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Categories>>Healthcare>>Current Report

Future Directions in Regenerative Medicine

Published Date : 24 February 2011 Pages : 184 Add to Cart - Future Directions in Regenerative Medicine
     
Big Pharma has begun investing in regenerative medicine: Genzyme in 2008, Pfizer and Novartis in 2009, and Cephalon in 2010. In 3-5 years, investment will reach a “tipping point”, after which no medical industry players will want to be left behind.
 
 This report covers the development of therapies to replace human cells or promote their regeneration: including cell therapies, tissue engineering, drugs, and medical devices. Each company profiled has at least one project in preclinical or Phase I study. Many also have later stage or launched products, which are covered briefly to illustrate the potential of the next generation of candidates.
 
 Scope of this research

 
 • Understand the concepts behind regenerative medicine, its potential applications, and advantages over traditional medicine.
 • Compare the opportunities and challenges presented by the different therapeutic modalities.
 • Understand the hurdles that must be overcome by regenerative medicine candidates before they can successfully enter the market.
 • Identify emerging technologies that will shape the regenerative medicine industry in the coming years.
 • Identify companies that may be competitors for a market, or alternatively potential partners or investment opportunities.
 
 Research and analysis highlights
 
 The first regenerative cell therapies to generate significant market value (within the next five years) will be based on allogeneic adult cells, and will target tissues that are naturally sheltered from patients’ immune systems.
 
 Autologous cells are not rejected by the patient’s immune system, so are potentially safer than allogeneic cells and more suitable for permanent tissue replacement. “High tech” therapies based on reprogrammed autologous cells (e.g. induced pluripotent stem cells) may still be 20 years from market.
 
 Tissue engineering still faces technical hurdles, including vascularization of grafted tissue and safe breakdown of scaffold materials. Research and regulatory efforts must be coordinated internationally to develop a stronger “evidence base” for regenerative medicine that is accessible and acceptable to all stakeholders.
 
 Key reasons to purchase this research
 
 • What is regenerative medicine and why are so many companies and investors excited about it?
 • Which companies are currently developing new regenerative treatments and what approaches are they pursuing?
 • What partnerships have been formed to develop new therapies, and where are the opportunities for further deals?
 • What will the next generation of regenerative medicine candidates look like, and which indications will they treat?
 • What hurdles do these candidates face en route to the marketplace?

 
 About the author 2
 Disclaimer 2
 
 Executive summary 12
 An introduction to regenerative medicine 12
 Allogeneic regenerative cell therapies 12
 Autologous regenerative cell therapies 13
 Tissue engineering 14
 Regenerative drug molecules 14
 Regenerative devices and implants 15
 The future of regenerative medicine 15
 
 Chapter 1 An introduction to regenerative medicine 17
 Summary 17
 Introduction 17
 Cell-based therapies 18
 Tissue engineering 19
 Acellular therapies 20
 
 Chapter 2 Allogeneic regenerative cell therapies 21
 Summary 21
 Introduction 21
 Case studies 23
 Advanced Cell Technology 24
 Altrika 25
 Athersys 26
 BetaLogics 29
 BioTime – embryonic progenitor cells 29
 California Stem Cell 31
 Cardio3 Biosciences 32
 Celgene Cellular Therapeutics 33
 Effector Cell Institute 33
 Gamida Cell 34
 Genzyme and Osiris Therapeutics 35
 Geron 36
 International Stem Cell 39
 ISTO Technologies 40
 MediStem – universal donor cells and cord blood transplants 41
 Mesoblast – mesenchymal precursor cells 43
 NeuralStem – fetal neural stem cells 45
 Pfizer 46
 Pluristem Therapeutics 47
 Promethera Biosciences 49
 Proteonomix 50
 ReNeuron Group 50
 Saneron CCEL Therapeutics. 51
 Stematix 52
 StemCells 52
 Stemedica Cell Technologies 54
 Stempeutics Research 55
 TiGenix – allogeneic MSCs 55
 TissueGene 56
 Summary of allogeneic cell therapies in development 57
 Discussion 63
 Technical issues 63
 Regulatory issues 66
 Logistical issues 66
 Conclusions 67
 
