Stem Cell Markets - New Market Report

London (PRWEB) November 05, 2013 A stem cell is an extraordinary type of cell that has the ability to self-renew for long periods of time and to differentiate into specialized cells under appropriate physiological or experimental conditions. Traditionally, stem cells have been classified as either embryonic, adult (tissue-specific or cord blood) stem cells. Recent understanding of stem cell biology may provide new approaches for the treatment of a number of diseases as well as tissue/organ injuries, including cardiovascular disease, neurological disease, musculoskeletal disease, diabetes and hematopoietic disorders. Stem cell fate is determined by both intrinsic regulators and the extra-cellular environment (niche), and their expansion and differentiation ex vivo are generally controlled by growing them in a specific configuration (monolayer or three-dimensional culture). This process, which is vital to enable stem cells to be used for therapeutic purposes, is called differentiation. Differentiation is a process involving unspecialized cells progressing to become specialized cells with restricted developmental potential. The purpose of this TriMark Publications report is to describe the specific market segments of the medical research space using stem cells for research and development (R&D) purposes. This study reviews all of the generally accepted analytical methods that are currently in use today for preparing and using stem cells. It examines the use of stem cells in developing new therapies for disease. 1. Overview 14 1.1 Statement of the Report 14 1.2 Scope of This Report 15 1.3 Methodology 15 1.4 Executive Summary 16 2. Biology of Stem Cells 20 2.1 Scope of This Chapter 20 2.1.1 Stem Cells 20 2.1.2 Pluripotent Embryonic Stem Cells 20 2.1.3 Induced Pluripotent Stem Cells (iPSC) 21 2.2 Basic Properties of Stem Cells 22 2.2.1 Capability of Self-Renewal 22 2.2.2 Unspecialized Nature 22 2.2.3 Ability to Give Rise to Specialized Cells 23 2.3 Types of Human Stem Cells 23 2.3.1 Embryonic Stem Cells 23 2.3.1.1 Embryonic Stem Cell Research 24 2.3.2 Embryonic Germ Cells 24 2.3.3 Fetal Stem Cells 25 2.4 Umbilical Cord Stem Cells 25 2.5 Adult Stem Cells 26 2.5.1 Hematopoietic Stem Cells 26 2.5.2 Mesenchymal Stem Cells 26 2.5.3 Gut Stem Cells 27 2.5.4 Liver Stem Cells 28 2.5.5 Epidermal Stem Cells (Skin and Hair) 28 2.5.6 Neural Stem Cells 29 2.5.7 Pancreatic Stem Cells 29 2.5.8 Eye Stem Cells 30 2.6 Induced Pluripotent Stem Cells 30 2.6.1 Increased CIRM Funding for Induced Pluripotent Cells 31 2.6.2 First iPSC Clinical Trial 32 3. Stem Cells as an Enabling Technology in Drug Discovery 33 3.1 Immortalized Cells and Primary Cells in Current HTS 33 3.1.1 Stem Cells in HTS and Drug Discovery 34 3.1.2 Embryonic Stem Cells in HTS and Drug Discovery 34 3.2 Adult Stem Cells in HTS and Drug Discovery 35 3.3 Induced Pluripotent Stem Cells (iPSCs) in HTS and Drug Discovery 36 4. Clinical Trials in Cell Therapy Sector: An Overview 37 4.1 The Soon-to-Arrive 15 Cell and Stem Cell Therapies in Phase III Clinical Trials 37 4.1.1 Prochymal Stem Cell Therapy Sponsored by Osiris 37 4.1.2 Prochymal for Crohn’s Disease and Gastrointestinal Injury from Radiation 37 4.1.3 MPC Product Cell Therapy Sponsored by Mesoblast 37 4.1.4 MypCell Stem Cell Therapy Sponsored by Bioheart 38 4.1.5 Ixmyelocel-T Stem Cell Therapy Sponsored by Aastrom 38 4.1.6 ELAD Cell Therapy Sponsored by Vital Therapies 38 4.1.7 HP802 Cell Therapy Sponsored by Healthpoint Biotherapeutics (Smith & Nephew) 38 4.1.8 StemX Stem Cell Therapy Sponsored by Gamida Cell and Teva Pharmaceutical 39 4.1.9 LAVIV Fibroblast Cell Therapy Sponsored by GlaxoSmithKline 39 4.1.10 GSK 2696273 Stem Cell Therapy Sponsored by GlaxoSmithKline 39 4.1.11 Adult Autologous Stem Cell Therapy Sponsored by Baxter International 39 4.1.12 NT-501 Cell Therapy Sponsored by Neurotech Pharmaceuticals 40 4.1.13 Neocart Cell Therapy Sponsored by Histogenics 40 4.1.14 Juvenile Chondrocyte Grafts Cell Therapy Sponsored by ISTO Technologies 40 4.1.15 MACI Cell Therapy Sponsored by Genzyme 40 4.2 