Mesenchymal Stem Cells - Advances and Applications, 2021

EXECUTIVE SUMMARY

 
 Mesenchymal stem cells (MSCs) are multipotent cells that can differentiate into a variety of cell types, including but not limited to osteoblasts, chondrocytes, myocytes, and adipocytes. In addition to secreting factors that can stimulate tissue repair, MSCs can substantially alter their microenvironment, exerting effects that are both anti-inflammatory 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, expandability, transplantability, 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.
 
 Naturally, a broad range of research products have been developed around MSCs and their differentiated cell types. Growing attention is also being given to manufacturing technologies to support commercial-scale production of MSCs. MSCs are well-suited for use in the exponential growth field of 3D printing, because of their capacity to form structural tissues. Numerous market competitors areexploring commercialization strategies for MSC-derived extracellular vesicles (EVs) and exosomes, because these extracellular “packages” represent a novel strategy for accessing the therapeutic effects of stem cells without the risks of administering whole cells to patients. Finally, gene editing of MSCs for overexpressing antitumor genes or therapeutic factors is broadening their application.
 
 As the most common stem cell type being used within regenerative medicine today, there is huge potential for growth within the MSC market. There are more than one-hundred thousand scientific publications published about MSCs, as well over1,100MSC clinical trials underway worldwide. Current “hotspots” for MSC clinical trials include the U.S., E.U., China, Middle East, and South Korea. While many early-stage MSC trials have demonstrated safety and efficacy, only a small number of MSC products have reached commercialization, indicating that the therapeutic market for MSCs remains early-stage. Population aging and an increasing prevalence of chronic disease are also driving interest in MSC-based therapies. Furthermore,Google Trend data reveals that MSC searches are more than twice as common as the next most common stem cell type.The demand for both MSCs and MSC-based research products have surged in recent years.
 
 Today in 2021, nearly one-hundred different market competitors are developing various types of MSC-related products/services, therapies, and manufacturingtechnologies. Within this ever-changing landscape, having a thorough understanding of thecompetition and their relative strengths and weaknesses is essential. Therefore, this global strategic report details the activities of 98 leading MSC companies. It also presents detailed market size figures for the global MSC market, segmented by geography and business segment, accompanied by five-year forecasts through 2027.
 
 With the competitive nature of this global market, you do not have the time to do the research. Claim this report to become immediately informed, without sacrificing hours of unnecessary research or missing critical opportunities.
 
 The main objectives of this report are to provide the reader with the following details:
 

 • Market size determination for the global MSC market, segmented by geography and business segment
 • Five-year forecasts for the global MSC market
 • Details of the product candidates being developed by MSC companies
 • MSC market trends, opportunities, risks,and competitive dynamics
 • Major diseases addressed by MSCs in the ongoing clinical trials
 • Cost of manufacturing autologous and allogeneic MSCs
 • Consumption of MSCs for academic research, clinical trials, product development, and exosome production
 • Trend rate data for MSC scientific publications
 • Rates, quantities, geographic locations, and types of MSC clinical trials
 • Types and sources of MSC industry funding
 • Recent business developments related to MSCs
 • MSC-based products with marketing approvaland the companies commercializing them
 • Currently marketed MSC-based bone matrices
 • Pricing comparison of MSC-based products with marketing approval
 • Emerging applications for MSCs, including genetic modification, 3D bioprinting, clean meat production and cosmeceuticals
 • Company profiles for 98 MSC market competitors, including theirproprietary technologies and products/services under development
 • And so much more
 
 For more comprehensive details about the contents of this report, view the Table of Contents, List of Figures, and List of Tables.
  

1.REPORT OVERVIEW 16
 1.1 Statement of the Report 17
 1.2 Target Demographic 19
 1.3 Report Sources 19
 1.4 Purpose of the Report 20
 1.4.1 To Survey Recent MSC Advancements 20
 1.4.2 To Provide a “Snapshot” of Global MSC Market 20
 1.4.3 To Assess Opportunities for Commercialization 21
 1.4.4 To Identify Major Market Players and Assess the Competitive Environment 21
 1.4.5 To Identify Existing and Emerging Trends 21
 1.4.6 To Identify Critical Opportunities and Threats within the MSC Market 22
 1.5 Executive Summary 22
 1.6 Introduction 24
 
