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Stem Cell Markets

February 3, 2014

LONDON, Feb. 3, 2014 /PRNewswire/ — Reportbuyer.com just published a new market research report:

Stem Cell Markets

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.

TABLE OF CONTENTS

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 111
8.7.1 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) 239
14.32.1.1 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 Pip

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