therefore, to establish iPSC quality standards for clinical use, determining which factors can affect iPSC quality and setting up requirements for clinical application of iPSCs are critical issues. This challenge intrinsically questions whether iPSCs can be equated with ESCs. To date, the existence of epigenetic differences between iPSCs and ESCs has been shown [7], although these differences do not negate the applicability of iPSCs.
\nRecently, the previous consensus on human pluripotent stem cells was revisited with consideration of iPSCs [8]. However, international standardization of iPSC generation techniques and quality verification is challenging. Many problems must be solved, including the scientific validity of new insight into iPSCs, to determine their applicability to consensus guidelines. In addition, these guidelines mainly target requirements for cell banking. In the case of iPSCs, there will be clinical research using autogenic iPSCs similar to the first case in RIKEN [3]. Therefore, the number of institutions in which autogenic iPSCs are generated could increase above the number of institutions for cell banking. Whether the institutional criteria for generating autogenic iPSCs should be equal to those for cell banking remains vague. These points should respectively be verified and adjusted based on scientific acceptability.
\nWhen human iPSCs are applied for clinical use as a transplantation cell source, the requirements for iPSCs to satisfy clinical conditions must be validated in advance. Although most provisions for “clinical-grade” iPSCs are associated with “safety,” this term encompasses many elements at each stage of iPSC application to regenerative medicine. However, the most suitable and the safest method for generating iPSCs for clinical use has not been defined because experience in treating patients with iPSC-derived regenerative cells remains limited. Therefore, to establish novel iPSC-based regenerative therapy, all factors that might affect safety must be presented and discussed in each case.
\nFor clinical application of iPSCs, safety is mainly divided into two considerations. The first is that iPSCs must meet standards for general cell products. To establish iPSCs of clinical grade, cell culture protocols must avoid any risk of contamination with unpredictable pathogens and meet the standards for general cell products, such as good manufacturing practice (GMP) [5, 8]. Removing animal-derived products from the culture system is important for this purpose. Furthermore, iPSCs and iPSC-derived cells must not include pathogens such as harmful viruses or bacteria before clinical use. With respect to establishing cell culture protocols, accurate sample identification must be provided throughout iPSC generation and differentiation. Therefore, to meet the standards for general cell products, the establishment of extensive systems and equipment for culturing iPSCs is required.
\nThe second aspect of safety is meeting the high quality standards for clinical applicability. However, whereas standards for general cell products have been defined, standards for high-quality iPSCs that meet applicability to clinical use remain vague. For example, methods for denying the possible tumorigenicity of iPSCs and their derivatives remain undefined. In addition, in the course of generating iPSCs, many steps affect iPSC quality. Worldwide standardization of each stage of iPSC generation is desirable, but there are numerous problems to be solved before achieving this goal.
\nThe first step for applying iPSCs application to clinical use is sampling somatic cells from donors. Although this step appears simple, it already includes safety considerations. When treatment with iPSCs is proposed, whether iPSCs are generated from the patient’s own somatic cells or brought from a pool of allogeneic iPSCs such as the iPSC bank project [4] must be decided. Using allogeneic iPSCs requires co-treatment with an immune suppressor and can lead to a risk of malignant tumor and adverse effects. Generating autogenic iPSCs for each patient is ideal, but it requires a tremendous cost and time investment. Particularly, if the patient’s condition demands expediency, autogenic iPSCs might not be suitable. Even if autogenic iPSCs are available, the appropriateness of applying quality standards for the allogenic iPSC bank to autogenic iPSCs has to be considered. In addition, the choice of somatic cell sources for iPSC generation is important. Naturally, invasive cell sampling is not preferable, but the type of original cells can affect iPSC features through the residual epigenetic status of the original cells [9–12]. Therefore, this first step already requires evaluation of the appropriate choice for each case.
\nThe step following somatic cell sampling is somatic cell reprogramming. In this stage, the suitability of the combination of reprogramming factors and gene introduction vehicles must be verified. Although achievement of residual transgene-free iPSC lines was already established [13–19], the safest and most preferred type of gene vehicle and combination of reprogramming factors for clinical use are now in discussion. In addition, there are many reagent options for culturing human iPSCs, and reagent selection must be verified in advance.
