Exploring Sources Of Variability Related To The Clinical Translation Of Regenerative Engineering Products

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Exploring Sources of Variability Related to the Clinical Translation of Regenerative Engineering Products

Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 0309489091
Total Pages : 133 pages
Book Rating : 4.3/5 (94 download)

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Book Synopsis Exploring Sources of Variability Related to the Clinical Translation of Regenerative Engineering Products by : National Academies of Sciences, Engineering, and Medicine

Download or read book Exploring Sources of Variability Related to the Clinical Translation of Regenerative Engineering Products written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2019-07-19 with total page 133 pages. Available in PDF, EPUB and Kindle. Book excerpt: The emerging multidisciplinary field of regenerative engineering is devoted to the repair, regeneration, and replacement of damaged tissues or organs in the body. To accomplish this it uses a combination of principles and technologies from disciplines such as advanced materials science, developmental and stem cell biology, immunology, physics, and clinical translation. The term "regenerative engineering" reflects a new understanding of the use of tissue engineering for regeneration and also the growing number of research and product development efforts that incorporate elements from a variety of fields. Because regenerative engineered therapies rely on live cells and scaffolds, there are inherent challenges in quality control arising from variability in source and final products. Furthermore, each patient recipient, tissue donor, and product application is unique, meaning that the field faces complexities in the development of safe and effective new products and therapies which are not faced by developers of more conventional therapies. Understanding the many sources of variability can help reduce this variability and ensure consistent results. The Forum on Regenerative Medicine hosted a public workshop on October 18, 2018, in Washington, DC, to explore the various factors that must be taken into account in order to develop successful regenerative engineering products. Invited speakers and participants discussed factors and sources of variability in the development and clinical application of regenerative engineering products, characteristics of high-quality products, and how different clinical needs, models, and contexts can inform the development of a product to improve patient outcomes. This publication summarizes the presentation and discussion of the workshop.

Exploring Sources of Variability Related to the Clinical Translation of Regenerative Engineering Products

Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 0309489121
Total Pages : 133 pages
Book Rating : 4.3/5 (94 download)

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Book Synopsis Exploring Sources of Variability Related to the Clinical Translation of Regenerative Engineering Products by : National Academies of Sciences, Engineering, and Medicine

Download or read book Exploring Sources of Variability Related to the Clinical Translation of Regenerative Engineering Products written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2019-06-19 with total page 133 pages. Available in PDF, EPUB and Kindle. Book excerpt: The emerging multidisciplinary field of regenerative engineering is devoted to the repair, regeneration, and replacement of damaged tissues or organs in the body. To accomplish this it uses a combination of principles and technologies from disciplines such as advanced materials science, developmental and stem cell biology, immunology, physics, and clinical translation. The term "regenerative engineering" reflects a new understanding of the use of tissue engineering for regeneration and also the growing number of research and product development efforts that incorporate elements from a variety of fields. Because regenerative engineered therapies rely on live cells and scaffolds, there are inherent challenges in quality control arising from variability in source and final products. Furthermore, each patient recipient, tissue donor, and product application is unique, meaning that the field faces complexities in the development of safe and effective new products and therapies which are not faced by developers of more conventional therapies. Understanding the many sources of variability can help reduce this variability and ensure consistent results. The Forum on Regenerative Medicine hosted a public workshop on October 18, 2018, in Washington, DC, to explore the various factors that must be taken into account in order to develop successful regenerative engineering products. Invited speakers and participants discussed factors and sources of variability in the development and clinical application of regenerative engineering products, characteristics of high-quality products, and how different clinical needs, models, and contexts can inform the development of a product to improve patient outcomes. This publication summarizes the presentation and discussion of the workshop.

Exploring the State of the Science in the Field of Regenerative Medicine

Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 0309455111
Total Pages : 137 pages
Book Rating : 4.3/5 (94 download)

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Book Synopsis Exploring the State of the Science in the Field of Regenerative Medicine by : National Academies of Sciences, Engineering, and Medicine

Download or read book Exploring the State of the Science in the Field of Regenerative Medicine written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2017-06-16 with total page 137 pages. Available in PDF, EPUB and Kindle. Book excerpt: Regenerative medicine holds the potential to create living, functional cells and tissues that can be used to repair or replace those that have suffered potentially irreparable damage due to disease, age, traumatic injury, or genetic and congenital defects. The field of regenerative medicine is broad and includes research and development components of gene and cell therapies, tissue engineering, and non-biologic constructs. Although regenerative medicine has the potential to improve health and deliver economic benefits, this relatively new field faces challenges to developing policies and procedures to support the development of novel therapies are both safe and effective. In October 2016, the National Academies of Sciences, Engineering, and Medicine hosted a public workshop with the goal of developing a broad understanding of the opportunities and challenges associated with regenerative medicine cellular therapies and related technologies. Participants explored the state of the science of cell-based regenerative therapies within the larger context of patient care and policy. This publication summarizes the presentations and discussions from the workshop.

