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Mesenchymal Stem Cells - Advances & Applications (2018)

Published By :

BioInformant

Published Date : Feb 2018

Category :

Biotechnology

No. of Pages : 216 Pages

Mesenchymal stem cells (MSCs) are multipotent cells that can differentiate into a variety of cell types, including osteoblasts, chondrocytes, myocytes, adipocytes, and potentially other cell types.

In addition to secreting factors that can stimulate tissue repair, MSCs can substantially alter their microenvironment, exerting effects that are both anti-nflammatory and anti-fibrotic. MSCs are advantageous over other stem cells types for a variety of reasons, including that they are immuno-privileged, making them an advantageous cell type for allogenic transplantation.  MSCs appear to be an exceptionally promising tool for cell therapy, because of their unusual advantages, which include availability, expand ability, transplant ability, and ethical implications.

Interest in therapeutic applications of human MSCs arises from their diverse ability to differentiate into a range of cell types, as well as their ability to migrate to sites of tissue injury/inflammation or tumor growth. Additionally, MSCs well-suited for use in the exponential growth area of 3D printing, because of their capacity to form structural tissues.

Growing attention is now being given to manufacturing technologies to support commercial-scale production of MSCs. Numerous market competitors are also exploring commercialization strategies for MSC-derived exosomes, because exosomes represent a novel strategy for accessing the therapeutic effects of stem cells without the risks and difficulties of administering the cells to patients.

As the most common stem cell type being used in regenerative medicine, there is substantial potential for growth within the MSC market. Today, there are more than 40,000 scientific publications published about the cell type , more than 800 clinical trials underway worldwide , and Google Trend data reveals that MSC searches are more than twice as common as the next most common adult stem cell type .

The Burgeoning Market for Mesenchymal Stem Cells (MSCs)

Mesenchymal stem cells (MSCs) are the most utilized cell type within the regenerative medicine industry. To support this rapidly expanding marketplace, this 200+ page global strategic report presents trend rate data for MSC market, including rates of MSC patents, grants, scientific publications, and clinical trials, as well associal analytics that identify online behavior related to MSCs.

The report describes the current status of mesenchymal stem cell (MSC) research, ongoing clinical trials involving MSCs, late stage MSC clinical trials, and uses of MSCs in cell therapy. It explores recent advances in MSC products and technologies, identifies research priorities by market segment, and assesses 73 leading competitors within the MSC marketplace.

Because MSC therapy is an integrated component of Advanced Therapy Medicinal Products (ATMPs), this market report also provides an introduction to ATMPs.

For pharmaceutical companies, the report reveals how advances in MSC research can reveal potential new drug targets, improve methods of drug delivery, and provide personalized treatment strategies. With “Big Pharma” diversifying their product development pipelines by investing in cell therapy companies, MSC companies now represent promising candidates for collaboration, investment, and acquisition.

Based in Washington, DC, Bio Informant is first and only market research firm to specialize in the stem cell industry. Unlike other publishers that hire analysts from foreign countries, Bio Informant is an American-based company with more than a decade of experience with tracking the stem cell market (2006 to present). Bio Informant compiled this global strategic report using interviews with more than 90 individuals from across the stem cell industry.

Bio Informant conducted interviews with representatives from Cynata Therapeutics (first company to bring a iPSC-derived MSC therapeutic product into a clinical trial), Rooster Bio (global leader in  MSC manufacturing technology that can produce to tens of billions of cells in suspension bioreactors), Pluristem Therapeutics (commercializing placenta-derived mesenchymal-like adherent stromal cells in late-stage clinical trials), Bio Eden (leading company preserving MSCs derived from dental tissues), Regenexx (world’s leading provider of MSC therapies for orthopedic applications), and many more.

The report also incorporates secondary findings from SEC filings, company websites, press releases, investor presentations, government policy documents, Google Trends, and Google Adwords.