Cell Therapy Clinical Trials by Geography 41 4.3 Cell Therapy Clinical Trials by Top Ten Countries 41 4.4 Cell Therapy Clinical Trials by Type of Sponsorship 42 4.5 Cell Therapy Clinical Trials by Cell Type 44 4.6 Cell Therapy Clinical Trials by Stem Cell Type 44 4.7 Stem Cell Therapy Clinical Trials Involving Non-Stem Cells 45 4.8 Cell Therapy Involving MSCs by Source 46 4.9 Clinical Trials Involving Stem Cells by Donor Type 47 4.10 Cell Therapy Clinical Trials by Indication 48 4.11 Cell and Tissue Therapy Clinical Trials by Phase of Development 49 4.12 Clinical Development in Europe 53 4.12.1 U.K. Cell Therapy Clinical Trials 54 4.12.2 Cell Types Involved in U.K. Clinical Trials 55 4.12.3 U.K. Cell Therapy Clinical Trials by Indication 56 5. Funding for Stem Cell Research 57 5.1 Scope of This Chapter 57 5.2 The Intense Competitive Pressure for Funding 57 5.3 Funding in Leading Countries 58 5.3.1 NIH Stem Cell Research Funding 58 5.3.2 California Institute for Regenerative Medicine (CIRM) and Stem Cell Research 59 5.3.2.1 CIRM Therapies in the Pipeline 59 5.3.2.2 CIRM Stem Cell Therapy Research in Progress 60 5.3.2.3 CIRM Projects in the Pipeline 62 5.3.2.4 CIRM’s Funding Intent 65 5.3.2.5 Human Stem Cell Use 65 5.3.2.6 CIRM Funded Research Categories 66 5.3.3 Stem Cell Research Funding in the State of Connecticut 69 5.3.4 Maryland Stem Cell Research Funds 71 6. Stem Cell Activity in Selected Countries 72 6.1 U.S. 72 6.1.1 Innovative Stem Cell Companies in the U.S. 72 6.1.1.1 StemCells, Inc. 72 6.1.1.2 Aastrom Biosciences 73 6.1.2 Key Institutions in the U.S. 73 6.1.2.1 California Institute for Regenerative Medicine 73 6.1.2.2 The New York Stem Cell Foundation 73 6.1.2.3 NIH Center for Regenerative Medicine 73 6.2 Canada 73 6.2.1 Innovative Stem Cell Companies in Canada 74 6.2.1.1 Northern Therapeutics 74 6.2.1.2 Octane Biotech 74 6.2.2 Key Institutions in Canada 75 6.2.2.1 Institute of Biomaterials & Biomedical Engineering, University of Toronto 75 6.2.2.2 Terry Fox Research Institute 75 6.2.2.3 Institute for Research in Immunology and Cancer, University of Montreal 75 6.3 U.K. 75 6.3.1 Innovative Companies in the U.K. 76 6.3.1.1 Intercytex 76 6.3.1.2 Azellon Cell Therapeutics 76 6.3.1.3 Cell Medica 76 6.3.2 Key Institutions in the U.K. 76 6.3.2.1 Loughborough University 76 6.3.2.2 U.K. Stem Cell Foundation 76 6.3.2.3 University College, London 77 6.4 Sweden 77 6.4.1 Innovative Companies in Sweden 77 6.4.1.1 Vitrolife 77 6.4.1.2 Cellartis 77 6.4.1.3 Biolamina 78 6.4.2 Key Institutions 78 6.4.2.1 Karolinska Institutet 78 6.4.2.2 The University of Lund 78 6.5 Brazil 78 6.5.1 Innovative Company 79 6.5.1.1 Excellion and CellPraxys 79 6.5.2 Key Institutions 79 6.5.2.1 Universidade de Sao Paulo 79 6.5.2.2 Fiocruz and Hospital Sao Rafael 79 6.5.2.3 Universidade Federal do Rio de Janeiro 80 6.5.2.4 Pontificia Universidade Catolica do Parana 80 7. Commercial Cell Therapy Products 81 7.1 Dermagraft 82 7.1.1 Diabetic Foot Ulcer 83 7.2 AlloStem 83 7.3 MySkin 84 7.4 CryoSkin 85 7.5 PureGen 85 7.6 BioDfactor 86 7.7 CaReS 86 7.8 ReCell 87 7.9 Prokera 87 7.10 AmnioGraft 88 7.11 BioSeed-C 88 7.12 Chondrotissue 89 7.13 Celution System 89 7.14 Provenge 90 7.15 Epidex 91 7.16 Hyalograft C 91 7.17 LAVIV 92 7.18 Epicel 92 7.19 Carticel 93 7.19.1 Carticel Implantation Procedure 93 7.20 MACI Implant 95 7.21 J-TEC Epidermis 96 7.22 J-TEC Cartilage 97 7.23 J-TEC Corneal Epithelium 97 7.24 DIABECELL 98 7.25 NuCel 99 7.26 Osteocel Plus 99 7.27 Apligraf 100 7.28 GINTUIT 100 7.29 Trinity Evolution 101 7.30 ChondroCelect from TiCenix 101 7.31 Grafix from Osiris 101 7.32 DeNovo NT from Zimmer 102 7.33 Hearticellgram-AMI 102 7.34 Cartistem 103 7.35 Cupistem 103 7.36 CureXcell 103 7.37 Prochymal 104 7.38 Kaloderm 104 7.39 Holoderm 105 7.40 Neoderm 105 8. Regenerative Medicine Industry: An Overview 106 8.1 The Major Divisions of Regenerative Medicine Industry 106 8.2 The Three Major Sub-Sectors of Regenerative Medicine 107 8.3 Cell and Tissue-Based Companies by Location 108 8.4 Cell and Tissue-Based Clinical Trials by Location 109 8.5 Cell and Tissue Therapies Being