Regenerative Medicine Markets

  • March 2013
  • -
  • TriMark Publications
  • -
  • 296 pages

Regenerative medicine is a way of treating injured and diseased human tissue by using laboratory-grown or therapeutically-induced human tissue as a replacement. As such, astounding new advancements in the ability to repair or replace damaged human tissue and organ functions are being made. Whereas before, remedies for damaged tissue or organ functions due to congenital deformities, injuries, diseases or simple wear-and-tear relied upon either the body's ability to repair itself (or not), or a surgeon's skilled hands. Now, the area of regenerative medicine promises to revolutionize humanity's ability to remediate countless physical maladies that have perpetually afflicted humans and other animals. Compared to a select few life forms--like the starfish--man-made solutions for tissue repair and organ replacement haven't come close to nature's solutions.

And where there once was no solution even offered by nature, researchers are now at the cusp of overcoming such limitations by literally regrowing damaged tissue and restoring organ functions through the use of tissue engineering and stem cell therapy. This is the promise of regenerative medicine. This TriMark Publications report discusses the current state of regenerative medicine. The study provides a thorough overview of regenerative medicine sector together with analyses of the funding trends, intellectual property, market opportunities, therapeutic pipeline, research collaborations, partnership activities, and guidelines for establishing new ventures. The report enables the reader gain in-depth knowledge about ongoing tissue engineering and stem cell therapy research programs carried out in universities and other research centers. Moreover, this analysis profiles the leading companies developing regenerative medicine solutions.

Table Of Contents

TABLE OF CONTENTS

1. Overview 16
1.1 Statement of Report 16
1.2 Scope of this Report 18
1.3 Methodology 18
1.4 Executive Summary 19

2. Regenerative Medicines: An Overview of Segments 22
2.1 Tissue Engineering 22
2.1.1 Tissue-Engineered Skin 23
2.1.2 Tissue-Engineered Cartilage 23
2.1.3 Tissue-Engineered Bone 24
2.1.4 Tissue-Engineered Peripheral Nerves 25
2.1.5 Tissue-Engineered Cornea 26
2.1.6 Tissue-Engineered Blood Vessels 26
2.1.7 Progress and Promises for Tissue Engineering Industry 27
2.1.7.1 Key Positioning Strategies in Tissue Engineering Industry 27
2.1.7.2 Tissue Engineering Industry Participants 27
2.1.7.3 Tissue Engineering Firms by their Product Applications 28
2.1.7.4 Number of TEFs Focused on Skin, Cartilage, Bone and Urological Products
28
2.1.7.5 Number of Tissue Engineering Firms Focused on Cardiovascular Products 29
2.1.7.6 Number of Tissue Engineering Firms Focused on Neurological Products 30
2.1.7.7 Number of Tissue Engineering Firms Focusing on Pancreas, Liver and
Kidney 30
2.1.7.8 Tissue Engineering Firms Focused on Ophthalmic Products 31
2.1.7.9 Tissue Engineering Firms Involved in Dental Products 31
2.1.7.10 Number of TEFs Involved in Autologous and Allogenic Products 31
2.1.7.11 Geographic Distribution of Tissue Engineering Firms in Major Markets 31
2.2 Cell Therapy 32
2.2.1 Progress in Cell Therapy Product Research 34
2.2.2 Commercially Available Cell Therapy Products 35
2.2.3 Major Cell Therapy Companies 36
2.2.4 Locations of Cell Therapy Companies 38
2.2.5 Disease Focus by Cell Therapy 39
2.2.6 Cell Therapy Products and Companies 39
2.2.6.1 Autologous Structural Products for Cartilage, Skin, Bone, etc. 41
2.2.7 Potential Patients for Cell Therapy in the U.S. 41
2.2.8 Number of Patients Treated Between 1988 and 2010 by Cell Therapy 41
2.2.9 Cell Therapy Pipeline 42
2.2.10 Cell Therapy Clinical Trials by Indication 43
2.2.10.1 Major Cell Therapy Clinical Trials for Diabetes 43
2.2.10.2 Progress in Clinical Trials for Diabetes 44
2.2.10.3 Estimated Completion Dates for Cell Therapy Clinical Trials in Diabetes
44
2.2.11 Major Four Targeted Disease Conditions for Clinical Trials 45
2.2.12 Commercial Success of Cell Therapies in Europe 46
2.2.13 Deals in Cell Therapy, 2007-2011 49
2.2.14 Commercial-Stage Cell Therapy Companies and Products 50
2.2.15 Cell Therapy Clinical Trials in the U.K. 51
2.2.15.1 Clinical Trials Involving Allogeneic vs. Autologous Products in the
U.K. 52
2.2.15.2 Cell Types Involved in the U.K. Clinical Trials 53
2.2.15.3 U.K. Cell Therapy Clinical Trials by Indication 53
2.3 Cell Culture Products 54
2.3.1 Market for Reagents Used in Cell Culture 55
2.3.2 Cell Culture Media 56
2.3.3 Market for Sera Used in Cell Culture 57
2.3.3.1 Suppliers of Culture Media and Reagents 58
2.3.3.2 In Vitro Test Kits 59
2.3.3.3 Suppliers of Cells and Tissues 59
2.3.3.4 Equipment for Stem Cell Research 60
2.3.3.5 Computer Software for Stem Cell Research 62
2.4 Scaffolding Biomaterials 63
2.5 Growth Factors 64

