Stem Cell Technology: Current Applications and Future Directions

Published by: BCC Research

Published: Jul. 1, 2008 - 233 Pages

Table of Contents

INTRODUCTION

STUDY GOALS AND OBJECTIVES

REASONS FOR DOING THE STUDY

SCOPE OF REPORT

INTENDED AUDIENCE

INFORMATION SOURCES

ANALYST CREDENTIALS

RELATED REPORTS

BCC ONLINE SERVICES

DISCLAIMER

SUMMARY

SUMMARY TABLE U.S. MARKET FOR STEM CELLS IN REGENERATIVE MEDICINE REVENUE, THROUGH 2012 ($ MILLIONS)

SUMMARY FIGURE U.S. MARKET FOR STEM CELLS IN REGENERATIVE MEDICINE REVENUE, 2005-2012 ($ MILLIONS)

OVERVIEW

HISTORICAL REVIEW OF STEM CELL BIOLOGY

HISTORY OF STEM CELL BIOLOGY

EARLY OBSERVATION AND CLASSIFICATIONS

STEM CELL CLASSIFICATION

Derivation of Human Tissue Types during Development from Embryonic Stem Cells

TABLE 1 DERIVATION OF HUMAN TISSUE TYPES DURING DEVELOPMENT

FIGURE 1 FLOW DIAGRAM OF HUMAN DEVELOPMENT PROCESS

Derivation of Human Tissue Following Maturation from Adult Stem Cells

STEM CELL CONCEPTS IN HEALTH CARE

INITIAL STEM CELL ISOLATION AND CHARACTERIZATION

Initial Stem Cell Isolation …(Continued)

EARLY CELL-BASED THERAPEUTICS

Xeno Transplants

Blood Transfusions and Bone Marrow Transplantation

AREAS OF HEALTH CARE NEED AND STEM CELLS

DISEASE- AND DEGENERATION-RELATED HEALTH CARE NEED

Disease- and Degeneration-…(Continued)

ORGAN TRANSPLANTATION-RELATED HEALTH CARE NEED

CANCER- AND GENETIC DISORDER-RELATED HEALTH CARE NEED

INFECTIOUS DISEASE-RELATED HEALTH CARE NEED

HEALTH CARE NEED AND COSTS

Health Care Need and Costs (Continued)

CURRENT STATE OF REGENERATIVE MEDICINE

STEM CELL CLASSIFICATION BASED ON SOURCE

Embryonic Stem Cells

Adult (and Progenitor) Stem Cells

Adult (and Progenitor) …(Continued)

STEM CELL CLASSIFICATION BASED ON DIFFERENTIATION POTENTIAL

Pluripotent Stem Cell Differentiation Potential

Multipotent Stem Cell Differentiation Potential

Unipotent Stem Cell Differentiation Potential

TABLE 2 STEM CELL CLASSIFICATION BASED ON DIFFERENTIATION POTENTIAL

DYNAMICALLY EVOLVING AREAS IN STEM CELL BIOLOGY

CLONAL STEM CELLS LINES IN NONHUMAN PRIMATES

EMBRYONIC STEM CELL LINES DERIVED FROM INNER CELL MASS OF VIABLE EMBRYOS

STEM CELLS FROM NEONATAL FLUID

ADULT STEM SOURCING/NICHES

Adult Stem Sourcing/Niches (Continued)

TABLE 3 ADULT STEM CELL TYPES AND POTENTIAL TISSUE

SOURCES

DISEASE-SPECIFIC EMBRYONIC STEM CELL LINES

ADULT STEM CELL REPROGRAMMING

PERSONALIZED HEALTH CARE

CELL-BASED THERAPEUTICS

Using Embryonic-derived Stem Cells

Using Adult/Progenitor-derived Stem Cells

ENGINEERED TISSUE FOR TRANSPLANTATION

Using Embryonic-derived Stem Cells

Using Adult Stem Cells (and Progenitor Cells)