Sold or Tested 109 8.6 Breakdown of Therapeutics Companies 110 8.7 Gene Therapy Clinical Trials 1118.7.1 Distribution of Gene Therapy Clinical Trials by Country 112 8.7.2 Indications Addressed by Gene Therapy Clinical Trials 112 8.7.3 Vectors Used in Gene Therapy Clinical Trials 113 8.7.4 Gene Types Transferred in Gene Therapy 114 8.7.5 Number of Gene Therapy Clinical Trials Approved Worldwide 115 9. Cell Therapy Industry: An Overview 117 9.1 Cell Based Therapies 117 9.1.1 Cells as Immunotherapies 119 9.1.2 Tissue Engineering 119 9.1.3 Small Molecules and Biologics 120 9.1.4 Stem Cells for Drug Discovery and Toxicity Testing 121 9.2 Cell and Tissue Banking 121 9.3 Industry Parameters for Tissue Engineering and Stem Cell Companies 123 9.3.1 Commercial Products and Services in Tissue Engineering and Stem Cell Sector 123 9.3.2 Breakdown of TE and Stem Cell Industry Spending by Segment 124 9.3.3 Spending in the TE and Stem Cell Sector by Developmental Stage 127 9.3.4 Number of Companies at Each Stage of Development 127 9.3.5 Geographical Distribution of Spending for TE and Stem Industry 128 9.4 Stem Cell Use in the U.S. 129 9.4.1 Autologous Stem Cell Use in the U.S. 129 9.4.2 Limbal Stem Cells 129 9.4.3 Bone Marrow Stem Cells 130 9.4.4 Adipose Tissue Stem Cells 130 9.4.5 Allograft Stem Cell Use in the U.S. 130 9.5 Cell Therapy and Regenerative Medicine Companies in Europe 131 9.5.1 European Cell Therapy Product Approach 132 9.5.2 Autologous vs. Allogeneic Firms in Europe 133 9.5.3 Cell Therapies in Europe by Country 133 9.5.4 European Stem Cell Platforms by Cell Source 134 9.5.5 Stem Cell Therapy by Type in Europe 135 10. Stem Cell Therapy Industry: Market Analysis 137 10.1 Economic Benefits of Cell Therapies and Regenerative Medicines 138 10.2 Cell Therapy Industry and Capital Formation 139 10.3 Cell Therapy Market Size and Value 140 10.4 Structure of CTI 141 10.5 CTI’s Complementarities to Pharma, Biotech and Medical Device Industry 142 10.6 Exploration to Exploitation of Cell Therapy 142 10.7 Market Capitalization of Stem Cell Companies 142 10.8 Global Market for Stem Cells 143 10.8.1 U.S. Market for Stem Cells 144 10.8.2 Stem Cell Market in Europe 145 10.9 Cord Blood Banking 146 10.9.1 Public Cord Blood Banks 147 10.9.1.1 Collection Process 147 10.9.1.2 Acceptance Criteria 147 10.9.1.3 Processing 148 10.9.1.4 Storage of Cord Blood 148 10.9.2 Private Cord Blood Banks 149 10.9.2.1 Public vs. Private Cord Blood Banking 150 10.9.3 Dual Private-Public Banking of Cord Blood 150 10.9.4 Worldwide Growth of Both Public and Private Cord Blood Banks 151 10.10 Cell Therapy Market in Ophthalmology 152 10.10.1 Cell Therapy Clinical Trials in Ophthalmology 153 10.11 Cell Therapy in Cancer 155 10.12 Global Market for CT and TE products for Cardiology and Vascular Diseases 156 10.13 Market for CT and RM products in Neurology 158 10.14 Global Market for CT and TE Products for Orthopedics, Musculoskeletal and Spine Disorders 159 10.15 Global Market for CT and TE Products for Skin/Integument 160 10.16 Cell Therapy in Dentistry 162 10.17 Market for Cell Culture 163 11. Toxicity Testing 167 11.1 Toxicity Tests 167 11.2 History of Animal Use in Toxicity Testing 168 11.3 Reasons for Deviating from Animal Tests 168 11.4 Alternative Methods 169 12. Noteworthy Events in Cell Therapy Sector 177 12.1 Clinical Milestones in Cell Therapy Sector, 2011-2012 177 12.2 Recent Acquisitions and Partnerships in Cell Therapy Sector 179 12.3 Noteworthy Financings in Cell Therapy Sector, 2010-2012 180 12.4 Limited Pharma Engagement in Cell Therapy Sector, 2007-2012 181 13. Markers Used in Stem Cell Studies 182 14. Company Profiles 185 14.1 Aastrom Biosciences 185 14.1.1 Aastrom’s Ixmyelocel-T 185 14.1.2 Aastrom’s Manufacturing Process 186 14.1.3 Aastrom’s Clinical Development Programs 186 14.1.4 Aastrom’s Patents and Proprietary Rights 187 14.2 Advanced Cell Technology, Inc. 187 14.2.1 ACT’s Cell Therapy Research Programs 187 14.2.1.1 ACT’s Ophthalmology Programs 187 14.2.1.2 Treating Macular Degeneration 188 14.2.1.3 Photoreceptor Progenitor Program 189 14.2.1.4 Retinal