Claim this report to:

  • Identify the market segments that compose the MSC industry
  • Reveal the key market players competing in each market niche
  • Identify opportunities for MSC product development
  • Access market size determinations for the MSC market, with projections through 2022
  • Exploit emerging opportunities within the MSC marketplace

Table of Contents

1. Report Overview 14
1.1 Statement of the Report 14
1.2 Executive Summary 16

2. Introduction 18

3. Advanced Therapy Medicinal Products (ATMPs) 20
3.1 Major Therapeutic Areas of Interests in ATMPs Sector 20
3.2 Price of Market-Stage ATMPs 21
3.3 FDA-Approved ATMPs 21
3.4 EC-Approved ATMPs 22

4. Stem Cells: A Brief Overview 24
4.1 Embryonic Stem Cells (ESCs) 24
4.2 Induced Pluripotent Stem Cells (iPSCs) 25
4.3 Types of Specialized Cells Derived from Stem Cells 26
4.4 Types of Stem Cells in Human Body 27
4.4.1 Human Embryonic Stem Cells (hESCs) 27
4.4.2 Embryonic Germ Cells (EG-Cells) 27
4.4.3 Fetal Stem Cells 28
4.4.4 Umbilical Cord Stem Cells 28
4.5 Adult Stem Cells 29
4.5.1 Hematopoietic Stem Cells (HSCs) 29
4.5.2 Mesenchymal Stem Cells (MSCs) 30
4.5.3 Neural Stem Cells (NSCs) 30
4.6 Characteristics of Different Types of Stem Cells 31
4.7 Applications of Stem Cells in Medicine 31

5. Mesenchymal Stem Cells (MSCs): A Detailed Overview 33
5.1 A New Name for MSCs 33
5.1.1 History and Timeline of MSCs Nomenclature 34
5.2 Functions of MSCs 35
5.3 Sources of MSCs 36
5.4 Isolation and Culturing of hMSCs 37
5.4.1 Cell Surface Markers in MSCs 38
5.4.2 In Vitro Differentiation Potential of MSCs 39
5.5 Key Features of Different Types of MSCs 40
5.6 Chronic Diseases Treatable by hMSCs 42
5.7 Common Diseases Registered for MSC-Based Cell Therapy 43
5.8 Advantages of MSCs in Cell Therapy 45
5.9 Comparison of MSCs with Other Stem Cell Types 46
5.10 Drawbacks of Autologous MSCs and Advantages of Allogeneic MSCs 46
5.10.1 Application Strategies for Allogeneic MSCs 47
5.11 Mechanism of Action of MSCs in Treating Diseases 48
5.12 Tissue Regeneration 49
5.13 Immune Modulation 49
5.14 Manufacture of MSCs 51
5.14.1 Safety and Potency Assays 51
5.14.2 Surface Markers of MSC 52
5.14.3 BM-MNC Isolation and Plating 53
5.14.4 Passaging and Harvesting 53
5.14.5 Cryopreservation of MSCs 54
5.14.6 Donor Eligibility and Cell Collection 55
5.14.7 Regulatory Framework of MSC Therapies 55
5.14.8 Contract Development and Manufacturing Organizations (CDMO) 56

6.1 MSCs for GvHD 57
6.2 MSCs for Cardiovascular Repair 58
6.3 MSCs for Liver Disease 58
6.4 MSC for Bone/Cartilage Disease 59
6.5 Approved MSC-Based Products 60
6.5.1 Cartistem 60
6.5.2 Stempeucel 60
6.5.3 Mesenchymal Precursor Cells (MPCs) from Mesoblast 61
6.5.4 Cupistem 62
6.5.5 Prochymal 62
6.5.6 AlloStem 62
6.5.7 Cellgram-AMI 63
6.5.8 Osteocel Plus 63
6.5.9 Trinity Evolution 64
6.5.10 CardioRel 64
6.5.11 Temcell 64
6.6 Bone Matrices Containing MSCs 65
6.6.1 Cost of Bone Matrices Containing MSCs 65
6.6.2 Tissue Engineered Orthopedic Product Candidates Containing MSCs 66
6.7 Pricing of Approved Cell Therapy Products 67