Regenerative Engineering

Author : Cato T. Laurencin
Publisher : CRC Press
ISBN 13 : 9781138075177
Total Pages : 435 pages
Book Rating : 4.0/5 (751 download)

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Book Synopsis Regenerative Engineering by : Cato T. Laurencin

Download or read book Regenerative Engineering written by Cato T. Laurencin and published by CRC Press. This book was released on 2018-11-06 with total page 435 pages. Available in PDF, EPUB and Kindle. Book excerpt: Distinct from tissue engineering, which focuses primarily on the repair of tissues, regenerative engineering focuses on the regeneration of tissues: creating living, functional tissue that has the ability to replace organs that are dysfunctional. The challenge of working in an area like regenerative engineering lies, in part, in the breadth of information required to truly appreciate and begin to think about this field. Regenerative Engineering introduces the field through the presentation of fundamental concepts of cell biology, stem cell science, materials science, and cell-material interactions. It also focuses on specific organ and tissue types and presents up-to-date examples of ongoing work, often in the context of a specific clinical need. Regenerative medicine focuses on the biological aspects of tissue regeneration via stem cells, factors, and cytokines, while tissue engineering focuses on the integration of materials science and life sciences. This book integrates these two areas, presenting each concept in the framework of regenerative engineering. Features: Covers a number of cutting-edge topics related to regenerative medicine and tissue engineering Includes an introductory chapter on materials science Features a number of the contributors who are world-class researchers, one of whom is Dr. Anthony Atala, whose work dealing with organ regenerative engineering was featured on Sixty Minutes Incorporates problem-based learning throughout the text, which is not hypothetical but based on actual biological, engineering, or clinical scenarios Combining science, engineering and medicine, Regenerative Engineering incorporates all of the essential elements needed for further advancement in this field. The book explores the development and examination of vital organs and tissue types and addresses concerns as it relates to the regenerative engineering of various organ tissues, vascular tissues, bone, ligament, neural tissue, and the interfaces between tissues.

Engineering Stem Cells For Tissue Regeneration

Author : Li Song
Publisher : World Scientific
ISBN 13 : 9813147768
Total Pages : 568 pages
Book Rating : 4.8/5 (131 download)

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Book Synopsis Engineering Stem Cells For Tissue Regeneration by : Li Song