Ganglion Cell Progenitor Program 189 14.2.1.5 Corneal Endothelial Program 190 14.2.1.6 Neuroprotective Biologics 190 14.2.1.7 Autoimmune/Inflammation Programs 190 14.2.1.8 Platelet Program 191 14.2.1.9 ACT’s Intellectual Property 191 14.3 AlloSource, Inc. 192 14.3.1 Allografts from AlloSource 192 14.3.2 Osteobiologics 193 14.3.2.1 Traditional Grafts 193 14.3.2.2 Spinal Grafts 193 14.3.2.3 Sports Medicine Grafts 194 14.3.2.4 Large Grafts 194 14.3.2.5 Specialty Grafts 194 14.3.3 Skin Allografts 195 14.4 Asterand plc 195 14.4.1 Asterand’s Human Tissue and Biofluid Repository 195 14.4.2 Frozen and Fixed Tissues 196 14.4.3 RNA and DNA 196 14.4.4 Biofluids 197 14.4.4.1 Blood/Serum/Plasma 197 14.4.4.2 Synovial Fluid 197 14.4.5 Cell Lines 198 14.4.5.1 Human Breast Cancer Cell Lines 198 14.4.5.2 Prostrate Cell Lines 198 14.4.6 Tissue Microarrays 198 14.4.6.1 Human Primary Cells 198 14.5 Athersy’s, Inc. 199 14.5.1 Athersys’ Product Candidates 199 14.5.2 Athersys’ Pipeline 200 14.5.3 MultiStem Programs 200 14.6 BioE, Inc. 201 14.6.1 Cell Technologies 201 14.6.1.1 Application of BioE’s MLPC 201 14.6.1.2 Regenerative Medicine Applications 202 14.6.1.3 Cord Blood Processing Applications 202 14.6.2 Other Products 203 14.6.2.1 PrepaCyte-WBC 203 14.6.2.2 ActiCyte TC Media Kit 204 14.6.2.3 VitaLyse Reagent System 204 14.7 Bioheart, Inc. 204 14.7.1 MyoCell 205 14.7.2 MyoCell SDF-1 205 14.7.3 MyoCath 206 14.7.4 LipiCell 206 14.8 BioMimetic Therapeutics, Inc. 206 14.8.1 Augment Bone Graft 207 14.8.2 Augment Injectable Bone Graft 207 14.8.3 Augment Chronic Tendinopathy 208 14.8.4 Augment Rotator Cuff Graft 208 14.9 BioSafe Group SA 209 14.9.1 Sepax 2 209 14.9.2 Coolmix 209 14.9.3 SepaxNet 2 210 14.10 BioTime, Inc. 210 14.10.1 PureStem Embryonic Progenitor Cells 210 14.10.1.1 Ectoderm Progenitors 210 14.10.1.2 Neural Crest Progenitors 211 14.10.1.3 Mesoderm Progenitors 211 14.10.2 PureStem Packages 211 14.10.3 Recombinant Proteins 211 14.11 Brainstorm Cell Therapeutics, Inc. 211 14.11.1 Stem Cell Therapy 212 14.11.2 NurOwn 212 14.12 Cardio3 BioSciences 213 14.12.1 Product Pipeline 213 14.12.1.1 C3BS-CQR-1 (C-Cure) 213 14.12.1.2 Protein (C3BS-GQR-1) 214 14.12.1.3 C-CATHez 214 14.13 Cellartis 214 14.13.1 iPS Engineering Hub 214 14.13.2 Cardiomyocyte Clusters 215 14.13.3 Hepatocytes 215 14.13.4 Stem Cell Culture Systems-DEF-CS 215 14.13.5 Hepatocyte-Like Cells-hES-HEP 216 14.14 Cellerant Therapeutics, Inc. 216 14.14.1 Cellerant Pipeline 216 14.14.1.1 CLT-008: Myeloid Progenitor Cells to Treat Neutropenia 216 14.14.1.2 CLT-008 to Fight Acute Radiation Syndrome 217 14.14.1.3 Cancer Stem Cell Antibodies 218 14.15 CellSeed, Inc. 218 14.15.1 Epithelial Cell Sheet for Corneal Regeneration 218 14.15.2 Regenerated Cardiac Patch 219 14.15.3 Epithelial Cell Sheet for Esophageal Regeneration 219 14.15.3.1 Product Concept 219 14.15.4 Cell Sheet for Periodontal Regeneration 220 14.15.5 Regenerated Cartilage Sheet 220 14.16 Cellular Dynamics International, Inc. (CDI) 220 14.16.1 iCell Cardiomyocytes 220 14.16.2 iCell Endothelial Cells 221 14.16.3 iCell Hepatocytes 221 14.16.4 iCell Neurons 222 14.16.5 MyCell Products 222 14.17 Cytori Therapeutics, Inc. 223 14.17.1 Development Pipeline 223 14.17.2 PureGraft 850 224 14.17.3 PureGraft 250 224 14.17.4 LipoBank 224 14.17.5 Celbrush 224 14.18 CryoLife, Inc. 225 14.18.1 SynerGraft Technologies 225 14.18.2 Cardiac Tissues 225 14.18.3 Vascular Tissues 225 14.18.4 HeRO Graft 225 14.18.5 BioGlue 226 14.18.6 BioFoam Surgical Matrix 226 14.19 Forticell Bioscience, Inc. 226 14.19.1 OrCel 226 14.20 Gamida Cell 227 14.20.1 StemEx 227 14.20.2 NiCord 227 14.20.3 CordBridge 227 14.20.4 NK Cell Product 227 14.21 Geron Corporation 227 14.21.1 Hematologic Malignancies 228 14.21.2 Imetelstat 228 14.22 Humacyte, Inc. 229 14.22.1 Investigational Biologic Grafts 229 14.23 Intercytex Ltd. 229 14.23.1 VAVELTA 229 14.24 Integra LifeSciences Holdings Corporation 230 14.24.1 DuraGen 230 14.24.2 Integra Dermal Regeneration Template 230 14.24.3 Integra Bilayer Wound Matrix 231 14.25 International Stem Cell Corporation (ISCO) 231 14.25.1 ISCO’s Therapeutic