7. Stem Cell Research Publications, Funding And Patents 69
7.1 Volume of Scientific Papers Published on MSCs 71
7.1.1 Number of Publications on MSCs by Major Applications 72
7.2 Stem Cell Research around the World 72
7.3 NIH Funding for MSCs Research 73
7.4 Stem Cell Patents Landscape 78

8. Clinical Trials Involving MSCS: An Overview 80
8.1 Current Clinical Trial Scenario 80
8.2 Geographical Share of MSC Clinical Trials 81
8.2.1 Number of Clinical Trials using MSCs by Geography/Country 82
8.3 Sources of MSCs for Current Clinical Trials 82
8.4 Diseases Addressed by MSCs in the Ongoing Clinical Trials 83
8.5 Active Clinical Trials using MSCs 84
8.6 MSC Clinical Trial Outcomes, 2011-2016 85
8.7 Selected Clinical Trials Sponsored by Universities 86
8.7.1 Celal Bayar University (NCT02824393) 87
8.7.2 University of Jordan (NCT02118519) 87
8.7.3 Ankara University (NCT03106662) 87
8.7.4 University Hospital of Liege (NCT00504803) 87
8.7.5 Acibadem University (NCT02285673) 88
8.7.6 University of Sao Paulo (NCT01297972) 88
8.7.7 Cairo University (NCT02387749) 88
8.8 Selected Clinical Trials Sponsored by Cell Therapy Companies 89
8.8.1 Scinow Biotechnology Co., Ltd. (NCT03184935) 89
8.8.2 Mesoblast Ltd. (NCT00294112) 90
8.8.3 Cellular Biomedicine Group Ltd. (NCT01809769) 90
8.8.4 Alliancells Bioscience Corporation Ltd. (NCT01573923) 90
8.8.5 Pharmicell Co., Ltd. (NCT01676441) 90
8.8.6 Shenzhen Hometcorn Biotechnology Co., Ltd. 91
8.8.7 Sclnow Biotechnology Co., Ltd. (NCT03180450) 91
8.9 Clinical Trials using MSCs for Cardiovascular Diseases 92
8.9.1 Corporate Investment in Cardiovascular Diseases using MSC Therapy 93
8.9.1.1 MPC-150-IM from Mesoblast 94
8.9.1.2 CLBS10 from Caladrius 95
8.9.1.3 C-Cure from Celyad 95
8.9.1.4 Ixmyelocel-T from Vericel 95
8.9.1.5 MultiStem from Athersys 96
8.10 MSCs for Osteoarthritis 96
8.11 MSCs in Wound Healing 98
8.12  MSCs for Liver Diseases 99
8.13 MSCs for Lung Disorders 100
8.14 Clinical Trials using MSCs for Eye Disorders 101
8.15  MSCs for Kidney Disorders 102
8.16 MSCs for Diabetes 103
8.17 MSCs for Graft vs. Host Disease (GvHD) 104
8.18 MSCs for Inflammatory Bowel Diseases 105
8.19 MSCs for Multiple Sclerosis 106
8.20 Status of MSC Clinical Research in Specific Diseases 106
8.20.1 Graft v. Host Disease (GvHD) 106
8.20.2 OA & RA 107
8.20.3 Inflammatory Airway and Pulmonary Diseases 107
8.20.4 Multiple Sclerosis (MS) 107
8.20.5 Inflammatory Bowel Disease (IBD) 108
8.20.6 Genetically Engineered MSCs 108