\nThe next stage of clinical therapy using iPSCs is the induction of targeted cells from iPSCs. iPSC lines do not exhibit identical points of differentiation [6, 12]. Although efficient induction of intended differentiated cells and selection of suitable cell lines are important, ensuring the safety of iPSC derivatives is a more important consideration. In particular, avoiding contamination of undifferentiated cells is essential for achieving clinical application. However, methods for detecting residual undifferentiated cells also remain undefined. Selection of appropriate iPSC lines is also important for avoiding tumorigenesis, which is known to differ among cell lines [20].
\nAfter obtaining targeted cells for treatment, the method by which these cells are transplanted is also associated with safety concerns. An appropriate transplantation protocol must be examined and established in advance. In addition, establishment of safety nets for post-treatment patients is also important.
\nTherefore, although the requirements for establishing a definitive standard for clinical-grade iPSCs are unresolved, many points that affect the safety of treatments must be recognized and appropriately verified before initiating treatment.
\nAs described above, meeting standards for general cell products is required for clinical use of iPSCs. A culture condition for human pluripotent stem cells was first established for maintaining human ESCs [21] and contained several animal-derived products such as mouse embryonic fibroblasts for feeder layers and fatal bovine serum in culture medium. This culture system was applied to human iPSCs, and it successfully maintained their pluripotency and self-proliferation [2]. Since then, toward realizing the clinical use of human iPSCs, the need for an established, chemically defined condition for human iPSCs has attracted attention.
\nTo this end, many researchers have challenged the removal of animal-derived feeder cells from culture conditions. The initial condition for culturing human iPSCs contained mouse embryonic fibroblasts or immortalized mouse fibroblasts such as SNL cells [2]. Although auto-fibroblasts were applied and successfully served as alternative to animal-derived feeder cells for human iPSC generation [22], the availability of human auto-fibroblasts is quantitatively limited. Therefore, to apply human iPSCs to clinical use, replacing feeder layers with a chemically defined substitute is required.
\nPreviously, gelatinous protein mixtures were applied to culturing human pluripotent stem cells. For example, human ESCs were successfully maintained with Matrigel and chemically defined medium [23]. Although Matrigel was applicable for maintenance of human pluripotent stem cells [24–26] and achieved feeder-free human iPSC generation [27, 28], this condition was not animal product-free because the matrix is derived from Engelbreth-Holm-Swarm mouse tumor [29] and contains many types of collagens, laminin, and proteoglycans. Therefore, the essential components for human iPSC culture have been investigated.
\nOther types of matrices, such as CellStart [30, 31] and synthetic polymers [32, 33], were tested and successfully used as feeder cell substitutes for the maintenance and generation of human pluripotent stem cells. In addition, recombinant cell adhesion proteins have received attention as a defined alternative for feeder cells. For example, vitronectin is a glycoprotein present in the extracellular matrix that mediates cell adhesion and was shown to be an alternative for feeder cells in human pluripotent stem cell culture [34]. Laminin, a component of the basal lamin, is another possible alternative to feeder cells in maintenance and generation of human iPSCs [35, 36]. These products allow removal of animal-derived feeder layers from human iPSC cultures and, therefore, are useful for establishing xeno-free culture conditions for human iPSCs.
\nThe initial culture medium for iPSCs also contained animal products such as fatal bovine serum. There have been many subsequent reports of xeno-free media such as TeSR2 [37], NutriStem [38], Essential E8 [34], and StemFit [39] for human iPSC generation and maintaining. The combination of these matrices and media can achieve generation of human iPSCs under completely defined conditions, thus making iPSC generation in xeno-free conditions achievable.