Programs 231 14.25.2 Parthenogenesis 232 14.26 Japan Tissue Engineering Co., Ltd. 232 14.26.1 Cultured Epidermis 232 14.26.2 Cultured Cartilage 233 14.26.3 Cultured Corneal Epithelium 233 14.27 Medistem, Inc. 233 14.27.1 Intellectual Property 234 14.27.1.1 Method for Expansion of Stem Cells 234 14.27.1.2 Placentally-Derived Stem Cells for the Treatment of Cancer 234 14.27.1.3 Transcatheter Tumor Immunoembolization 234 14.27.1.4 Stem Cell Therapy for Cardiac Valvular Dysfunction 234 14.27.1.5 Allogeneic Stem Cell Transplants in Non-Conditioned Recipients 234 14.27.1.6 Stem Cell Mediated Treg Activation for Therapeutic Immune Modulation 234 14.27.1.7 Compositions and Methods of Stem Cell Therapy for Autism 235 14.27.1.8 Stem Cell Therapy for Weight Loss 235 14.27.1.9 Menstrual Blood Cellular Populations, Isolation and Use Thereof 235 14.27.1.10 Endometrial Derived Reparative/Regenerative Cells 235 14.27.1.11 Stem Cell Therapy for Autism 235 14.27.2 Product Pipeline 235 14.27.2.1 Endometrial Regenerative Cell Platform 235 14.27.2.2 Angiostem Platform 236 14.27.2.3 Tolerostem Cell Platform 236 14.28 Mesoblast Ltd. 236 14.28.1 Mesoblast’s Products 236 14.28.1.1 Rheumatoid Arthritis 236 14.28.1.2 Type 2 Diabetes 236 14.28.1.3 Intervertebral Disc Repair 237 14.28.1.4 Spinal Fusion 237 14.28.1.5 Congestive Heart Failure 237 14.28.1.6 Heart Attack 237 14.29 Millipore Corporation 237 14.30 NeoStem, Inc. 238 14.30.1 Therapeutic Targets 238 14.30.1.1 Amrocyte 238 14.30.1.2 Athelos 238 14.30.1.3 VSEL Technology 239 14.31 Neuralstem, Inc. 239 14.31.1 NeuralStem Cell Therapy 239 14.32 Opexa Therapeutics, Inc. 239 14.32.1 Tcelna (Imilecleucel-T) 2314.32.1.1 Fast Track Regulatory Approval 240 14.33 Organogenesis, Inc. 240 14.33.1 Apligraf 240 14.33.2 GINTUIT 241 14.34 Osiris Therapeutics, Inc. 241 14.34.1 Prochymal 241 14.34.2 Chondrogen 242 14.35 Regenocyte 242 14.35.1 Adult Stem Cell Therapy 242 14.36 ReNeuron Group plc 243 14.36.1 ReN001 for Stroke 243 14.37 Saneron CCEL Therapeutics, Inc. 243 14.37.1 U-CORD-CELL Program 243 14.37.2 SERT-CELL Program 243 14.38 StemCells, Inc. 244 14.38.1 Tools and Technologies 244 14.38.2 Cell Lines 244 14.39 StemCell Technologies, Inc. 245 14.39.1 Products from Stem Cell Technologies 245 14.40 Stem Cell Innovations, Inc. 246 14.40.1 CNS Program 246 14.40.2 SC Proven Products 246 14.40.2.1 Cell Lines 246 14.40.2.2 Cell Culture Products 247 14.40.2.3 Antibody Detection Reagents 247 14.40.2.4 Purified Whole Stem Cell Lysates 247 14.41 Tengion, Inc. 247 14.41.1 Tengion’s Scientific Platform 247 14.41.2 Tengion’s Pipeline 248 14.42 Terumo BCT 249 14.42.1 Trima Accel Automated Blood Collection System 249 14.42.2 COBE Spectra Apheresis System 249 14.42.3 Elutra Cell Separation System 250 14.42.4 Atreus Whole Blood Processing System 250 14.42.5 Quantum Cell Expansion System 250 14.42.6 Spectra Optia Apheresis System 251 14.42.7 COBE 2991 Cell Processor 251 14.42.8 Mirasol Pathogen Reduction Technology (PRT) System 252 14.42.9 OrbiSac System 252 14.43 ViaCyte, Inc. 252 14.43.1 VC-01 253 14.44 VistaGen Therapeutics, Inc. 253 14.44.1 VistaGen’s Technology 253 14.44.2 CardioSafe 3D 254 14.44.3 LiverSafe 3D 254 14.44.4 AV 101 255 14.45 ZenBio, Inc. 255 14.45.1 Subcutaneous Preadipocytes and Adipocytes 255 14.45.2 Visceral Preadipocytes and Adipocytes 255 14.45.3 Hepatic Cells 256 14.45.4 Skeletal Myoblasts 256 14.45.5 Adult Stem Cells 256 14.45.6 Human Dermal Fibroblasts 257 14.45.7 Human Keratinocytes 257 14.45.8 Human Mesothelial Cells 257 14.45.9 Peripheral Blood Mononuclear Cells 258 14.45.10 Human Mobilized Peripheral Blood CD34+ Progenitor Cells 258 14.45.11 Human Umbilical Cord Blood Progenitor Cells 258 14.45.12 Human Umbilical Vein Endothelial Cells (HUVEC) 258 14.45.13 Human Mammary Luminal and Basal Epithelial Cells 258 14.45.14 Human Melanocytes 259 14.45.15 Human Sebocytes 259 14.45.16 3T3-L1 259 14.45.17 Renal Proximal Convoluted Tubule Epithelial Cells 260 14.45.18 ZenBio’s Cell Culture Media 260 Appendix 1: Strategic Roadmap to Cell Therapy Industry 261 Appendix 1.1: Options for Commercial Manufacturing of Stem Cell