Tissue Engineering & Stem Cell Technology Report 2007

Table of Contents

Chapter 1. Introduction

• 1.1 Introduction
• 1.2 Stem cells
  • 1.2.1 History
  • 1.2.2 Definitions
• 1.3 Embryonic stem (ES) cells
• 1.4 Embryonic germ (EG) cells
  • 1.4.1 Embryonic stem (ES) cells versus embryonic germ (EG) cells
• 1.5 Adult stem cells
  • 1.5.1 Advantages of adult stem cells
  • 1.5.2 Disadvantages of adult stem cells
  • 1.5.3 Adult stem cell plasticity and transdifferentiation
  • 1.5.4 Questions about adult stem cells
• 1.6 Cloning
  • 1.6.1 Therapeutic cloning
  • 1.6.2 Reproductive cloning
  • 1.6.3 Dolly the sheep
  • 1.6.4 Other cloning successes
• 1.7 Tissue engineering
  • 1.7.1 History
  • 1.7.2 Progress
• 1.8 Conclusions

Chapter 2. Key players

• 2.1 Introduction
  • 2.1.1 Novocell
  • 2.1.2 ES Cell International
  • 2.1.3 Reliance Life Sciences
  • 2.1.4 Cytori Therapeutics
  • 2.1.5 Intercytex
• 2.2 Companies that have stem cell lines currently stored at the NIH Human Embryonic Stem Cell Registry in the US
  • 2.2.1 BresaGen
  • 2.2.2 Cellartis
  • 2.2.3 Cythera/ Novocell
  • 2.2.4 ES Cell International (ESI)
  • 2.2.5 Geron
  • 2.2.6 Reliance Life Sciences
• 2.3 Pharmaceutical industry
  • 2.3.1 Amersham
  • 2.3.2 Amgen
  • 2.3.3 AstraZeneca
  • 2.3.4 Johnson & Johnson
  • 2.3.5 Merck
  • 2.3.6 Novartis AG
  • 2.3.7 Schering AG
• 2.4 Key companies - US
  • 2.4.1 Aarstrom Biosciences Inc.
  • 2.4.2 Advanced Cell Technology Inc.
  • 2.4.3 BioE
  • 2.4.4 Cellerant
  • 2.4.5 Cytori Therapeutics
  • 2.4.6 Genentech
  • 2.4.7 Osiris
  • 2.4.8 Stem Cells Inc.
  • 2.4.9 Stem Cell Therapeutics Corp
  • 2.4.10 Titan Pharmaceuticals Inc.
  • 2.4.11 Viacell
• 2.5 Key companies - UK
  • 2.5.1 Angel BioTechnology
  • 2.5.2 Axordia
  • 2.5.3 Epistem
  • 2.5.4 Intercytex
  • 2.5.5 Novathera
  • 2.5.6 Odontis
  • 2.5.7 RegenTec
  • 2.5.8 Reinnervate
  • 2.5.9 ReNeuron
  • 2.5.10 Renovo
  • 2.5.11 Stem Cell Sciences
• 2.6 Key companies - global
  • 2.6.1 Australia
    • 2.6.1.1 Mesoblast Limited
  • 2.6.2 Israel
    • 2.6.2.1 Pluristem
    • 2.6.2.2 BrainStorm Cell Therapeutics
    • 2.6.2.3 Gamida
  • 2.6.3 Thailand
    • 2.6.3.1 TheraVitae
  • 2.6.4 India
    • 2.6.4.1 Stempeutics
  • 2.6.5 Singapore
  • 2.6.6 Sweden
• 2.7 Other companies
  • 2.7.1 Bioheart, Inc.
  • 2.7.2 Aldagen
  • 2.7.3 Cellular Dynamics International
  • 2.7.4 RhinoCyte
  • 2.7.5 Stem Cell Innovations
  • 2.7.6 StemCell Technologies
  • 2.7.7 Vesta Therapeutics
  • 2.7.8 Vistagen Therapeutics
• 2.8 Conclusions

Chapter 3. The Market

• 3.1 Introduction
• 3.2 The Global burden of disease
• 3.3 Numbers of patients
• 3.4 Cost of illness
• 3.5 Major clinical applications
  • 3.5.1 Cardiac applications
  • 3.5.2 Other circulatory applications
  • 3.5.3 Cosmetic applications
  • 3.5.4 Dermatological applications
  • 3.5.5 Endocrine applications
  • 3.5.6 Hepatic applications
  • 3.5.7 Neural applications
  • 3.5.8 Optical applications
  • 3.5.9 Orthodontic applications
  • 3.5.10 Orthopaedic applications
  • 3.5.11 Renal applications
  • 3.5.12 Other applications
• 3.6 Regenerative medicine market
  • 3.6.1 Stem cell market
  • 3.6.2 Media coverage
  • 3.6.3 Tissue engineering
• 3.7 Conclusions

