Opportunities in Stem Cell Technology

 
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Published Feb 1, 2002 | 408 Pages | Pub ID: KLI504938

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In the nascent, but rapidly growing field of stem cell therapies, products are a long way from being commercialized. However, the market potential for stem cell therapies products is very large. This report aims to identify those technologies and opportunities in the United States with the greatest future opportunities, the opportunities to develop enabling technologies in the field, and the organizations and laboratories performing current research. In addition, a section is included that covers the legislative, political and social issues surrounding stem cell technology and research. These issues are impacting the development of the technology.

Objectives

This report is a convenient and comprehensive report on stem cells and the technologies being development. Objectives of the report include the following:

  • To describe research activities and potential
  • To outline problems involved in developing these technologies and the fairly rigorous regulatory challenges that companies will be facing when licensing these new therapies.
  • To provide the kind of current information and analysis the reader will need to make strategic business or investment decisions in the area of stem cell technology.
  • To provide in-depth information on most companies, organizations, and research facilities involved in the field.

Audience

This report is designed to be used primarily by executives, investors, venture capitalists, and business development managers and analysts involved in the pharmaceutical or biotechnology areas that may have an interest in stem cell technology. Companies and organizations seeking to identify partners with complementary technologies may also find this report valuable.

Stem cell research and the accompanying enabling technologies have virtually exploded since embryonic stem cells were first isolated in 1998. Many of the enabling and complementary technologies impacting stem cells are only now catching up to the rate of research. As such, there is a section on companies supplying the research, including those with cell lines, cell and tissue culture media, and reagents. The report includes detailed profiles and information on:

  • 82 companies involved in the development of stem cell therapeutics, worldwide,
  • 57 academic organizations involved in stem cell research in the U.S.,
  • 19 laboratories outside the U.S. with advanced research in the field,
  • 20 detailed profiles on key companies in the industry,
  • 32 suppliers to the Stem Cell Industry, of media, sera, and reagents specifically intended for stem cell research,
  • 10 organizations on the NIH list as suppliers having embryonic stem cell lines.
  • 149 key researchers at academic organizations worldwide, and
  • 11 key researchers at commercial organizations.

Because of the early stages of product development, near-term estimates on products currently in development would be pure speculation. The vast majority of products to be discussed have yet to be developed, and we expect any projections made here would be shown to be inaccurate within 5 years.

Foreword


    Objectives
    Target Audience
    Scope and Content of Report
    Methodology

Chapter One: Introduction


    What Exactly Is a Stem Cell?
    History of the Technology
    Corporate Development of Stem Cell Technologies
    When Will There Be Payoff?
    Stem Cell Background
    • Stem Cell Terminology
    • Stem Cell Medical Science

    Regenerative Biology
    Challenges in Stem Cell Research
    • Immune Response
    • Can Stem Cells Be Effective in Regenerating Tissues?

    Technical Challenges in Stem Cell Research
    • Embryonic Stem Cells
    • Adult Stem Cells

    Comparisons of Embryonic and Adult Stem Cells
    • Similarities: Adult and Embryonic Stem Cells
    • Differences: Adult and Embryonic Stem Cells
    • What Is Known About Human Pluripotent Stem Cells?

    Adult Stem Cells
    • What Is Known About Adult Stem Cells?

    NIH Funding for Stem Cell Research

Chapter Two: Demographics and Disease Modalities


    Potential Disease Modalities
    Summary of Important Similarities and Differences Between Adult and Embryonic Stem Cells
    Actual and Potential Uses of Human Adult Stem Cells
    • Potential Uses of Human ES Cells (Plus Certain Nonhematopoietic Uses of Adult Stem Cells)
    • Using Human Embryonic Stem Cells for Therapeutic Transplants
    • Special Considerations Regarding the Therapeutic Application of Human ES Cells
    • Other Potential Uses of Human Embryonic Stem Cells
    • Conclusions

Chapter Three: Stem Cell Products In Research And Development


    The Potential for Stem Cell Products
    Areas of Product Development
    Neural, Brain, and Spinal Stem Cell Applications
    Liver Stem Cell Applications
    Pancreas Stem Cell Applications
    Cardiac Stem Cell Applications
    Renal Stem Cell Applications
    Blood Stem Cell Applications
    Retinal Stem Cell Applications
    Diabetes—Stem Cell Applications
    Orthopedics—Stem Cell Applications
    Other Stem Cell Applications
    Indications

Chapter Four: Stem Cell Companies


    Introduction
    • Companies Involved in Stem Cell Product Development
    • Source and Type of Stem Cells
    • Therapeutic Area Targeted by Stem Cell Technology
    • Safety Issues and Cellular Therapies

    Select Stem Cell Company Profiles
    • Aastrom Biosciences, Inc.
    • Bioheart, Inc.
    • BioTransplant, Inc.
    • Cell Based Delivery, Inc.
    • Diacrin, Inc.
    • Geron Corporation, Inc.
    • ImClone Systems Incorporated
    • Incara Pharmaceuticals, Inc.
    • Islet Technology
    • MorphoGen Pharmaceuticals, Inc.
    • NeoTherapeutics, Inc.
    • NeuralStem Biopharmaceuticals, Ltd.
    • Nexell Therapeutics, Inc.
    • Osiris Therapeutics, Inc.
    • ReNeuron, Inc.
    • SELECT Therapeutics, Inc./Cell Science Therapeutics, Inc.
    • Stem Cell Pharmaceuticals Inc.
    • StemCells, Inc.
    • Titan Pharmaceuticals, Inc.

