Cell Therapy

This chapter combines standards related to very general concepts (e.g., process control, clinical outcomes, and design control) with standards following the workflow from procurement of the cellular therapy product to administration.

Author: Adrian Gee

Publisher: Springer Science & Business Media

ISBN: 9780387895840

Category: Science

Page: 256

View: 604


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 Cell Therapy for Diabetes

There is no cure for diabetes, and treatment usually consists of continued insulin replacement for the duration of the ... Figure 10.1 illustrates three different methods that are currently being considered for cell therapy of diabetes.

Author: Shimon Efrat

Publisher: Springer Science & Business Media

ISBN: 1607613662

Category: Medical

Page: 291

View: 591


Stem Cell Therapy for Diabetes, one of the latest installments of the Stem Cell Biology and Regenerative Medicine series, reviews the three main approaches for generation of sufficient numbers of insulin-producing cells for restoration of an adequate beta-cell mass: beta-cell expansion, stem-cell differentiation, and nuclear reprogramming. Adeptly collecting the research of the leading scientists in the field, Stem Cell Therapy for Diabetes compares the merits of employing autologous versus banked allogeneic cell sources for generation of surrogate beta cells, and addresses tissue engineering and ways for cell protection from recurring autoimmunity and graft rejection. Stem Cell Therapy for Diabetes provides essential reading for those especially interested in tracking the progress in applying of one of the most exciting new developments in bio-medicine towards a cure for diabetes.

An Essential Guide to Cardiac Cell Therapy

Stem cell therapy for cardiac diseases has been used in clinical studies, but many key questions regarding this novel therapy remain unanswered. Further preclinical studies are needed in order to assess its safety and efficacy.

Author: Emerson Perin

Publisher: CRC Press

ISBN: 9781841844718

Category: Medical

Page: 210

View: 579


Sparked by a new understanding that the development of tissues is not restricted to the embryonic phase of development and thus that regeneration of tissues can occur in adults, the emerging field of stem cell therapy has grown exponentially in the last several years. Crucially, the research and findings associated with stem cell research overlap into many other areas, such as basic cell biology, molecular biology and hematology, and the proliferation of clinical studies involving stem cell research is gradually crossing over into the practice of medicine as many patients may become candidates for such novel treatments. As a response to this, Guide to Cardiac Cell Therapy is a comprehensive but understandable resource that makes this exciting field accessible to clinical practitioners. Bridging the gap between basic science and practice, it is a useful introduction to the area as well as a cutting-edge update of the developments in stem cell therapy as applied to cardiovascular disease.

Cell Therapy

I should like to thank Sara Richman of the Center for Cell and Gene Therapy for reviewing this chapter. References at 1. California Institute of Regenerative Medicine. (2008). CIRM major facilities speed stem cell science and create ...

Author: Adrian P. Gee

Publisher: Springer Nature

ISBN: 9783030755379

Category: Cellular therapy

Page: 681

View: 844


This new edition presents a fully-updated and expanded look at current Good Manufacturing Practice (cGMP) for cell therapy products. It provides a complete discussion of facility design and operation including details specific to cord blood banking, cell processing, vector production and qualification of a new facility. Several chapters cover facility infrastructure including cleaning and maintenance, vendor qualification, writing a Standard Operating Procedure, staff training, and process validation. The detailed and invaluable product information covers topics like labelling, release and administration, transportation and shipment, et al. Further chapters cover relevant topics like writing and maintaining investigational new drug applications, support opportunities in North America and the European Union, commercial cell processing and quality testing services, and financial considerations for academic GMP facilities. A chapter on future directions rounds out Cell Therapy: cGMP Facilities and Manufacturing making it essential reading for any cell therapy professional involved in the development, use, or management of this type of facility.

Stem Cell Therapy

Repairing damaged cells for treating or preventing a disease Fouad Sabry. Chapter. 7: Cell. therapy. Cell therapy, also known as cellular therapy, cell transplantation, or cytotherapy, is a type of treatment in which viable cells are ...

Author: Fouad Sabry

Publisher: One Billion Knowledgeable

ISBN: PKEY:6610000394371

Category: Medical

Page: 366

View: 257


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.

Guide to Cell Therapy GxP

Although there has recently been an acceleration in the field, the concept of cellular therapies is not new. The first successful hematopoietic stem cell (HSC) transplantation was recorded in 1968 and is now an accepted treatment for ...

Author: Joaquim Vives

Publisher: Academic Press

ISBN: 9780128031162

Category: Medical

Page: 266

View: 978


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

Cell Therapy Against Cerebral Stroke

Especially, the growing accumulation of information and induced evidence suggest that cell therapy holds great potential as stroke therapy. In this book, the authors describe recent advances and perspectives in cell therapy against ...

Author: Kiyohiro Houkin

Publisher: Springer

ISBN: 9784431560593

Category: Medical

Page: 156

View: 914


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.

Stem Cell Therapy for Vascular Diseases

1.10 Stem Cell Therapy for Vascular Diseases Vascular disorders are frequently chronic conditions characterized by impaired blood flow; the general goal of stem cell therapy for these diseases is to restore blood flow, improving the ...

Author: Tulio Pinho Navarro

Publisher: Springer Nature

ISBN: 9783030569549

Category: Medical

Page: 425

View: 817


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.

Handbook of Stem Cell Therapy

Expert Rev Cardiovasc Ther 4:557–568 Haider KH (2017) Hematopoietic stem cell transplantation: the quality matters. J Stem Cell Res Ther 7:6 Haider KH (2018) Bone marrow cell therapy and cardiac reparability: better cell ...

Author: Khawaja H. Haider

Publisher: Springer Nature

ISBN: 9789811926556

Category: Medical

Page: 1527

View: 207


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.​