\nThere are two considerations when choosing the types of donor cells. The first is whether allogenic iPSCs or autogenic iPSCs will be used. Applying autogenic iPSCs to each patient is ideal because this method is not expected to require co-treatment with an immune suppressor [40, 41]. The first case of therapy using iPSCs was performed using autogenic iPSCs [3] and was important for reaffirming the usefulness of iPSCs as a source of autogenic regenerative cells. Nevertheless, because of the immense amount of time and effort required to make autogenic iPSCs from each patient, allogenic iPSCs that are matched in human leukocyte antigen (HLA) type are an important option for establishing treatment with iPSC-derived cells [4], especially in cases that demand expedient treatment. However, covering an entire population with HLA-matched allogenic iPSCs is nearly impossible due to the high diversity of HLA genes [42]. Therefore, to achieve complete coverage of the population with iPSC banks is an important issue. In previous reports, hypoimmunogenic human pluripotent stem cells were successfully generated through genome editing [43–45]. Although these methods could complete the missing part of the iPSC bank, whether these genome-edited pluripotent cells are safe needs further validation. At this time, the imperfect coverage of iPSC banks has to be recognized. When the time limit for generating iPSCs is not severe, autogenic iPSCs might become an important option. Therefore, whether standard guidelines for clinical-grade iPSCs can be defined equally for allogenic and autogenic iPSCs is in question. In a recent report, contaminated undifferentiated iPSC-derived cells readily grew teratomas in syngeneic conditions but not in allogenic conditions supported with an immune suppressor [46]. This difference of tumorigenesis between iPSC derivatives in autogenic and allogenic conditions could complicate definition of standards for clinical-grade iPSCs.
\nThe other consideration about choosing types of donor cells is selection of the type of somatic cells for reprogramming. To date, there have been many efforts to minimize the invasiveness of sample acquisition. Previously, generating iPSCs from keratinocytes derived from plucked hair [47], fibroblasts derived from oral mucosa [48], and peripheral blood cells obtained by venipuncture [49–51] was established as less-invasive methods. However, the characteristics of iPSCs can be affected by the type of somatic cells used for their generation [10–12]. Whether residual epigenetic memory derived from original somatic cells is permissible in clinical-grade iPSCs must be considered. In addition, although blood cells are becoming the preferred material for iPSC generation, the best choice for generating iPSCs of high quality avoiding capture of somatic mutations and aberrant epigenetic memory remains undefined. These questions remain important issues toward standardization of iPSC quality.
\nIn generating iPSCs for clinical use, achieving residual transgene-free products is essential because of the possibly harmful effect of residual transgenes. Since the first report of human iPSC generation with retroviral gene introduction [2], there has been much technical progress in methods of gene introduction for iPSC generation. Currently, methods of generating transgene-free human iPSCs are established using adenovirus vectors [13], sendai virus vectors [14], transposons [16], RNA [18], recombinant protein [15, 17], or episomal vectors [19]. Even when non-viral methods such as episomal vectors are used, there is low incidence of genomic insertion of exogenous sequence. In the case of viral vectors, transposons, and episomal vectors, verification of vehicle elimination in iPSCs is necessary. Because methods for verifying the removal of these vehicles are not identical in each case, unionization and standardization of verification methods are difficult. An appropriate method must be established for each type of vehicle, or whole-genome sequencing to detect aberrant vehicle-derived sequence insertions might be essential for identifying residual transgene sequences in iPSCs.
\nIn the first report of successful mouse somatic cell reprogramming with exogenous gene introduction, forced expression of
At the other extreme, there have been many efforts to generate iPSCs using chemical compounds. Although progress in developing gene vehicles enabled generation of residual transgene-free iPSCs, the ultimate goal is to generate iPSCs without gene introduction. Many previous reports demonstrated improved reprogramming efficiency with small molecules, with some specific small molecules serving as a substitute for reprogramming factors [58]. Finally, in mice, a combination of small molecules completely reprogrammed somatic cells into pluripotent states without forced expression of exogenous genes [59, 60]. Although these chemically generated iPSCs require further verification in terms of quality such as residual epigenetic modification of somatic cells, they have the potential to become mainstream for iPSC-associated researches.
\nThe quality of mouse iPSCs has been mainly evaluated through chimerism experiments [61]. Germline contribution of iPSCs and induction of iPSC-derived mice have been the ultimate verifications of pluripotency. Previous reports of iPSC generation with TBX3 [55], L-MYC [56], or GLIS1 [57] also evaluated the quality of iPSCs through mouse chimera formation and germline contribution. However, these experiments are not applicable to human iPSCs because of ethical concerns. In addition, although an in vivo teratoma formation assay has also been used to establish the differentiation capacity of iPSCs, quantifying teratoma formation is rather difficult in contrast to in vitro differentiation because the amount of time to teratoma formation and pathological interpretation are needed. Therefore, the quality of human iPSCs has been evaluated with an in vitro differentiation assay.