3. Regenerative Medicine: The Next Evolution of Medical Treatment 66
3.1 Scope of this Chapter 66
3.2 Need for Regenerative Medicine 66
3.3 Current State of Regenerative Medicines 66
3.4 Future of Regenerative Medicine 67
3.4.1 Number of Products in Pipeline 68
3.5 Projected Timeline for Regenerative Medicine 72
3.6 Selected Regenerative Medicine Products in the Market 72
3.6.1 Medtronic’s Infuse Bone Graft and LT-Cage Device 73
3.6.2 Genzyme’s Corticel 73
3.6.3 OP-1 from Stryker 75
3.6.4 Osteocel from Osyris/Nuvasive 75
3.6.5 Spinal Implants from RTI Biologics 76
3.6.6 Apligraf from Organogenesis 76
3.6.7 Dermograft from Advanced BioHealing 76
3.6.8 Integra’s Bilayer Matrix for Wound Dressing 77
3.6.9 Alloderm from LifeCell 77
3.6.10 Celution from Cytori Therapeutics 78
3.6.11 Other Products of Importance in Regenerative Medicine 78
3.6.12 Tissue-Engineered Wound Healing Products 78
3.6.12.1 Oasis 79
3.6.12.2 Permacol 79
3.6.12.3 EZ-Derm 79
3.6.12.4 Matriderm 80
3.6.12.5 TransCyte 80
3.6.12.6 ICX-SKN 80
3.6.12.7 OrCel 81
3.6.12.8 Epicel 81
3.6.12.9 Myskin 82
3.6.12.10 VCT01 82
3.6.13 ICX-TRC—Hair Regeneration Therapy 82
3.6.14 Cartilage Regeneration 82
3.6.14.1 Novocart 82
3.6.14.2 BioSeed-C 83
3.6.14.3 BioSeed—Oral Bone 83
3.6.14.4 Chondrotissue 83
3.6.14.5 co.don Chondrotransplant 83
3.6.14.6 co.don Chondrotransplant DISC 83
3.6.14.7 co.don Chondrosphere 83
3.6.14.8 co.don Osteotransplant DENT 84
3.6.14.9 MACI Implant 84
3.6.14.10 Cartilink-3 84
3.6.14.11 Accell Evo3 Demineralized Bone Matrix 84
3.6.14.12 OsSatura BCP 84
3.6.15 Mozobil 84
3.7 Clinical Milestones in RM Sector, 2011-2012 84
3.7.1 GINTUIT (March 2012) 84
3.7.2 Ixmyelocel-T (February 2012) 84
3.7.3 Autologous CD34+ Stem Cells (February 2012) 85
3.7.4 HuCNS-SC (February 2012) 85
3.7.5 DeNovo ET (February 2012) 85
3.7.6 Retinal Pigment Epithelium Cells (January 2012) 85
3.7.7 AMR-001 (January 2012) 85
3.7.8 Avance Nerve Graft (January 2012) 85
3.7.9 Adipose-Derived Stem Cells to Treat Myocardial Ischemia (January 2012) 86
3.7.10 T-Cells Resistant to HIV (January 2012) 86
3.7.11 Tissue-Engineered Windpipe (November 2011) 86
3.7.12 Revascor (November 2011) 86
3.7.13 ReN001 Stem Cell Therapy (September 2011) 86
3.7.14 HP802-247 Allogeneic Cell Suspension for Leg Ulcers (August 2011) 86
3.7.15 ALD-301 for Critical Limb Ischemia (May 2011) 86
3.7.16 JVS-100 for Heart Failure (April 2011) 87
3.7.17 MultiStem for Ulcerative Colitis (March 2011) 87
3.7.18 HuCNS-SC Human Neural Stem Cells (March 2011) 87
3.8 Accelerated Pace of Deals in RM Sector 87
3.8.1 Acquisitions and Partnerships 87
3.8.1.1 Shire’s Acquisition of Advanced BioHealing, Inc. (May 2011) 87
3.8.1.2 Terumo Americas Holding’s Acquisition of Harvest Technologies (April
2011) 87
3.8.1.3 Sanofi’s Acquisition of Genzyme Corporation (February 2011) 87
3.8.1.4 NeoStem’s Acquisition of Progenitor Cell Therapy, LLC (January 2011) 87
3.8.1.5 Strategic Alliance between Mesoblast and Cephalon, Inc. (December 2011)
88
3.8.2 Notable Financings 88
3.8.2.1 Financing to AlloCure, Inc. (April 2012) 88
3.8.2.2 Financing to Promethera Biosciences (March 2012) 88
3.8.2.3 Financing to In Vivo Therapeutics Holdings Corp. (February 2012) 88
3.8.2.4 Financing to Organovo (March 2012) 88
3.8.2.5 Financing to Cytomedix, Inc. (February 2012) 88
3.8.2.6 Financing to Fate Therapeutics, Inc. (May 2011) 88
3.8.2.7 Financing to Cellular Dynamics International, Inc. (April 2011) 89
3.8.2.8 Financing to Cytori Therapeutics (December 2010) 89
3.8.2.9 Overview of Capital Formation in RM Industry 89

