November 26, 2020

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Stem Cell Manufacturing

Stem Cell Manufacturing
Author : Joaquim M. S. Cabral,Claudia Lobato da Silva,Lucas G. Chase,Maria Margarida Diogo
Publisher : Elsevier
Release Date : 2016-07-24
Category : Medical
Total pages :340
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Stem Cell Manufacturing discusses the required technologies that enable the transfer of the current laboratory-based practice of stem cell tissue culture to the clinic environment as therapeutics, while concurrently achieving control, reproducibility, automation, validation, and safety of the process and the product. The advent of stem cell research unveiled the therapeutic potential of stem cells and their derivatives and increased the awareness of the public and scientific community for the topic. The successful manufacturing of stem cells and their derivatives is expected to have a positive impact in the society since it will contribute to widen the offer of therapeutic solutions to the patients. Fully defined cellular products can be used to restore the structure and function of damaged tissues and organs and to develop stem cell-based cellular therapies for the treatment of cancer and hematological disorders, autoimmune and other inflammatory diseases and genetic disorders. Presents the first ‘Flowchart‘ of stem cell manufacturing enabling easy understanding of the various processes in a sequential and coherent manner Covers all bioprocess technologies required for the transfer of the bench findings to the clinic including the process components: cell signals, bioreactors, modeling, automation, safety, etc. Presents comprehensive coverage of a true multidisciplinary topic by bringing together specialists in their particular area Provides the basics of the processes and identifies the issues to be resolved for large scale cell culture by the bioengineer Addresses the critical need in bioprocessing for the successful delivery of stem cell technology to the market place by involving professional engineers in sections of the book

Mesenchymal Stem Cell Manufacturing for Clinical Use

Mesenchymal Stem Cell Manufacturing for Clinical Use
Author : Franca Fagioli
Publisher : Unknown
Release Date : 2015
Category : Science
Total pages :129
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Mesenchymal stromal/stem cells (MSCs) are adult, self-renewable, multipotent cells that can be isolated in various tissues, most commonly bone marrow (BM) and adipose tissue. Because of their capacity for self-renewal and differentiation into tissues of mesodermal origin and due to their immunomodulatory ability, MSCs are used in many preclinical and clinical studies as possible new therapeutic agents for the treatment of a very broad range of conditions, including heart, hepatic, and neurodegenerative diseases.

Stem Cells and Good Manufacturing Practices

Stem Cells and Good Manufacturing Practices
Author : Kursad Turksen
Publisher : Humana Press
Release Date : 2015-02-14
Category : Science
Total pages :220
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This volume collects a series of protocols describing the kinds of infrastructures, training, and standard operating procedures currently available to actualize the potential of stem cells for regenerative therapies. Stem Cells and Good Manufacturing Practices: Methods, Protocols, and Regulations pulls together key GMP techniques from laboratories around the world. Written in the highly successful Methods in Molecular Biology series format, chapters include introductions to their respective topics, lists of the necessary materials, step-by-step, readily reproducible laboratory protocols, and tips on troubleshooting and avoiding known pitfalls. Inclusive and authoritative, Stem Cells and Good Manufacturing Practices: Methods, Protocols, and Regulations will be an invaluable resource to both basic and clinical practitioners in stem cell biology.

Progress in Stem Cell Transplantation

Progress in Stem Cell Transplantation
Author : Taner Demirer
Publisher : BoD – Books on Demand
Release Date : 2015-12-02
Category : Science
Total pages :208
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This book documents the increased amount of stem cell-related research, basic and clinical applications as well as views for the future. The book covers a wide range of issues related to new developments and innovations in cell-based therapies discussed in basic and clinical chapters from authors around the world involved in stem cell studies and research. It thereby complements and extends the basic coverage of stem cells, such as mesenchymal stem cells, effect of stem cells on aging, cover hematopoietic stem cells, storage and cryopreservation, issues related to clinical applications such as haploidentical transplants and use of stem cells for the treatment of Huntingtons disease. Clearly, the treatment of various malignant and nonmalignant diseases depends heavily on stem cells, and this book is well positioned to provide comprehensive coverage of these developments.