THERAPEUTIC STEM CELL BANKING

STEM-CELL-BASED BIOMEDICAL RESEARCH

MARKETS FOR STEM-CELL-BASED CELLULAR THERAPEUTICS

HEALTH CARE NEED AND THE APPLICATION OF STEM CELLS

Cardiovascular System-related Clinical Stem Cell Applications

Nervous System-related Clinical Stem Cell Applications

Skeletal/Muscular System-related Clinical Stem Cell Applications

Whole Organ (Tissue) System-related Clinical Stem Cell Applications

Stem-cell-related Cancer and Clinical Applications

Infectious Disease/Cancer (General) and Clinical Applications

GOVERNMENT REGULATIONS AND THE USE OF STEM CELLS IN RESEARCH AND THERAPEUTIC APPLICATIONS

GOVERNMENT REGULATION OF THE APPLICATION OF STEM-CELL-BASED THERAPEUTICS

Government Regulation of…(Continued)

GOVERNMENT REGULATION OF THE APPLICATION OF STEM-CELL-BASED RESEARCH

TABLE 4 THE NATIONAL INSTITUTES OF HEALTH STEM CELL RESEARCH FUNDING, 2004-2009 ($ MILLIONS)

TABLE 4 (CONTINUED)

FIGURE 2 THE NATIONAL INSTITUTES OF HEALTH HUMAN STEM CELL RESEARCH FUNDING, 2004-2009 ($ MILLIONS)

TABLE 5 THE NATIONAL INSTITUTES OF HEALTH HUMAN EMBRYONIC STEM CELL REGISTRY

TABLE 5 (CONTINUED)

TABLE 6 STATES FUNDING STEM-CELL-RELATED RESEARCH

FUTURE IMPACT OF STEM CELLS ON UNMET HEALTH CARE NEED

FUTURE IMPACT OF STEM …(CONTINUED)

STEM CELL TECHNOLOGY IN THE REGENERATIVE MEDICINE MARKET

TABLE 7 PROJECTED U.S. GROWTH TREND FOR STEM CELLS IN REGENERATIVE MEDICINE, THROUGH 2012 ($ MILLIONS)

FIGURE 3 PROJECTED U.S. GROWTH TREND FOR STEM CELLS IN REGENERATIVE MEDICINE, 2005-2012 ($ MILLIONS)

INTRODUCTION TO STEM CELLS TECHNOLOGY IN REGENERATIVE MEDICINE MARKET

STEM CELLS IN CELLULAR THERAPEUTICS

Stem Cells in Cellular Therapeutics (Continued)

Stem Cells in Cellular Therapeutics (Continued)

FIGURE 4 FLOW DIAGRAM OF PROCESS USING STEM CELLS IN CELLULAR THERAPEUTICS

Stem Cells in Cellular Therapeutics (Continued)

TABLE 8 PROJECTED U.S. GROWTH TREND FOR STEM CELLS IN CELL-BASED THERAPEUTICS FOR HUMAN ADULT AND EMBRYONIC STEM CELLS, THROUGH 2012 ($ MILLIONS)

FIGURE 5 PROJECTED U.S. GROWTH TREND FOR STEM CELLS IN CELL-BASED THERAPEUTICS FOR HUMAN ADULT AND EMBRYONIC STEM CELLS, 2005-2012 ($ MILLIONS)

Stem Cells in Cellular Therapeutics towards Engineering Tissue in Vitro for Transplantation

Stem Cells in Cellular Therapeutics …(Continued)

Stem Cells in Cellular Therapeutics …(Continued)

FIGURE 6 FLOW DIAGRAM OF PROCESS USING STEM CELLS IN ENGINEERING TISSUE FOR TRANSPLANTATION

THERAPEUTIC STEM CELL BANKING

FIGURE 7 FLOW DIAGRAM FOR PROCESS OF THERAPEUTIC BANKING OF STEM CELLS

Therapeutic Stem Cell Banking (Continued)

TABLE 9 PROJECTED U.S. GROWTH TREND FOR THERAPEUTIC STEM CELL BANKING, THROUGH 2012 ($ MILLIONS)

FIGURE 8 PROJECTED U.S. GROWTH TREND FOR THERAPEUTIC STEM CELL BANKING, 2005-2012 ($ MILLIONS)

INTRODUCTION TO STEM CELLS TECHNOLOGY IN THERAPEUTIC-RELATED RESEARCH

STEM CELL TECHNOLOGY IN CELL-BASED ASSAYS AND DIAGNOSTIC RESEARCH APPLICATIONS

TABLE 10 PROJECTED U.S. GROWTH TREND FOR STEM-CELLRELATED THERAPEUTIC RESEARCH ($ MILLIONS)

