Stem Cell Markets


June 1, 2010
266 Pages - SKU: TRI2692266
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Table of Contents Related Reports
1. Overview
1.1 Statement of Report
1.2 Scope of the Report
1.3 Methodology
1.4 Executive Summary
1.4.1 Toxicity Screening for Drug Discovery and Development
1.4.2 Autologous Cell Therapy
1.4.2.1 Current Range of Applications for Autologous Cell Therapy (ACT)
1.4.2.2 Commercially Available Autologous Treatments
1.4.2.3 Autologous Treatment for Neurodegenerative Diseases
1.4.2.4 Autologous Cell Therapy and Wound Healing
1.4.2.5 Autologous Cell Therapy and Cosmetic Surgery
1.4.3 Allogeneic Cell Therapy
1.4.3.1 Allogeneic First Generation (Non-Stem Cell) Products
1.4.3.2 Second Generation (Stem Cell-Based) Products
1.4.3.3 Secondary Products
1.4.4 Three Basic Types of Allogeneic Stem Cell Products
1.4.4.1 Hematopoietic Stem Cells
1.4.4.2 Neural Stem Cells
1.4.4.3 Mesenchymal Stem Cells, Pancreatic Islet Stem Cells
1.5 Current State of Stem Cell Market
2. Biology of Stem Cells
2.1 Scope of this Chapter
2.2 Basic Properties of Stem Cells
2.3 Classification of Stem Cells, Stem Cell Lineages and their Derivation
2.3.1 Embryonic Stem Cells
2.3.1.1 Embryonic Germ Cells
2.3.1.1 Fetal Stem Cells
2.3.1.2 Umbilical Cord Stem Cells
2.3.2 Adult Stem Cells
2.3.2.1 Hematopoietic Stem Cells (Bone Marrow and Peripheral Blood)
2.3.2.2 Mesenchymal Stem Cells (Bone Marrow Stroma)
2.3.2.3 Gut Stem Cells
2.3.2.4 Liver Stem Cells
2.3.2.5 Bone and Cartilage Stem Cells
2.3.2.6 Epidermal Stem Cells (Skin and Hair)
2.3.2.7 Neuronal Stem Cells
2.3.2.8 Pancreatic Stem Cells
2.3.2.9 Eye Stem Cells
2.4 Stem Cell Lineage
2.5 Stem Cell Derivations
2.6 Sources of Stem Cells
2.7 Differentiation of Stem Cells
2.8 Self-Renewal of Stem Cells
2.9 Dedifferentiation of Cells
2.10 Nuclear Reprogramming of Stem Cells
3. Stem Cell Therapy
3.1 Scope of this Chapter
3.2 Diseases with Unmet Clinical Need: Primary Driver of Stem Cell Therapy
Market
3.3 Leading Healthcare Segments Offering Scope for Easy Entry into Stem Cell
Market
3.3.1 Stem Cell Therapy in Orthopedics
3.3.1.1 Stem Cells for the Repair of Tendons, Cartilages and Bone
3.3.2 Stem Cell Therapy for Cardiac Diseases
3.3.3 Stem Cell Therapy for Wound Healing
3.3.4 Stem Cell Therapy for Diabetes
3.3.5 Stem Cell Therapy for Neurodegenerative Diseases
3.3.5.1 Clinical Activity for Cell Therapy into CNS
3.3.6 Stem Cell Retinal Replacement Therapy
3.3.7 Stem Cell Therapy for Liver Diseases
3.3.7.1 Hepatocyte-like Cells for Liver Disease
3.3.7.2 Cell Therapy for Liver Cirrhosis
3.3.8 Cell Therapy for Peripheral Vascular Diseases
3.3.9 Cell Therapy for Blood Disorders
3.3.10 Biomaterials and Stem Cell Therapy
3.3.11 Stem Cell Application in Drug Discovery
3.4 Stem Cell Products in Development
3.5 Stem Cell and Related Products in the Global Market
3.5.1 Medtronic’s Infuse Bone Graft and the LT-Cage Device
3.5.2 GenZyme’s Carticel®
3.5.3 Stryker’s OP-1
3.5.4 Osyris/Nuvasive’s Osteocel®
3.5.5 RTI’s Spinal Implants
3.5.6 Organogenesis’ Apligraf®
3.5.7 Advanced Biohealing’s Dermagraft
3.5.8 Integra’s Bilayer Matrix Wound Dressing
3.5.9 LifeCell’s AlloDerm®
3.5.10 Gytori’s Celution®
3.6 Other Products of Importance in the Global Market
3.6.1 Tissue-Engineered Wound Healing Products
3.6.1.1 Oasis®
3.6.1.2 Permacol™
3.6.1.3 EZ-Derm®
3.6.1.4 Matriderm®
3.6.1.5 Alloderm®
3.6.1.6 TransCyte®
3.6.1.7 ICX-SKN®
3.6.1.8 OrCel®
3.6.1.9 Epicel®
3.6.1.10 Myskin™
3.6.1.11 EpiDex™
3.6.1.12 Genzyme’s MACI® Implant
3.6.1.13 Genzyme’s Epicel®
3.6.1.14 ICX-TRC—Hair Regeneration Therapy
3.6.1.15 VCT01™
3.6.2 Cartilage Regeneration
3.6.2.1 ChondroCelect/TGX001
3.6.2.2 TGX002
3.6.2.3 TGX003
3.6.2.4 NOVOCART™
3.6.3 BioTissue Technologies’ Products
3.6.3.1 BioSeed®-S
3.6.3.2 MelanoSeed
3.6.3.3 Oral Mucosa BioSeed®-M
3.6.3.4 BioSeed®-Oral Bone
3.6.3.5 BioSeed®-C
3.6.4 co.don®’s Autologous Cell Transplant Products
3.6.5 Fidia Advanced Biopolymers’ Regenerative Medicine Products
3.6.5.1 Hyalograft 3D™
3.6.5.2 Laserskin®
3.6.5.3 TISSUEtech autograft system™
3.6.5.4 Hyalograft™ C
3.6.6 Genzyme Biosurgery’s Tissue Engineering Products
3.6.6.1 Carticel®
3.6.6.2 Epicel®
3.6.7 Interface Biotech AS’ Tissue Engineered Products
3.6.7.1 Cartilink™-1
3.6.7.2 Cartilink™-2
3.6.8 Isotis S.A’s Tissue Engineered Products
3.6.8.1 OsSatura™
3.6.8.2 EpiDex
3.6.8.3 AcuDress
3.6.9 Karocell Tissue Engineering AB’s Tissue-Engineered Products
3.6.9.1 Skin Cells
3.6.9.2 Cartilage Cells
3.6.9.3 Melanocytes
3.6.9.4 Urothelial Tissue
3.6.10 Smith & Nephew’s Tissue Engineering Products
3.6.10.1 TransCyte
3.6.10.2 Dermagraft
3.6.11 Tetec Tissue Engineering Technologies AG’s Tissue Engineered Product
3.6.11.1 Novacart®
3.6.12 Verigen Transplantation Service International (VTSI)’s Tissue-Engineered Products
3.6.12.1 CACI
3.6.12.2 MACI®
3.6.12.3 MACI® (A)
3.6.13 XCELLentis’ Tissue-Engineered Products
3.6.13.1 Ceal Platform
3.6.13.2 LyphoDerm
4. Market Analysis of the Stem Cell Space
4.1 Scope of this Chapter
4.1.1 Various Market Segments in Stem Cell Space