Download or read book Engineering Stem Cells For Tissue Regeneration written by Li Song and published by World Scientific. This book was released on 2017-11-24 with total page 568 pages. Available in PDF, EPUB and Kindle. Book excerpt: Tissue engineering integrates knowledge and tools from biological sciences and engineering for tissue regeneration. A challenge for tissue engineering is to identify appropriate cell sources. The recent advancement of stem cell biology provides enormous opportunities to engineer stem cells for tissue engineering. The impact of stem cell technology on tissue engineering will be revolutionary. This book covers state-of-the-art knowledge on the potential of stem cells for the regeneration of a wide range of tissues and organs, including cardiovascular, musculoskeletal, neurological and skin tissues. The technology platforms for studying and engineering stem cells, such as hydrogel and biomaterials development, microfluidics system and microscale patterning, are also illustrated. Regulatory challenges and quality control for clinical translation are also detailed. This book provides an comprehensive update on the advancement in the field of stem cells and regenerative medicine, and serves as a valuable resource for both researchers and students. Contents: Tissue Engineering: From Basic Biology to Cell-Based Applications (R M Nerem)Recent Advances and Future Perspectives on Somatic Cell Reprogramming (K-Y Kim & I-H Park)Hematopoietic Stem Cells (J J Trowbridge)Mesenchymal Stem Cells for Tissue Regeneration (N F Huang & S Li)Delivery Vehicles for Deploying Mesenchymal Stem Cells in Tissue Repair (M S Friedman & J K Leach)Stem Cells for Cardiac Tissue Engineering (J L Young et al.)Cardiovascular System: Stem Cells in Tissue-Engineered Blood Vessels (R Sawh-Martinez et al.)Stem Cells for Vascular Regeneration: An Engineering Approach (L E Dickinson & S Gerecht)Stem Cells and Wound Repair (S H Ko et al.)Engineering Cartilage: From Materials to Small Molecules (J M Coburn & J H Elisseeff)Adult Stem Cells for Articular Cartilage Tissue Engineering (S Saha et al.)Stem Cells for Disc Repair (A A Allon et al.)Skeletal Tissue Engineering: Progress and Prospects (N J Panetta et al.)Clinical Applications of a Stem Cell Based Therapy for Oral Bone Reconstruction (B McAllister & K Haghighat)Therapeutic Strategies for Repairing the Injured Spinal Cord Using Stem Cells (M S Beattie & J C Bresnahan)Potential of Tissue Engineering and Neural Stem Cells in the Understanding and Treatment of Neurodegenerative Diseases (C Auclair-Daigle & F Berthod)High-Throughput Systems for Stem Cell Engineering (D A Brafman et al.)Microscale Technologies for Tissue Engineering and Stem Cell Differentiation (J W Nichol et al.)Quality Control of Autologous Cell- and Tissue-Based Therapies (N Dusserre et al.)Regulatory Challenges for Cell-Based Therapeutics (T McAllister et al.) Readership: Life science scientists; biomedical researchers; cell biologists; academics, postgraduate students and advanced undergraduate students in cell biology, biochemistry and genetics; surgeons; clinicians; biotechnology and pharmaceutical industry professionals. Keywords: Stem Cells;Tissue Engineering;Regenerative Medicine;Biotechnology;Cell EngineeringReview:0

Engineering Stem Cells for Tissue Regeneration

Author : Ngan Huang
Publisher :
ISBN 13 : 9789813147751
Total Pages : 542 pages
Book Rating : 4.1/5 (477 download)

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Book Synopsis Engineering Stem Cells for Tissue Regeneration by : Ngan Huang

Download or read book Engineering Stem Cells for Tissue Regeneration written by Ngan Huang and published by . This book was released on 2018 with total page 542 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Principles of Regenerative Medicine

Author : Anthony Atala
Publisher : Academic Press
ISBN 13 : 9780123814234
Total Pages : 1202 pages
Book Rating : 4.8/5 (142 download)

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Book Synopsis Principles of Regenerative Medicine by : Anthony Atala

Download or read book Principles of Regenerative Medicine written by Anthony Atala and published by Academic Press. This book was released on 2010-12-16 with total page 1202 pages. Available in PDF, EPUB and Kindle. Book excerpt: Virtually any disease that results from malfunctioning, damaged, or failing tissues may be potentially cured through regenerative medicine therapies, by either regenerating the damaged tissues in vivo, or by growing the tissues and organs in vitro and implanting them into the patient. Principles of Regenerative Medicine discusses the latest advances in technology and medicine for replacing tissues and organs damaged by disease and of developing therapies for previously untreatable conditions, such as diabetes, heart disease, liver disease, and renal failure. Key for all researchers and instituions in Stem Cell Biology, Bioengineering, and Developmental Biology The first of its kind to offer an advanced understanding of the latest technologies in regenerative medicine New discoveries from leading researchers on restoration of diseased tissues and organs

Bone Tissue Engineering

Author : Jeffrey O. Hollinger
Publisher : CRC Press
ISBN 13 : 1135501912
Total Pages : 500 pages
Book Rating : 4.1/5 (355 download)

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Book Synopsis Bone Tissue Engineering by : Jeffrey O. Hollinger

Download or read book Bone Tissue Engineering written by Jeffrey O. Hollinger and published by CRC Press. This book was released on 2004-10-14 with total page 500 pages. Available in PDF, EPUB and Kindle. Book excerpt: Focusing on bone biology, Bone Tissue Engineering integrates basic sciences with tissue engineering. It includes contributions from world-renowned researchers and clinicians who discuss key topics such as different models and approaches to bone tissue engineering, as well as exciting clinical applications for patients. Divided into four sections, t

Frontiers in Tissue Engineering

Author : C.W. Patrick
Publisher : Elsevier
ISBN 13 : 9780080532059
Total Pages : 700 pages
Book Rating : 4.5/5 (32 download)