\nFor example, the in vitro differentiation assay of human iPSCs revealed that differentiation was affected by donor cell types [10–12]. This phenomenon is termed “epigenetic memory” and, interestingly, does not arise from somatic cell reprogramming with nuclear transfer. Although epigenetic memory decreases with increasing culture time [12], residual epigenetic modification of iPSC origin cells must be considered when iPSCs are applied to clinical use. In addition, the gene expression of iPSCs showing a tumorigenic tendency after neural differentiation was analyzed [20], revealing that activated expression of genes containing specific LTR7 sequences in iPSCs was statistically associated with tumorigenesis. Such predictive markers for the quality of human iPSCs are important for rapid selection of cell lines suitable for clinical use.
\nRecent progress in next-generation sequencing (NGS) techniques has provided platforms for exhaustive analysis of iPSC RNA, genome, and epigenome. This type of analysis can detect chromosomal aberrations in human iPSCs as sequence abnormalities [62]. Although whether somatic cell reprogramming itself can lead to genomic abnormalities in iPSCs is in discussion, long-term culture of pluripotent stem cells is known to lead to genomic abnormalities [63]. Because mutations in protein-coding regions of the genome could trigger tumorigenesis of iPSCs, analysis of iPSCs with NGS can assume a large role in evaluating iPSC quality and selecting iPSCs suitable for clinical use.
\nAs presented above, evaluation of human iPSC quality has been performed without chimera assays. Whether all of perceptions in mouse iPSC experiments are directly applicable to human iPSCs remains a matter of debate. Therefore, investigating the chimeric contribution capacity of human iPSCs has an ultimate importance in quantifying the pluripotency of human iPSCs. In this regard, recent analysis indicated the possibility of transcending boundaries between human iPSCs and chimera formation assays. Human iPSCs and ESCs have features similar to mouse epiblast stem cells, which are in an advanced differentiation state compared to mouse ESCs [64]. Common human iPSCs and mouse epiblast stem cells are thought to be in a “primed state” distinct from the “naïve state” of mouse ESCs. Pluripotent stem cells in a primed state have difficulty in contributing chimeras in preimplantation embryos [65]. In addition, generating chimeras of human and mouse cells is ethically problematic. Therefore, methods for evaluating the quality of human iPSCs have not been standardized. However, a recent report showed that human iPSCs could contribute to chimeras in stage-matched post-implantation mouse embryos [66]. Although the observation period of chimeric embryos was limited, chimera formation experiments with human iPSCs and stage-matching post-implantation mouse embryos might represent a novel assay for evaluating the quality of human iPSCs.
\niPSCs are used as a cell source for inducing intended types of differentiated cells and are not transplanted to patients directly. Therefore, as with quality control of iPSCs, quality control of iPSC-derived products is important for ensuring the safety of clinical application of iPSCs and contains two important considerations for achieving safety.
\nThe first is purification of intended cells from a mixture of differentiated cells. Even a small contamination of undifferentiated cells in the final product could lead to teratoma development after transplantation [67]. Therefore, appropriate methods for purification are required to ensure safety. Purification of products derived from pluripotent stem cells has been previously attempted using a surface marker of pluripotent stem cells to remove undifferentiated cells [68, 69] or cell sorting targeting surface markers specific to intended cells [70, 71]. However, fluorescence-activated cell sorting with cell surface markers is difficult to apply to mass culture systems because of the large time investment required. To achieve applicability to mass culture systems, purification with medium conditions [72, 73] or with reagents with specific cytotoxic effects against undifferentiated cells [74, 75] was developed. These techniques are expected to be useful for achieving safe iPSC-derived products.
\nTo validate the quality of products derived from iPSCs, detection of residual undifferentiated cells in the product is another essential technique for avoiding tumorigenesis after transplantation. If the methods described above for purification achieve high accuracy, methods for evaluating the elimination of undifferentiated cells and assuring safety are required. However, current validation methods for detecting residual undifferentiated cells in final products from iPSCs are limited. Examining expression of pluripotent markers in products from iPSCs with qRT-PCR [76, 77] and detecting specific glycoproteins in the cell culture supernatants [78] were reported as useful methods for evaluating elimination of undifferentiated cells. To ultimately demonstrate safety, the absence of tumorigenesis in in vivo transplantation assays is required, but the appropriate observation period and numerous transplanted cells remain evasive. In addition, whether xeno-transplantation experiments truly replicate transplantation of human cases needs further validation.