Products 261 Appendix 1.2: Regulations for a Cell Therapy Industry 261 Appendix 1.3: In-House Manufacturing of Cell Therapy Products 261 Appendix 1.4: Contract Manufacturing 262 Appendix 1.5: Effective Clinical Delivery Plan for Cell Therapies 262 Appendix 1.6: Business Models in Cell Therapy Sector 263 Appendix 1.6.1: Current Models for Autologous Cell Therapies 263 Appendix 1.6.2: Current Models for Allogeneic Cell Therapies 264 Appendix 1.7: Value Chain Considerations and Developmental Path 265 Appendix 1.8: Stem Cells: From the Laboratory to the Market 265 Appendix 1.9: Value Analysis 266 Appendix 1.10: Clinical Study Development 267 Appendix 1.11: Product Commercialization 267 Appendix 1.12: Importance of Specialty Society Support 268 Appendix 1.13: Payor Coverage 268 Appendix 2: Stem Cells: Research Spotlight, 2012 269 Appendix 2.1: Bioengineered Vein from Patient’s Own Stem Cells 269 Appendix 2.2: Stem Cell Therapies to Repair Damaged Retina 269 Appendix 2.3: Bone Marrow Stem Cells in Heart Disease 269 Appendix 2.4: A Possible Cure for Deafness 270 Appendix 2.5: Clinical Trials of Stem Cell Therapies for CNS Disorders 270 Appendix 2.6: Key Developments in Stem Cell Therapy in Cardiology 272 Appendix 2.6.1: Recent Developments in Acute MI 273 Appendix 2.6.2: Chronic Ischemic Cardiomyopathy and Heart Failure 274 Appendix 2.7: Stem Cells and Neurodegenerative Diseases 276 Appendix 2.7.1: Modeling Diseases with iPS Cells 276 Appendix 2.7.2: Modeling Disease with Direct Neuronal Conversion 277 Appendix 2.7.3: Stem Cell Transplants for Neuronal Diseases 277 Appendix 2.8: Ophthalmologic Stem Cell Transplantation Therapies 278 Appendix 2.8.1: Stem Cell Types for Eye Disease Clinical Trials 278 Appendix 2.8.1.1: Pluripotent Stem Cells 279 Appendix 2.8.2: RPE and Photoreceptor Diseases 279 Appendix 2.8.3: Pluripotent Stem Cells for Retinal and RPE Degeneration 280 Appendix 2.8.4: Patch of hESC-Derived RPE Monolayer 280 Appendix 2.8.5: Patient-Derived RPE 280 Appendix 2.8.6: NSCs for AMD 281 Appendix 2.8.7: UCSCs for RP and AMD 281 Appendix 2.8.8: Bone Marrow Stem Cells for Photoreceptor Diseases 281 Appendix 2.8.9: Corneal Repair 281 Appendix 3: RM Clinical Milestones in the News, March 2012-March 2013 282 Appendix 4: Financial Overview of RM Sector 285 Appendix 4.1: Sector Activity 285 Appendix 4.2: Public Company Performance 286 Appendix 4.3: RM Financial News and Commercial Deals, 2012-2013 288 Appendix 5: Top 50 Stem Cell Influencers in Stem Cells Arena 294 INDEX OF FIGURES Figure 2.1: Differentiation of Stem Cells into Adult Differentiated Cells 20 Figure 2.2: Pluripotent Embryonic Stem Cell 21 Figure 2.3: Induced Pluripotent Stem Cell (iPSC) 22 Figure 2.4: Differentiation of Stem Cells into Specialized Cells 23 Figure 2.5: Clinical Trials Using MSCs by Disease Type 27 Figure 2.6: Induction and Differentiation of iPSCs 31 Figure 3.1: Outline of Drug Discovery Process 33 Figure 3.2: The Development of Totipotent, Pluripotent and Multipotent Stem Cells 34 Figure 4.1: Number of Cell Therapy Clinical Trials (Total 226) by Geography, 2012 41 Figure 4.2: Number of Cell Therapy Clinical Trials by Top Ten Countries, 2012 42 Figure 4.3: Cell Therapy Clinical Trials by Type of Sponsorship, 2012 43 Figure 4.4: Cell Therapy Clinical Trials by Cell Type, 2012 44 Figure 4.5: Cell Therapy Clinical Trials by Stem Cell Type, 2012 45 Figure 4.6: Stem Cell Therapy Clinical Trials Involving Non-Stem Cells, 2012 46 Figure 4.7: Cell Therapy Involving MSCs by Source, 2012 47 Figure 4.8: Clinical Trials Involving Stem Cells by Donor Type, 2012 48 Figure 4.9: Cell Therapy Clinical Trials by Indication, 2012 49 Figure 4.10: Global Cell and Tissue Therapy Clinical Trials by Phase, 2012 50 Figure 4.11: Cell Therapy Products Currently in Late Stage Trials (Phase II/III, III, Pivotal), 2012 51 Figure 4.12: Currently in Early-to-Mid Stage Trials (Phase I, I/II, II), 2012 52 Figure 4.13: Clinical Trials for Commercial Cell Therapy Products, 2012 53 Figure 4.14: Stem Cell Therapy Clinical Development in Europe 54 Figure 4.15: Somatic Cell Therapy Clinical Development