9. Partnering Activities In Cell Therapy Sector 110
9.1 Collaboration between Lonza and Nikon 111
9.2 Hitachi’s Purchase of PCT from Caladrius Biosciences 111
9.3 Collaboration between Regeneus Ltd. and Asahi Glass. Co. on Progenza 112
9.4 Collaboration between RepliCel Life Sciences and Shiseido Co., Ltd. 112
9.5 Collaboration between SanBio Life Sciences and Sumitomo 112
9.6 Partnership and License Agreement between Healios K.K. and Athersys Inc. 113
9.7 Cell Therapy Ltd.’s License to Daiichi Sankyo 113
9.8 TiGenix’s License to Takeda Pharmaceuticals 114
9.9 Celyad’s License to Ono Pharmaceuticals 114
9.10 Collaboration Kolon Life Sciences and Mitsubishi Tanabe 114
9.11 Collaboration between Steminent Biotherapeutics and ReproCELL Inc. 115
9.12 Kite Pharma’s Partnership with Daiichi Sankyo 115
9.13 Acquisition of Cellular Dynamics by Fujifilm Holdings 115
9.14 License Agreement between Cynata Therapeutics and Fujifilm 116
9.15 Gilead to Acquire Kite Pharma 116
9.16 Big Pharma’s Strategy in Advanced Therapy Sector 116
9.16.1 Collaboration between Sangamo and Pfizer 117
9.16.2 Acquisition of 3D Printing Systems from Tissue Regeneration Systems by DePuy Synthes Products (J&J) 118
9.16.3 New JLABS Opened by J&J 118
9.16.4 Collaboration between GSK and Miltenyl Biotec 118
9.17 Big Pharma’s Interest in Cell Therapy 119
9.17.1 GlaxoSmithKline (GSK) 119
9.17.2 Pfizer 120
9.17.3 Novartis 120
9.17.4 AstraZeneca 120
9.17.5 Roche 121
9.17.6 Johnson & Johnson 121
9.17.7 Sanofi 121
9.18 Big Pharma Strategy in Advanced Therapies 122
9.18.1 Value of Big Pharma Deals in Cell and Gene Therapy 123
9.19 Recent Events in Advanced Therapies Sector 124
9.20 Geographical Distribution of Cell Therapy Companies 125