Stem Cells in Clinical Practice and Tissue Engineering

Stem Cells in Clinical Practice and Tissue Engineering
Author : Rakesh Sharma
Publisher : BoD – Books on Demand
Release Date : 2018-05-02
Category : Science
Total pages :352
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Stem Cells in Clinical Practice and Tissue Engineering is a concise book on applied methods of stem cell differentiation and optimization using tissue engineering methods. These methods offer immediate use in clinical regenerative medicine. The present volume will serve the purpose of applied stem cell differentiation optimization methods in clinical research projects, as well as be useful to relatively experienced stem cell scientists and clinicians who might wish to develop their stem cell clinical centers or research labs further. Chapters are arranged in the order of basic concepts of stem cell differentiation, clinical applications of pluripotent stem cells in skin, cardiac, bone, dental, obesity centers, followed by tissue engineering, new materials used, and overall evaluation with their permitted legal status.

Cell Therapy

Cell Therapy
Author : Adrian Gee
Publisher : Springer Science & Business Media
Release Date : 2009-09-18
Category : Science
Total pages :256
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Cell Therapy: cGMP Facilities and Manufacturing is the source for a complete discussion of facility design and operation with practical approaches to a variety of day-to-day activities, such as staff training and competency, cleaning procedures, and environmental monitoring. This in-depth book also includes detailed reviews of quality, the framework of regulations, and professional standards. It meets a previously unmet need for a thorough facility-focused resource, Cell Therapy: cGMP Facilities and Manufacturing will be an important addition to the cell therapy professional’s library. Additional topics in Cell Therapy: cGMP Facilities and Manufacturing...Standard operating procedures - Supply management - Facility equipment - Product manufacturing, review, release and administration - Facility master file.

Stem Cells and Cell Therapy

Stem Cells and Cell Therapy
Author : Mohamed Al-Rubeai,Mariam Naciri
Publisher : Springer Science & Business Media
Release Date : 2013-10-01
Category : Medical
Total pages :189
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With the discovery of stem cells capable of multiplying indefinitely in culture and differentiating into many other cell types in appropriate conditions, new hopes were born in repair and replacement of damaged cells and tissues. The features of stem cells may provide treatment for some incurable diseases with some therapies are already in clinics, particularly those from adult stem cells. Some treatments will require large number of cells and may also require multiple doses, generating a growing demand for generating and processing large numbers of cells to meet the need of clinical applications. With this in mind, our aim is to provide a book on the subject of stem cells and cell therapy for researchers and students of cell biotechnology, bioengineering and bioproduction. This book is exceptional as it teaches researchers stem cells and cell therapy in that it covers the concepts and backgrounds necessary so that readers get a good understanding of the production of stem cells. The book covers three topics: The basics of stem cells and cell therapy, the use of stem cells for the treatment of human diseases, and stem cell processing. It includes chapters on neural and vascular stem vascular stem cell therapy, expansion engineering of embryonic stem cells, stem cell based production of blood cells and separation technologies for stem cells and cell therapy products. It is an informed and informative presentation of what modern research, science and engineering have learned about stem cells and their production and therapies. Addressing both the medical and production issues, this book is an invaluable contribution to having an academic and industrial understanding with respect to R&D and manufacturing of clinical grade stem cells.

Stem Cell Bioprocessing and Manufacturing

Stem Cell Bioprocessing and Manufacturing
Author : Joaquim M S Cabral,Cláudia Lobato Da Silva,Maria Margarida Diogo
Publisher : Mdpi AG
Release Date : 2020-08-24
Category : Science
Total pages :170
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The next healthcare revolution will apply regenerative medicines using human cells and tissues. The aim of the regenerative medicine approach is to create biological therapies or substitutes in vitro for the replacement or restoration of tissue function in vivo lost through failure or disease. However, whilst science has revealed the potential, and early products have shown the power of such therapies, there is an immediate and long-term need for expertise with the necessary skills to face the engineering and life science challenges before the predicted benefits in human healthcare can be realized. Specifically, there is a need for the development of bioprocess technology for the successful transfer of laboratory-based practice of stem cell and tissue culture to the clinic as therapeutics through the application of engineering principles and practices. This Special Issue of Bioengineering on Stem Cell Bioprocessing and Manufacturing addresses the central role in defining the engineering sciences of cell-based therapies, by bringing together contributions from worldwide experts on stem cell biology and engineering, bioreactor design and bioprocess development, scale-up, and manufacturing of stem cell-based therapies.