FIGURE 9 PROJECTED U.S. GROWTH TREND FOR STEM-CELLRELATED THERAPEUTIC RESEARCH, 2005-2012 ($ MILLIONS)

THERAPEUTIC STEM-CELL-RELATED RESEARCH SUPPORT

TABLE 11 PROJECTED U.S. GROWTH TREND FOR STEM-CELLRELATED CELL-BASED ASSAYS/DIAGNOSTICS THERAPEUTIC RESEARCH BY SEGMENT, THROUGH 2012 ($ MILLIONS)

FIGURE 10 PROJECTED U.S. GROWTH TREND FOR STEM-CELLRELATED CELL-BASED ASSAYS/DIAGNOSTICS THERAPEUTIC RESEARCH BY SEGMENT, 2005-2012 ($ MILLIONS)

FACTORS DRIVING AND INHIBITING APPLICATION OF STEM CELL TECHNOLOGY

Factors Driving and Inhibiting …(Continued)

Factors Driving and Inhibiting …(Continued)

Factors Driving and Inhibiting …(Continued)

TABLE 12 FACTORS DRIVING AND INHIBITING THE APPLICATION OF STEM-CELL-BASED THERAPEUTICS

MARKETS BY TYPES OF APPLICATIONS

INTRODUCTION TO STEM-CELL-THERAPEUTIC-BASED APPLICATIONS

STEM CELL APPLICATIONS: REGENERATIVE MEDICINE

Stem Cell Applications Specifically by Tissue Type

Stem Cell Applications Specifically by Organ System Type

Stem Cell Applications in Infectious Disease, Genetic Disorders, and Cancer-related

TABLE 13 STEM CELL TECHNOLOGY APPLICATIONS IN REGENERATIVE MEDICINE

STEM CELL APPLICATIONS IN RESEARCH AND DEVELOPMENT

Stem Cell Applications in Academic Research

Stem Cell Applications in Biotechnology and Medical Device Research

Stem Cells in Pharmaceutical Research

TABLE 14 STEM CELL TECHNOLOGY AREAS OF APPLICATION WITHIN THE LIFE SCIENCES

STEM CELL TECHNOLOGY AND DEVELOPMENT

STEM CELL PRODUCTION

STEM CELL ACQUISITION

CHARACTERIZATION AND EXPANSION

MAINTENANCE AND STORAGE

FIGURE 11 FLOW DIAGRAM FOR PROCESS OF STEM CELL PRODUCTION

STEM CELL PRODUCTION ECONOMICS

STEM CELL PRODUCTION ECONOMICS (CONTINUED)

NOVEL STEM CELL PRODUCTION DEVELOPMENTS

ISOLATION AND ENGINEERING

NOVEL DEVELOPMENTS IN THE PRODUCTION OF ADULT STEM CELLS

NOVEL DEVELOPMENTS IN THE PRODUCTION OF EMBRYONIC STEM CELLS

Novel Developments in the Production …(Continued)

LEADERS IN STEM CELL RESEARCH DEVELOPMENT

ACADEMIC RESEARCH AND DEVELOPMENT LEADERS

Academic Stem Cell Research and Development Scientists

George Q. Daley, MD, Ph.D

Kevin Eggan, Ph.D

Doug Melton, Ph.D

Amy Wagers, Ph.D

Robert Langer, Sc.D

Irving Weissman, MD

Stuart Orkin, MD

Joseph Vacanti, MD

Kenneth Chien, MD, Ph.D

Rudolf Jaenisch, MD

Daniel Tenen, MD

Konrad Hochedlinger, Ph.D.

Paul Matsudaira, Ph.D

Anthony Atala, MD

Elaine Fuchs, Ph.D.

David J. Mooney, Ph.D.

James A. Thomson, Ph.D

Shinya Yamanaka, MD, Ph.D.

Kacey G. Marra, Ph.D

Gordon Keller, Ph.D

Johnny Huard, Ph.D

Hans Keirstead, Ph.D.

Shoukhrat Mitalipov, Ph.D.