Chapter 4. Issues

• 4.1 Introduction
• 4.2 Ethical Issues
  • 4.2.1 The Ethics of how life is defined
  • 4.2.2 The Ethics of using stem cells
• 4.3 Social Issues
  • 4.3.1 Tissue source
  • 4.3.2 Hybrids
  • 4.3.3 Long term implications of stem cell research
• 4.4 Moral issues
• 4.5 Religious issues
  • 4.5.1 Catholicism
  • 4.5.2 Protestantism
  • 4.5.3 Judaism
  • 4.5.4 Islam
  • 4.5.5 Hinduism
• 4.6 Political issues
  • 4.6.1 US
• 4.7 Conclusions

Chapter 5. Regulations and patents

• 5.1 Introduction
• 5.2 Regulatory issues
  • 5.2.1 UK Government initiatives
  • 5.2.2 UK Stem cell bank
  • 5.2.3 UK - Current regulations
  • 5.2.4 US Government initiatives
    • 5.2.4.1 History
    • 5.2.4.2 Appropriations Bill, HR 3061 (Sec. 510)
  • 5.2.5 US Current regulations
  • 5.2.6 Ongoing controversy
  • 5.2.7 Political landscape
  • 5.2.8 Cell line viability
  • 5.2.9 Xenotransplantation
  • 5.2.10 Rest of World
  • 5.2.11 Europe
  • 5.2.12 Asia
    • 5.2.12.1 Japan
    • 5.2.12.2 China
    • 5.2.12.3 Singapore
    • 5.2.12.4 India
    • 5.2.12.5 South Korea
  • 5.2.13 Australia
    • 5.2.14.1 Canada
    • 5.2.14.2 South America
  • 5.2.13 Australasia
  • 5.2.14 Canada and South America
  • 5.2.15 Middle East
  • 5.2.16 Africa
• 5.3 Conclusions
• 5.4 Patenting Issues
  • 5.4.1 Background
  • 5.4.2 Patenting - Europe
  • 5.4.3 Patenting - UK
    • 5.4.3.1 Processes for obtaining stem cells from human embryos
    • 5.4.3.2 Human totipotent cells
    • 5.4.3.3 Human embryonic pluripotent cells
  • 5.4.4 Patenting - USA
    • 5.4.4.1 Wisconsin Alumni Research Foundation (WARF)
    • 5.4.4.2. Geron
  • 5.4.5 Patenting controversy
  • 5.4.6 Patenting - global
• 5.5 Conclusions

Chapter 6. Trends, Drivers and Opportunities

• 6.1 Introduction
• 6.2 Stem Cell Research - SWOT analysis
  • 6.2.1 Strengths
  • 6.2.2 Weaknesses
  • 6.2.3 Opportunities
  • 6.2.4 Threats
• 6.3 Trends
  • 6.3.1 Portfolio diversification
  • 6.3.2 Strong proprietary rights
  • 6.3.3 Strategic partnerships
• 6.4 Drivers
  • 6.4.1 Funding
  • 6.4.2 Results
• 6.5 Opportunities
  • 6.5.1 Suppliers to the stem cell industry
  • 6.5.2 Cord blood banking
• 6.6 Conclusions

Chapter 7. Stem cell research funding

• 7.1 Introduction
• 7.2 Charities and research councils
  • 7.2.1 Wellcome Trust/ Juvenile Diabetes Research Foundation
  • 7.2.2 Wellcome Trust/ Medical Research Council/ Wolfson Foundation
  • 7.2.3 Juvenile Diabetes Research Foundation (JDRF)
• 7.3 Private funds
  • 7.3.1 The Starr Foundation
  • 7.3.2 Ansary Center for Stem Cell Therapeutics
  • 7.3.3 Johns Hopkins.
  • 7.3.4 University of Texas Health Centre
  • 7.3.5 University of California, San Francisco (UCSF)
• 7.4 Public funds
  • 7.4.1 Venture Capital
  • 7.4.2 Other public funds
  • 7.4.3 California
  • 7.4.4 New Jersey
  • 7.4.5 Massachusetts
  • 7.4.6 Connecticut
  • 7.4.7 Illinois
  • 7.4.8 Maryland
  • 7.4.9 Ohio
  • 7.4.10 Others
  • 7.4.11 European Union
• 7.5 Conclusions

Chapter 8. Conclusions - the future of the stem cell market

• 8.1 Introduction
• 8.2 Progress
  • 8.2.1 Science
  • 8.2.2 Media
  • 8.2.3 Geography
  • 8.2.4 Funding
  • 8.2.5 Patenting
  • 8.2.6 Politics
• 8.3 Recommendations