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Book Synopsis Frontiers in Tissue Engineering by : C.W. Patrick

Download or read book Frontiers in Tissue Engineering written by C.W. Patrick and published by Elsevier. This book was released on 1998-02-20 with total page 700 pages. Available in PDF, EPUB and Kindle. Book excerpt: Frontiers in Tissue Engineering is a carefully edited compilation of state-of-the-art contributions from an international authorship of experts in the diverse subjects that make up tissue engineering. A broad representation of the medical, scientific, industrial and regulatory community is detailed in the book. The work is an authoritative and comprehensive reference source for scientists and clinicians working in this emerging field. The book is divided into three parts: fundamentals and methods of tissue engineering, tissue engineering applied to specialised tissues, and tissue engineering applied to organs. The text offers many novel approaches, including a detailed coverage of cell-tissue interactions at cellular and molecular levels; cell-tissue surface, biochemical, and mechanical environments; biomaterials; engineering design; tissue-organ function; new approaches to tissue-organ regeneration and replacement of function; ethical considerations of tissue engineering; and government regulation of tissue-engineered products.

Fundamentals of Tissue Engineering and Regenerative Medicine

Author : Ulrich Meyer
Publisher : Springer Science & Business Media
ISBN 13 : 3540777555
Total Pages : 1049 pages
Book Rating : 4.5/5 (47 download)

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Book Synopsis Fundamentals of Tissue Engineering and Regenerative Medicine by : Ulrich Meyer

Download or read book Fundamentals of Tissue Engineering and Regenerative Medicine written by Ulrich Meyer and published by Springer Science & Business Media. This book was released on 2009-02-11 with total page 1049 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Fundamentals of Tissue Engineering and Regenerative Medicine" provides a complete overview of the state of the art in tissue engineering and regenerative medicine. Tissue engineering has grown tremendously during the past decade. Advances in genetic medicine and stem cell technology have significantly improved the potential to influence cell and tissue performance, and have recently expanded the field towards regenerative medicine. In recent years a number of approaches have been used routinely in daily clinical practice, others have been introduced in clinical studies, and multitudes are in the preclinical testing phase. Because of these developments, there is a need to provide comprehensive and detailed information for researchers and clinicians on this rapidly expanding field. This book offers, in a single volume, the prerequisites of a comprehensive understanding of tissue engineering and regenerative medicine. The book is conceptualized according to a didactic approach (general aspects: social, economic, and ethical considerations; basic biological aspects of regenerative medicine: stem cell medicine, biomolecules, genetic engineering; classic methods of tissue engineering: cell, tissue, organ culture; biotechnological issues: scaffolds; bioreactors, laboratory work; and an extended medical discipline oriented approach: review of clinical use in the various medical specialties). The content of the book, written in 68 chapters by the world’s leading research and clinical specialists in their discipline, represents therefore the recent intellect, experience, and state of this bio-medical field.

Stem Cells and the Future of Regenerative Medicine

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309170427
Total Pages : 112 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Stem Cells and the Future of Regenerative Medicine by : Institute of Medicine

Download or read book Stem Cells and the Future of Regenerative Medicine written by Institute of Medicine and published by National Academies Press. This book was released on 2002-01-25 with total page 112 pages. Available in PDF, EPUB and Kindle. Book excerpt: Recent scientific breakthroughs, celebrity patient advocates, and conflicting religious beliefs have come together to bring the state of stem cell researchâ€"specifically embryonic stem cell researchâ€"into the political crosshairs. President Bush's watershed policy statement allows federal funding for embryonic stem cell research but only on a limited number of stem cell lines. Millions of Americans could be affected by the continuing political debate among policymakers and the public. Stem Cells and the Future of Regenerative Medicine provides a deeper exploration of the biological, ethical, and funding questions prompted by the therapeutic potential of undifferentiated human cells. In terms accessible to lay readers, the book summarizes what we know about adult and embryonic stem cells and discusses how to go about the transition from mouse studies to research that has therapeutic implications for people. Perhaps most important, Stem Cells and the Future of Regenerative Medicine also provides an overview of the moral and ethical problems that arise from the use of embryonic stem cells. This timely book compares the impact of public and private research funding and discusses approaches to appropriate research oversight. Based on the insights of leading scientists, ethicists, and other authorities, the book offers authoritative recommendations regarding the use of existing stem cell lines versus new lines in research, the important role of the federal government in this field of research, and other fundamental issues.