 Chapter 3 Autologous regenerative cell therapies 69
 Summary 69
 Introduction 69
 Case studies 71
 Aastrom Biosciences 72
 Aldagen 72
 American Medical Systems Holdings 75
 Amorcyte 75
 Azellon 75
 Bioheart 76
 BioTime – induced pluripotent stem cells 77
 BrainStorm Cell Therapeutics 79
 Cytori Therapeutics 80
 Ectycell 81
 GeneGrafts 82
 GlaxoSmithKline 83
 Intercytex 84
 LoneStar Heart – regenerative cell induction 86
 MedCell Bioscience 86
 MediStem – Tolerostem 86
 MultiGene Vascular Systems 87
 Novartis – monocyte derived islet cells 88
 StemSave 88
 TCA Cellular Therapy 89
 Tissue Genesis Inc. 89
 TriStem 90
 Summary of autologous cell therapies in development 91
 Discussion 96
 Technical issues 96
 Regulatory issues 98
 Logistical issues 99
 Conclusions 100
 
 Chapter 4 Tissue engineering 102
 Summary 102
 Introduction 102
 Case studies 103
 Advanced BioHealing 104
 CellSeed 104
 Cerco Medical 105
 Cytograft Tissue Engineering 106
 Japan Tissue Engineering Company 107
 Living Cell Technologies 108
 Lonza Group and Regenicin 109
 Organogenesis 109
 Organovo 110
 Pervasis Therapeutics 112
 Tengion 114
 ViaCyte 115
 Summary of tissue engineering treatments in development 116
 Discussion 119
 Technical issues 119
 Regulatory issues 120
 Logistical issues 120
 Conclusions 121
 
 Chapter 5 Regenerative drug molecules 122
 Summary 122
 Introduction 122
 Case studies 124
 Angion Biomedica 124
 Cardio3 Biosciences 124
 DeveloGen 125
 DiaMedica 125
 ImmuneRegen BioSciences 126
 Epistem 127
 Fate Therapeutics 128
 Juventas Therapeutics 128
 LoneStar Heart – cardiac stem cell modulators 129
 Mesoblast – SDF-1 130
 NeuralStem – NSI-189 130
 NeuroNova 131
 Novartis – TherAtoh 131
 Olympus Biotech 132
 Sanofi-Aventis 133
 Stryker 133
 Stem Cell Therapeutics 134
 Tissue Repair Company 134
 Trillium Therapeutics 137
 Summary of regenerative drug molecules in development 137
 Discussion 140
 Technical issues 140
 Regulatory issues 141
 Logistical issues 141
 Conclusions 141
 
 Chapter 6 Regenerative devices and implants 143
 Summary 143
 Introduction 143
 Case studies 144
 Alacer Biomedical 144
 Kensey Nash 145
 Mesynthes 146
 Nanotope 146
 Neopec 148
 Neotherix 149
 RepRegen 150
 TheraGlass 151
 TiGenix – biomaterials 152
 Tissue Regenix Group 152
 Summary of regenerative devices in development 153
 Discussion 155
 Technical issues 155
 Regulatory issues 156
 Logistical issues 156
 Conclusions 156
 
 Chapter 7 The future of regenerative medicine 158
 Summary 158
 Introduction 158
 Investment in regenerative medicine 158
 Reimbursement 160
 Hope versus hype 161
 Appendix 163
 Scope 163
 Methodology 163
 Primary research 163
 Secondary research 164
 Abbreviations 164
 References 172
 Company websites 172
 Journal and magazine articles 178
 Patent documents 181
 
 Table of figures
 Figure 1: Allogeneic regenerative cell therapy 23
 Figure 2: Autologous regenerative cell therapy 71
 Figure 3: Tissue engineering 103
 Figure 4: NovoGen bioprinting 111
 Figure 5: Regenerative drug therapy 123
 Figure 6: Regenerative medical device therapy 144
 
 Table of tables
 Table 1: Allogeneic regenerative cell therapies under development (part 1) 57
 Table 2: Allogeneic regenerative cell therapies under development (part 2) 58
 Table 3: Allogeneic regenerative cell therapies under development (part 3) 59
 Table 4: Allogeneic regenerative cell therapies under development (part 4) 60
 Table 5: Allogeneic regenerative cell therapies under development (part 5) 61
 Table 6: Allogeneic regenerative cell therapies under development (part 6) 62
 Table 7: Autologous regenerative cell therapies under development (part 1) 92
 Table 8: Autologous regenerative cell therapies under development (part 2) 93
 Table 9: Autologous regenerative cell therapies under development (part 3) 94
 Table 10: Autologous regenerative cell therapies under development (part 4) 95
 Table 11: Tissue engineering treatments under development (part 1) 117
 Table 12: Tissue engineering treatments under development (part 2) 118
 Table 13: Regenerative drug molecules under development (part 1) 138
 Table 14: Regenerative drug molecules under development (part 2) 139
 Table 15: Regenerative drug molecules under development (part 3) 140
 Table 16: Regenerative devices under development (part 1) 154
 Table 17: Regenerative devices under development (part 2) 155

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Published By : Business Insights

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