4.1.2 Market for Cell Therapy in the U.S.
4.2 Market Segmentation by Source of Stem Cell Used
4.2.1 Human Embryonic Stem Cells (hESCs) in Cell Therapy
4.2.1.1 Investing Companies in hESCs
4.2.1.2 Engineered Cartilage using hESCs
4.2.1.3 Lung Tissue Differentiated from hESCs
4.2.1.4 Human Mesenchymal Stem Cells (MSCs)
4.2.2 Neural Stem Cells
4.2.3 Human Hematopoietic Stem Cells
4.2.4 Cord Blood Stem Cells
4.2.5 Cancer Stem Cells
4.3 Cord Blood Banking Market
4.3.1 Cord Blood Stem Cell Applications
4.3.1.1 Repairing Blood Vessels Using Cord Blood Stem Cells
4.3.1.2 Cardiomyocetes and Cord Blood Stem Cells
4.3.1.3 Congenital Heart Defects and Cord Blood Stem Cells
4.3.1.4 Peripheral Vascular Disease and Cord Blood Stem Cells
4.3.2 Growth of Public and Private Cord Blood Banks
4.3.2.1 Public Cord Blood (CB) Banks
4.3.2.2 Private Cord Blood Banks
4.3.2.3 The Collection Process of Cord Blood Cells
4.4 Cell Culture Products
4.4.1 In Vitro Test Kits
4.4.2 Suppliers of Cells and Tissues
4.4.3 Suppliers of Culture Media and Cell Reagents
4.4.4 Equipments for Stem Cell Research
4.4.5 Computer Software for Stem Cell Research
4.5 Cell Therapy Market
4.5.1 The Size of the Cell Therapy Industry
4.5.2 The Age, Size and Location of Firms
4.5.3 Firm Technology and Disease Focus
4.5.4 Cell Therapy Products and Companies
4.5.5 Products on the Market
4.5.5.1 First Generation (Non-Stem Cell Based) Primary Products
4.5.5.2 Second Generation (Stem Cell Based) Primary Products
4.5.5.3 Secondary Products
4.5.5.4 Products in Development
4.5.5.5 The Disease Targets of Trials
4.5.5.6 Stem Cell Industry Pipeline
4.6 Industry Collaboration in Stem Cell Space
4.7 Increasing Commercial Success in Stem Cell Industry
4.8 Transition from Tissue Engineering to Regenerative Medicine
4.9 Challenges to Commercial Development of Cell Therapies
4.9.1 Problems of Commercial Viability and Sustainability
4.9.2 Poor Sales and Limited Prospects for Some Forms of Cell Therapy
4.9.3 Lack of Investment from Large Companies
4.9.4 Lack of Clinical Demand and Uptake
4.10 Partnership of Stem Cell Companies with Large Pharmaceutical Companies
4.10.1 Strategic Approaches for Cell-based Companies
4.10.2 The Need for Support from Large Pharmaceuticals
5. Strategic Roadmap to Cell Therapy Industry
5.1 Scope of this Chapter
5.2 Options for the Commercial Manufacturing of Stem Cell Products
5.3 Regulatory Requirements for a Cell Therapy Industry
5.4 In-House Manufacturing of Cell Therapy Products
5.5 Contract Manufacturing
5.6 Effective Clinical Delivery Plan for Cell Therapies
5.7 Business Models in Stem Cell Therapy Sector
5.8 Current Models for Autologous Cell Therapies
5.9 Current Models for Allogeneic Cell Therapies
5.10 Value Chain Considerations and Developmental Path
5.11 Stem Cells: From the Laboratory to the Market
5.11.1 Value Analysis
5.11.2 Clinical Study Development
5.11.3 Product Commercialization
5.11.4 Importance of Specialty Society Support
5.11.5 Payor Coverage
6. Funding for Regenerative Medicine Research
6.1 Scope of this Chapter
6.2 The Intense Competitive Pressure for Funding
6.3 History of Stem Cell Research, Tissue-Engineering and Regenerative Medicine
6.4 The Story of Federal Funding of Stem Cell Research
6.4.1 Policy Changes
6.4.2 Types of Research Ineligible for NIH Funding
6.4.3 NIH Guidelines Addressing the Projected Growth of Stem Cell-Related Clinical Trials
6.4.4 CIRM Funding for Stem Cell Research and Regenerative Medicine
6.5 The Strong Financial Case for Stem Cell Research and Regenerative Medicine
6.5.1 Regenerative Medicine Cost vs. Existing Treatments
7. Current Stem Cell Research
7.1 Scope of this Chapter
7.2 Stem Cell Policies in North America
7.3 Stem Cell Policies in South America
7.4 Stem Cell Policies in Europe
7.5 Stem Cell Policies in Asia/Oceania
7.6 California Institute for Regenerative Medicine (CIRM)
7.6.1 CIRM Collaborative Funding
7.6.2 CIRM’s Funding for Clinical Applications
7.6.3 Early Translational Awards
7.6.4 Disease Team Awards
7.7 Stem Cell Research Programs in Connecticut Department of Public Health
7.7.1 Types of Awards by Connecticut Stem Cell Research Program, 2010
7.7.1.1 Seed Grant Awards
7.7.1.2 Established Investigator Awards
7.7.1.3 Group Project Awards
7.7.1.4 Core Facilities Awards
7.8 Maryland Technology Development Corporation (TEDCO)
7.8.1 TEDCO’s Programs: Funding Opportunities
7.8.1.1 Fort Detrick Technology Transfer Initiative (FDTTI)
7.8.1.2 J&J Investment Fund
7.8.1.3 NAVAIR Technology Insertion (NAVTI) Program
7.8.1.4 The TechStart Program
7.8.1.5 University Technology Development Fund (UTDF)
7.8.1.6 Working Capital Loan Fund
7.9 Maryland Technology Transfer and Commercialization Fund (MTTCF)
7.9.1 Maryland Stem Cell Research Fund
7.10 The New Jersey Commission on Science and Technology (NJCST)
7.10.1 Stem Cell Research in New Jersey
7.10.2 Stem Cell Research Grant Program
7.11 New York State Stem Cell Science (NYSTEM)
7.11.1 Investigator Initiated Research Projects and Innovative (IIRP),Developmental or Exploratory Activities (IDEA) in Stem Cell Research