\nOne of the most important issues for clinical iPSC application is the establishment of safety nets for post-treatment patients. If tumorigenic cell contaminates the final iPSC-derived product and might be transplanted into patients, measures to avoid health hazard to patients must be established. Although surgical resection of iPSC-derived tumors is one conceivable method, there will be cases that cannot be managed through surgery due to the invasiveness of the operation.
\nIntroducing a suicide system into human iPSCs before transplantation is another useful approach for ensuring safe clinical application of iPSCs. When iPSC-derived tumors occur in patients, ablation of iPSC-derived cells by switching the suicide system “on” can prevent invasive surgery in high-risk patients. For example, herpes simplex virus thymidine kinase (HSV-TK) phosphorylates ganciclovir (GCV) and leads to cytotoxicity in the presence of GCV. HSV-TK has been widely used as “suicide gene” in human ESC experiments [79]. The combination of HSV-TK and GCV was also tested in an in vivo mouse model with mouse iPSCs [80, 81]. Another possibility is the combination of inducible caspase-9 and a chemical inducer of dimerization, which was shown to work as suicide system in human iPSC derivatives [82]. Whereas the HSV-TK suicide system is cell cycle dependent, inducible caspase-9 achieves cell cycle-independent ablation of target cells. Although these systems can become an important option for treatment of iPSC-derived tumors, modified genomic introduction methods of suicide genes are required for clinical use. Because random exogenous introduction using lentiviral and retroviral vectors could break functional gene sequences in iPSCs, validation of target sites for suicide gene insertion and targeted genome editing in iPSCs is required for clinical application.
\nThis type of strategy has a disadvantage in that all iPSC-derived cells are diminished with the suicide system. When iPSC-derived tumors occur, diminishing only tumor cells while retaining the useful cells in the engrafted treatment is ideal. With this in mind, some reports showed selective suicide systems in which the suicide gene is inserted under control of a promoter of pluripotent markers [80]. However, in this area of research, how selective removal of tumor cells should be ensured remains to be solved.
\nCurrently, in contrast to research ensuring the safety of iPSCs and iPSC-derivatives, research establishing methods to manage cases in which iPSC-derived tumors occur in post-treatment patients is less common. To ensure safe clinical application of iPSCs, countermeasures for every possible contingency after treatment using iPSCs must be prepared in advance. Thus, this type of research is of considerable importance in the area of regenerative medicine.
\niPSCs are expected to serve as a novel cell source for regenerative medicine, although there are many points that require verification before expanding their application to broad clinical uses. Standardization of iPSC quality is required, but current verification and validation procedures are not perfect. This incompleteness must be widely recognized. To establish safe iPSC use in regenerative therapy, appropriate improvements of these issues and defined guidelines for iPSCs are expected.
\nInteractive media are means of communication in which the output values depend on inputs. This means that the user is actively involved in the communication. The media still has the same purpose, but entries or inputs made by user create the interaction and some interesting options when it comes to the output of the system. Interactive media is referred to conceptual design of interaction, new media, interactivity, interaction between people and computers, graphical user interface, digital culture, interactive design, and virtual reality. One of the most important characteristics of interactivity is the interaction between user and machine, where each of them has an active role.
\nInteractive multimedia allows the user to control, combine, and manipulate a variety of media types, such as text, computer graphics, audio and video materials, as well as animation. Interactive multimedia integrates computer, storage, data, phone, TV, and other information technologies. The most common interactive multimedia applications include education and training programs, video games, electronic encyclopedias, and travel guides. The user or participant in an interactive multimedia application changes their role—for the viewer becomes an active participant. It is expected that interactive multimedia systems become the next generation of electronic information systems. It should be mentioned that another name for interactive multimedia is hybrid technology, because it is able to combine the possibilities for storage capacities of computers and a digital database with an advanced tool for viewing and manipulating these materials.
\nNowadays, the fastest-changing area is dedicated to the development of teaching materials based on usage of computers, particularly interactive multimedia programs that run on personal computers. These new computer and information technologies offer students and teachers access to materials like never before. Through the storage capacity of the computer, multimedia can “deliver” enormous amounts of data to users in more useful and accessible ways [1, 2].
\nThe interaction itself involves at least two parties—the user and the system. The previously mentioned participants are complex and completely different in the way of communication and perception of task. The interface must be a link between them in order to have successful interaction. This transcription can fail in a great number of cases for several reasons. The usage of interaction models can help better understand what is happening in the interaction and to identify possible problems. Models allow, together with developing environment, to compare the different styles of interaction and to discuss issues of interaction as well [3].
