Although the concept of using advanced therapy products such as stem cells seems to be a key strategy in the treatment of various diseases, much information in this area remains unknown. Stem cell products are highly complex, much more complex than chemical-based drugs. More and more often there are data indicating the risk of using stem cells. These risks are determined by various factors that are related to quality, biological activity, and the use itself, and thus administration. Therefore, it is very important to constantly systematize knowledge in this area. This book was created to present both the perspective of basic research, including the manipulation and changes in the properties of cells, and the changes and novelties in therapies themselves.

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

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.

This book is a compilation of the bench experience of leading experts from various research labs involved in the cutting edge area of research. The authors describe the use of stem cells both as part of the combinatorial therapeutic intervention approach and as tools (disease model) during drug development, highlighting the shift from a conventional symptomatic treatment strategy to addressing the root cause of the disease process. The book is a continuum of the previously published book entitled "Stem Cells: from Drug to Drug Discovery" which was published in 2017.

A discussion of all the key issues in the use of human pluripotent stem cells for treating degenerative diseases or for replacing tissues lost from trauma. On the practical side, the topics range from the problems of deriving human embryonic stem cells and driving their differentiation along specific lineages, regulating their development into mature cells, and bringing stem cell therapy to clinical trials. Regulatory issues are addressed in discussions of the ethical debate surrounding the derivation of human embryonic stem cells and the current policies governing their use in the United States and abroad, including the rules and conditions regulating federal funding and questions of intellectual property.

Perinatal Stem Cells provides researchers and clinicians with a comprehensive description of the current clinical and pre-clinical applications of stem cells derived from perinatal sources, such as amniotic fluid, placenta and placental membranes, the umbilical cord and Wharton's jelly. It's compiled by leading experts in the field, offering readers detailed insights into sources of perinatal stem cells and their potential for disease treatment. Therapeutic applications of perinatal stem cells include the treatment of in utero and pregnancy related diseases, cardiac disease, liver disease, pulmonary disease, inflammatory diseases, for hematopoietic regeneration, and for neural protection after stroke or traumatic brain injury. In addition, the rapid advance in clinical translation and commercialization of perinatal stem cell therapies is highlighted in a section on Clinical and Industry Perspective which provides insight into the new opportunities and challenges involved in this novel and exciting industry. - Explores current clinical and pre-clinical application of stem cells derived from perinatal sources - Offers detailed insight into sources of perinatal stem cells and their potential for disease treatment - Discusses progress in the manufacturing, banking and clinical translation of perinatal stem cells - Edited by a world-renowned team to present a complete story of the development and promise of perinatal stem cells

Since different types of stem cells for therapeutic applications have recently been proposed, this timely volume explores various sources of stem cells for tissue and organ regeneration and discusses their advantages and limitations. Also discussed are pros and cons for using embryonic stem cells, induced pluripotent stem cells, and adult stem cells isolated from postnatal tissues. Different types of adult stem cells for therapeutic applications are also reviewed, including hematopoietic stem cells, epidermal stem cells, endothelial progenitors, neural stem cells, mesenchymal stem cells, and very small embryonic-like stem cells. This book also addresses paracrine effects of stem cells in regenerative medicine that are mediated by extracellular microvesicles and soluble secretome. Finally, potential applications of stem cells in cardiology, gastroenterology, neurology, immunotherapy, and aging are presented. This is an ideal book for students and researchers working in the stem cell research field.

"Pluripotent stem cells have garnered tremendous interest in recent years, which is primarily driven by the hope of finding a cure for several debilitating human diseases. Cell transplantation (regeneratve medicine) offers considerable therapeutic potentia"

In the 1950s, Nobel Prize winner Dr. E. Donnall Thomas was the first to successfully transplant hematopoietic stem cells. Since then, studies on stem cells have evolved and expanded worldwide. There are more than 650,000 scientific publications on stem cells and more than 8000 stem cell clinical trials. This book summarizes types of stem cells, key studies, ongoing trials, and future perspectives. It also includes ethical, formal, and legal aspects to give the reader a comprehensive view of the field.

The commercialization of biotechnology has resulted in an intensive search for new biological resources for the purposes of increasing food productivity, medicinal applications, energy production, and various other applications. Although biotechnology has produced many benefits for humanity, the exploitation of the planet's natural resources has also resulted in some undesirable consequences such as diminished species biodiversity, climate change, environmental contamination, and intellectual property right and patent concerns.This book discusses the role of biological, ecological, environmental, ethical, and economic issues in the interaction between biotechnology and biodiversity, using different contexts. No other book has discussed all of these issues in a comprehensive manner. Of special interest is their impact when biotechnology is shared between developed and developing countries, and the lack of recognition of the rights of indigenous populations and traditional farmers in developing countries by large multinational corporations.