4. Recent Advances in Regenerative Medicine and Stem Cell Research 90
4.1 Bioengineered Autologous Vein 90
4.2 Stem Cell Treatment for Spinal Cord Injury 90
4.3 Repairing Damaged Retina 90
4.4 A Possible Cure for Deafness 91
4.5 Clinical Trials for Stem Cell Therapies for CNS Disorders by StemCells, Inc.
91
4.6 First Clinical Use of Bioengineered Vascular Graft Made from Autologous Stem
Cells 92
4.6.1 Recent Developments in Stem Cell Therapy in Cardiology 92
4.6.2 Recent Developments in Acute MI 92
4.6.3 Chronic Ischemic Cardiomyopathy and Heart Failure 94
4.6.4 Stem Cells and Neurodegenerative Diseases 95
4.7 Disease Modeling: The Use of Inducible Cells 96
4.7.1 Modeling Disease with iPS Cells 96
4.7.2 Modeling Disease with Direct Neuronal Conversion 97
4.8 Stem Cell Transplants 97
4.8.1 Recent Developments in Ophthalmologic Stem Cell Transplantation Therapies
98
4.8.2 Stem Cell Types for Eye Disease Clinical Trials 98
4.8.2.1 Pluripotent Stem Cells 99
4.8.2.2 Neural Stem Cells 99
4.8.2.3 RPE Stem Cells 99
4.8.2.4 Limbal Stem Cells 99
4.8.2.5 Umbilical Cord Stem Cells 99
4.8.2.6 Bone Marrow Stem Cells 99
4.8.2.7 Pluripotent Stem Cells for Retinal and RPE Degeneration 99
4.8.2.8 Patch of hESC-Derived RPE Monolayer 100
4.8.2.9 Patient-Derived RPE 100
4.8.2.10 NSCs for AMD 100
4.8.2.11 UCSCs for RP and AMD 101
4.8.2.12 Bone Marrow Stem Cells for Photoreceptor Diseases 101
4.8.2.13 Corneal Repair 101
4.8.2.14 Bioengineered Eye Tissues 101
4.9 Regenerative Strategies in the Treatment of Diabetes 101
4.9.1 Cell-Based Therapy for Diabetes 102
4.9.2 Embryonic Stem Cells and Induced Pluripotent Cells 102

5. Stem Cell Industry Highlights, 2012 104
5.1 Business Development 104
5.2 Clinical Trials 104
5.3 Market Authorization 104
5.4 Regulations 105
5.5 Capital Market and Finances 105
5.6 Investments in Xeno-Cell Therapy 105
5.7 Collaborations in Stem Cell Science 106
5.7.1 California Institute for Regenerative Medicine (CIRM) 106
5.7.2 The International Translational Regenerative Medicine Center 111

6. Regenerative Medicines: A Brief Update from Selected Countries 112
6.1 U.S. 112
6.1.1 Key Institutions 112
6.1.1.1 California Institute for Regenerative Medicine 112
6.1.1.2 The New York Stem Cell Foundation 112
6.1.1.3 NIH Center for Regenerative Medicine 112
6.1.2 Innovative Company 112
6.1.2.1 Aastrom Biosciences 112
6.2 Canada 113
6.2.1 Key Institutions 113
6.2.1.1 Institute of Biomaterials andamp; Biomedical Engineering, University of
Toronto 113
6.2.1.2 Terry Fox Research Institute 113
6.2.1.3 Institute for Research in Immunology and Cancer, University of Montreal
113
6.2.2 Innovative Companies 113
6.2.2.1 Northern Therapeutics 113
6.2.2.2 Octane Biotech 113
6.3 U.K. 113
6.3.1 Key Institutions 114
6.3.1.1 Loughborough University 114
6.3.1.2 U.K. Stem Cell Foundation 114
6.3.1.3 University College, London 114
6.3.2 Innovative Companies 114
6.3.2.1 Intercytex 114
6.3.2.2 Azellon Cell Therapeutics 115
6.3.2.3 Cell Medica 115
6.4 Sweden 115
6.4.1 Key Institutions 115
6.4.1.1 Karolinska Institutet 115
6.4.1.2 The University of Lund 115
6.4.2 Innovative Companies 116
6.4.2.1 Vitrolife 116
6.4.2.2 Cellartis 116
6.4.2.3 Biolamina 116
6.5 Brazil 116
6.5.1 Key Institutions 116
6.5.1.1 Universidade de SaoPaulo 116
6.5.1.2 Fiocruz and Hospital Sao Rafael 116
6.5.1.3 Universidade Federal do Rio de Janeiro 117
6.5.1.4 Pontificia Universidade Catolica do Parana 117
6.5.2 Innovative Company 117
6.5.2.1 Excellion andamp; CellPraxys 117

7. Market Analysis for Regenerative Medicine Sector 118
7.1 Scope of this Chapter 118
7.2 Opportunities for RM Products 118
7.3 Commercial RM Products 119
7.3.1 Leading Commercial Cell Therapy Products 119
7.3.2 FDA Approved Cell-Based Products 120
7.3.3 Growth Spurt by Regenerative Medicine (RM) 121
7.4 Global Market for Tissue-Engineered Products 122
7.4.1 Tissue Engineering and Stem Cell Industry 124
7.5 Market for Stem Cell Therapy in Cardiology 124
7.6 Market for RM Products in Orthopedics 126
7.6.1 No Strong Alternatives for Medtronic’s INFUSE 127
7.6.2 Demineralized Bone Matrix (DBM) 128
7.6.3 The Unproven Stem Cells in Orthopedics 128
7.6.4 Future of Bone Replacement Market 129
7.7 Global RM Market for Neurology Products 130
7.8 Market for RM Dental Products 131
7.9 Market for RM Cancer Products 132
7.10 RM Market for Urology Products 133
7.11 Global Market for Skin Products 134
7.12 Overall Global RM Market 135
7.13 U.S. Market for Tissue-Engineered Skin 136
7.14 U.S. RM Market for Orthopedic/Spine Products 138
7.15 U.S. RM Market for Nerve Repair Products 140
7.16 U.S. RM Market for Cardiovascular and Stroke Products 141
7.17 U.S. Market for Anti-Inflammatory RM Products 142
7.18 U.S. Market for RM Products in Diabetes 142
7.19 Overall U.S. Regenerative Medicine Market 143
7.19.1 U.S. RM Market by Segment 144