Mesenchymal Stem Cell Therapy

Mesenchymal Stem Cell Therapy
Author : Lucas G. Chase,Mohan C Vemuri
Publisher : Springer Science & Business Media
Release Date : 2012-12-12
Category : Science
Total pages :456
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Over the past decade, significant efforts have been made to develop stem cell-based therapies for difficult to treat diseases. Multipotent mesenchymal stromal cells, also referred to as mesenchymal stem cells (MSCs), appear to hold great promise in regards to a regenerative cell-based therapy for the treatment of these diseases. Currently, more than 200 clinical trials are underway worldwide exploring the use of MSCs for the treatment of a wide range of disorders including bone, cartilage and tendon damage, myocardial infarction, graft-versus-host disease, Crohn’s disease, diabetes, multiple sclerosis, critical limb ischemia and many others. MSCs were first identified by Friendenstein and colleagues as an adherent stromal cell population within the bone marrow with the ability to form clonogenic colonies in vitro. In regards to the basic biology associated with MSCs, there has been tremendous progress towards understanding this cell population’s phenotype and function from a range of tissue sources. Despite enormous progress and an overall increased understanding of MSCs at the molecular and cellular level, several critical questions remain to be answered in regards to the use of these cells in therapeutic applications. Clinically, both autologous and allogenic approaches for the transplantation of MSCs are being explored. Several of the processing steps needed for the clinical application of MSCs, including isolation from various tissues, scalable in vitro expansion, cell banking, dose preparation, quality control parameters, delivery methods and numerous others are being extensively studied. Despite a significant number of ongoing clinical trials, none of the current therapeutic approaches have, at this point, become a standard of care treatment. Although exceptionally promising, the clinical translation of MSC-based therapies is still a work in progress. The extensive number of ongoing clinical trials is expected to provide a clearer path forward for the realization and implementation of MSCs in regenerative medicine. Towards this end, reviews of current clinical trial results and discussions of relevant topics association with the clinical application of MSCs are compiled in this book from some of the leading researchers in this exciting and rapidly advancing field. Although not absolutely all-inclusive, we hope the chapters within this book can promote and enable a better understanding of the translation of MSCs from bench-to-bedside and inspire researchers to further explore this promising and quickly evolving field.

Perinatal Stem Cells

Perinatal Stem Cells
Author : Zhong Chao Han,Tsuneo A. Takahashi,Zhibo Han,Zongjin Li
Publisher : Springer
Release Date : 2019-04-06
Category : Health & Fitness
Total pages :173
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This book provides a comprehensive introduction to various types of perinatal stem cells. Given their unique regenerative abilities, stem cells offer a promising avenue in the treatment of degenerative diseases or injury. Currently, the limitations of postnatal cell sources and expanding efficiency may limit autologous stem cell therapies. Although embryonic stem cells (ESCs) and induced pluripotent stem cells (iPSCs) can be cultured indefinitely ex vivo, and can differentiate into three germ layers, ethical issues, the teratoma formation of ESCs and oncogenic risk of iPSCs are major obstacles to their clinical application. More recently, perinatal stem cells have been isolated from the umbilical cord, Wharton’s Jelly, placenta, amniotic membrane and amniotic fluid, which are normally discarded as medical waste. This book, after describing perinatal stem cells in detail, introduces readers to the various types of perinatal stem cells, addressing their characterization, banking, quality control and stability. Importantly, it also reviews the clinical applications of perinatal stem cells to therapy of diseases. Accordingly, it offers a valuable resource for clinicians, researchers and graduate students alike.

Translational Regenerative Medicine

Translational Regenerative Medicine
Author : Anthony Atala,Julie Allickson
Publisher : Academic Press
Release Date : 2014-12-01
Category : Science
Total pages :606
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Translational Regenerative Medicine is a reference book that outlines the life cycle for effective implementation of discoveries in the dynamic field of regenerative medicine. By addressing science, technology, development, regulatory, manufacturing, intellectual property, investment, financial, and clinical aspects of the field, this work takes a holistic look at the translation of science and disseminates knowledge for practical use of regenerative medicine tools, therapeutics, and diagnostics. Incorporating contributions from leaders in the fields of translational science across academia, industry, and government, this book establishes a more fluid transition for rapid translation of research to enhance human health and well-being. Provides formulaic coverage of the landscape, process development, manufacturing, challenges, evaluation, and regulatory aspects of the most promising regenerative medicine clinical applications Covers clinical aspects of regenerative medicine related to skin, cartilage, tendons, ligaments, joints, bone, fat, muscle, vascular system, hematopoietic /immune system, peripheral nerve, central nervous system, endocrine system, ophthalmic system, auditory system, oral system, respiratory system, cardiac system, renal system, hepatic system, gastrointestinal system, genitourinary system Identifies effective, proven tools and metrics to identify and pursue clinical and commercial regenerative medicine