 2. MESECHYMAL STEM CELLS (MSCS): AN OVERVIEW 26
 
2.1 The Impact of MSCs on Regenerative Medicine 26
 2.2 Timeline of MSC Nomenclature 27
 2.3 Sources of MSCs 27
 2.3.1 Bone Marrow-Derived MSCs (BM-MSCs) 28
 2.3.2 Adipose-Derived MSCs (AD-MSCs) 29
 2.3.3 Umbilical Cord-Derived MSCs (UC-MSCs) 29
 2.4 Cell Surface Markers in MSCs 30
 2.5 In Vitro Differentiation Potentials of MSCs 31
 2.6 Soluble Factors Secreted by MSCs 32
 
 3. MANUFACTURE OF MESENCHYMAL STEM CELLS 34
 
3.1 Methods of Isolation of MSCs 35
 3.2 From Conventional Cultures to Bioreactors 36
 3.2.1 Monolayer Culture Systems 36
 3.2.2 Bioreactor-Based Cell Expansion 37
 3.2.3 Stirred Tank Bioreactor 37
 3.2.4 Rocking Bioreactor 38
 3.2.5 Hollow Fiber Bioreactors 38
 3.2.6 Fixed-Bed Bioreactors 39
 3.3 Main Features of Commercial Bioreactors 44
 3.4 Microcarriers used for the Expansion of MSCs 46
 3.5 Downstream Processing of MSCs 48
 3.5.1 Cell Detachment and Separation 48
 3.5.2 Cell Washing and Concentration 50
 3.5.3 Safety and Potency Assays 50
 3.5.4 Surface Markers for Identification during MSC Manufacture 50
 
 4. COMPARISON OF AUTOLOGOUS AND ALLOGENEIC MSC MANUFACTURE 52
 
4.1 Manufacturing Cost Compared 52
 4.1.1 Cost Differential 53
 4.1.2 Cost of Donor Screening and Testing 53
 4.1.3 Cost for Release Testing 54
 4.2 Comparison of the Two Business Models 54
 4.2.1 Risk of Immune Reaction 54
 4.2.2 Risk of Cross Contamination 55
 4.2.3 Commercially Attractive Option 55
 4.3 Cost Breakdown in MSC Manufacturing 55
 4.4 Opportunities for Cost Reduction 57
 4.5 Partial Automation vs. Full Automation 58
 4.5.1 Partial Automation: The Most Attractive Option 60
 
 5. SMALL SCALE PROCESSING OF MSCS 61
 
5.1 Model Design 61
 5.2 Culture Media 62
 
 6. LARGE-SCALE EXPANSION OF MSCS 67
 
6.1 The Four Common Bioprocessing Strategies for Large-Scale Expansion 68
 6.2 Commonly Used Sources of MSCs for Large-Scale Expansion 69
 6.3 The Commonly Used Culture Medium for the Large-Scale Expansion of MSCs 70
 6.3.1 Expansion Ratio Achieved with Different Culture Media 70
 6.4 Comparison between Large-Scale Bioprocessing Strategies 72
 6.5 Contract Manufacturing for Cell Therapies 72
 6.5.1 Contract Manufacturing Organizations (CMOs) 73
 6.5.2 Contract Development and Manufacturing Organizations (CDMOs) 73
 6.5.2.1 Major Services Offered by CMOs 73
 6.5.2.2 Regional Distribution of CMOs 74
 6.6 Global Cell Therapy Manufacturing Capacity 75
 6.6.1 Major Cell Therapy CMOs/CDMOs in the U.S 76
 6.6.2 Major CMOs/CDMOs for Cell Therapy Manufacturing in Europe 77
 
 7. ESTIMATED CONSUMPTION OF MSCS IN THE INDUSTRY 78
 
7.1 Consumption of MSCs in Academic and Preclinical Settings 79
 7.2 MSC Consumption in Clinical Settings 79
 7.3 Consumption of MSCs by Target Indications in Clinical Trials 80
 7.4 Future Consumption through 2030 81
 7.4.1 Consumption for MSC Therapeutics 81
 7.4.2 Consumption for Engineered Tissues and Organs 81
 7.4.3 MSC Consumption by MSC-Derived Products 82
 7.4.4 MSC Consumption in Emerging Industries 82
 7.5 Cost of MSCs per Patient used in Clinical Trials by Indication 82
 