10. Market Analysis 131

11. Company Profiles 133
11.1 AdiCyte 133
11.2 AdiSave 134
11.3 AlloSource Inc. 134
11.3.1 AlloStem 134
11.4 American CryoStem Corporation 135
11.4.1 Clinical Adipose-Tissue Platform 135
11.5 Anterogen Co., Ltd. 136
11.5.1 Cupistem Injection 136
11.6 Apceth Biopharma GmbH 137
11.6.1 Apceth’s Allogeneic MSC Platform 137
11.6.2 Apceth’s Genetically-Engineered MSCs 137
11.7 Athersys Inc. 138
11.7.1 MultiStem 138
11.8 Astarte Biologics Inc. 139
11.9 BioCardia Inc. 140
11.9.1 Product Pipeline 140
11.10 BioRestorative Therapies Inc. 141
11.10.1 brtxDISC 141
11.10.2 ThermoStem Program 141
11.11 Bone Therapeutics SA 142
11.11.1 Collaborators 142
11.12 Brainstorm Cell Therapeutics 143
11.12.1 NurOwn Technology 143
11.13 Caladrius Biosciences Inc. 144
11.13.1 CLBS03 144
11.13.2 CLBS12 144
11.14 Capricor Therapeutics Inc. 145
11.14.1 CAP-1002 145
11.14.2 CAP-2003 146
11.15 Cell Applications Inc. 146
11.16 Cell Cure Neurosciences Ltd. 147
11.16.1 OpRegen 147
11.17 CellGenix Technologie Transfer GmbH 148
11.17.1 Cell Types Offered 148
11.17.2 CellGro Cytokines 148
11.17.3 Serum-Free Media 149
11.17.4 Supplements and Cells 149
11.18 CellProthera SAS 149
11.18.1 ProtheraCytes 150
11.19 Celltex Therapeutics Corporation 150
11.20 Cellular Dynamics International Inc. 151
11.21 Celprogen Inc. 152
11.22 Cell Therapies Pty Ltd. 154
11.22.1 Contract Manufacturing Services 155
11.22.2 Apheresis Management Services 155
11.22.3 Clinical Trial Support Services 155
11.22.4 Consultancy & Advisory Services 155
11.23 Celvive Inc. 156
11.23.1 The StemCell Bag 156
11.24 Cesca Therapeurics Inc. 157
11.24.1 CAR-TXpress 157
11.24.2 AutoXpress (AXP) 158
11.24.3 Point-of-Care Solutions for Cell-Based Therapies (PXP) 158
11.24.4 CellXpress 158
11.25 Celyad SA 159
11.26 Cyagen Biosciences Inc. 160
11.26.1 Cells 160
11.26.2 Media 161
11.27 Cynata Therapeucics Ltd. 161
11.27.1 Cymerus Platform Technology 162
11.28 Cytori Therapeutics Inc. 162
11.28.1 Cytori Cell Therapy 163
11.29 Escape Therapeutics Inc. 163
11.30 Future Health BioBank 164
11.31 Gamida Cell Ltd. 164
11.31.1 NAM Technology 165
11.31.2 NiCord 165
11.31.3 Cordin 166
11.31.4 NAM-NK Cells 166
11.32 Intercytex Ltd. 167
11.32.1 ICH-RHY 167
11.33 International Stem Cell Corp. 168
11.34 Invitrx Therapeutics Inc. 169
11.34.1 Therapeutic Procedures 169
11.34.2 Invitra ECM Suspension 169
11.34.3 Cosmetic Procedures 170
11.35 JCR Pharmaceuticals Co., Ltd. 170
11.35.1 Temcell HS Inj. 170
11.36 Kadimastem Ltd. 171
11.36.1 Solution for Diabetes 171
11.36.2 Solution for Neurodegenerative Diseases 171
11.37 Kiadis Pharma N.V. 172
11.37.1 ATIR101 172
11.37.2 ATIR201 173
11.38 Kite Pharma Inc. 173
11.38.1 Kite Pharma’s Research 173
11.39 Life Sciences Inc. 174
11.39.1 Technology 175
11.39.2 RCT-01 175
11.39.3 RCS-01 176
11.39.4 RCH-01 176
11.39.5 RCI-02 176
11.40 Living Cell Technologies Ltd. 177
11.40.1 NTCELL 177
11.41 Lonza Group Ltd. 178
11.42 Magenta Therapeutics Inc. 179
11.42.1 Magenta’s Stem Cell Platform 179
11.43 Medeor Therapeutics Inc. 179
11.43.1 MDE-10X 180
11.44 Medipost Co., Ltd. 180
11.44.1 Cartistem 181
11.44.2 Pneumostem 181
11.44.3 Neurostem 181
11.45 Mesoblast Inc. 182
11.45.1 MPC-150-IM 183
11.45.2 MPC-300-IV 183
11.45.3 MPC-06-ID 184
11.45.4 MSC-100-IV 184
11.45.5 Temcell HS Injection 184
11.46 NuVasive Inc. 185
11.46.1 Osteocel 185
11.47 Neuralstem Inc. 186
11.47.1 NSI-189 186
11.48 Octane Biotech Inc. 187
11.48.1 Turn-Key Production System for Cell and Tissue Therapy 187
11.48.2 Automated Bioreactors 187
11.48.3 Atomically Enhanced Implants 188
11.48.4 Drug-Enhanced Implants 188
11.48.5 Cell-Enhanced Implants 188
11.49 Organogenesis Inc. 189
11.49.1 Apligraf 189
11.49.2 Dermagraft 189
11.50 Orthofix International N.V. 190
11.50.1 BioStim 190
11.50.2 Biologics 191
11.50.2.1 Trinity ELITE 191
11.50.2.2 Trinity Evolution 191
11.50.2.3 VersaShield 191
11.50.2.4 Collage 192
11.50.2.5 AlloQuent 192
11.51 Osiris Therapeutics Inc. 193
11.51.1 Grafix 193
11.51.2 BIO4 194
11.51.3 Stravix 194
11.51.4 Cartiform 194
11.52 OxStem Ltd. 195
11.53 PharmaCell B.V. 196
11.54 Pharmicell Co. Ltd. 196
11.54.1 Cellgram-AMI 197
11.55 Pluristem Therapeutics Inc. 197
11.55.1 PLX Products 198
11.55.2 PLX-PAD 198
11.55.3 PLX-R18 198
11.55.4 Prochymal 199
11.56 Precious Cells International Ltd. 199
11.57 Promethera Biosciences S.A. 200
11.57.1 HepaStem for ACLF 200
11.57.2 HepaStem for NASH 201
11.57.3 H2Stem 201
11.57.4 Heparesc 201
11.58 Provia Laboratories, LLC 202
11.59 Regen BioPharma Inc. 202
11.59.1 HemaXellerate (Phase I/II) 202
11.60 Regeneus Ltd. 203
11.60.1 Progenza 203
11.60.2 RGSH4K 204
11.60.3 Secretions 204
11.61 Reliance Life Sciences Pvt. Ltd. 204
11.61.1 CardioRel 205
11.62 Reneuron Group plc 205
11.62.1 CTX Cell Line 206
11.62.2 hRPC 206
11.62.3 Exosome Platform 207
11.63 Stemedica Cell Technologies Inc. 207
11.63.1 BioSmart Technology 207
11.63.2 Clinical Pipeline 208
11.64 StemGen Therapeutics 208
11.64.1 Lipokraft 209
11.64.2 Lipokraft Advance 209
11.64.3 Amniokraft 209
11.65 Stempeutics Research Pvt. Ltd. 209
11.65.1 Stempeucel 210
11.65.2 Stempeucare 210
11.65.3 Stempeutron 211
11.66 Stratatech Corp. 211
11.66.1 StrataGraft 211
11.66.2 ExpressGraft 212
11.67 ThermoFischer Scientific Inc. 214
11.68 TiGenix N.V. 215
11.68.1 TiGenix’s Pipeline 215
11.69 U.S. Stem Cell Inc. 216
11.69.1 MyoCell 216
11.69.2 MyoCell SDF-1 217
11.69.3 AdipoCell 217
11.70 Vericel Corporation 218
11.70.1 Ixmyelocel-T 218
11.70.2 MACI 218
11.70.3 Epicel 219
11.70.4 Carticel 219
11.71 ViaCyte Inc. 219
11.71.1 VC-01 220
11.71.2 VC-02 220
11.72 Xintea AB 221
11.72.1 XINMARK 221
11.73 Zen-Bio Inc. 222