7.11.2 Targeted RFA for Investigation of iPS and Other Derivation Approaches
7.11.3 Shared Facilities/Resources and Equipment/Instrumentation for Stem Cell
Research
7.11.4 Consortia Planning Awards
7.11.5 Institutional Development
7.11.6 Center for Stem Cell and Regenerative Medicine
7.11.7 Funding
8. Company Profiles
8.1 Aastrom Biosciences, Inc.
8.1.1 Aastrom’s TRC Technology
8.1.2 Aastrom’s Patents
8.1.3 Aastrom’s Clinical Development Programs
8.2 Advanced Cell Technology, Inc.
8.2.1 ACT’s Human ES Cell Technologies
8.2.2 ACT’s Cellular Reprogramming
8.2.3 ACT’s Stem Cell Differentiation
8.2.4 ACT’s Adult Stem Cell Program
8.2.5 ACT’s Intellectual Property
8.3 Aldagen, Inc.
8.4 Asterand plc
8.4.1 Asterand’s Models and Methods to Improve Drug Discovery
8.4.2 Asterand’s Product Offerings
8.4.2.1 Asterand’s Frozen and Fixed Tissues
8.4.2.2 Asterand Cell Lines
8.5 Alseres Pharmaceuticals, Inc.
8.5.1 Alseres’ Product Pipeline
8.5.1.1 Cethrin®, a Rho Inhibitor
8.5.1.2 Inosine
8.5.1.3 Oncomodulin and ALSE-100
8.5.1.4 Altropane® - PD
8.5.2 Alseres’ Science and Technology
8.5.2.1 Nerve Repair Pathways
8.5.2.2 The Pro-Regenerative Pathway
8.5.2.3 The Anti-Regenerative Pathway
8.5.2.4 Molecular Imaging
8.6 Amgen, Inc.
8.6.1 Amgen’s Clinical Developments
8.6.1.1 Amgen’s Clinical Developments in Osteoporosis
8.6.1.2 Amgen’s Clinical Developments in Oncology
8.6.2 Amgen’s Select Product Candidates
8.6.2.1 Amgen’s New Product Candidates
8.7 Amorcyte, Inc.
8.7.1 Amorcyte’s Technology
8.7.1.1 AMR-001: A Cell Therapy for Acute Myocardial Infarction
8.8 Angioblast Systems, Inc.
8.8.1 Angioblast’s Technology
8.8.1.1 Angioblast’s Allogenic Adult Stem Cells
8.8.1.2 Angioblast’s Protein Therapeutics
8.8.1.3 Angioblast’s Gene Silencing
8.9 Athersys, Inc.
8.9.1 Athersys’ Current Programs
8.9.2 Athersys’ Regenerative Medicine Programs
8.9.2.1 Multistem for Heart Attack
8.9.2.2 HSC Transplant Support in Hematologic Malignancy
8.9.2.3 Stroke
8.10 BeFutur Biotechnologies
8.10.1 BeFutur’s Serum Free Technology
8.10.2 BeFutur’s Stem Cells
8.11 BD Biosciences
8.12 BioE, Inc.
8.12.1 BioE’s Cell Technologies
8.12.1.1 Application of BioE's Multi-Lineage Progenitor Cell
8.12.1.2 Application of the MLPC in Regenerative Medicine
8.12.1.3 Application of PrepaCyte for Cord Blood
8.12.2 BioE’s Products
8.12.2.1 Multi-Lineage Progenitor Cell (MLPC®)
8.12.2.2 PrepaCyte®-CB
8.12.2.3 PrepaCyte®-WBC
8.12.2.4 ActiCyte®
8.12.2.5 VitaLyse®
8.13 Bioheart, Inc.
8.13.1 Bioheart’s Product Candidates
8.13.1.1 MyoCell®
8.13.1.2 MyoCell SDF-1
8.13.1.3 The TGI 1200 Cell Isolation system
8.13.1.4 Bioheart 3370®
8.13.1.5 MyoCath
8.14 BioMimetic Therapeutics, Inc.
8.14.1 BioMimetic’s Products
8.14.1.1 Augment™ Bone Graft
8.14.1.2 Augment™ Injectable Bone Graft
8.15 Biosafe Group SA
8.15.1 Biosafe’s Sepax System
8.15.2 Coolmix
8.15.3 SepaxNet
8.16 Brainstorm Cell Therapeutics, Inc.
8.16.1 BrainStorm Technology—NurOwn™
8.17 Cardio3 BioSciences
8.17.1 C-Cure™
8.17.2 Dopamine Transporter (DAT)
8.18 CaridianBCT
8.18.1 Caridian’s Products
8.18.1.1 Trima Accel® Collection System
8.18.1.2 Spectra Optia® Apheresis System
8.18.1.3 COBE® Spectra Apheresis System
8.18.1.4 Elutra® Cell Separation System
8.18.1.5 Atreus® Whole Blood Processing System
8.18.1.6 OrbiSac® System
8.18.1.7 COBE® 2991 Cell Processor
8.19 Cellartis AG
8.19.1 Cellartis’ Products
8.19.1.1 Cardiomyocyte Monolayers
8.19.1.2 Cardiomyocyte Clusters
8.19.1.3 Hepatocyte-like Cells
8.19.1.4 Mesenchymal Progenitors
8.19.1.5 The hES Cell Lines
8.19.1.6 Monoclonal Antibodies
8.19.1.7 VitroHES™
8.19.1.8 Stem Culture Tools
8.20 Cellerant Therapeutics, Inc.
8.20.1 Cellerant’s Pipeline
8.20.1.1 CLT-008
8.21 CellCyte Genetics Corporation
8.21.1 CellCyte’s Product Candidates
8.21.2 CellCyte’s Therapeutic Pipeline
8.21.2.1 Heart Repair
8.21.2.2 Cells for Use in the Liver