 8. PUBLISHED SCIENTIFIC PAPERS ON MSCS 84
 
8.1 Number of Papers on MSCs & iPSCs Compared 85
 8.2 Number of Papers on MSCs by Source 87
 8.3 Number of Papers Published on Clinical Trials Involving MSCs 88
 8.3.1 Number of Papers on Clinical Trials using MSCs for Specific Diseases 89
 
 9. CLINICAL TRIALS OF MSCS, MSC-BASED COVID-19, MSC-EXOSOMES 91
 
9.1 Analysis of Data from ClinicalTrials.gov 91
 9.2 Sources of MSCs for Clinical Trials 92
 9.3 Autologous vs. Allogeneic MSCs 93
 9.4 Regional Distribution of MSC-Based Clinical Trials 94
 9.4.1 Major Countries Involved in MSC-Based Clinical Trials 95
 9.5 Types of Funding for MSC-Based Clinical Trials 97
 9.6 Types of MSC-Based Clinical Trials 98
 9.7 MSC-Based Clinical Trials by Phase of Development 99
 9.8 Clinical Trials Involving MSCs for the Treatment of COVID-19 100
 9.8.1 MSC-Based COVID-19 Clinical Trials by Geography 100
 9.9 Clinical Trials Involving MSC-Derived Exosomes 102
 9.10 NIH Funding for MSC Research 103
 9.11 CIRM’s Funding for MSC Projects 105
 9.11.1 CIRM Funding for MSC-Based Clinical Trials 106
 
 
 10. CURRENT SUB-OPTIMAL CLINICAL OUTCOMES & SOLUTIONS 107
 
10.1 To Overcome Challenges Arising from MSC Manufacture 107
 10.1.1 Heterogeneity in the MSC Product 107
 10.2 Cryopreservation and Culture Rescue 109
 10.2.1 Bioengineering Solutions to Boost MSC Function 109
 10.2.2 Engineering MSCs to Carry Anti-Cancer “Trogan Horses” 111
 10.3 Overcoming Clinical Challenges Related to Infusion 112
 10.3.1 Local Administration 112
 10.3.2 Insufficient Retention and Survival 112
 10.3.3 Strategies to Improve Local Administration 112
 10.4 To Overcome Clinical Challenges from the Host 113
 
 11. MODIFICATION OF MSCS 115
 
11.1 Genetic Modification 116
 11.1.1 Gene Modification to Improve Migration 116
 11.1.2 Gene Modification to Improve Adhesion 116
 11.1.3 Genetic Modification to Improve Survival 116
 11.1.4 Genetic Modification to Reduce Premature Senescence 117
 11.2 Preconditioning Modifications 117
 11.2.1 Preconditioning to Improve Migration 117
 11.2.2 Preconditioning to Improve Adhesion 118
 11.2.3 Preconditioning to Improve Survival 118
 11.2.4 Preconditioning to Reduce Senescence 118
 11.3 Therapeutic Application of Modified MSCs 118
 11.3.1 Modified MSCs for Neurological Conditions 119
 11.3.2 Modified MSCs for Cardiovascular Diseases 120
 11.3.3 Modified MSCs for Lung Injury 120
 11.3.4 Modified MSCs for Diabetes 121
 
 12. MAJOR DISEASES ADDRESSED BY MSCS IN CLINICAL TRIALS 122
 
12.1 Clinical Trials using MSCs for Autoimmune Diseases 122
 12.2 Clinical Trials using MSCs for Cardiovascular Diseases 123
 12.3 Clinical Trials using MSCs for Neurodegenerative Diseases 124
 12.4 Clinical Trials using MSCs for Bone and Cartilage Diseases 125
 
