Title Page -- Copyright -- Table of Contents -- List of contributors -- Foreword -- Preface -- Part I: The stem cell business -- Chapter 1: Therapeutic Stem Cells Answer a Strategic Breakthrough Need of Healthcare -- Introduction -- Strategic breakthrough need -- Cytotherapeutics -- Perspectives -- References -- Chapter 2: Ethical Considerations on the Research and Business of Stem Cells -- Introduction -- Scientific and medical considerations -- Ethical and policy considerations -- A brief history of human stem cell research -- Procurement, use and ethical considerations regarding all stem cell research -- Perspectives -- Note -- Disclaimer -- References -- Chapter 3: Projected Growth of the World-Wide Stem Cell Market -- Introduction -- Definition of the stem cell therapeutics market -- Key assumptions -- Market estimates and segmentation -- Perspectives -- Notes -- References -- Chapter 4: Cell therapy manufacturing: identifying and meeting demand -- Introduction -- The cell therapy industry: an overview -- Manufacturing challenges unique to the cell therapy industry and their commercial implications -- Lessons from predecessors: whole cell vs. mAb therapy manufacturing -- Manufacturing challenges for cell therapies -- Manufacturing strategies -- Current upstream manufacturing technologies -- Perspectives -- Acknowledgements -- References -- Chapter 5: The History of Stem Cell Transplantation -- Introduction: the beginnings -- Explosion of haematopoietic cell transplantation -- Novel cell therapy: mesenchymal stromal cells (MSCs) -- Preclinical attempts to characterise mesenchymal stromal cells -- Early regulatory considerations -- Early MSC clinical trials -- Subsequent MSC clinical trials -- Other novel stromal cell products -- Potential disease targets for clinical use of MSCs and related cells -- Ongoing investigations -- Unresolved issues.

Perspectives -- References -- Chapter 6: Regulatory and intellectual property considerations for therapeutic human stem cell-based regenerative medicine product development: a US perspective -- US laws, FDA regulations and guidance -- Definitions, processes, products and jurisdiction -- Intellectual property (IP) and related regulatory considerations for SCBRMPs -- Approaches for potentially expedited product development and timelines -- Leveraging FDA and other stakeholder resources toward regulatory approval and beyond -- Some strategies to address the challenges and opportunities of SCBRMP development and regulation -- Perspectives -- Disclaimer and additional information -- References -- Chapter 7: The regulation of stem cells in the UK and the EU -- Introduction -- Consent (the UK) -- Licensing (the UK) -- Banking (the UK) -- Therapeutic use as a medicinal product -- Summary -- Medical tourism -- Perspectives -- Notes -- Part II: Stem cells as research tools -- Chapter 8: The Business of Stem Cell Research Tools -- Stem cells as research tools and market segmentation -- Stem cell products and reagents -- Stem cells as research tools in pharmaceutical drug development -- Featured company profiles and revenues -- Perspectives -- References -- Chapter 9: Stem cell-derived cardiomyocytes and hepatocytes as tools for drug development and screening applications -- Introduction -- Pluripotent stem cells as a source of humanised drug discovery cell models -- Market opportunity for cardiomyocytes -- Market opportunity in hepatocytes -- Technical hurdles of pluripotent stem cell-derived models to be overcome -- Perspectives -- References -- Chapter 10: Stem cell tools for compound development -- Introduction -- Overview of stem cell biology -- Stem cells versus cell lines and primary cells -- ESCs or iPSCs? -- Applications -- Organs-on-a-chip.

Current challenges with the use of stem cells -- Perspectives -- References -- Chapter 11: Stem Cell Origin of Cancer: Prospects for Functional Therapeutics and Regenerative Medicine -- Overview of stem cell maintenance, differentiation, and dysregulation -- The cancer stem cell concept -- Cell of origin of cancer stem cells -- Cancer stem cell homeostasis -- Context-dependent epigenetic re-programming of stem cells during oncogenesis -- Perspectives -- Acknowledgements -- References -- Part III: Stem cells as veterinary medicines -- Chapter 12: The Market for Stem Cell Medicines for Domestic and High Value Animals -- Introduction -- Cell types currently in use veterinary regenerative medicine -- Regulatory oversight of veterinary stem cell therapy -- Value of domestic and companion animals -- The global veterinary market structure -- Initial veterinary stem cell disease targets -- Mechanism of action: impact on uses -- Global sales of veterinary stem cells -- Trends in consumer veterinary product purchasing -- Market pricing of stem cell services and products -- Veterinary insurance coverage -- Perspectives -- Acknowledgements -- References -- Chapter 13: Stem Cells in Veterinary Medicine: A Conceptual Approach -- Introduction -- Biological products used in veterinary medicine -- Adipose-tissue-derived stromal vascular fraction -- Platelet-rich plasma -- Mesenchymal stem cells -- Perspectives -- References -- Chapter 14: Stem Cell Veterinary Medicines: A Practical Approach -- Introduction -- Cell sources for use in veterinary regenerative medicine -- Orthopaedics and sports medicine -- Pain therapy -- Renal disease -- Neurology -- Dermatology -- Cardiology -- Safety assessment -- Perspectives -- Acknowledgements -- References -- Chapter 15: Stem Cell Veterinary Medicines as Signs Pointing Towards Successful Human Stem Cell Therapeutics.