\nTraditionally, the purpose of an interactive system is to assist the user in achieving the goals from the application domain.
Task analysis includes the identification of problems in terms of domains, objectives, intentions, and tasks. It can use human knowledge about tasks and objectives, in order to assess an interactive system that is designed to support them. The terms (concepts) which are used in the design of a system and a customer description are separated, so that they can be treated as separate components—the system and the user, respectively [3, 4, 5].
\nThe term
Besides cognitive aspects of design, physical aspects are also important. Sets of controls and display components should be grouped logically, in order to allow faster access to the user. This is not so important when only one user is active. But, when we take controls in power plants, aircrafts, and air traffic into consideration, it becomes vital. In each of these cases, users are under pressure, and they are faced with a huge range of displays and controls, so their appropriate physical appearance is significant.
\nThe importance of a logical grouping of controls has already been mentioned, as well as the fact that the controls should not be separated. The exact manner of organization (which will be presented) will depend on the domain of application itself. Possible ways of organizations can include the following things:
Apart from setting up the controls and displays, the whole interface system should be properly distributed according to the position of the user himself. Thus, for example, a user should be able to reach all necessary controls and to see all the displays without excessive body movement. The most important displays should be at eye level, and controls should be adjusted for space maneuvering. Display reflections should be avoided as well [3, 6].
\nErgonomics deals with solving physical problems in the interface schedule and arrangement and takes into account the design of work environment as well. Where will the system be used? Who will use it? Will people sit, stand, or move around? Again, this will depend on the domain in a great extent, and it will be critical when it comes to specific controls and operational settings. However, the physical environment in which the system is used can affect the health and safety of its users. This should be taken into account in any design [2].
\nWork on computer should not be considered as a dangerous activity, but one should bear in mind the possible implications of design on the health and safety of users. Factors in the physical environment directly affect the quality of interaction and user’s performances:
The interaction can be observed as a dialog between the user and the computer. The choice of interface style can have a profound effect on the nature of a dialog. There is a great number of common interface styles including:
\nSome of the interactions between humans and computers (or machines or technology) focus on understanding, which means that the attention is paid to the way how people interact with technology. However, a great deal of interaction between man and computer refers to how things work and how they are created. The credits for these features go to
In this part, attention will be paid to the
When someone is asked what design is, simple definition might be that the design is related to the achievement of objectives within the constraints. This definition does not say everything about the design, but it helps users to focus on the following elements:
It is impossible to accomplish all of the user’s objectives within constraints, but in life, everything is a matter of compromise, even in such cases. The best designs are created in areas where the designer understands the compromises and the factors affecting them.
\nThe most important part of interaction design or interactivity is user. It is necessary to set up a user in the first place and to keep the user in the central place [3, 6, 8].
\nHere is a brief overview of the simplified view of the four major phases focused on interaction design and interactivity, as well as supporting iteration loop:
One man cannot read and look at all the required techniques. Time is limited and there is no link between the period of design and quality of the final design. This means that a design should be accepted as final, even if it is not perfect; it is often better to have a product which is acceptable, is done on time, and costs less than to have one that has perfect interaction but was not done on time and was over a budget. For example, if a user encounters a system that appears to be perfect, one can be pretty sure that it is a poorly designed system; the system is poorly designed, not because the design is bad but because a lot of effort has been spent for the design process and designing [7, 8].
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Today his focus is on defining the growth and development strategy for the company.",institutionString:null,institution:{name:"TU Wien",country:{name:"Austria"}}},{id:"19816",title:"Prof.",name:"Alexander",middleName:null,surname:"Kokorin",slug:"alexander-kokorin",fullName:"Alexander Kokorin",position:null,profilePictureURL:"https://mts.intechopen.com/storage/users/19816/images/1607_n.jpg",biography:"Alexander I. Kokorin: born: 1947, Moscow; DSc., PhD; Principal Research Fellow (Research Professor) of Department of Kinetics and Catalysis, N. Semenov Institute of Chemical Physics, Russian Academy of Sciences, Moscow.\r\nArea of research interests: physical chemistry of complex-organized molecular and nanosized systems, including polymer-metal complexes; the surface of doped oxide semiconductors. 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