8.21.2.3 Delivery of Stem Cells to the Bone Marrow
8.21.2.4 Oncology-Adenocarcinoma Tumor Detection
8.21.3 CellCyte’s Device Division
8.21.3.1 Cell Expansion
8.21.3.2 Stem Cell Purification
8.22 Cellerix
8.22.1 Cellerix’s Products
8.22.1.1 Ontaril®
8.22.1.2 Cx501
8.23 CellSeed, Inc.
8.23.1 Regenerative Cornea Product from CellSeed
8.23.2 Regenerative Living Cardiac Patch
8.24 Cellular Dynamics International, Inc. (CDI)
8.24.1 Induced Pluripotent Stem (iPS) Cell Technology
8.24.2 Cardiomyocytes
8.24.3 Mastocytes
8.25 CellTran Ltd.
8.25.1 Myskin™
8.25.2 Lyphoderm
8.25.3 Products in Development
8.25.3.1 Vitiligo Treatment
8.25.3.2 Corneal Epithelial Treatment
8.25.3.3 Cell Migration Dressing
8.26 Cerco Medical
8.26.1 Cerco’s Concept
8.27 Cellular Engineering Technologies, Inc.
8.27.1 CET’s Human Amniotic Epithelial Stem Cells
8.27.2 CET’s Cryopreservation Media
8.27.3 CET’s Adipogenic Differentiation Media
8.27.4 CET’s Cardiomyocyte Differentiation Media
8.27.5 CET’s Chondrogenic Differentiation Media
8.27.6 CET’s Neural Differentiation Media
8.27.7 CET’s Osteogenic Differentiation Media
8.27.8 CET’s Amniotic Epithelial Stem Cell Expansion Media
8.27.9 CET’s Cord Blood Multipotent Unrestricted Somatic Stem Cell Expansion Media
8.27.10 CET’s Mesenchymal Stem Cell Expansion Media
8.27.11 CET’s Human Immunological Cells
8.27.12 CET’s Human Foreskin Fibroblast Cells
8.27.13 CET’s Human Umbilical Vein Endothelial Cell Expansion Media
8.27.14 CET’s Cryopreservation Media
8.27.15 CET’s Bioelectrode Cell-based Assays
8.27.16 CET’s Hepatic Drug Screening
8.27.17 CET’s Neural Drug Screening
8.27.18 CET’s Contract Research Services
8.28 Cord Blood America, Inc.
8.29 CorMatrix® Cardiovascular, Inc.
8.29.1 ECM Technology™
8.30 Cryo-Cell International, Inc.
8.31 Cytori Therapeutics, Inc.
8.31.1 Market for Clinical-Grade Cells
8.31.2 StemSource® and Cell Banking
8.31.3 Celution® System Pipeline
8.31.3.1 Cardiovascular Disease
8.32 CryoLife, Inc.
8.32.1 CryoLife’s Services and Products
8.32.1.1 Tissue Preservation Services
8.32.1.2 Human Cardiac Tissue
8.32.1.3 Human Vascular Tissue
8.32.1.4 Human Orthopedic Tissue
8.32.1.5 ProPatch Soft Tissue Repair Matrix
8.33 Epistem PLC
8.33.1 Xenografting
8.33.2 Cancer Stem Cell Assays
8.33.3 Angiogenesis Models
8.33.4 Colon Cancer Models
8.33.5 Oncology Biomarker Models
8.33.6 In Vitro Cytotoxicity Testing
8.33.7 Target Validation-Oncology
8.33.8 Inflammatory Bowel Disease
8.33.9 Dermatology
8.33.10 Histology and Molecular Services
8.33.11 Epistem’s Biomarkers
8.33.12 Epistem’s New Therapies
8.34 ES Cell International Pvt, Ltd.
8.34.1 ESI’s Technology
8.34.2 ESI’s Intellectual Property
8.35 Forticell Bioscience, Inc.
8.36 OrCel®
8.36.1 Technology
8.37 Gamida Cell
8.37.1 Gamida’s Technology
8.38 GenVec, Inc.
8.39 Geron Corporation
8.39.1 Geron and Human Embryonic Stem Cell Therapies
8.39.2 Geron’s Oligodendrocyte Progenitor Cells for Spinal Cord Injury (GRNOPC1)
8.39.3 Geron’s Cardiomyocytes for Heart Disease (GRNCM1)
8.39.4 Geron’s Islet Cells for Diabetes (GRNIC1)
8.39.5 Geron’s Osteoblasts for Osteoporosis and Non-Union Bone Fractures
8.39.6 Geron’s Chondrocytes for Osteoarthritis
8.39.7 Geron’s Dendritic Cells for Cancer Immunotherapy and to enable Therapeutic Graft Acceptance
8.39.8 Geron’s Immortalized Cells for Research
8.39.9 Geron’s hESC-derived Cells for Drug Screening and Toxicology
8.40 Glycosan Biosystems, Inc.
8.40.1 Extracel™ Hydrogel Kit
8.40.2 Extracel-X™ Hydrogel Kit
8.40.3 Extracel-HP™ Hydrogel Kit
8.40.4 Extracel-SS™ Hydrogel Kit
8.40.5 HyStem™ Hydrogel Kit
8.40.6 HyStem-C™ Hydrogel Kit
8.40.7 HyStem-HP™ Hydrogel Kit
8.40.8 HyStem-CSS™ Hydrogel Kit
8.40.9 PEGDA
8.40.10 PEGTA
8.40.11 PEGSSDA™ (PEGSSDA)
8.41 Humacyte, Inc.
8.41.1 Humacyte’s Technologies
8.41.1.1 Vascular Products
8.41.1.2 Injectable Products