8. Stem Cell Industry 146
8.1 Global Market for Stem cells 147
8.2 Stem Cell Use in the U.S. 148
8.2.1 Autologous Stem Cell Use in the U.S. 148
8.2.2 U.S. Stem Cell Market Overview 149
8.2.2.1 Potential U.S. Population for Cell-Based Therapies 150
8.2.3 U.S. Market for Stem cells 151
8.3 European Market for Stem Cells 153
8.3.1 Autologous and Allogeneic Cell Therapy Companies in Europe 154
8.4 Asia-Pacific Market for Stem Cells 155
8.5 Autologous Cell Therapy 156
8.5.1 Commercially Available Autologous Treatments 156
8.5.1.1 Autologous Cell Therapy for Alzheimer’s disease 157
8.5.1.2 Autologous Cell Therapy for Multiple Sclerosis 157
8.5.1.3 Autologous Cell Therapy for Wound Healing 157
8.5.1.4 Autologous Therapy for Cosmetic Surgery 158

9. Business Models and Requirements for a Successful Regenerative Medicine
Industry 159
9.1 Scope of this Chapter 159
9.2 Business Models in Regenerative Medicine 159
9.2.1 Current Model for Autologous Cell Therapies 160
9.2.2 Current Models for Allogeneic Cell Therapies 161
9.3 Key Factors for Successful Business Models for Cell Therapies 163
9.4 Requirements for Commercial Manufacturing of Cell Therapy Products 163
9.4.1 Elements of Commercial Manufacturing 163
9.4.1.1 Regulatory Requirements 163
9.4.1.2 Manufacturing Process Scale 164
9.4.1.3 In-House Manufacturing 164
9.4.1.4 Contract Manufacturing: Commercial and Academic 165