 13. PRESENT STATUS OF MESENCHYMAL STEM CELL INDUSTRY 127
 
13.1 Sources of MSCs for Research and Clinical Applications 127
 13.2 Allogeneic Products Gaining Traction 128
 13.3 MSC-Based Products with Marketing Approval 129
 13.3.1 Alofisel 131
 13.3.2 Stemirac 132
 13.3.3 Stempeucel 132
 13.3.4 Temcell HS 132
 13.3.5 Neuronata-R 133
 13.3.6 Prochymal (Remestemcel-L) 133
 13.3.7 Cupistem 133
 13.3.8 Cartistem 133
 13.3.9 Cellgram-AMI 134
 13.3.10 Queencell 134
 13.4 Currently Marketed MSC-Based Bone Matrices 134
 13.4.1 Osteocel 135
 13.4.2 AlloStem 136
 13.4.3 Cellentra VCBM 136
 13.4.4 HiQCell 137
 13.4.5 Trinity ELITE 137
 13.4.6 Map3 137
 13.4.7 Trinity Evolution 137
 13.4.8 Carticel 138
 13.4.9 Chondron 138
 13.4.10 DeNovo NT 138
 13.4.11 Chondrocelect 138
 13.4.12 Ossron 139
 13.4.13 JACC 139
 13.4.14 MACI 139
 13.4.15 Ortho-ACI 140
 13.4.16 Spherox 140
 13.4.17 Ossgrow 140
 13.4.18 Cartigrow 141
 13.4.19 ViviGen 141
 13.4.20 Bio4 141
 13.4.21 Cartiform 141
 13.5 From Whole Cell MSC Therapy to MSC-Derived Exosome Therapy 142
 13.5.1 Advantages of MSC-Derived Exosomes 142
 13.5.2 Contents of MSC-Derived Exosomes 142
 13.5.3 Exosomes as Diagnostics 143
 13.5.4 Exosomes as Drug Delivery Vectors 143
 13.6 MSC-Based Therapy for COVID-19 143
 13.7 MSC-Based Clean Meat Production 144
 13.8 Stem Cell-Based Cosmetics 144
 13.8.1 Marketed Stem Cell-Based Cosmetic Products 145
 
 14. MARKET ANALYSIS 153
 
14.1 Price Tags for MSC-Based Cell Therapy (CT) Treatment 154
 14.2 Price Tags for MSC-Based Matrices 155
 14.3 Market Size of MSC-Based Therapies 156
 14.4 Global Market for MSC-based Therapeutics 157
 14.5 Global Demand for Mesenchymal Stem Cells (MSCs) 159
 14.5.1 MSCs Required for Academic and Preclinical Research 159
 14.5.2 Required MSCs for Clinical Trials 159
 14.5.3 MSCs Required for Developing MSC-Based Therapeutics 159
 14.5.4 MSCs Required for Developing MSC-Derived Products 160
 14.5.5 MSCs Required for Emerging Industries 160
 14.5.6 Global Market Size for Mesenchymal Stem Cells 160
 14.6 Market Share of MSC-Based Business Segments 162
 