8.41.1.3 Human Embryonic Stem Cell Therapies
8.42 Intercytex Group plc
8.42.1 Intercytex’s Pipeline
8.42.1.1 VAVELTA® - Skin Repair and Rejuvenation
8.42.1.2 SHEF-1 - Stem Cell Line
8.42.1.3 ICX-SKN—Skin Graft Replacement for Burns and Acute Wounds
8.42.1.4 ICX-TRC - Hair Regeneration
8.42.1.5 Cyzact®—Chronic Wound Repair
8.43 Integra LifeSciences Holding, Corp.
8.43.1 Integra’s Duraplasty Products
8.43.2 Integra’s Collagen for Spine
8.43.3 Integra’s Dermal Regeneration and Engineered Wound Dressings
8.43.4 Integra’s Nerve and Tendon Products
8.43.5 Human Cells, Tissues and Cellular and Tissue-Based Products from Integra
8.44 International Stem Cell Corporation
8.44.1 ISCO’s Technology
8.44.1.1 Somatic Cell Nuclear Transfer
8.44.1.2 Parthenogenesis
8.44.1.3 ISCO’s Therapeutic Focus
8.44.1.4 Retinal Degeneration
8.44.1.5 Diabetes Therapies
8.44.1.6 Liver Therapies
8.44.2 ISCO’s Products
8.45 Japan Tissue Engineering Co., Ltd.
8.45.1 Cultured Epidermis
8.45.2 Cultured Cartilage
8.45.3 Cultured Corneal Epithelium
8.46 LifebankUSA
8.46.1 Cord Blood Banking
8.47 Life Technologies Corporation
8.47.1 Life Technologies’ Customers
8.47.1.1 Life Science Researchers
8.47.1.2 Commercial Producers of Biopharmaceutical and Other High-Valued Proteins
8.47.1.3 Applied Markets
8.47.2 Life Technologies’ Products
8.48 Lonza
8.48.1 Lonza’s Products and Applications
8.49 MedCell Bioscience, Ltd.
8.49.1 MedCell’s MS-ten Technology
8.50 Medistem, Inc.
8.50.1 Method for Expansion of Stem Cells
8.50.2 Compositions of Placentally-derived Stem Cells for the Treatment of Cancer
8.50.3 Transcatheter Tumor Immunoembolization
8.50.4 Stem Cell Therapy for Cardiac Valvular Dysfunction
8.50.5 Treatment of Erectile Dysfunction by Stem Cell Therapy
8.50.6 Allogeneic Stem Cell Transplants in Non-Conditioned Recipients
8.50.7 Stem Cell Mediated Treg Activation/Expansion for Therapeutic Immune Modulation
8.50.8 Cellular Therapy for Lower Back Pain
8.50.9 Compositions and Methods of Stem Cell Therapy for Autism
8.50.10 Stem Cell Therapy for Weight Loss
8.50.11 Menstrual Blood Cellular Populations, Isolation, and Use Thereof
8.50.12 Endometrial Derived Reparative/Regenerative Cells
8.50.13 Treatment of Insulin Resistance and Diabetes
8.50.14 Combination Treatment of Cardiovascular Disease
8.50.15 Stem Cell Therapy for Autism
8.50.16 Endometrial Regenerative Stem Cell Line
8.50.17 Medistem’s Angiostem Platform
8.51 Mesoblast Limited
8.51.1 Mesoblast’s Technologies
8.51.2 Mesoblast’s Applications in Bone Repair
8.51.2.1 Cartilage Regeneration
8.51.2.2 Disc Regrowth
8.51.3 Mesoblast’s Application in Heart Attack
8.51.3.1 Congestive Heart Failure
8.51.3.2 Peripheral Arterial Disease
8.51.4 Mesoblast’s Application in Wound Ulcers
8.51.5 Mesoblast’s Process and Product Development
8.51.5.1 GMP Process Development
8.51.5.2 Proof of Principle Models
8.52 Millipore Corporation
8.52.1 Millipore’s Drug Discovery and Development Services
8.52.2 Millipore’s Research and Development
8.53 Miltenyi Biotec
8.53.1 Miltenyi Biotec’s MACS® Technology
8.53.2 MACS® Cell Analysis
8.53.3 MACS® Cell Culture product line
8.54 Neostem, Inc.
8.54.1 NeoStem’s Services
8.55 NeuralStem, Inc.
8.55.1 NeuralStem’s Focus on Regenerative Medicine
8.55.2 The Potential of NeuralStem’s Tissue-Derived Stem Cell-based Therapy
8.55.3 Potential Markets
8.55.4 NeuralStem’s Technology
8.55.5 NeuralStem’s Research Programs
8.56 NeuroGeneration
8.56.1 NeuroGeneration’s Stem Cell Therapy
8.57 Novocell, Inc.
8.57.1 Novocell and Stem Cell Engineering
8.57.2 Novocell and Cell Encapsulation
8.57.3 Novocell’s Clinical Trials
8.58 Opexa Therapeutics, Inc.
8.58.1 Opexa’s Products
8.58.1.1 Tovaxin®
8.58.1.2 Current MS Treatments
8.59 Organogenesis, Inc.
8.59.1 Products from Organogenesis
8.59.1.1 Apligraf®
8.59.1.2 VCT01™
