Stem Cells in Regenerative Medicine E-Book

• Herausgeber: John Wiley & Sons
• Kategorie: Wissenschaft und neue Technologien
• Sprache: Englisch

Seitenzahl: 2318

Veröffentlichungsjahr: 2015

Beschreibung

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.

Leseprobe

Table of Contents

Cover

Title Page

Copyright

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?