in Europe 54 Figure 4.16: Cell Types in U.K. Clinical Trials, 2013 56 Figure 4.17: U.K. Cell Therapy Clinical Trials by Indication 56 Figure 5.1: Increase in Worldwide Funding for Cell Therapy Research, 2008-2018 57 Figure 5.2: CIRM Funds for Stem Cell Research Committed, 2007-2012 59 Figure 5.3: CIRM Therapy Investment by Stem Cell Type, 2012 60 Figure 5.4: CIRM’s Funding Intent, 2012 65 Figure 5.5: Stem Cell Derivation by Award Number 66 Figure 5.6: CIRM Funded Disease Categories by Award Number, 2012 69 Figure 7.1: Worldwide Sales of Carticel, 2010-2012 95 Figure 8.1: Cell Therapy: The Largest Component of Regenerative Medicine Industry 106 Figure 8.2: The Three Broad Divisions of Regenerative Medicine 107 Figure 8.3: The Three Major Sub-Sectors of Regenerative Medicines 108 Figure 8.4: Cell and Tissue-Based Companies by Location, 2012 108 Figure 8.5: Cell and Tissue-Based Clinical Trials by Location, 2012 109 Figure 8.6: Cell and Tissue Therapies Being Sold or Tested, 2012 110 Figure 8.7: Breakdown of Therapeutics Companies 111 Figure 8.8: Number of Gene Therapy Clinical Trials, 2013 111 Figure 8.9: Geographical Distribution of Gene Therapy Trials by Country, 2013 112 Figure 8.10: Indications Addressed by Gene Therapy Clinical Trials, 2013 113 Figure 8.11: Vectors Used in Gene Therapy Clinical Trials, 2013 114 Figure 8.12: Gene Types Transferred in Gene Therapy, 2013 114 Figure 8.13: Number of Gene Therapy Clinical Trials Approved Worldwide, 1989-2012 115 Figure 9.1: Cell Therapy Industry Sectors 117 Figure 9.2: Tissue Engineering Companies Worldwide, 2013 119 Figure 9.3: Percent of Public vs. Private TE Companies Worldwide 120 Figure 9.4: Cell and Tissue Banks Breakdown 122 Figure 9.5: AAB and FACT Accredited Cord Blood Banks by Geography, 2013 122 Figure 9.6: Breakout of Spending for Preclinical Studies by Product Platform 125 Figure 9.7: Breakout of Spending for TE and Stem Cell Clinical Trials 125 Figure 9.8: Breakout of Spending for Commercial TE and Stem Cell Products 126 Figure 9.9: Breakout of Spending for TE and Stem Cell Services 126 Figure 9.10: Spending by TE and Stem Cell Therapeutics Developmental Stages by Total Spending 127 Figure 9.11: Number of TE and Stem Cell Companies by Stage of Development 128 Figure 9.12: Geographical Distribution of Spending for TE and Stem Industry 128 Figure 9.13: Total Number of Cell Therapy and Regenerative Medicine Companies by Continent 131 Figure 9.14: Number of Cell Therapy and Regenerative Medicine SMEs in Selected European Countries 132 Figure 9.15: European Stem Cell SMEs by Type and Tissue Source 133 Figure 9.16: European Somatic SMEs by Type and Tissue Source 133 Figure 9.17: Concentration of European Cell Therapy Firms, 2012 134 Figure 9.18: European Stem Cell Platforms by Cell Source 134 Figure 9.19: Stem Cell Therapy by Type in Europe 135 Figure 9.20: Somatic Cell Therapy by Type in Europe 136 Figure 10.1: Indicator of Frequency of General Usage of the Terms “Tissue Engineering,” “Regenerative Medicine” and “Cell Therapy”, 2003-2011 137 Figure 10.2: The Cost Impact of Aging Population in the U.S., 2010 and 2030 138 Figure 10.3: Cell Therapy Industry (CTI) Market, 2008-2014 140 Figure 10.4: Global Market for Stem Cells, 2012-2019 144 Figure 10.5: U.S. Stem Cell Market, 2012-2019 145 Figure 10.6: European Stem cell Market, 2012-2019 146 Figure 10.7: Global Market for Stem Cell Banking, 2012-2019 147 Figure 10.8: Worldwide Growth of (CAGR = 6.5%) Public Cord Blood Banks, 2005-2012 149 Figure 10.9: Worldwide Growth (CAGR = 15.2%) of Private Cord Blood Banks, 2005-2012 150 Figure 10.10: Worldwide Growth (CAGR = 20.8%) of Public/Private Cord Blood Banks, 2005-2012 151 Figure 10.11: Worldwide Growth (CAGR = 11.0%) of Both Public and Private Cord Blood Banks, 2005-2012 152 Figure 10.12: Global Market for CT and TE in Ophthalmology, 2012-2019 153 Figure 10.13: Global Market for CT and TE Products in Cancer, 2012-2019 156 Figure 10.14: Global Market for CT and TE Products for Cardiology and Vascular Diseases, 2012-2019 157 Figure 10.15: Global Market for CT and TE Products for