8.59.1.3 CelTx™ for Oral Soft Tissue Regeneration
8.59.2 Bio-surgery
8.59.2.1 FortaFlex®
8.59.3 Licensing Opportunities
8.59.3.1 FortaFlex® Collagen Biomaterial Technology
8.60 Orthovita, Inc.
8.60.1 Orthovita’s Products and Product Candidates
8.60.1.1 Orthovita’s Bone Defect Grafting Products
8.60.1.2 Orthovita’s Spinal Fusion and Grafting Products
8.60.1.3 Orthovita’s Trauma Products
8.60.1.4 Orthovita’s Dental, Periodontal, Oral and Cranio-Maxillofacial Products
8.61 Osiris Therapeutics, Inc.
8.62 Pervasis Therapeutics, Inc.
8.62.1 Vascugel®
8.62.2 PVS-10200 - Minimally Invasive
8.63 Pleuron Corp.
8.63.1 Plureon’s Technology
8.64 Pluristem Therapeutics, Inc.
8.64.1 Pluristem's PluriX™ 3D Bioreactor
8.64.2 Pluristem's PLacental eXpanded (PLX) Cells
8.64.3 PLX-PAD for Peripheral Artery Disease
8.64.4 PLX-IBD for Inflammatory Bowel Disease (Crohn’s Disease and Ulcerative Colitis)
8.64.5 PLX-MS for Multiple Sclerosis
8.64.6 PLX-STROKE for Ischemic Stroke
8.65 Reinnervate LLC
8.65.1 Reinnervate’s Technology
8.65.2 Reinnervate’s Culture Apparatus for Three Dimensional Cell Growth
8.65.3 Production of Synthetic Retinoids to Control Cell Differentiation
8.66 Regenocyte Therapeutic
8.66.1 Regenocyte’s Adult Stem Cell Therapy
8.67 ReNeuron Group Plc
8.67.1 ReNeuron’s Platform Technologies
8.67.2 ReNeuron’s Cell Therapy Programs
8.67.3 ReNcell® Products
8.68 Saneron Therapeutics, Inc.
8.68.1 Saneron’s U-CORD-CELL™ Program
8.68.2 Saneron’s SERT-CELL™ Program
8.69 Scikon Innovation, Inc.
8.69.1 Scikon’s Human Cell Products
8.70 Stem Cells, Inc.
8.70.1 StemCell’s Specialty Cell Culture Products
8.70.2 StemCell’s Patents
8.71 StemCell Technologies, Inc.
8.71.1 SCT’s Products
8.71.2 Hematopoietic Stem Cell Research
8.71.3 SCT’s Mesenchymal Stem Cell Products for Human Cells
8.71.4 SCT’s Products for Neural Stem Cells Research
8.71.5 Stem Cell Innovations (SCI)
8.71.6 SCI’s Research and Development
8.71.7 SCI’s Services
8.71.7.1 PluriCells™ and Derivatives
8.71.7.2 ACTIVTox®
8.71.7.3 PREDICTIVTox®
8.71.7.4 Endogenous Protein Production
8.72 Stem Cell Sciences KK
8.72.1 Cell-Based Therapy
8.72.2 SCS KK’s Product/Service
8.72.2.1 CultiCell Medium for Embryonic Stem Cells
8.72.3 Contract/Sponsored Research on ES-Derived Functional Cells
8.73 Stem Cell Therapy International, Inc.
8.73.1 Biological Preparations
8.73.2 Treatment of Patients with Diabetes
8.73.3 Treatment of Patients with Diabetic Retinopathy
8.73.4 Atherosclerosis Coronary Heart Disease and Cerebral Ischemia
8.73.5 Liver Cirrhosis
8.73.6 Non-Specific Ulcerative Colitis (Crohn’s Disease)
8.73.7 Immunomodulation before Capital Surgical Operations Wound Dystrophy
8.73.8 Acute Surgical Complications
8.73.9 Peritoneal Commissures of the Abdominal Cavity
8.73.10 Immunodeficient States in Children
8.73.11 Sickle-Cell Anemia Therapy
8.73.12 Complex Therapy of Down’s Disease
8.73.13 Complex Therapy of Cosmetic Problems
8.73.14 Diseases and Disorders of Nervous System
8.74 Stempeutics Research Private Limited
8.74.1 Research: Mesenchymal Stem Cells Derived from Wharton’s Jelly
8.74.2 Research: Mesenchymal Stem Cells Derived from Adipose Tissue
8.74.3 Research: Mesenchymal Stem Cells Derived from Dental Pulp
8.74.4 Research: Large Scale Upscaling of Mesenchymal Stem Cells
8.74.5 Research: Human Embryonic Stem Cells
8.74.6 Stempeutics’ Clinical Trials
8.74.6.1 Acute Myocardial Infarction (AMI)
8.74.6.2 Critical Limb Ischemia (CLI)
8.74.6.3 Chronic Obstructive Pulmonary Disease
8.74.6.4 Liver Cirrhosis
8.74.6.5 Osteoarthritis
8.74.6.6 Diabetes Mellitus - Type II
8.74.6.7 Cerebral Stroke (This Trial is being Conducted in Malaysia)
8.75 Tengion, Inc.
8.75.1 Tengion’s Technology
8.75.2 Tengion’s Pipeline
8.76 TheraVitae
8.76.1 TheraVitae’s Stem Cell Technology
8.76.2 TheraVitae’s Products
8.76.2.1 VesCell™ for Heart Disease