Guidelines for Human Embryonic Stem Cell Research

Author : National Research Council
Publisher : National Academies Press
ISBN 13 : 0309096537
Total Pages : 224 pages
Book Rating : 4.3/5 (9 download)

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Book Synopsis Guidelines for Human Embryonic Stem Cell Research by : National Research Council

Download or read book Guidelines for Human Embryonic Stem Cell Research written by National Research Council and published by National Academies Press. This book was released on 2005-09-15 with total page 224 pages. Available in PDF, EPUB and Kindle. Book excerpt: Since 1998, the volume of research being conducted using human embryonic stem (hES) cells has expanded primarily using private funds because of restrictions on the use of federal funds for such research. Given limited federal involvement, privately funded hES cell research has thus far been carried out under a patchwork of existing regulations, many of which were not designed with this research specifically in mind. In addition, hES cell research touches on many ethical, legal, scientific, and policy issues that are of concern to the public. This report provides guidelines for the conduct of hES cell research to address both ethical and scientific concerns. The guidelines are intended to enhance the integrity of privately funded hES cell research by encouraging responsible practices in the conduct of that research.

Understanding the Role of the Immune System in Improving Tissue Regeneration

Author : Engineering National Academies of Sciences (and Medicine)
Publisher :
ISBN 13 : 9780309688185
Total Pages : 0 pages
Book Rating : 4.6/5 (881 download)

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Book Synopsis Understanding the Role of the Immune System in Improving Tissue Regeneration by : Engineering National Academies of Sciences (and Medicine)

Download or read book Understanding the Role of the Immune System in Improving Tissue Regeneration written by Engineering National Academies of Sciences (and Medicine) and published by . This book was released on 2022 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: "The Forum on Regenerative Medicine of the National Academies of Sciences, Engineering, and Medicine convened a two-day virtual public workshop to address knowledge gaps in the understanding of promising approaches to manipulate the immune system and/or the regenerative medicine product to improve outcomes of tissue repair and regeneration in patients. The workshop, titled 'Understanding the Role of the Immune System in Improving Tissue Regeneration,' explored the role of the immune system in the success or failure of regenerative medicine therapies. Participants considered potential strategies to effectively 'prepare' patients' immune systems to accept regenerative therapies and increase the likelihood of successful clinical outcomes and also discussed risks associated with modulating the immune system. This Proceedings of a Workshop highlights the presentations and discussions that occurred during the workshop"--

Convergence

Author : National Research Council
Publisher : National Academies Press
ISBN 13 : 0309301645
Total Pages : 152 pages
Book Rating : 4.3/5 (93 download)

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Book Synopsis Convergence by : National Research Council

Download or read book Convergence written by National Research Council and published by National Academies Press. This book was released on 2014-06-16 with total page 152 pages. Available in PDF, EPUB and Kindle. Book excerpt: Convergence of the life sciences with fields including physical, chemical, mathematical, computational, engineering, and social sciences is a key strategy to tackle complex challenges and achieve new and innovative solutions. However, institutions face a lack of guidance on how to establish effective programs, what challenges they are likely to encounter, and what strategies other organizations have used to address the issues that arise. This advice is needed to harness the excitement generated by the concept of convergence and channel it into the policies, structures, and networks that will enable it to realize its goals. Convergence investigates examples of organizations that have established mechanisms to support convergent research. This report discusses details of current programs, how organizations have chosen to measure success, and what has worked and not worked in varied settings. The report summarizes the lessons learned and provides organizations with strategies to tackle practical needs and implementation challenges in areas such as infrastructure, student education and training, faculty advancement, and inter-institutional partnerships.

Regenerative Pharmacology

Author : George J. Christ
Publisher : Cambridge University Press
ISBN 13 : 1107354730
Total Pages : 361 pages
Book Rating : 4.1/5 (73 download)

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Book Synopsis Regenerative Pharmacology by : George J. Christ

Download or read book Regenerative Pharmacology written by George J. Christ and published by Cambridge University Press. This book was released on 2013-04-15 with total page 361 pages. Available in PDF, EPUB and Kindle. Book excerpt: Regenerative medicine is broadly defined as the repair or replacement of damaged cells, tissues and organs. It is a multidisciplinary effort in which technologies derive from the fields of cell, developmental and molecular biology; chemical and material sciences (i.e. nanotechnology); engineering; surgery; transplantation; immunology; molecular genetics; physiology; and pharmacology. As regenerative medicine technologies continue to evolve and expand across the boundaries of numerous scientific disciplines, they remain at the forefront of the translational research frontier with the potential to radically alter the treatment of a wide variety of disease and dysfunction. This book will draw attention to the critical role that pharmacological sciences will undeniably play in the advancement of these treatments. This book is invaluable for advanced students, postdoctoral fellows, researchers new to the field of regenerative medicine/tissue engineering, and experienced investigators looking for new research avenues. The first state-of-the-art book in this rapidly evolving field of research.