Neurological Diseases, 2012-2019 159 Figure 10.16: Global Market for CT and TE Products for Orthopedics, Musculoskeletal and Spine Disorders, 2012-2019 160 Figure 10.17: Global Market for CT and TE Products for Skin/Integument, 2012-2019 161 Figure 10.18: Global Market for CT and TE Products for Dental/Oral Applications, 2012-2019 163 Figure 10.19: Global Market for Reagents, Media and Sera, 2012-2019 164 Figure 10.20: Global Market for Cell Culture Reagents, 2012-2019 165 Figure 10.21: Global Market for Cell Culture Media, 2012-2019 165 Figure 10.22: Global Market for Cell Culture Sera, 2012-2019 166 Figure 13.1: Markers Used to characterize hESCs 182 Figure 13.2: Markers Used to Characterize MSCs 183 Figure 13.3: Markers Used in Neural Stem Cell Studies 184 Figure A1.1: Value Chain of Mesenchymal Stem Cell Therapeutics 265 Figure A1.2: Use of Coverage and Reimbursement Knowledge in the Product Life Cycle 266 Figure A2.1: Eye Tissues Being Targeted for Stem Cell Replacement 278 Figure A2.2: Human Stem Cell Sources Explored for Eye Tissue Replacement 278 Figure A4.1: Public vs. Private Regenerative Medicine Companies, 2013 285 Figure A4.2: RM Sector Investment Breakdown, 2013 286 Figure A4.3: Comparison of S&P to Underweighted Regenerative Medicine Index, March 2012- March 2013 286 Figure A4.4: Comparison of NASDAQ to Underweighted Regenerative Medicine Index, March 2012- March 2013 287 INDEX OF TABLES Table 3.1: Stem Cells Isolated from Embryonic or Adult Sources 35 Table 4.1: U.K. Cell Therapy Clinical Trials, 2012 and 2013 55 Table 5.1: NIH Stem Cell Research Funding, 2002-2012 58 Table 5.2: CIRM Stem Cell Research in Progress 61 Table 5.3: CIRM’s Therapy Development Projects 63 Table 5.4: CIRM Funding for Huntington’s Disease, 2013 67 Table 5.5: CIRM Funding Heart Diseases, 2013 67 Table 5.6: CIRM Grants Targeting HIV/AIDS 69 Table 5.7: Stem Cell Research Funding in the State of Connecticut, 2013 70 Table 7.1: Currently Available Cell Therapy Products 81 Table 9.1: Cell Therapies Available by Geography/Country, March 2013 118 Table 9.2: Key Industry Parameters: Tissue Engineering and Stem Cell Therapeutics, 2007 and 2011 123 Table 9.3: Sales of Commercial Tissue Engineering and Stem Cell Products, 2011 124 Table 9.4: Partial List of Firms Supporting Stem Cell Industry 131 Table 10.1: Industry-Sponsored Active Cell Therapy Clinical Trials, 2007 and 2012 139 Table 10.2: Market Capitalization of Stem Cell Companies, 2011 and 2012 143 Table 10.3: Stem Cell Therapy in Ophthalmology by Application as of April 2013 154 Table 11.1: Selected Suppliers of In Vitro Test Kits, 2013 170 Table 11.2: Selected Cell and Tissue Suppliers, 2013 171 Table 11.3: Selected Suppliers of Media and Cell Reagents, 2013 172 Table 11.4: Selected Cell Culture Equipment and other Product Suppliers, 2013 173 Table 11.5: Selected Suppliers of Software for Cell Culture, 2013 174 Table 14.1: Aastrom’s Active Clinical Programs, 2012 186 Table 14.2: Number of U.S. Patents with Expiration Range 187 Table 14.3: ACT’s Pipeline of Therapeutic Programs, 2012 187 Table 14.4: Patents Owned by ACT, 2012 191 Table 14.5: Development Status of Athersys’ Key Programs 200 Table 14.6: Cardio3 Biosciences’ Product Pipeline 213 Table 14.7: Cellerant’s Pipeline 216 Table A1.1: Elements of a Cell Therapy Manufacturing Facility 261 Table A1.2: Cell Therapy CMO Qualification Audit: Points to Investigate 262 Table A1.3: Areas for Coverage and Reimbursement Competency and Planning 267 Table A2.1: Recently Published Stem Cell Therapy Clinical Trials for Ischemic Heart Disease 273 Table A4.1: Companies Included in the Underweighted Regenerative Medicine Index 287 Read the full report: Stem Cell Markets http://www.reportbuyer.com/pharma_healthcare/biotechnology/stem_cells/stem_cell_markets.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Biological_Therapy For more information: Sarah Smith Research Advisor at Reportbuyer.com Email: query@reportbuyer.com Tel: +44 208 816 85 48 Website: http://www.reportbuyer.com/ Read the full story at http://www.prweb.com/releases/2013/11/prweb11303376.htm