10. Company Profiles 167
10.1. Aastrom Biosciences, Inc. 167
10.1.1 Aastrom’s Cellular Therapy and Ixmyelocel-T 167
10.1.1.1 Advantages of Patient’s Bone Marrow and Ixmyelocel-T 167
10.1.2 Aastrom’s Clinical Trials 168
10.1.2.1 REVIVE-CLI 168
10.1.2.2 RESTORE-CLI 168
10.2 Advanced Cell Technology, Inc. (ACT) 168
10.2.1 ACT’s Human ES Cell Programs 169
10.2.2 ACT’s Human Embryonic Stem Cell Technologies 169
10.2.3 ACT’s Cell Therapy Research Program 170
10.2.3.1 Retinal Pigment Epithelium Program 170
10.2.3.2 Hemangioblast Program 170
10.2.3.3 Adult Stem Cell Program 170
10.2.4 ACT’s Intellectual Property 171
10.3 AlloCure, Inc. 172
10.3.1 AlloCure’s Technology 172
10.3.2 AlloCure’s Clinical Trials 173
10.3.2.1 Acute Kidney Injury 173
10.3.2.2 Epidemiological Study of AKI 173
10.3.2.3 Phase I Clinical Trial in AKI 174
10.3.2.4 Phase II Clinical Trial in AKI 174
10.4 Altrika Ltd. 174
10.4.1 Myskin 174
10.4.2 Cryoskin 174
10.5 American Type Culture Collection, Inc. (ATCC) 175
10.5.1 ATCC’s Cell Lines and Hybridomas 175
10.5.2 ATCC’s Media, Sera and Reagents 175
10.5.3 MTT Cell Proliferation Assay 175
10.5.4 XTT Cell Proliferation Assay Kit 175
10.5.5 Universal Mycoplasma Detection Kit 176
10.5.6 DNA and RNA 176
10.5.7 STR Profile Database 176
10.5.8 hTERT Immortalized Cell Lines 176
10.5.9 Embryonic Stem Cell Products 177
10.5.10 Bacteria and Phages 177
10.5.11 Fungi and Yeast 177
10.5.12 Protozoa and Algae 177
10.5.13 Viruses and Related Reagents 177
10.5.14 Microbial DNA and RNA 178
10.5.15 ATCC’s Tissue Biology Products 178
10.6 Avita Medical Limited 178
10.6.1 ReCell 178
10.7 Amorcyte, LLC 178
10.7.1 AMR-001 179
10.8 Ars Arthro AS 179
10.8.1 CaReS 179
10.8.2 Fibrocell 179
10.8.3 Fibroplus 179
10.9 Axiogenesis AG 179
10.9.1 Human iPS Cell-Derived Cardiomyocytes 180
10.9.2 Murine Cardiomyocytes ES 180
10.9.3 Murine Cardiomyocytes iPS 180
10.9.4 Murine Endothelial Cells 180
10.9.5 Murine Smooth Muscle Cells 181
10.10 AxoGen, Inc. 181
10.10.1 Avance Nerve Graft 181
10.10.2 AxoGuard Nerve Protector 182
10.10.3 AxoGuard Nerve Connector 182
10.11 Bellicum Pharmaceuticals, Inc. 182
10.11.1 Bellicum’s Technology 183
10.11.2 Bellicum’s Pipeline 184
10.12 BetaStem Therapeutics, Inc. 184
10.12.1 BetaStem’s Technology 185
10.13 Bioheart, Inc. 185
10.13.1 MyoCell 185
10.13.2 MyoCell SDF-1 186
10.13.3 MyoCath 186
10.13.4 LipiCell 186
10.14 Biomet, Inc. 187
10.14.1 Endobon Xenograft Granules 187
10.14.2 RegenerOss Allograft 188
10.14.3 Ground Cancellous Bone 188
10.15 BioMimetic Therapeutics, Inc. 189
10.15.1 Augment Bone Graft 190
10.15.2 Augmatrix Biocomposite Bone Graft 190
10.16 BioTissue Technologies AG 191
10.16.1 BioSeed-C 191
10.16.2 Chondrotissue 191
10.16.3 BioSeed-Oral Bone 192
10.17 Biovest International, Inc. 192
10.17.1 Autovaxid 192
10.17.2 Xcellerator 193
10.17.3 Maximizer 193
10.17.4 Minimax 193
10.18 BrainStorm Cell Therapeutics, Inc. 193
10.18.1 NurOwn 194
10.19 California Stem Cell, Inc. 194
10.19.1 Clinical Pipeline 194
10.19.1.1 MotorGraft 194
10.19.1.2 Cancer Stem Cell 194
10.19.2 Cell Products 195
10.19.2.1 MotorPlate and MotorVial 195
10.19.2.2 NeuroPlate and NeuroVial 195
10.19.2.3 OPCVial 195
10.19.2.4 HepatoPlate 196
10.19.3 Cell Culture Products 196
10.19.3.1 StemBlast 196
10.19.3.2 MotorBlast 196
10.19.3.3 NeuroBlast 197
10.19.3.4 OPC Media 197
10.19.3.5 Cellular Transplant Solution 197
10.20 Cardio3 Biosciences SA 197
10.20.1 Products Pipeline 198
10.20.1.1 C3BS-CQR-1 (C-Cure) 198
10.20.1.2 Positive Phase II Results for C-Cure 198
10.20.1.3 C3BS-CQR-1 (Protein) 198
10.20.1.4 C-CATHez (Medical Device) 198
10.21 Cellartis AB (Cellectis) 199
10.21.1 iPS Engineering Hub 199
10.21.2 Hepatocytes hiPS-HEP 199
10.21.3 Cardiomyocyte Clusters hES-CMC 200
10.21.4 Stem Cell Culture System DEF-CS 200
10.22 CellSeed, Inc. 200
10.22.1 Epithelial Cell Sheet for Corneal Regeneration 200
10.22.2 Regenerated Cardiac Patch 201
10.22.3 Epithelial Cell Sheet for Esophageal Regeneration 201
10.22.4 Cell Sheet for Periodontal Regeneration 201
10.22.5 Regenerated Cartilage Sheet 201
10.23 Cellular Dynamics International, Inc. 201
10.23.1 iCell Cardiomyocytes 202
10.23.2 iCell Endometrial Cells 202
10.23.3 iCell Hepatocytes 202
10.23.4 iCell Neurons 202
10.23.5 MyCell Products 202
10.24 Chromocell Corporation 203
10.24.1 Chromovert Technology 203
10.24.2 Chromovert Applications 203
10.24.2.1 Pain Relief 203
10.24.2.2 Anxiety Treatments 204
10.24.2.3 Respiratory Disorders 204
10.25 Cognate Bioservices, Inc. 204
10.25.1 Process Development 204
10.25.2 Regulatory Services 204
10.25.3 Assay Development 205
10.25.4 Preclinical Services 205
10.25.5 Stem Cell Services 206
10.26 Cook Biotech, Inc. 206
10.26.1 Cook’s Technology 206
10.26.2 Biodesign Dural Graft 207
10.26.3 Dynamatrix Extracellular Membrane 207
