Stem Cell Assays

The scope for improving health care using stem cell therapies is thrilling, but has considerable technical challenges and methodological constraints that need to be addressed. Keeping with the tradition of Humana Press to bring these developments to the forefront in a timely manner, this book presents scientific advances in stem cell methods for a wider use by novice and expert scientists, through the series of Methods in Molecular Biology.

Neural stem cells offer a valuable model system for delineating the cellular and developmental processes in normal and diseased states of the central nervous system. In particular, neural stem cells have huge potential in regenerative medicine, owing to their expansion capability in culture and the ability to differentiate into multiple sub-neural lineages. Neural Stem Cell Assays provides a detailed and comprehensive review of the basic methods for neural stem cell cultures. Including an overview of progress in the field over the past decade, Neural Stem Cell Assays is a one-stop reference for consistent methods and reliable tools that span the entire assay work flow, from isolation or generation of neural stem cells to characterization, manipulation and final application of neural stem cells in disease paradigms such as Parkinson's disease, multiple sclerosis and amyotrophic lateral sclerosis. An excellent source of information for academic, pharmaceutical and biotechnology researchers who are new to the neural stem cell field, Neural Stem Cell Assays is an invaluable to experienced users who wish to integrate newly developed tools and technologies into their workflow. The book also covers important course material for students at the undergraduate and graduate level who are learning the basics of neural stem cell cultures, and differentiation to sub-neural lineages.

Mesenchymal Stem Cells have seen an unprecedented level of interest in the last decade, primarily due to their relative ease of isolation, the large numbers of cells present in the adult, and the ability to propagate these cells in culture. In Mesenchymal Stem Cell Assays and Applications, expert researchers from across the globe explore the latest techniques to propagate, characterize, and engineer this special cell type. Chapters outline a set of protocols and assays used by leading investigators in the field, providing standards that can be applied by all researchers to the population of cells used in their experiments. Composed in the highly successful Methods in Molecular BiologyTM series format, each chapter contains a brief introduction, step-by-step methods, a list of necessary materials, and a Notes section which shares tips on troubleshooting and avoiding known pitfalls. Ground-breaking and current, Mesenchymal Stem Cell Assays and Applications is a necessary handbook for all researchers working with this ambiguous population of cells.

This volume explores the fields of stem cell biology, regenerative medicine, and cancer biology. The chapters in this book cover topics such as embryonic stem cells (ES) and induced pluripotent cells (iPS); ES/iPSC derived tissue stem cells; tissue resident stem cells; assays for primitive malignant cells; and CRISPR/Cas9 engineering and transgenic model development. Written in the highly successful Methods in Molecular Biology series format, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible laboratory protocols, and tips on troubleshooting and avoiding known pitfalls. Cutting-edge and thorough, Stem Cell Assays: Methods and Protocols is a valuable laboratory manual that allows researchers and scientists to learn about new techniques and approaches in this developing field.

This volume of the Springer book series Advances in Experimental Medicine and Biology covers potency assays, one of the most complex yet fundamental evaluations that critically influence stem cell regenerative medicine. Developing potency assays for cell-based medicinal products comes with numerous challenges due to the highly specialised nature of the application and purpose. This book provides the reader with the knowledge necessary to understand issues governing the successful development of potency assays, highlighting an international outlook of how the various challenges raised are being managed. Stakeholders concerned with potency assay development range from patient and clinician to contract research organisations, small and medium enterprise, regulatory authorities and even politicians. The value of potency assays is poised to increase given the inevitable watershed as early-stage clinical trials addressing safety progress to trials testing efficacy. Contributors from clinical, academic, industrial and regulatory sectors establish a broad point of view for guidance and timely debate. Potency assays require extensive collaboration across disciplines and sectors, as well as compromise and the authors aim to constructively address the many key aspects involved. Potency assays provide a quantitative measure of the biological activity of advanced therapy medicinal products (ATMPs) and thus are required for their market authorization. As the pace of ATMP development accelerates, the need to develop specific, accurate, and robust potency assays for each product is also accelerating. The volume Potency Assays for Stem Cell Advanced Therapy Medicinal Products presents a broad outlook on the development, quality attributes, and implementation of potency assays for ATMPs. The first few chapters introduce a nuanced historical perspective on the science of potency assay development, describe specific quality attributes of an idealized potency assay, indicate pitfalls associated with developing such assays for ATMPs, and review guidance recommended by regulatory authorities on assay suitability for product approval. Subsequent chapters highlight efforts to develop potency assays for specific ATMPs, including skeletal stem cells, mesenchymal stromal cells, extracellular vesicles, CAR T-cells, and discuss emerging technologies/platforms for potency assay design. The volume concludes with a chapter reviewing potency assays used for the release of commercial ATMP products, which amalgamates information contained in previous chapters. Overall, the knowledge contributed from leading authorities in both academia and industry is an ideal resource for technicians, scientists, clinicians, process engineers, and regulators working with ATMPs. -Donald G. Phinney, PhD Professor, Department of Molecular Medicine, Herbert Wertheim UF Scripps Institute for Biomedical Innovation & Technology .

This book is a unique guide to emerging stem cell technologies and the opportunities for their commercialisation. It provides in-depth analyses of the science, business, legal, and financing fundamentals of stem cell technologies, offering a holistic assessment of this emerging and dynamic segment of the field of regenerative medicine. • Reviews the very latest advances in the technology and business of stem cells used for therapy, research, and diagnostics • Identifies key challenges to the commercialisation of stem cell technology and avenues to overcome problems in the pipeline • Written by an expert team with extensive experience in the business, basic and applied science of stem cell research This comprehensive volume is essential reading for researchers in cell biology, biotechnology, regenerative medicine, and tissue engineering, including scientists and professionals, looking to enter commercial biotechnology fields.

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