Gordon Keller, Ph.D

TABLE 15 HIGHLIGHTED STEM CELL RESEARCH PUBLICATIONS, 2005-2008

TABLE 15 (CONTINUED)

TABLE 15 (CONTINUED)

INDUSTRY RESEARCH AND DEVELOPMENT LEADERS

TECHNOLOGY PATENT ANALYSIS

GENERAL TRENDS

TABLE 16 STEM CELL PATENT TRENDS, 2000-2008

FIGURE 12 STEM CELL PATENT TRENDS, 2000-2008

TRENDS BY COUNTRY

TABLE 17 STEM CELL PATENT COUNTRY CODES, 2000-2008

TABLE 18 STEM CELL PATENT TRENDS BY COUNTRY, 2000-2008

TABLE 19 STEM CELL PATENT TRENDS BY COUNTRY OF PATENTS, 2000-2008 (%)

FIGURE 13 STEM CELL PATENT TRENDS BY COUNTRY % OF PATENTS, 2000-2008 (%)

TRENDS BY COMPANIES

TABLE 20 STEM CELL PATENT TRENDS BY COMPANIES ASSIGNED TWO OR MORE PATENTS, 2000-2008

STEM CELL INDUSTRY STRUCTURE

DRIVING FORCES IN STEM-CELL-BASED INDUSTRIES

DRIVING FORCES IN THE HEALTH CARE MARKET

BIOTECHNOLOGY

PHARMACEUTICAL

COMPETITIVE ADVANTAGES IN STEM-CELL-BASED INDUSTRIES

TECHNOLOGY DEVELOPMENT AND UTILIZATION

COST OF NEW PRODUCT DEVELOPMENT, MANUFACTURING, AND LAUNCH

Cost of New Product Development, … (Continued)

MARKET POSITIONING AND CAPTURE

Market Positioning and Capture (Continued)

Market Positioning and Capture (Continued)

IMPORTANT SHIFTS IN INDUSTRY

CONTINUOUSLY EVOLVING TECHNOLOGICAL BASE

Continuously Evolving Technological Base (Continued)

EFFECTS OF FLUCTUATIONS IN FEDERAL GOVERNMENT AND FOOD AND DRUG ADMINISTRATION REGULATORY FACTORS

TABLE 21 RESTRICTIONS ON STEM CELL RESEARCH BY STATE

TABLE 21 (CONTINUED)

TABLE 21 (CONTINUED)

TABLE 21 (CONTINUED)

TABLE 21 (CONTINUED)

TABLE 21 (CONTINUED)

TABLE 21 (CONTINUED)

Food and Drug Administration Approval Requirements for Implementation of Stem-cell-based Therapeutics

STAGE OF STEM CELL LIFE CYCLE

TABLE 22 TOTAL NUMBER OF STEM CELL CLINICAL TRIALS, 2000-2008

FIGURE 14 TOTAL NUMBER OF STEM CELL CLINICAL TRIALS, 2000-2008

TABLE 23 TOTAL NUMBER OF STEM CELL CLINICAL TRIALS FUNDED BY INDUSTRY, 2000-2008

FIGURE 15 TOTAL NUMBER OF STEM CELL CLINICAL TRIALS FUNDED BY INDUSTRY, 2000-2008

TABLE 24 STEM CELL CLINICAL TRIALS RELATED TO CANCER (PERIPHERAL BLOOD/BONE MARROW TRANSPLANTATION), 2000-2008 (%)

FIGURE 16 STEM CELL CLINICAL TRIALS RELATED TO CANCER (PERIPHERAL BLOOD/BONE MARROW TRANSPLANTATION), 2000-2008 (%)

IMPACT ON EXISTING HEALTH CARE MARKET MAY BE SIGNIFICANT

MAJOR STEM CELL COMPANIES

MAJOR STEM CELL MARKETS

Stem Cell Market Segmentation

Stem Cell Market Forces

Stem Cell Market Forces (Continued)

GENERAL STEM CELL TECHNOLOGY ISSUES

STEM CELL TECHNOLOGY ISSUES BY TECHNOLOGY

TYPE

Embryonic Stem Cells

Adult Stem Cells

STEM CELL COMPANIES PERCENT MARKET SHARE

Stem Cell Companies Percent Market Share (Continued)

TABLE 25 MARKET SHARE OF STEM CELL THERAPEUTICS (AND BANKING) COMPANIES, 2005-2007 (%)