List of Chart

Figure 3.1: Major Indications of Advanced Therapy Clinical Trials 18
Figure 4.1: Differentiation of Stem Cells into Adult Specialized Cells 21
Figure 4.2: Differentiation of Embryonic Stem Cells into Adult Specialized Cells 22
Figure 4.3: Differentiation of Induced Pluripotent Stem Cells into Adult Specialized Cells 23
Figure 4.4: Types of Specialized Cells Derived from Stem Cells 23
Figure 4.5: Applications of Stem Cells 29
Figure 5.1: Types of Common Diseases Registered for MSC-Based Cell Therapy 41
Figure 5.2: Some Mechanisms of MSCs in Therapeutic Application 45
Figure 5.3: Steps in the Manufacturing Process of MSCs 48
Figure 6.1: Clinical Trials of MSCs Classified by Disease Type 54
Figure 7.1: Stem Cell Research Publications Landscape 66
Figure 7.2: Number of Published Scientific Papers on MSCs 68
Figure 7.3: Number of Publications on MSCs by Major Applications, 2016 69
Figure 8.1: Currently Active Clinical Trials using MSCs 78
Figure 8.2: MSC-Based Clinical Trials by Geography 78
Figure 8.3: Sources of MSCs used in Current Clinical Trials 80
Figure 8.4: Diseases Addressed by MSCs in the Ongoing Clinical Trials 80
Figure 9.1: Value of Deals Undertaken by Big Pharma in Gene and Cell Therapy Sector, 2016 120
Figure 9.2: Geographical Distribution of Cell Therapy Companies 123
Figure 10.1: Global Market for Mesenchymal Stem Cells and Products, 2016-2022 129

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