10.26.4 tarSys 207
10.26.5 Oasis Wound Matrix 207
10.26.6 Biodesign Staple Line Reinforcement 208
10.26.7 Biodesign Hiatal Hernia Graft 208
10.26.8 CorMatrix ECM 208
10.26.9 ECM for Cardiac Tissue Repair 209
10.26.10 Biodesign Incision Graft 209
10.26.11 Biodesign Inguinal Hernia Graft 209
10.26.12 Biodesign Parastomal Reinforcement Graft 210
10.26.13 Biodesign Umbilical Hernia Graft 210
10.26.14 Biodesign Anterior Pelvic Floor Graft 210
10.26.15 Biodesign Fistula Plug 211
10.26.16 LIFT with Biodesign 211
10.26.17 Biodesign Posterior Pelvic Floor Graft 211
10.26.18 Biodesign Peyronie’s Repair Graft 212
10.26.19 Biodesign Tension-Free Urethral Sling 212
10.27 Cytomedix, Inc. 212
10.27.1 Cytomedix’s AutoloGel System 213
10.27.1.1 The Working of AutoloGel System 213
10.27.1.2 Balancing Effect of AutoloGel System 213
10.27.1.3 Formulation of AutoloGel System 214
10.27.2 Cytomedix’s Angel PRP 214
10.28 Cytonet, LLC 215
10.28.1 Cytonet’s Liver Cell Therapy 215
10.28.2 SELICA III Clinical Trial 215
10.29 Cytori Therapeutics, Inc. 215
10.29.1 Cytori’s Commercial Activities and Markets 215
10.29.2 Cytori’s Pipeline 216
10.29.2.1 Celution System for Cardiovascular Disease 216
10.29.2.2 Other Applications of Celution System 217
10.29.2.3 PureGraft 217
10.29.2.4 StemSource 217
10.30 DanDrit Biotech A/S 218
10.30.1 Dendritic Cell 218
10.30.1.2 Colorectal Cancer Trial Phase II in Singapore 219
10.30.1.3 Non-Small-Cell Lung Cancer, Phase II 219
10.31 Fibrocell Science, Inc. 219
10.31.1 Fibrocell’s Technology 220
10.31.2 Pipeline 220
10.32 Forticell Bioscience, Inc. 220
10.32.1 OrCel 220
10.33 Gamida Cell Ltd. 221
10.33.1 Gamida’s Technology 221
10.33.1.1 Copper Chelator Based Technology 221
10.33.1.2 NAM Based Technology 221
10.33.1.3 StemEx 222
10.33.1.4 NiCord 222
10.33.1.5 CordBridge 223
10.33.1.6 NK Cell Product 223
10.34 Harvest Technologies Corporation 223
10.34.1 Smart PReP2 APC+ 223
10.34.2 SmartPReP 2 BMAC 224
10.35 Histogenics Corporation 224
10.35.1 NeoCart 224
10.35.2 VeriCart 226
10.36 Humacyte, Inc. 226
10.36.1 Humacyte Grafts 226
10.37 Integra Lifesciences Holdings Corporation 227
10.37.1 Integra’s Products Overview 227
10.37.2 Integra’s Orthopedics Product Portfolio 227
10.37.3 Integra’s Extremity Reconstruction Product Portfolio 227
10.37.3.1 Skin and Wound 227
10.37.3.2 Bone and Joint Fixation Devices and Instruments 228
10.37.3.3 Lower Extremity Products 228
10.37.3.4 Upper Extremity Products 228
10.37.3.5 Bone Graft Substitutes for Extremity Reconstruction 228
10.37.3.6 Nerve and Tendon 228
10.37.4 Integra’s Spine Product Portfolio 228
10.37.4.1 Integrated Interbody Fusion Devices 229
10.37.4.2 Minimally Invasive Solutions 229
10.37.4.3 Deformity Correction 229
10.37.4.4 Orthobiologics 229
10.37.4.5 Integra’s Research and Development in Regenerative Medicine 229
10.38 Intercytex Ltd. 229
10.38.1 VAVELTA 230
10.38.2 Epidermolysis Bullosa 230
10.38.3 Scar Contractures 231
10.38.4 Acne Scarring 231
10.38.5 International Stem Cell Corporation 231
10.38.6 Therapeutic Programs 232
10.39 iPierian, Inc. 232
10.39.1 Technology 233
10.39.2 Product Development 233
10.40 Japan Tissue Engineering Co., Ltd. 233
10.40.1 Autologous Cultured Epidermis 233
10.40.2 Autologous Cultured Cartilage 234
10.40.3 Autologous Cultured Corneal Epithelium 235
10.41 Kensey Nash Corporation 235
10.41.1 Medeor Matrix 236
10.41.2 Meso BioMatrix Scaffold 236
10.41.3 Epi-Guide Bioresorbable Barrier Matrix 236
10.41.4 OsseoFit Porous Tissue Matrix 237
10.41.5 Vitoss Scaffold Foam Products 237
10.42 Kiadis Pharma B.V. 237
10.42.1 Kiadis’ Pipeline 238
10.42.1.1 ATIR 238
10.42.1.2 Reviroc 239
10.42.1.3 Rhitol 240
10.43 Living Cell Technologies Limited (LCT) 240
10.43.1 Diabecell 240
10.43.2 Ntcell 240
10.44 Life Cell Corporation 241
10.44.1 AlloDerm 241
10.44.2 Cymetra Micronized AlloDerm Tissue 241
10.44.3 Strattice Reconstructive Tissue Matrix 242
10.44.4 SPY Elite System 242
10.45 MaxCyte, Inc. 243
10.45.1 MaxCytes Technology Platform 243
10.45.2 Drug Discovery Applications 243
10.45.2.1 GPCRs 243
10.45.2.2 Ion Channels 243
10.45.3 Antibody Production 244
10.45.4 General Protein Production 244
10.45.5 Viral Vector and VLP Production 244
10.45.6 Insect Cell Transfection 244
10.45.7 Cell Therapy 244
10.45.7.1 Dendritic Cell Vaccines 244
10.45.7.2 Regenerative Medicine 245
10.45.7.3 Chimeric Antigen Receptor (CAR) Immunotherapy 245
10.46 MediStem, Inc. 245
10.46.1 Intellectual Property 246
10.46.1.1 Method for Expansion of Stem Cells 246
10.46.1.2 Compositions of Placentally-Derived Stem Cells for the Treatment of
Cancer 246
10.46.1.3 Transcatheter Tumor Immunoembolization 246
10.46.1.4 Stem Cell Therapy for Cardiac Valvular Dysfunction 246
10.46.1.5 Treatment of Erectile Dysfunction by Stem Cell Therapy 246