COMPANY PROFILES

AASTROM BIOSCIENCES, INC

TABLE 26 AASTROM BIOSCIENCES, INC. STEM CELL CLINICAL TRIALS

TABLE 26 (CONTINUED)

TABLE 27 AASTROM BIOSCIENCES, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED

ALDAGEN, INC

TABLE 28 ALDAGEN, INC. STEM CELL CLINICAL TRIALS

TABLE 29 ALDAGEN, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED

ADVANCED CELL TECHNOLOGY, INC

TABLE 30 ADVANCED CELL TECHNOLOGY, INC. STEM CELL CLINICAL TRIALS

TABLE 31 ADVANCED CELL TECHNOLOGY, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED

TABLE 31 (CONTINUED)

ARTERIOCYTE, INC.

TABLE 32 ARTERIOCYTE, INC. STEM CELL CLINICAL TRIALS

ATHERSYS, INC.

BD BIOSCIENCES

BIO-MATRIX SCIENTIFIC GROUP, INC.

BIOE

TABLE 33 BIOE STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED

BIOHEART, INC

TABLE 34 BIOHEART, INC. STEM CELL CLINICAL TRIALS

TABLE 35 BIOHEART, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED

CELGENE CORP

CELLERANT THERAPEUTICS, INC

TABLE 36 CELLERANT THERAPEUTICS, INC. STEM CELL CLINICAL TRIALS

TABLE 37 CELLERANT THERAPEUTICS, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED

CELLULAR DYNAMICS INTERNATIONAL, INC

COGNATE BIOSERVICES, INC.

TABLE 38 COGNATE BIOSERVICES, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED

CRYO-CELL INTERNATIONAL, INC.

CYTOMATRIX, LLC

TABLE 39 CYTOMATRIX, LLC STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED

CYTORI THERAPEUTICS, INC

TABLE 40 CYTORI THERAPEUTICS, INC. STEM CELL CLINICAL TRIALS

TABLE 41 CYTORI THERAPEUTICS, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED

TABLE 41 (CONTINUED)

ENDGENITOR TECHNOLOGIES, INC.

FORTICELL BIOSCIENCE, INC.

TABLE 42 FORTICELL BIOSCIENCE, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED

GERON CORP

TABLE 43 GERON CORP STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED

HEALTHEUNIVERSE, INC.

TABLE 44 HEALTHEUNIVERSE, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED

INTERNATIONAL STEM CELL CORPORATION

INVITROGEN CORPORATION

MATTEK CORPORATION

TABLE 45 MATTEK CORP STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED

MEDISTEM LABORATORIES, INC.

TABLE 46 MEDISTEM LABORATORIES, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED

MEDRA, INC

MILLIPORE

MORPHOGENESIS, INC

TABLE 47 MORPHOGENESIS, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED

MG BIOTHERAPEUTICS, LLC

MORAGA BIOTECHNOLOGY CORPORATION

NEOSTEM, INC

TABLE 48 NEOSTEM, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED

NEURALSTEM, INC

TABLE 49 NEURALSTEM, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED

NEUROGENERATION

NEURONYX, INC

TABLE 50 NEURONYX, INC. STEM CELL CLINICAL TRIALS

TABLE 51 NEURONYX, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED

NUTECH MEDICAL, INC.

NOVOCELL, INC.

TABLE 52 NOVOCELL, INC STEM CELL CLINICAL TRIALS

TABLE 53 NOVOCELL, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED

OPEXA THERAPEUTICS, INC.

TABLE 54 OPEXA THERAPEUTICS, INC. STEM CELL CLINICAL TRIALS

ORGANOGENESIS, INC.

TABLE 55 ORGANOGENESIS, INC. STEM CELL CLINICAL TRIALS

TABLE 56 ORGANOGENESIS, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED

OSIRIS THERAPEUTICS, INC.

TABLE 57 OSIRIS THERAPEUTICS, INC. STEM CELL CLINICAL TRIALS

TABLE 57 (CONTINUED)

TABLE 58 OSIRIS THERAPEUTICS, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED

PHARMASTEM THERAPEUTICS, INC

TABLE 59 PHARMASTEM THERAPEUTICS, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED

PRIMEGEN BIOTECH, LLC

PROGENITOR CELL THERAPY, LLC

REGENETECH, INC

TABLE 60 REGENETECH, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED

SANERON CCEL THERAPEUTICS, INC.