 15. COMPANY PROFILES 164
 
15.1 101 Bio 164
 15.1.1 Exosome Services 164
 15.2 Adipomics, Inc. 165
 15.3 Aegle Therapeutics 165
 15.3.1 Aegle’s Platform Technology 166
 15.3.1.1 Epidermolysis Bullosa 166
 15.4 Aethlon Medical, Inc. 166
 15.4.1 Hemopurifier in Cancer 167
 15.5 AgeX Therapeutics, Inc. 167
 15.5.1 PureStem Technology 167
 15.5.2 Induced Tissue Regeneration (iTR) 168
 15.5.3 UniverCyte 168
 15.6 Alexerion Biotech Corp. 169
 15.6.1 Drug Development 169
 15.7 AlloSource, Inc. 170
 15.7.1 Products 170
 15.7.1.1 AlloStem 170
 15.8 American CryoStem Corporation 171
 15.8.1 Services 171
 15.8.1.1 ATGRAFT Fat Storage 171
 15.8.1.2 Adult Stem Cell Program 171
 15.8.2 Products 171
 15.8.2.1 CELECT Tissue Harvesting System 171
 15.8.2.2 ATCELL-AD-MSCs 172
 15.8.2.3 ACSelerateMAX Growth Medium 172
 15.9 American Type Culture Collection (ATCC) 173
 15.9.1 Stem Cell Products 173
 15.10 AMS Biotechnology, Ltd. (AMSBIO) 174
 15.10.1 Products 174
 15.11 Anemocyte S.r.l 175
 15.11.1 Total GMP Capacity 175
 15.11.2 Product Types 175
 15.11.3 Manufacturing Services 175
 15.12 Anjarium Biosciences 176
 15.12.1 Anjarium’s Hybridosome Platform 176
 15.13 Anterogen, Co., Ltd. 177
 15.13.1 Products 177
 15.13.1.1 Cupistem Injection 177
 15.13.1.2 Queencell Injection 177
 15.14 Apceth Biopharma GmbH 178
 15.14.1 Global Services 178
 15.14.2 Assay Development Services 179
 15.15 Aruna Bio 180
 15.15.1 AB126 180
 15.16 Athersys, Inc. 181
 15.16.1 MultiStem 181
 15.17 Avalon GloboCare Corp. 182
 15.17.1 Avalon’s Core Platforms 182
 15.18 Axol Bioscience, Ltd. 183
 15.18.1 Products 183
 15.19 Azymus Therapeutics 184
 15.19.1 AZ Platform 184
 15.20 BioCat GmbH 185
 15.20.1 Exosome Purification Kits 185
 15.21 BioFluidica 186
 15.21.1 Technology Platform 186
 15.22 Bio-Techne 187
 15.22.1 Total GMP Capacity 187
 15.22.2 Prtoduct Types 187
 15.23 BioVision, Inc. 188
 15.24 Baylx, Inc. 189
 15.24.1 Product Candidates 189
 15.25 BrainStorm Cell Therapeutics 190
 15.25.1 MSC-NTF Cells 190
 15.26 Capricor Therapeutics 191
 15.26.1 Exosome Program 191
 15.27 Catalent Pharma Solutions 192
 15.27.1 Cell Therapy Expertise 192
 15.28 CCRM 193
 15.28.1 Total GMP Capacity 193
 15.28.2 Product Types 193
 15.28.3 Manufacturing Services 193
 15.29 CellResearch Corporation, Pte Ltd. 194
 15.29.1 Umbilical Cord Lining Stem Cells 194
 15.30 Celltex Therapeutics Corporation 195
 15.30.1 Therapy Services 195
 15.31 Ciloa 196
 15.31.1 Exosome Customization Technology 196
 15.32 Codiak Biosciences 197
 15.32.1 engEx Platform 197
 15.32.2 exoASO-STAT6 197
 15.32.3 exoIL-12 197
 15.33 Corestem, Inc. 198
 15.33.1 Neuronata-R 198
 15.34 CO-DON AG 199
 15.34.1 M-ACT 199
 15.35 Cognate BioServices, Inc. 200
 15.35.1 Total GMP Capacity 200
 15.35.2 Product Types 200
 15.36 Creative Bioarray 201
 15.37 Creative Biolabs 201
 15.37.1 Products 202
 15.37.2 Services 202
 15.38 Cynata Therapeutics, Ltd. 203
 15.38.1 Cymerus Platform 203
 15.38.2 GvHD 203
 15.38.3 Critical Limb Ischemia 204
 15.38.4 Asthma 204
 15.38.5 Heart Attack 204
 15.38.6 Diabetic Wounds 204
 15.38.7 Coronary Artery Disease (CAD) 205
 15.38.8 Acute Respiratory Distress Syndrome (ARDS) 205
 15.38.9 Sepsis 205
 15.38.10 Osteoarthritis 205
 15.39 DePuy Synthes 206
 15.39.1 ViviGen 206
 15.40 Direct Biologics 207
 15.40.1 ExoFlo 207
 15.41 EVerZom 208
 15.41.1 Services 208
 15.42 Evox Therapeutics, Ltd. 209
 15.42.1 Protein Therapeutics – REPLACE 209
 15.42.2 RNA Therapeutics – CORRECT 209
 15.43 Exerkine Corp. 210
 15.43.1 Clinical Development 210
 15.43.1.1 Genetic Diseases 210
 15.43.1.2 Aging-Associated Diseases 210
 15.44 ExoCan Healthcare Technologies, Pvt. Ltd. 211
 15.44.1 Technology 211
 15.44.1.1 ExoEnrich Exosome Isolation Kit 211
 15.44.1.2 ExoEngineering 211
 15.45 ExoCoBio, Co., Ltd. 212
 15.45.1 Products 212
 15.46 Exogenus Therapeutics 213
 15.47 EXoPERT 214
 15.47.1 EXo-i 214
 15.48 Exopharm 215
 15.48.1 LEAP Technology 215
 15.48.2 Cevaris & Plexaris 215
 15.49 Exosome Diagnostics, Inc. 216
 15.49.1 ExoDx Prostate Test 216