10.46.1.6 Allogeneic Stem Cell Transplants in Non-Conditioned Recipients 246
10.46.1.7 Stem Cell Mediated Treg Activation for Therapeutic Immune Modulation
247
10.46.1.8 Cellular Therapy for Lower Back Pain 247
10.46.1.9 Compositions and Methods of Stem Cell Therapy for Autism 247
10.46.1.10 Stem Cell Therapy for Weight Loss 247
10.46.1.11 Menstrual Blood Cellular Populations, Isolation, and Use Thereof 247
10.46.1.12 Endometrial Derived Reparative/Regenerative Cells 247
10.46.1.13 Treatment of Insulin Resistance and Diabetes 248
10.46.1.14 Combination Treatment of Cardiovascular Disease 248
10.46.1.15 Stem Cell Therapy for Autism 248
10.46.2 Product Pipeline 248
10.46.2.1 Endometrial Regenerative Cell Platform 248
10.46.2.2 Angiostem Platform 248
10.46.2.3 Tolerostem Platform 248
10.47 Mesoblast Ltd. 249
10.47.1 Revascor 249
10.47.2 MPCs for Diabetics 249
10.47.3 Bone Marrow Derived Allogeneic MPCs 249
10.47.4 Macular Degeneration 250
10.47.5 Diabetic Macular Edema 250
10.47.6 Intervertebral Disc Repair Product 250
10.47.7 Lumbar and Cervical Spinal Fusion Product 251
10.47.8 Fracture Repair Product 251
10.47.9 Arthritis Product 251
10.48 MolMed S.p.A. 252
10.48.1 MolMed’s Technological Platforms 253
10.49 NanoCor Therapeutics, Inc. 253
10.49.1 Carfostin 253
10.50 Neuralstem, Inc. 253
10.50.1 Neuralstem’s Technology Platforms: Stem Cells 253
10.50.2 Pharmaceutical Compounds 254
10.50.3 Neuralstem’s Clinical Trials for Stem Cells 255
10.50.4 Clinical Trials for Neuralstem’s Pharmaceutical Compound 255
10.51 NeuroNova AB 255
10.51.1 Neurogenesis Qualifier 255
10.51.2 NeuroNova’s Projects 256
10.52 Olympus Terumo Biomaterials Corp. 256
10.52.1 OSferion60 256
10.52.2 Terudermis 256
10.52.3 OSferion 258
10.52.4 Teruplug 258
10.52.5 Bone Cream 258
10.53 NewLink Genetics Corporation 258
10.54 OncoMed Pharmaceuticals, Inc. 259
10.54.1 OncoMed’s Research on Cancer Stem Cells 259
10.54.2 OncoMed’s Platform 260
10.54.3 OncoMed’s Development Pipeline 260
10.55 Opexa Therapeutics, Inc. 261
10.55.1 T-Cell Platform 261
10.56 Organogenesis, Inc. 261
10.56.1 Apligraf 261
10.56.2 Gintuit 262
10.57 Orthovita, Inc. 262
10.57.1 Vitoss 263
10.58 Osiris Therapeutics, Inc. 263
10.58.1 Osiris’ Technologies 264
10.58.1.1 Stem Cell Source 264
10.58.1.2 Manufacturing Process 264
10.59 Osteotech, Inc. 265
10.59.1 MagniFuse 265
10.59.2 Plexur P 265
10.59.3 Plexur M 266
10.59.4 FacetLinx Fusion Technology 266
10.59.5 Grafton 266
10.59.6 Xpanse Bone Inserts 267
10.59.7 GraftCage TLX and GraftCage ACX 267
10.60 Pervasis Therapeutics, Inc. 267
10.61 Pluristem Therapeutics, Inc. 268
10.62 Proneuron Biotechnologies, Inc. 269
10.62.1 Spinal Cord Technology 269
10.63 RegeneRx 270
10.63.1 Tß4 Peptide Research 270
10.64 ReNeuron Group PLC 271
10.64.1 ReN001 271
10.64.2 ReN009 271
10.64.3 ReNcell VM and ReNcell CX 272
10.65 Revivicor, Inc. 272
10.65.1 Xenotransplantation Technology 272
10.66 SanBio, Inc. 273
10.66.1 SanBio’s Product Pipeline 273
10.66.1.1 SB623 273
10.66.1.2 SB618 273
10.66.1.3 SB308 273
10.67 Saneron CCEL Therapeutics, Inc. 274
10.67.1 U-Cord Cell Program 274
10.67.2 Sert-Cell Program 274
10.68 Sangamo Biosciences, Inc. 274
10.68.1 SB-728 274
10.68.2 SB-313 275
10.68.3 Hemophilia 275
10.69 Stem Cell Authority Ltd. 275
10.69.1 MIRACHYMAL Stem Cells 275
10.70 StemCells, Inc. 275
10.70.1 StemCells’ Research Collaborations 276
10.70.1.1 Stanford University and Stanford School of Medicine 276
10.70.1.2 UC Irvine 276
10.70.1.3 OHSU Casey Eye Institute 276
10.70.1.4 McLaughlin Research Institute 276
10.70.2 StemCells’ Therapeutic Programs 276
10.70.3 Cells and Cell Lines 277
10.70.4 Cell Culture Products 277
10.70.5 Antibody Detection Reagents 277
10.70.6 Purified Whole Stem Cell Lysates 277
10.71 Stemline Therapeutics, Inc. 278
10.71.1 Cancer Stem Cells 279
10.71.2 Stemline Therapeutics’ Platform 279
10.72 Stratetech Corporation 279
10.72.1 Stratatech’s Core Technology 279
10.73 Synthecon, Inc. 280
10.73.1 Rotary Cell Culture Systems 280
10.73.2 Biofelt (Bioabsorbable Scaffold) 281
10.73.3 Biomerix 3D Scaffolds 281
10.73.4 RollerCell 40 281
10.74 Tengion, Inc. 282
10.74.1 Tengion’s Scientific Platform 282
10.74.2 Tengion’s Pipeline 283
10.75 TiGenics NV 283
10.75.1 ChondroCelect 284
10.75.2 CX601 284
10.75.3 Cx611 285
10.75.4 Cx621 285
10.76 Tissue Genesis, Inc. 285
10.76.1 Clinical Therapies from Tissue Genesis 285
10.76.1.1 Icellator 286
10.76.1.2 Adipase 286
10.77 Thermogenesis Corp. 286
10.77.1 AXP System 286
10.77.2 MXP System 287
10.77.3 Manual Systems 287
10.77.4 Res-Q 60 BMC System 288
10.77.5 BioArchive System 288
10.78 ViaCyte, Inc. 288
10.78.1 Technology Overview 289
10.79 Vistagen Therapeutics, Inc. 289
10.79.1 Vistagen’s Technology 289
10.79.2 CardioSafe 3D 290
10.79.3 LiverSafe 3D 290
10.80 Zen-Bio, Inc. 290