STEM CELL INNOVATIONS

TABLE 61 STEM CELL INNOVATIONS STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED

STEM CELLS, INC

TABLE 62 STEM CELLS, INC. STEM CELL CLINICAL TRIALS

TABLE 63 STEM CELLS, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED

STEM CELL THERAPY INTERNATIONAL CORP

STEMCELL PHARMA, INC.

STEMCYTE, INC

STEMEDICA CELL TECHNOLOGIES, INC

TENGION, INC

TABLE 64 TENGION, INC. STEM CELL CLINICAL TRIALS

THERADIGM, INC

TABLE 65 THERADIGM, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED

THERMOGENESIS CORP

VESTA THERAPEUTICS, INC.

TABLE 66 VESTA THERAPEUTICS, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED

VIACELL, INC

TABLE 67 VIACELL, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED

VIACORD

VISTAGEN THERAPEUTICS, INC.

TABLE 68 VISTAGEN THERAPEUTICS, INC. STEM CELL CLINICAL TRIALS

TABLE 69 VISTAGEN THERAPEUTICS, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED

VITRO DIAGNOSTICS, INC.

VITRO DIAGNOSTICS, INC. (CONTINUED)

INTERNATIONAL ASPECTS OF REGENERATIVE MEDICINE/STEM CELL MARKET

INTERNATIONAL ASPECTS OF…

TABLE 70 LEADING GLOBAL REGENERATIVE MEDICINE/STEM CELL COMPANIES

REFERENCES

REFERENCES

REFERENCES (CONTINUED)

REFERENCES (CONTINUED)

REFERENCES (CONTINUED)

REFERENCES (CONTINUED)

REFERENCES (CONTINUED)

REFERENCES (CONTINUED)

REFERENCES (CONTINUED)

REFERENCES (CONTINUED)

REFERENCES (CONTINUED)

APPENDIX A — ABBREVIATIONS

APPENDIX B — GLOSSARY

APPENDIX B — GLOSSARY

APPENDIX B — GLOSSARY (CONTINUED)

APPENDIX B — GLOSSARY (CONTINUED)

APPENDIX C - STEM CELL PATENTS, 2000-2008

TABLE 71 STEM CELL PATENTS BETWEEN THE YEARS 2000 AND 2008

TABLE 71 (CONTINUED)

TABLE 71 (CONTINUED)

TABLE 71 (CONTINUED)

TABLE 71 (CONTINUED)

TABLE 71 (CONTINUED)

TABLE 71 (CONTINUED)

TABLE 71 (CONTINUED)

TABLE 71 (CONTINUED)

TABLE 71 (CONTINUED)

TABLE 71 (CONTINUED)

TABLE 71 (CONTINUED)

TABLE 71 (CONTINUED)

TABLE 71 (CONTINUED)

TABLE 71 (CONTINUED)

TABLE 71 (CONTINUED)

TABLE 71 (CONTINUED)

TABLE 71 (CONTINUED)

LIST OF TABLES

SUMMARY TABLE U.S. MARKET FOR STEM CELLS IN REGENERATIVE MEDICINE REVENUE, THROUGH 2012 ($ MILLIONS)

TABLE 1 DERIVATION OF HUMAN TISSUE TYPES DURING DEVELOPMENT

TABLE 2 STEM CELL CLASSIFICATION BASED ON DIFFERENTIATION POTENTIAL

TABLE 3 ADULT STEM CELL TYPES AND POTENTIAL TISSUE SOURCES

TABLE 4 THE NATIONAL INSTITUTES OF HEALTH STEM CELL RESEARCH FUNDING, 2004-2009 ($ MILLIONS)

TABLE 5 THE NATIONAL INSTITUTES OF HEALTH HUMAN EMBRYONIC STEM CELL REGISTRY

TABLE 6 STATES FUNDING STEM-CELL-RELATED RESEARCH

TABLE 7 PROJECTED U.S. GROWTH TREND FOR STEM CELLS IN REGENERATIVE MEDICINE, THROUGH 2012 ($ MILLIONS)