 15.50 ExosomePlus 217
 15.51 Exosome Sciences 218
 15.51.1 TauSome Biomarker 218
 15.52 Exosomics S.p.A 219
 15.52.1 ExoRef 219
 15.52.2 SeleCTEV Enrichment Kits 219
 15.52.3 SoRTEV Enrichment Kit 219
 15.53 Fraunhofer Institute for Cell Therapy and Immunology 220
 15.53.1 Total GMP Capacity 220
 15.53.2 Product Types 220
 15.53.3 Manufacturing Services 220
 15.54 HansaBioMed Life Sciences, Ltd. 221
 15.54.1 Products 221
 15.55 Hope Biosciences, LLC 222
 15.55.1 Hope’s Cell Culture Process 222
 15.56 Japan Tissue Engineering, Co., Ltd. 223
 15.56.1 JACC 223
 15.57 JCR Pharmaceuticals, Co., Ltd. 224
 15.57.1 TEMCELL HS Inj. 224
 15.58 Kimera Labs, Inc. 224
 15.59 Lonza Group Ltd. 225
 15.59.1 Total GMP Capacity 225
 15.59.2 Product Types 225
 15.59.3 Manufacturing Services 225
 15.60 Mantra Bio 226
 15.60.1 Partnering 226
 15.61 Medipost, Co., Ltd. 227
 15.61.1 Cartistem 227
 15.62 MDimune 228
 15.62.1 BioDrone Technology 228
 15.63 NanoSomix, Inc. 229
 15.63.1 Technology 229
 15.64 NanoView Biosciences 230
 15.64.1 Products 230
 15.64.1.1 ExoView R 100 230
 15.64.1.2 ExoView Tetraspanin Kits 230
 15.65 NeurExo Sciences 231
 15.66 Nipro Corporation 232
 15.66.1 Stemirac 232
 15.67 Novus Biologicals, LLC 233
 15.67.1 Exosomes Research Tools 233
 15.68 NuVasive, Inc. 234
 15.68.1 Osteocel Family 234
 15.69 OmniSpirant Limited 235
 15.69.1 Technology 235
 15.70 Orthocell, Ltd. 236
 15.70.1 Ortho-ATI 236
 15.70.2 CelGro 236
 15.71 Orthofix Medical, Inc. 237
 15.71.1 Trinity ELITE 237
 15.71.2 Trinity EVOLUTION 237
 15.72 Osiris Therapeutics, Inc. 238
 15.72.1 Cartiform 238
 15.72.2 Bio4 238
 15.73 Pharmicell, Co., Ltd. 239
 15.73.1 Cellgram-AMI 239
 15.73.2 Stem Cell Culture Media Cosmetics 240
 15.74 Pluristem Therapeutics, Inc. 241
 15.74.1 Products 241
 15.74.2 PLX-PAD 241
 15.74.3 PLX-R18 242
 15.74.4 PLX-Immune 242
 15.74.5 Partnerships and Collaborations 243
 15.74.5.1 Collaboration with NASA 243
 15.74.5.2 Collaboration with NIAID 243
 15.74.5.3 Collaboration with U.S. Department of Defence (DOD) 243
 15.74.5.4 License Agreement with Chart Industries, Inc. 243
 15.74.5.5 Collaboration with Thermo Fisher Scientific 244
 15.74.5.6 Partnership with Cha Biotech 244
 15.75 Regeneus, Ltd. 245
 15.75.1 HiQCell 245
 15.76 Regrow Biosciences, Pvt., Ltd. 246
 15.76.1 Ossgrow 246
 15.76.2 Cartigrow 246
 15.77 ReNeuron 247
 15.77.1 Exosome Platform 247
 15.78 RoosterBio 248
 15.78.1 Products 248
 15.78.2 Services 249
 15.79 RoslinCT 250
 15.79.1 Total GMP Capacity 250
 15.79.2 Product Types 250
 15.79.3 Manufacturing Services 250
 15.80 RTI Surgical, Inc. 251
 15.80.1 Map3 Allograft Chips 251
 15.81 Sentien Biotechnologies, Inc. 252
 15.81.1 SBI-101 252
 15.81.2 Pipeline 253
 15.82 STEMCELL Technologies, Inc. 254
 15.82.1 Products 254
 15.83 Stemedica Cell Technologies, Inc. 255
 15.83.1 BioSmart Technology 255
 15.83.2 Pipeline 255
 15.84 Stemmatters Biotechnologia e Medicina Regenerative SA 256
 15.85 Stempeutics Research, Pvt., Ltd. 257
 15.85.1 Stempeucel 257
 15.85.2 Stempeutron 257
 15.85.3 Stempeucare (Cutisera) 258
 15.86 System Biosciences, LLC 259
 15.86.1 Products 259
 15.86.2 Services 259
 15.87 Takeda Pharmaceuticals U.S.A., Inc. 260
 15.87.1 Alofisel 260
 15.88 Tempo Bioscience 261
 15.88.1 Products 261
 15.88.1.1 Human Cell Models 261
 15.88.1.2 Services & Alliances 262
 15.89 Tavec Pharma 263
 15.89.1 Technology 263
 15.90 United Therapeutics Corp. 264
 15.90.1 Unexisome 264
 15.91 Vericel Corporation 265
 15.91.1 MACI 265
 15.91.2 Carticel 265
 15.92 Versatope Therapeutics 266
 15.92.1 VT-105 266
 15.93 Vesigen Therapeutics, Inc. 267
 15.93.1 Technology 267
 15.94 Waisman Biomanufacturing 268
 15.94.1 Total GMP Capacity 268
 15.94.2 Product Types 268
 15.94.3 Manufacturing Services 268
 15.95 WuXi Advanced Therapies 269
 15.95.1 Total GMP Capacity 269
 15.95.2 Product Types 269
 15.96 XOStem, Inc. 270
 15.97 Zen-Bio, Inc. 271
 15.97.1 Products 271
 15.97.1.1 Human Exosomes 272
 15.97.2 Contract Services 273
 15.98 Zimmer Biomet 274
 15.98.1 Cellentra 274