Appendix 1: Allogeneic vs. Autologous Stem Cell Therapy 292
Appendix 1.1: Manufacturing Process 292
Appendix 1.2: Cost Differential 293
Appendix 1.3: Donor Screening and Testing 294
Appendix 1.4: Release Testing 294
Appendix 1.5: Overall Analysis 294


INDEX OF FIGURES

Figure 2.1: Geographic Distribution of Tissue Engineering Firms in Major Markets
32
Figure 2.2: The Potential Uses of Embryonic Stem Cells 33
Figure 2.3: Progress of Cell Therapy Product Research, 2012 34
Figure 2.4: Commercially Available Cell Therapy Products, 2012 35
Figure 2.5: Disease Focus by Regenerative Medicine 39
Figure 2.6: Estimated Completion Dates for Stem Cell Based Clinical Trials
Targeting Type 1 Diabetes,
2009-2015 45
Figure 2.7: Number of Clinical Trials by Targeted Condition, 2005-2011 45
Figure 2.8: Concentration of European Cell Therapy Firms, 2012 46
Figure 2.9: European Stem Cell Platforms by Cell Source 47
Figure 2.10: Autologous vs. Allogeneic Stem Cell Therapy Firms in Europe, 2012
48
Figure 2.11: Autologous and Allogeneic Somatic Cell Therapy Firms in Europe,
2012 48
Figure 2.12: Sponsors of Cell Therapy Clinical Trials in the U.K., 2012 52
Figure 2.13: Clinical Trials Involving Allogeneic vs. Autologous Cell Therapy
Products in the U.K., 2012 52
Figure 2.14: Cell Types Involved in the U.K. Cell Therapy Clinical Trials, 2012
53
Figure 2.15: U.K. Cell Therapy Clinical Trials by Indication, 2012 54
Figure 2.16: Cell Culture Products Market by Segment, 2012 55
Figure 2.17: Market for Reagents Used in Cell Culture, 2012-2019 56
Figure 2.18: Market for Media Used in Cell Culture, 2012-2019 57
Figure 2.19: Market for Serum Used in Cell Culture, 2012-2019 58
Figure 5.1: CIRM’s Grants for Disease Types by Funding Level, 2012 110
Figure 7.1: Commercially Available Regenerative Products 119
Figure 7.2: Global Market for Tissue Engineering Products, 2012-2019 123
Figure 7.3: Global RM Market for Cardiology and Vascular Products, 2012-2019 126
Figure 7.4: Alternatives for Medtronic’s Infuse 128
Figure 7.5: Global Market for RM Products in Orthopedics, Musculoskeletal and
Spine, 2012-2019 130
Figure 7.6: Global RM Market for Neurology Products, 2012-2019 131
Figure 7.7: Global RM Market for Dental Products, 2012-2019 132
Figure 7.8: Global Tissue Engineering and Cell Therapy Market for Cancer
Products, 2012-2019 133
Figure 7.9: Global Market for RM Products in Urology, 2012-2019 134
Figure 7.10: Global Market for RM Products in Skin/Integument, 2012-2019 135
Figure 7.11: Global Tissue Engineering and Cell Therapy Market, 2012-2019 136
Figure 7.12: U.S. Market for Tissue Engineered Skin Replacement and Substitutes,
2012-2019 137
Figure 7.13: U.S. Market for RM Products in Orthopedic/Spine, 2012-2020 139
Figure 7.14: U.S. Market for RM Products in Nerve Repair, 2012-2020 140
Figure 7.15: U.S. Market for RM Products in Cardiovascular Therapies, 2012-2020
141
Figure 7.16: U.S. Market for RM Products in Anti-Inflammatory Therapies,
2012-2020 142
Figure 7.17: U.S. Market for RM Products in Diabetes, 2012-2020 143
Figure 7.18: U.S. Market for Regenerative Medicines, 2012-2020 144
Figure 7.19: U.S. Regenerative Medicine Market by Segment, 2020 145
Figure 8.1: Global Market for Stem Cell Products, 2012-2020 148
Figure 8.2: U.S. Market for Stem Cell Products, 2012-2020 151
Figure 8.3: Estimat

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