8.76.2.2 VesCell™ for Peripheral Artery Disease (PAD)
8.76.2.3 Future Products
8.77 VistaGen Therapeutics, Inc.
8.77.1 VistaGen’s Embryonic Stem Cell Technologies
8.77.2 Tools for Drug Discovery and Regenerative Medicine
8.77.3 New Generation Drug Screening Assays for Neurological Drugs
8.77.4 New Generation Drug Screening Assays for Metabolic Diseases
8.77.5 Toxicity Screening
8.78 ZenBio, Inc.
8.78.1 ZenBio’s Culture Media
Appendix 1: Clinical Trials in Stem Cell Space
Appendix 2: Stem Cell Glossary
Appendix 3: Consultants in Cell Therapy Sector
INDEX OF FIGURES
Figure 2.1: Derivation of Human Embryonic Stem Cells (hESC)
Figure 2.2: Differentiation of Embryonic Stem Cells into Specialized Cell Types
Figure 2.3: Hematopoietic and Stromal Cell Differentiation
Figure 2.4: Somatic Cell Nuclear Transfer (SCNT)
Figure 3.1: Percent Population of Patient Pool with Unmet Clinical Need
Figure 3.2: Implantation of a Hydrogel at the Site of an Injured Tissue
Figure 3.3: Implantation of CS-PEG Hydrogel
Figure 3.4: Implantation of CMP-PEG Scaffold
Figure 4.1: Market for the Three Major Segments of Stem Cell Market, 2008-2012
Figure 4.2: Market for Cell Therapy Products in the U.S., 2009-2018
Figure 4.3: Utilization of Stem Cell Types in Stem Cell Market Place, 2008
Figure 4.4: Potential Uses of Human Embryonic Stem Cells (hESCs)
Figure 4.5: Global Market for Cord Blood Stem Cells, 2010-2015
Figure 4.6: Worldwide Growth of Public Cord Blood Banks, 2005-2009
Figure 4.7: Worldwide Growth of Private Cord Blood Banks, 2005-2009
Figure 4.8: Standard Procedure for Cord Blood Processing
Figure 4.9: Cell Culture Products by Market Segment
Figure 4.10: Global Market for Cell and Tissue Analysis Products, 2008-2014
Figure 4.11: Growth in Size of Cell Therapy Industry, 2000-2008
Figure 4.12: Percent Break-Up of Cell Therapy Companies by Product Type, 2008
Figure 4.13: Location of Primary Tissue Engineering Companies (%) by Geography,
2008/2009
Figure 4.14: Breakdown (%) of Primary Cell Therapy Products on Market by
Geography, 2008/2009
Figure 4.15: Geographical Distribution of Clinical Trials, 2008/2009
Figure 5.1: Value Chain of Mesenchymal Stem Cell Therapeutics
Figure 5.2: Use of Coverage and Reimbursement Knowledge in the Product Life
Cycle
Figure 6.1: Increase in Worldwide Funding for Cell Therapy Products, 2008-2018
Figure 7.1: CIRM’s Grant Awards (%) by Category, 2009
Figure 7.2: CIRM’s Funding (%) by Disease Application, 2009
Figure 7.3: CIRM’s Funding (%) by Disease Category, 2009
Figure 8.1: Cardio3 Biosciences’ Investors, 2008
Figure 8.2: Relative Success of Cord Blood Stem Cells from Autogenic Donor
Figure A1.1: Clinical Studies on Cell Therapy related Products by Country, 2010
INDEX OF TABLES
Table 2.1: Different Types of Stem Cells and Their Properties
Table 2.2: Adult Stem Cell (ASC) Differentiation Properties
Table 2.3: HSC Sources and Their Properties
Table 3.1: Stem Cell Therapeutics for Orthopedic Disease in Development
Table 3.2: Stem Cell-based Therapeutics for Cardiac and Ischemic Diseases in
Development
Table 3.3: Stem Cell Therapeutics for Type I Diabetes in Development
Table 3.4: Stem Cell Therapeutics for Neurological Disease in Development
Table 3.5: Stem Cell-based Therapeutics for Vascular Diseases in Development
Table 3.6: Stem Cell Therapeutics for Hematological Diseases in Development
Table 3.7: Products in Development: Target Indications, 2008
Table 3.8: Top Ten Regenerative Medicine Products, 2008
Table 3.9: Wound Healing Products
Table 3.10: Autologous Tissue-Engineering Products from BioTissue Technologies
AG
Table 3.11: co.don®'s Product Portfolio
Table 4.1: Entities Developing hSCs
Table 4.2: Biotech and Pharmaceutical Companies Investing in hESC Research
Table 4.3: Selected Cord Blood Banks Worldwide
Table 4.4: Selected Cord Blood Banks in the U.S.