Chapter Five: Academic Organizations In Stem Cell Research Activities


    Introduction
    Highlights of Recent Academic Research Activities
    Academic and Government Organizations Listed by Area of Activity
    Literature Review of Academic and Non-Commercial Organizations Involved with Stem Cells
    • Hematopoietic Stem Cell Transplantation: mostly stem cell support institutions that published clinical trials or research involving stem cells (2000-2001)

Chapter Six: Stem Cell Research Suppliers and Enabling Technologies


    Introduction
    Stem Cell Supply Research Activity
    Effectiveness of Research Products
    Challenges to the Supply Industry
    Activities of Suppliers in the Field
    Media Development Support for Stem Cell Research
    Acquisition Activity
    Established Suppliers
    Companies on the NIH Stem Cell Registry
    • Sixty-Four Stem-Cell Lines Eligible for Funding

    Concerns about Competence of Approved Cell Lines
    Organization Profiles: Organizations with NIH-Listed Stem Cell Lines
    Stem Cell Products Background
    • Bone Marrow Stroma
    • Mesenchymal Stem Cells
    • Stem Cell Factor
    • CFU Assays
    • Liquid Cell Culture Media
    • Isolation of Stem Cells
    • Clonogenic Progenitor Assays, In Vitro Tests

Chapter Seven: Legislative, Social, and Political Issues


    Concerns Regarding Origins of Stem Cells
    • Human Face to the Debates
    • Political Rulings

    Potential for Irresponsible Research
    • Human Cloning
    • Scientists Create Human Embryos to Harvest Stem Cells
    • Risks Associated with Stem Cells in Clinical Applications
    • Risks Associated with Human Cloning
    • Private Sector Cloning

    Impact of Restrictions on Embryonic Stem Cells
    Alternative Sources of Stem Cells
    • Sources of Human Embryonic Stem Cells
    • Sources of Other Human Stem Cells
    • Limitations of Adult Stem Cells

    Events in Stem Cell Legislation and Ethics
    • Public Opinion on Stem Cell Issues
    • Moral Issues—Opposing Views
    • Summary of NBAC Review: Ethical Issues Associated with Human Stem Cell
    • Research
    • National Institutes of Health Guidelines for Research Using Human Pluripotent Stem Cells
    • August 2001 Bush Administration Federal Funding Limitations

    International Stem Cell Rules and Legislation
    • European Group on Ethics in Science and New Technologies
    • Country-Specific Legislation and Guidelines

Chapter Eight: Strategic Issues


    The Investment Climate
    • Funding to Survive Clinical Trials
    • Licensing Stem Cell Technologies
    • Technology Partnerships
    • Stem Cell Licensing Issues

    US Regulatory Issues
    • Federal Agencies Involved in Stem Cell Regulation
    • FDA Regulatory Overview
    • Cell and Tissue Regulations
    • Implementation of the New Regulations
    • Standard Methods
    • FDA Market Approvals
    • Process for Approval of Drugs and Biologics
    • Process for Approval of Medical Devices
    • Regulatory Issues Specific to Stem Cell Products

    Regulatory Issues in Europe and Japan
    • Marketing Outside the United States

    Reimbursement
    Enabling Technologies
    • Growing or Culturing Stem Cells
    • Patents and Stem Cells

Appendix A: Stem Cells: A Primer


    National Institutes of Health
    • What is a Stem Cell?
    • How are pluripotent stem cells derived?
    • Potential Applications of Pluripotent Stem Cells
    • Adult Stem Cells
    • Summary

Appendix B: Stem Cell Researchers and Links


    Coalition for the Advancement of Medical Research

Appendix C: Stem Cell Glossary


    Key Terms in Stem Cell Technology
    General Glossary

List of Exhibits


    Table 1-1: Timeline of Human Embryonic Stem Cell Research
    Table 2-1: Diseases for Which Unrelated Marrow Donor Transplants Have Been Performed
    Table 4-1: Companies, Contact Details, and Descriptions
    Table 4-2: Cord blood and Therapeutic Stem Cell Services Companies
    Table 5-1. Stem Cells Academic/Government Organizations
    Table 6-1: Companies and Research Laboratories with Stem Cell Lines
    Table 6-2. Select Organizations Providing Cell Lines
    Table 6-3. Cell Culture Systems: Media, Sera and Cell Growth Systems for Stem Cell Reagents: Stem Cell Factors/Cytokines, Antibodies, Conjugates, Growth Factors, Kits, Services
    Table 7-1: Events in Stem Cell Policy and Ethics
    Table 7-2: Results of Poll asking "Do You Support Federal Funding for Stem-Cell Research?"
    Table 7-3: Organizations Involved in Bioethics
    Table 7-4: Summary of September 1999 NBAC Recommendations on Stem Cell Research
    Table B-1: Academic and Government Laboratories Involved in Stem Cell Research Sorted by Organization
    Table B-2: Researchers at Commercial Stem Cell Organizations Contributing to 7/01 NIH Report
    Table B-3: Stem Cell Web Links

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