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Author: Adrian Gee Publisher: Springer Science & Business Media ISBN: 0387895841 Category : Science Languages : en Pages : 256
Book Description
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.
Author: Adrian Gee Publisher: Springer Science & Business Media ISBN: 0387895841 Category : Science Languages : en Pages : 256
Book Description
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.
Author: Joaquim Vives Publisher: Academic Press ISBN: 0128031166 Category : Medical Languages : en Pages : 266
Book Description
Guide to Cell Therapy GxP is a practical guide to the implementation of quality assurance systems for the successful performance of all cell-based clinical trials. The book covers all information that needs to be included in investigational medicinal product dossier (IMPD), the launching point for any clinical investigation, and beyond. Guide to Cell Therapy GxP bridges a knowledge gap with the inclusion of examples of design of GLP-compliant preclinical studies; design of bioprocesses for autologous/allogeneic therapies; and instruction on how to implement GLP/GMP standards in centers accredited with other quality assurance standards. Guide to Cell Therapy GxP is an essential resource for scientists and researchers in hospitals, transfusion centers, tissue banks, and other research institutes who may not be familiar with the good scientific practice regulations that were originally designed for product development in corporate environments. This book is also a thorough resource for PhD students, Post-docs, Principal Investigators, Quality Assurance Units, and Government Inspectors who want to learn more about how quality standards are implemented in public institutions developing cell-based products. Easy access to important information on current regulations, state-of-the-art techniques, and recent advances otherwise scattered on various funding websites, within conference proceedings, or maintained in local knowledge Features protocols, techniques for trouble-shooting common problems, and an explanation of the advantages and limitations of a technique in generating conclusive data Includes practical examples of successful implementation of quality standards
Author: Hala M. Gabr Publisher: Academic Press ISBN: 0128215704 Category : Science Languages : en Pages : 166
Book Description
Stem cell therapy is a fast-growing field of medicine with remarkable prospects in a broad spectrum of diseases. Stem Cell Therapy: Practical Considerations addresses the biological properties of stem cells, mechanisms of action; as well as actual therapeutic decisions such as cell type, source, dose, manipulation, and route of injection. After discussing all this data, the book will illustrate how to travel through the idea from abstract question to laboratory experiment, animal experiment and then on to design a clinical trial throughout all its phases. Written for scientists and postgraduate students in the field of stem cell research and therapy. The authors will cover practical therapeutic issues they have long experienced in the field. Provides readers the basics and clinical practice of stem cell therapy Helps to debunk controversies regarding data fabrication in the field Guides the reader through the mechanisms of the regenerative function of stem cells; as well as the therapeutic decisions such as delivery route, delivery timing, cell doses, and follow-up
Author: Fouad Sabry Publisher: One Billion Knowledgeable ISBN: Category : Medical Languages : en Pages : 366
Book Description
What Is Stem Cell Therapy The use of a patient's own stem cells, either to cure or prevent a disease or condition, is the practice known as stem-cell therapy. As of the year 2016, hematopoietic stem cell transplantation is the only treatment that has been shown to be effective employing stem cells. The transplantation of bone marrow is the most common method used for this procedure; however, the cells may also be extracted from umbilical cord blood. Research is now being conducted to establish diverse sources for stem cells and to use stem-cell therapies for neurodegenerative disorders and ailments such as diabetes and heart disease. Additionally, research is being conducted to generate new stem cell sources. How You Will Benefit (I) Insights, and validations about the following topics: Chapter 1: Stem-cell therapy Chapter 2: Stem cell Chapter 3: Bone marrow Chapter 4: Hematopoietic stem cell transplantation Chapter 5: Embryonic stem cell Chapter 6: Regenerative medicine Chapter 7: Cell therapy Chapter 8: Cord blood Chapter 9: Adult stem cell Chapter 10: Stem-cell line Chapter 11: Knee cartilage replacement therapy Chapter 12: Cardiomyoplasty Chapter 13: Stem cell transplantation for articular cartilage repair Chapter 14: Mesenchymal stem cell Chapter 15: Clinical uses of mesenchymal stem cells Chapter 16: Muse cell Chapter 17: Guo Mei Chapter 18: Spinal cord injury research Chapter 19: Stem cell secretome Chapter 20: Shimon Slavin Chapter 21: Stem cell fat grafting (II) Answering the public top questions about stem cell therapy. (III) Real world examples for the usage of stem cell therapy in many fields. (IV) 17 appendices to explain, briefly, 266 emerging technologies in each industry to have 360-degree full understanding of stem cell therapy' technologies. Who This Book Is For Professionals, undergraduate and graduate students, enthusiasts, hobbyists, and those who want to go beyond basic knowledge or information for any kind of stem cell therapy.
Author: Lucas G. Chase Publisher: Springer Science & Business Media ISBN: 1627032002 Category : Science Languages : en Pages : 456
Book Description
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.