The concept of comparative medicine -- Large animal models -- Examples of veterinary medicines: dog cancer treatments -- Stem cells in veterinary medicine -- Xenogeneic stem cells -- Development of stem cell treatments for the companion dog -- Perspectives -- References -- Part IV: Stem cell therapeutics -- Chapter 16: Animal models in regenerative medicine -- The potential for stem cells to treat human disease -- What are stem cells and how are they derived? -- What are animal models and why use them? -- The nervous system as a model for repair -- Models of repair beyond the CNS -- Perspectives -- References -- Chapter 17: Stem cell characterisation: a guide to stem cell types, technologies, and future applications -- Introduction -- Types of stem cells -- Analytical tools used to characterise stem cells -- Perspectives -- References -- Chapter 18: Stem cell value chains -- Introduction -- Strategic planning -- Deconstructing the value chain for cell-based therapeutics requirement -- Outbound logistics -- Cell preservation technologies affecting the value chain -- Perspectives -- Acknowledgements -- References -- Chapter 19: Stem cell culture processes -- Introduction -- Stem cells in regenerative therapy applications -- Cell culture processes: therapeutic proteins vs. stem cells -- Autologous and allogeneic applications from a bioprocessing perspective -- Stem cell bioprocesses -- Reactor considerations in stem cell bioprocesses -- Product isolation -- Perspectives -- References -- Chapter 20: Indication transformation maps and the challenge of live cell delivery -- Market dynamics as adherent stem cell therapies emerge -- Distinctions between corporate and institutional manufacturing approaches -- Clinical development in a dynamic landscape -- The relevance of the product distribution chain -- Cell health and potency as a competitive parameter.

Community development -- Predictions for success -- Perspectives -- References -- Chapter 21: Delivery and Targeting of Therapeutic Cells -- Introduction -- Cell administration -- Tools for active cell targeting -- Engineered cell targeting -- Perspectives -- Acknowledgements -- References -- Chapter 22: Hematopoietic Stem Cells -- Early history of hematopoietic stem cells -- Early history of stem cell transplantation -- Current stem cell transplantation practices -- Pharmacoeconomics -- Perspectives -- References -- Chapter 23: MSCs: The New Medicine -- Introduction -- MSCs are pericytes -- MSCs: the new medicine -- Clinical trials -- Exogenous MSC targets: good and bad -- A new frontier -- The future -- References -- Chapter 24: Innovation and commercialisation of induced pluripotent stem cells -- Introduction -- iPS cells as a strategically planned breakthrough technology -- Scientific background to the discovery of iPS cells -- Defining iPS cells: key attributes -- Clinical product specifications -- Key considerations for the innovation and commercialisation of human iPS cells -- Perspectives -- Acknowledgements and Notices -- References -- Chapter 25: Embryonic stem cells -- Biology of human embryonic stem cells -- Therapeutic applications of hESCs -- Perspectives -- References -- Chapter 26: Allogeneic versus autologous stem cell transplantation in regenerative medicine -- Introduction -- Lessons from haematopoietic stem cell transplantation -- Mesenchymal stem cells (MSCs) -- Embryonic stem cells (ESCs) -- Perspectives -- References -- Part V: Perspectives -- Chapter 27: Immunological barriers to regenerative medicine: do they matter? -- Introduction -- The 'adoptive' approach -- ES and iPS cells: the misleading concept that stemness equals immune privilege -- The 'endogenous' approach.

Mesenchymal stromal cells: a paradigm for the endogenous approach to regenerative medicine.