TABLE 8 PROJECTED U.S. GROWTH TREND FOR STEM CELLS IN CELL-BASED THERAPEUTICS FOR HUMAN ADULT AND EMBRYONIC STEM CELLS, THROUGH 2012 ($ MILLIONS)

TABLE 9 PROJECTED U.S. GROWTH TREND FOR THERAPEUTIC STEM CELL BANKING, THROUGH 2012 ($ MILLIONS)

TABLE 10 PROJECTED U.S. GROWTH TREND FOR STEM-CELLRELATED THERAPEUTIC RESEARCH ($ MILLIONS)

TABLE 11 PROJECTED U.S. GROWTH TREND FOR STEM-CELLRELATED CELL-BASED ASSAYS/DIAGNOSTICS THERAPEUTIC RESEARCH BY SEGMENT, THROUGH 2012 ($ MILLIONS)

TABLE 12 FACTORS DRIVING AND INHIBITING THE APPLICATION OF STEM-CELL-BASED THERAPEUTICS

TABLE 14 STEM CELL TECHNOLOGY AREAS OF APPLICATION WITHIN THE LIFE SCIENCES

TABLE 15 HIGHLIGHTED STEM CELL RESEARCH PUBLICATIONS, 2005-2008

TABLE 16 STEM CELL PATENT TRENDS, 2000-2008

TABLE 17 STEM CELL PATENT COUNTRY CODES, 2000-2008

TABLE 18 STEM CELL PATENT TRENDS BY COUNTRY, 2000-2008

TABLE 19 STEM CELL PATENT TRENDS BY COUNTRY OF PATENTS, 2000-2008 (%)

TABLE 20 STEM CELL PATENT TRENDS BY COMPANIES ASSIGNED TWO OR MORE PATENTS, 2000-2008

TABLE 21 RESTRICTIONS ON STEM CELL RESEARCH BY STATE

TABLE 22 TOTAL NUMBER OF STEM CELL CLINICAL TRIALS, 2000-2008

TABLE 23 TOTAL NUMBER OF STEM CELL CLINICAL TRIALS FUNDED BY INDUSTRY, 2000-2008

TABLE 24 STEM CELL CLINICAL TRIALS RELATED TO CANCER (PERIPHERAL BLOOD/BONE MARROW TRANSPLANTATION), 2000-2008 (%)

TABLE 25 MARKET SHARE OF STEM CELL THERAPEUTICS (AND BANKING) COMPANIES, 2005-2007 (%)

TABLE 26 AASTROM BIOSCIENCES, INC. STEM CELL CLINICAL TRIALS

TABLE 27 AASTROM BIOSCIENCES, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED

TABLE 28 ALDAGEN, INC. STEM CELL CLINICAL TRIALS

TABLE 29 ALDAGEN, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED

TABLE 30 ADVANCED CELL TECHNOLOGY, INC. STEM CELL CLINICAL TRIALS

TABLE 31 ADVANCED CELL TECHNOLOGY, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED

TABLE 32 ARTERIOCYTE, INC. STEM CELL CLINICAL TRIALS

TABLE 33 BIOE STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED

TABLE 34 BIOHEART, INC. STEM CELL CLINICAL TRIALS

TABLE 35 BIOHEART, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED

TABLE 36 CELLERANT THERAPEUTICS, INC. STEM CELL CLINICAL TRIALS

TABLE 37 CELLERANT THERAPEUTICS, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED

TABLE 38 COGNATE BIOSERVICES, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED

TABLE 39 CYTOMATRIX, LLC STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED

TABLE 40 CYTORI THERAPEUTICS, INC. STEM CELL CLINICAL TRIALS

TABLE 41 CYTORI THERAPEUTICS, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED

TABLE 42 FORTICELL BIOSCIENCE, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED

TABLE 43 GERON CORP STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED

TABLE 44 HEALTHEUNIVERSE, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED

TABLE 45 MATTEK CORP STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED

TABLE 46 MEDISTEM LABORATORIES, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED

TABLE 47 MORPHOGENESIS, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED

TABLE 48 NEOSTEM, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED

TABLE 49 NEURALSTEM, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED

TABLE 50 NEURONYX, INC. STEM CELL CLINICAL TRIALS

TABLE 51 NEURONYX, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED

TABLE 52 NOVOCELL, INC STEM CELL CLINICAL TRIALS

TABLE 53 NOVOCELL, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED

TABLE 54 OPEXA THERAPEUTICS, INC. STEM CELL CLINICAL TRIALS

TABLE 55 ORGANOGENESIS, INC. STEM CELL CLINICAL TRIALS

TABLE 56 ORGANOGENESIS, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED

TABLE 57 OSIRIS THERAPEUTICS, INC. STEM CELL CLINICAL TRIALS

TABLE 58 OSIRIS THERAPEUTICS, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED

TABLE 59 PHARMASTEM THERAPEUTICS, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED

TABLE 60 REGENETECH, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED

TABLE 61 STEM CELL INNOVATIONS STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED

TABLE 62 STEM CELLS, INC. STEM CELL CLINICAL TRIALS

TABLE 63 STEM CELLS, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED

TABLE 64 TENGION, INC. STEM CELL CLINICAL TRIALS

TABLE 65 THERADIGM, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED

TABLE 66 VESTA THERAPEUTICS, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED

TABLE 67 VIACELL, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED

TABLE 68 VISTAGEN THERAPEUTICS, INC. STEM CELL CLINICAL TRIALS

TABLE 69 VISTAGEN THERAPEUTICS, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED

TABLE 70 LEADING GLOBAL REGENERATIVE MEDICINE/STEM CELL COMPANIES

TABLE 71 STEM CELL PATENTS BETWEEN THE YEARS 2000 AND 2008

LIST OF FIGURES

SUMMARY FIGURE U.S. MARKET FOR STEM CELLS IN REGENERATIVE MEDICINE REVENUE, 2005-2012 ($ MILLIONS)

FIGURE 1 FLOW DIAGRAM OF HUMAN DEVELOPMENT PROCESS

FIGURE 2 THE NATIONAL INSTITUTES OF HEALTH HUMAN STEM CELL RESEARCH FUNDING, 2004-2009 ($ MILLIONS)

FIGURE 3 PROJECTED U.S. GROWTH TREND FOR STEM CELLS IN REGENERATIVE MEDICINE, 2005-2012 ($ MILLIONS)

FIGURE 4 FLOW DIAGRAM OF PROCESS USING STEM CELLS IN CELLULAR THERAPEUTICS

FIGURE 5 PROJECTED U.S. GROWTH TREND FOR STEM CELLS IN CELL-BASED THERAPEUTICS FOR HUMAN ADULT AND EMBRYONIC STEM CELLS, 2005-2012 ($ MILLIONS)

FIGURE 6 FLOW DIAGRAM OF PROCESS USING STEM CELLS IN ENGINEERING TISSUE FOR TRANSPLANTATION

FIGURE 7 FLOW DIAGRAM FOR PROCESS OF THERAPEUTIC BANKING OF STEM CELLS

FIGURE 8 PROJECTED U.S. GROWTH TREND FOR THERAPEUTIC STEM CELL BANKING, 2005-2012 ($ MILLIONS)

FIGURE 9 PROJECTED U.S. GROWTH TREND FOR STEM-CELLRELATED THERAPEUTIC RESEARCH, 2005-2012 ($ MILLIONS)

FIGURE 10 PROJECTED U.S. GROWTH TREND FOR STEM-CELLRELATED CELL-BASED ASSAYS/DIAGNOSTICS THERAPEUTIC RESEARCH BY SEGMENT, 2005-2012 ($ MILLIONS)

FIGURE 11 FLOW DIAGRAM FOR PROCESS OF STEM CELL PRODUCTION

FIGURE 12 STEM CELL PATENT TRENDS, 2000-2008

FIGURE 14 TOTAL NUMBER OF STEM CELL CLINICAL TRIALS, 2000-2008

FIGURE 15 TOTAL NUMBER OF STEM CELL CLINICAL TRIALS FUNDED BY INDUSTRY, 2000-2008

FIGURE 16 STEM CELL CLINICAL TRIALS RELATED TO CANCER (PERIPHERAL BLOOD/BONE MARROW TRANSPLANTATION), 2000-2008 (%)

Abstract

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