Author: Kiyohiro Houkin Publisher: Springer ISBN: 4431560599 Category : Medical Languages : en Pages : 156
Book Description
This book presents comprehensive reviews for both translational research and clinical trials on cell therapy for stroke. Cerebral stroke is still a leading cause of death and disability. However, despite intensive research, few treatment options are available. The therapeutic potential of cell transplantation has been studied for various pathological conditions of the central nervous system (CNS) including traumatic brain injury, traumatic spinal cord injury, degenerative disease, demyelinating disease and ischemic stroke, as the injured neural tissue in the CNS has only a limited regenerative capacity. Recently, a growing body of evidence in this field suggests that cell transplantation holds great potential as a form of stroke therapy. The authors, who are experts in the field of neurosurgery, review and discuss optimal cell sources and various issues involved in translational research; further, they outline ongoing clinical trials in Japan.
Author: Nancy Smyth Templeton Publisher: CRC Press ISBN: 0824758609 Category : Science Languages : en Pages : 894
Book Description
This reference is completely revised and expanded to reflect the most critical studies, controversies, and technologies impacting the medical field, including probing research on lentivirus, gutless adenovirus, bacterial and baculovirus vectors, retargeted viral vectors, in vivo electroporation, in vitro and in vivo gene detection systems, and all inducible gene expression systems. Scrutinizing every tool, technology, and issue impacting the future of gene and cell research, it is specifically written and organized for laymen, scholars, and specialists from varying backgrounds and disciplines to understand the current status of gene and cell therapy and anticipate future developments in the field.
Author: Khawaja Husnain Haider Publisher: Springer Nature ISBN: 9811926557 Category : Science Languages : en Pages : 1527
Book Description
The handbook comprehensively reviews the therapeutic potential of stem cells and stem cell secretome-based cell-free strategies in regenerative medicine. The chapters in section I and section II respectively discuss the diverse applications of mesenchymal stem cells and non- mesenchymal stem cells, including skeletal myoblasts, endothelial progenitor cells, adipose tissue-derived stem cells, induced pluripotent stem cells, and neuronal stem cells in myocardial repair, inflammatory bowel disease, cognitive deficits, wound healing, retinal disorders, and COVID-19. The subsequent chapters in section IIIprimarily focused on the fast-emerging cell-free therapy approach in regenerative medicine for tissue repair and regeneration. These chapters review the impact of stem cell-derived secretome on various biological processes such as angiogenesis, neurogenesis, tissue repair, immunomodulation, musculoskeletal pathologies, wound healing, anti-fibrotic, and anti-tumorigenesis for tissue maintenance and regeneration.Lastly, section IV summarizes miscellaneous aspects of cell-based therapy, includingthe treatment advantages, opportunities, and shortcomings in stem cell-based therapy, potentially helping to refine future studies and translate them from experimental to clinical studies. Moreover, this section also has chapters on cancer stem cells as novel targets in cancer therapeutics. This Major Reference Book (MRW) is a valuable resource for researchers involved in stem cell research to understand the multifaceted therapeutic applications of stem cells and their derivative secretome in regenerative medicine.
Author: Tulio Pinho Navarro Publisher: Springer Nature ISBN: 3030569543 Category : Medical Languages : en Pages : 425
Book Description
Vascular diseases are the leading cause of death worldwide. Distinguished clinical and surgical approaches have attempted to overcome its morbidity and mortality; still 17.9 million people die every year due to vascular affections. Stem cell therapy has emerged as a promising therapeutic strategy. Stem cells synthesize and secrete cytokines that promote cell recruitment, immunomodulation, extracellular matrix remodeling, angiogenesis, and neuroregeneration, all of which promote regeneration. Besides that, stem cells are also capable of differentiating in various cell types, being employed in tissue engineering. Preclinical and clinical investigations have reported efficacy of stem cell therapy for various vascular diseases. Even though results are encouraging, the studies demonstrate variation in stem cell type and origin, route and protocol for administration, and concomitant use of other treatment strategies, impairing easy interpretation of results and clinical application. The purpose of this book is to compile and comprise the current state of the evidence regarding stem cell therapy for each vascular disease, elucidating possible clinical applications. More than an objective guide for readers on the use of this novel treatment strategy, this publication will advocate for stem cell therapy use and development and will be of significant interest to physicians in a wide range of disciplines as well as researchers.
Author: David C. Hess Publisher: Springer ISBN: 3319150634 Category : Science Languages : en Pages : 369
Book Description
Cell Therapy for Brain Injury is a thorough examination of using state-of-the-art cell therapy in the treatment of strokes and other traumatic brain injuries. This invaluable book covers this niche topic in depth from basic stem cell biology and principles of cell therapy through proposed mechanisms of action of cell therapy in stroke, pre-clinical data in stroke models, ongoing clinical trials, imaging and tracking of cells with MRI, neural stem cells in stroke and the "big pharma" perspective of cell therapy. Each chapter is written by well-known leaders in each field, thus providing a wealth of expertise. The breadth of this book makes it essential reading for neuroscientists, stem cell biologists, researchers or clinical trialists at pharmaceutical or biotechnology companies. It also serves as a thorough introduction for graduate students or post-doctoral fellows who hope to work in these fields.
Author: Adrian Gee
Author: Adrian Gee
Author: Joaquim Vives
Author: Hala M. Gabr
Author: Fouad Sabry
Author: Lucas G. Chase
Author: Kiyohiro Houkin
Author: Nancy Smyth Templeton
Author: Khawaja Husnain Haider
Author: Tulio Pinho Navarro
Author: David C. Hess