Table 4.5: Companies in the Cord Blood Stem Cell Technology and Therapeutics
Development Space
Table 4.6: Some Selected Suppliers of In Vitro Test Kits and their Products
Table 4.7: Suppliers of Cells and Tissues
Table 4.8: Suppliers of Media and Cell Reagents
Table 4.9: Providers of Equipments for Stem Cell Research
Table 4.10: Providers of Computer Software for Stem Cell Research
Table 4.11: Geographical Distribution of Stem Cell-Related Tissue Engineering
Companies, 2008
Table 4.12: Breakdown of Cell Therapy Firms by Country, 2008/2009
Table 4.13: Cell Therapy Products on the Market by Type and Application Area
Table 4.14: Data on Sales and Application for Skin and Cartilage Products,
2006-2008
Table 4.15: Reagent Sales by Selected Stem Cell Companies, 2008
Table 4.16: Sales of Secondary Products, 2007
Table 4.17: Disease Focus of Clinical Trials, 2008/2009
Table 4.18: Stem Cell Products in Phase II/III and Phase III Trials, 2008/2009
Table 4.19: Licensing Activity in Pharmaceutical and Cell Therapy Industries
Table 4.20: Investment Activity in Cell Therapy Sector
Table 4.21: Novel Partnership by Large Pharmaceuticals with Universities
Table 4.22: Cell Therapy Companies with Greater Than $10 Million by Market Cap,
2008
Table 5.1: Elements of a Manufacturing Facility
Table 5.2: Cell Therapy CMO Qualification Audit: Points to Investigate
Table 5.3: Areas for Coverage and Reimbursement Competency and Planning
Table 6.1: Cell-Based Regenerative Medicine Companies
Table 6.2: NIH Funding for Regenerative Medicine and Stem Cell Research,
2003-2009
Table 6.3: NIH Funding for Various Types of Stem Cell Research, 2004-2009
Table 6.4: CIRM Funded Grants To-Date
Table 6.5: Economic Costs of Major Illnesses in the U.S. and the Number of
Patients
Table 6.6: Costs per Quality-Adjusted Life Year for Various Interventions
Table 7.1: Stem Cell Policies in North America
Table 7.2: Stem Cell Policies in South America
Table 7.3: Stem Cell Policies in Europe
Table 7.4: Stem Cell Policies in Asia/Oceania
Table 7.5: List of Upcoming Request for Applications (RFAs) Showing Commitments
from Funding Partners
Table 7.6: Recipients of Funds from Connecticut Stem Cell Research Program, 2009
Table 7.7: Maryland Stem Cell Research Fund, 2008
Table 7.8: NJCST’s Award of Grants for Stem Cell Research, 2008
Table 7.9: NYSTEM’s IIRP Awards, 2008
Table 8.1: Aastrom’s Patents, 2010
Table 8.2: Aastrom’s Product Pipeline, 2010
Table 8.3: Patents Owned by Advanced Cell Technologies, Inc., 2009
Table 8.4: Asterand’s Frozen and Fixed Tissue Products, 2010
Table 8.5: Alseres’ Product Pipeline, 2009
Table 8.6: Amgen’s Outstanding Material Patents for Darbepoetin Alfa
Table 8.7: Amgen’s Outstanding Material Patents for Epoietin Alfa
Table 8.8: Amgen’s Outstanding Material Patents for Pegfilgrastim
Table 8.9: Amgen’s Product Candidates
Table 8.10: Amgen’s Product Candidates by Phase of Development
Table 8.11: Angioblast’s Product Development
Table 8.12: BD Biosciences’ Customers and Products
Table 8.13: BD Biosciences’ Revenue by Segment, 2008 and 2009
Table 8.14: Bioheart’s Patents, 2009
Table 8.15: Bioheart’s Pending Patent Applications, 2009
Table 8.16: Bioheart’s Clinical Trials, 2009
Table 8.17: BioMimetic’s Clinical Data, 2010
Table 8.18: Cellerant’s Pipeline
Table 8.19: Private Cord Blood Banking vs. Public Donation
Table 8.20: Cytori’s Celution® System Family and its Regulatory Status, 2009
Table 8.21: ESI’s Patents in Stem Cell Field, 2009
Table 8.22: Gamida’s Pipeline, 2009
Table 8.23: hESC-derived Product Candidates Being Developed by Geron or Its
Collaborators
Table 8.24: Intercytex’ Product Pipeline, 2009
Table 8.25: LifebankUSA’s Cord Blood Units Released for Transplant Standard Therapies
Table 8.26: Medistem’s Patent Applications
Table 8.27: Millipore’s Products in Apoptosis and Cell Biology
Table 8.28: Millipore’s Products in Biomarkers
Table 8.29: Millipore’s Products in Cell Culture and Stem Cell Biology
Table 8.30: Millipore’s Products in Cell Signaling and Epigenetics
Table 8.31: Millipore’s Drug Discovery and Development Services
Table 8.32: Potential Target Markets for Stem Cell Therapies in the U.S.
Table 8.33: Issued and Pending Patents Owned by NeuralStem, Inc.
Table 8.34: Opexa’s Pipeline, 2009
Table 8.35: Orthovita’s Bone Graft Products, 2009
Table 8.36: Orthovita’s Bone Marrow Aspiration Tools, 2009
Table 8.37: Osiris’ Biologic Drug Candidates, 2010
Table 8.38: Pervasive’s Product Pipeline
Table 8.39: Scikon’s Media for Cell seeding and Culture, 2010
Table 8.40: Current Status of StemCell’s Two Therapeutic Product Development Programs
Table 8.41: StemCell’s Specialty Cell Culture Products
Table 8.42: StemCell’s U.S. Patents, 2009
Table 8.43: Cell Types Separated by SCT’s Four Solutions
Table 8.44: Products Offered by SCT for Hematopoietic Stem Cell Research
Table 8.45: SCT’s Products for Human Embryonic Stem Cell Research
Table 8.46: SCT’s Products for Mesenchymal Stem Cell Research
Table 8.47: SCT’s Products for Neural Stem Research
Table 8.48: SCT’s Other Products for Stem Cell Related Research
Table 8.49: Tengion’s Pipeline
Table 8.50: ZenBio’s Products
Table A1.1: Stem Cells in Clinical Trials
Table A3.1: Consultants in Cell Therapy Sector
 
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