List of tables

• Table 1.1 Key achievements in stem cell research
• Table 1.2 Diseases and conditions treated with adult stem cell therapies
• Table 2.1 Organisations currently listed as the supplier of stem cell lines to the NIH Human Embryonic Stem Cell Registry
• Table 3.1 The world top 20 threats to health in 2002 and projected 2030
• Table 3.2 Number of potential patients in the US eligible for stem cell therapy
• Table 3.3 Annual direct expenditure in the US for leading diseases and conditions
• Table 3.4 Top surgical and non-surgical cosmetic procedures for men and women (2005)
• Table 5.1 Representative state-wide initiatives regarding the application of stem cell research
• Table 5.2 EU member states legislation (2006)

List of figures

• Figure 1.1 Number of papers published per annum (1996-2006)
• Figure 1.2 Schematic of embryonic stem cell differentiation
• Figure 1.3 Lung cells derived from human embryonic stem cells
• Figure 1.4 Foetal neural stem cells
• Figure 1.5 Schematic of embryonic tissue differentiation
• Figure 5.1 Published patents (1997 - 2005), Title search: "Stem cell*", "Embryonic stem cell*" and "Human embryonic stem cell*"
• Figure 5.2 Number of key patent families (2000 - 2005)
• Figure 7.1 Current translation pathway for stem cell research to commercialisation

Organisations Listed

• Aarstrom Biosciences Inc.
• Acorda Therapeutics
• Advanced BioHealing, Inc.
• Advanced Cell Technology Inc.
• Aldagen, Inc.
• American Society of Plastic Surgeons
• Amersham
• Amgen
• Angel BioTechnology
• Ansary Center for Stem Cell Therapeutics
• Arthritis Research Campaign, UK
• AstraZeneca
• Athersys
• Axordia
• Bart’s and The London NHS Trust, UK
• BioE
• Bioheart, Inc.
• Biotechnology and Biological Sciences Research Council, UK
• BrainStorm Cell Therapeutics
• BresaGen
• Burnham Institute for Medical Research
• The California Family Bioethics Council
• California Institute for Regenerative Medicine
• Cellartis
• CellCura
• Cellerant
• Cellular Dynamics International
• The Cellulite Clinic
• Center for Stem Cell and Regenerative Medicine, Ohio
• Cordlife
• Cythera/ Novocell
• Cytori Therapeutics
• Department of Health and Human Services, US
• Epistem
• ES Cell International (ESI)
• European Patent Office
• Fisher
• Food and Drug Administration, US
• Gamida
• Genentech
• Genzyme
• Geron
• GlobalStem Inc
• Human Fertilisation and Embryology Authority, UK
• Illinois Regenerative Medicine Institute
• Institute for Regenerative Medicine
• Intercytex
• Invitrogen
• The Joan and Sanford I Weill Medical Centre
• Johns Hopkins University
• Johnson and Johnson
• Juvenile Diabetes Research Foundation
• King’s College, London
• Maryland Technology Development Corporation
• Mediatech Inc
• Medical Research Council, UK
• Medra Clinic
• Memorial Sloan-Kettering Cancer Centre
• Merck
• Mesoblast Limited
• Nabi Medspa
• The National Academies, US
• The National Institutes of Health, US
• National Health Service
• National Science Foundation
• National Tax Limitation Committee
• Neuronova
• New Jersey Stem Cell Institute
• Novartis AG
• Novathera
• Novocell
• Odontis
• Organogenesis
• Osiris
• Pluristem
• RegenTec
• Reinnervate
• Reliance Life Sciences
• ReNeuron
• Renovo
• RhinoCyte, Inc.
• Rockefeller University
• Roslin Institute
• Royal College of Obstetrics and Gynaecologists, UK
• Schering AG
• Sigma-Aldrich
• Smith and Nephew
• The Starr Foundation
• Stem Cells Inc.
• Stem Cell Innovations
• StemCell Technologies Inc.
• Stem Cell Therapeutics Corp
• Stem Cell Sciences
• StemCo Biomedical
• Stempeutics
• Tengion
• TheraVitae
• Titan Pharmaceuticals Inc.
• Tulane University
• UK Stem Cell Bank
• United States Patents and Trademark Office
• University of Maryland
• University of Massachusetts
• University of Newcastle
• University of San Francisco, California
• University of Texas Health Centre
• University of Wisconsin
• Vesta Therapeutics Inc.
• Viacell
• Vistagen Therapeutics Inc.
• Wellcome Trust, UK
• WiCell Research Institute, US
• Wisconsin Alumni Research Foundation
• Wisconsin State Laboratory of Hygiene
• Wolfson Foundation, UK
• World Health Organisation