Perinatal Tissue-Derived Stem Cells

Perinatal Tissue-Derived Stem Cells
Author : Babak Arjmand
Publisher : Springer
Release Date : 2016-12-01
Category : Science
Total pages :239
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This book covers several aspects of perinatal tissue-derived stem cells, from theoretical concepts to clinical applications. Topics include functions and different sources, immunomodulatory properties, translational point of view, GMP facility design and manufacturing for clinical translation, therapeutic potentials, and finally ethical considerations. The text provides a brief review of each type of perinatal stem cells and then focuses on their multi- or pluripotent properties, regenerative capacity, and future therapeutic potential in regenerative medicine. Additionally, the book discusses GMP compliance in stem cell facilities and the manufacture of stem cells for clinical translation. The chapters are authored by world-renowned experts in the perinatal stem cell field. Perinatal Tissue-Derived Stem Cells: Alternative Sources of Fetal Stem Cells, part of Springer’s Stem Cell Biology and Regenerative Medicine series, is essential reading for basic and clinical scientists, clinicians, and pharmaceutical experts working or conducting research in the fields of stem cell biology, molecular aspects of stem cell research, tissue engineering, regenerative medicine, and cellular therapy.

Engineering Strategies for Regenerative Medicine

Engineering Strategies for Regenerative Medicine
Author : Tiago G. Fernandes,M. Margardia Diogo,Joaquim M.S. Cabral
Publisher : Academic Press
Release Date : 2019-11-14
Category : Science
Total pages :284
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Engineering Strategies for Regenerative Medicine considers how engineering strategies can be applied to accelerate advances in regenerative medicine. The book provides relevant and up-to-date content on key topics, including the interdisciplinary integration of different aspects of stem cell biology and technology, diverse technologies, and their applications. By providing massive amounts of data on each individual, recent scientific advances are rapidly accelerating medicine. Cellular, molecular and genetic parameters from biological samples combined with clinical information can now provide valuable data to scientists, clinicians and ultimately patients, leading to the development of precision medicine. Equally noteworthy are the contributions of stem cell biology, bioengineering and tissue engineering that unravel the mechanisms of disease, regeneration and development. Considers how engineering strategies can accelerate novel advances in regenerative medicine Takes an interdisciplinary approach, integrating different aspects of research, technology and application Provides up-to-date coverage on this rapidly developing area of medicine Presents insights from an experienced and cross-disciplinary group of researchers and practitioners with close links to industry

Stem Cell Banking

Stem Cell Banking
Author : Dusko Ilic
Publisher : Springer
Release Date : 2014-05-05
Category : Science
Total pages :168
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This book exemplifies experience across the globe in banking of cord blood, mesenchymal, embryonic and induced pluripotent stem cells for clinical use from the United States, Canada, the European Union, Switzerland and Japan to Iran, India and Serbia. The concerns are similar regardless of stem cell type or origin. Implementing core values and common standards depend often on specific circumstances of political and economic setting, which makes flexibility as important as systematic planning. Banking of stem cells is not just building a repository and storing samples. The planning, design, construction and maintenance involve multiple skilled professionals. Stem cell banks are points where technology and medicine converge with ethics, laws and regulations. If properly designed and organized, their utilization will have a broad impact not only on the scientific community and medical professionals but also on the general public.

Perinatal Stem Cells

Perinatal Stem Cells
Author : Anthony Atala,Sean V. Murphy
Publisher : Springer
Release Date : 2014-08-28
Category : Science
Total pages :373
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This comprehensive volume is one of the first books to offer the reader detailed insight into sources of perinatal stem cells, their biology, and their potential for disease treatment. It examines the research and therapeutic applications of perinatal stem cells including the treatment of renal disease, hematopoietic regeneration, cardiac disease, inflammatory disease, bone regeneration, pulmonary disease, and the treatment of spinal cord injury. Further, the book discusses current progress in the manufacturing, banking and clinical translation of perinatal stem cells. Through this book, readers will gain a thorough understanding of the current pre-clinical and clinical applications of perinatal stem cells as well as the efforts to support the transition of perinatal stem cell therapies from laboratories to clinics. Perinatal Stem Cells contains thirty-two chapters written by internationally recognized leaders in stem cell research. It is organized into four sections covering amniotic fluid stem cells, placental and placental membrane stem cells, umbilical cord stem cells, and clinical translation. This cohesive structure provides an effective framework for detailed insight into this new frontier. Edited by Dr. Anthony Atala, one of the foremost experts in the field, and his co-editor Dr. Sean V. Murphy, this volume is a definitive work for stem cell research and its future implications. It is a key resource for all stem cell researchers, clinicians, and government and industry staff working in this dynamic and exciting field.