Developmental Biology and Musculoskeletal Tissue Engineering

Author : Martin J. Stoddart
Publisher : Academic Press
ISBN 13 : 0128115386
Total Pages : 270 pages
Book Rating : 4.1/5 (281 download)

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Book Synopsis Developmental Biology and Musculoskeletal Tissue Engineering by : Martin J. Stoddart

Download or read book Developmental Biology and Musculoskeletal Tissue Engineering written by Martin J. Stoddart and published by Academic Press. This book was released on 2018-04-24 with total page 270 pages. Available in PDF, EPUB and Kindle. Book excerpt: Developmental Biology and Musculoskeletal Tissue Engineering: Principles and Applications focuses on the regeneration of orthopedic tissue, drawing upon expertise from developmental biologists specializing in orthopedic tissues and tissue engineers who have used and applied developmental biology approaches. Musculoskeletal tissues have an inherently poor repair capacity, and thus biologically-based treatments that can recapitulate the native tissue properties are desirable. Cell- and tissue-based therapies are gaining ground, but basic principles still need to be addressed to ensure successful development of clinical treatments. Written as a source of information for practitioners and those with a nascent interest, it provides background information and state-of-the-art solutions and technologies. Recent developments in orthopedic tissue engineering have sought to recapitulate developmental processes for tissue repair and regeneration, and such developmental-biology based approaches are also likely to be extremely amenable for use with more primitive stem cells. Brings the fields of tissue engineering and developmental biology together to explore the potential for regenerative medicine-based research to contribute to enhanced clinical outcomes Initial chapters provide an outline of the development of the musculoskeletal system in general, and later chapters focus on specific tissues Addresses the effect of mechanical forces on the musculoskeletal system during development and the relevance of these processes to tissue engineering Discusses the role of genes in the development of musculoskeletal tissues and their potential use in tissue engineering Describes how developmental biology is being used to influence and guide tissue engineering approaches for cartilage, bone, disc, and tendon repair

Regulatory Aspects of Gene Therapy and Cell Therapy Products

Author : Maria Cristina Galli
Publisher : Springer Nature
ISBN 13 : 3031345673
Total Pages : 243 pages
Book Rating : 4.0/5 (313 download)

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Book Synopsis Regulatory Aspects of Gene Therapy and Cell Therapy Products by : Maria Cristina Galli

Download or read book Regulatory Aspects of Gene Therapy and Cell Therapy Products written by Maria Cristina Galli and published by Springer Nature. This book was released on 2023-08-01 with total page 243 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book discusses the different regulatory pathways for Advanced Therapy Medicinal Products implemented by national agencies in North and South America, Europe and Asia and by international bodies in the effort of international harmonization. This book represents an update of the first edition, as it covers regulatory novelties and accumulated experience in the regions already addressed. In addition, this new edition offers a wider international perspective: new chapters are included covering Advanced Therapy Medicinal Products regulations in India, Malaysia, Spain and Thailand, the European Pharmacopoeia texts for gene therapy medicinal products as well as international harmonization programs. Each chapter, authored by experts from various regulatory bodies throughout the international community, walks the reader through the applications of nonclinical research to translational clinical research to licensure and therapeutic use of these innovative products. More specifically, each chapter offers insights into fundamental considerations that are essential for developers of Advanced Therapy Medicinal Products in the areas of product quality, pharmacology and toxicology, clinical trial design and HTA pathways, as well as pertinent ‘must-know’ guidelines and regulations. Regulatory Aspects of Gene Therapy and Cell Therapy Products: a Global Perspective is part of the American Society of Gene & Cell Therapy sub-series of the highly successful Advances in Experimental Medicine and Biology series. It is essential reading for graduate students, clinicians, and researchers interested in gene and cell therapy and the regulation of pharmaceuticals.