List Of Tables

 TABLE 2.1: Timeline of MSC Nomeclature 27
 TABLE 2.2: Sources of MSCs 28
 TABLE 2.3: Advantages and Disadvantages of BM-MSCs 29
 TABLE 2.4: Advantages and Disadvantages of AD-MSCs 29
 TABLE 2.5: Advantages and Disadvantages of UC-MSCs 30
 TABLE 2.6: Positive and Negative Markers for MSCs Derived from Different Sources 30
 TABLE 2.7: In Vitro Differentiation Potentials of MSCs 31
 TABLE 2.8: Soluble Factors Secreted by MSCs 32
 TABLE 3.1: Initial Story of MSCs: A Snapshot 34
 TABLE 3.2: Methods of Isolation of MSCs and Corresponding Culture Media 35
 TABLE 3.3: A Snapshot of Commercially Available Culture Systems 40
 TABLE 3.3: (CONTINUED) 41
 TABLE 3.3: (CONTINUED) 42
 TABLE 3.3: (CONTINUED) 43
 TABLE 3.3: (CONTINUED) 44
 TABLE 3.4: Main Features of Commercally Available Bioreactors 45
 TABLE 3.5: Microcarriers used for the Expansion of MSCs 46
 TABLE 3.5: (CONTINUED) 47
 TABLE 3.5: (CONTINUED) 48
 TABLE 3.6: Basic Assays for MSCs 50
 TABLE 3.7: Cell Surface Markers on MSCs and Fibroblasts 51
 TABLE 4.1: Cost of Manufacturing Allogeneic MSCs 52
 TABLE 4.2: Cost of Manufacturing Autologous MSCs 53
 TABLE 4.3: Comparison of Allogeneic and Autologous Therapies 55
 TABLE 4.4: Cost of Goods (CoG) in MSC Manufacturing 56
 TABLE 4.5: CoG Breakdown in Partially-Automated MSC Manufacturing 58
 TABLE 4.6: Cost Breakdown in Fully Automated MSC Manufacturing 59
 TABLE 4.7: Higher Throughput in Partially Automated Facilities 60
 TABLE 5.1: Key Process and Cost Assumptions 62
 TABLE 5.2: Quality Control Panel with Cost Assessments 63
 TABLE 5.3: Additional Supporting Labor Cost Assumptions 63
 TABLE 5.3: (CONTINUED) 64
 TABLE 5.4: Additional Supporting Facility and Process Assumptions 64
 TABLE 5.4: (CONTINUED) 65
 TABLE 6.1: Large-Scale Expansion of MSCs by Method, Cell Source and Media 67
 TABLE 6.1: (CONTINUED) 68
 TABLE 6.2: Expansion Ratio Achieved with Different Culture Media 71
 TABLE 6.3: Comparison between Large-Scale Bioprocessing Strategies 72
 TABLE 6.4: Regional Distribution of CMOs 74
 TABLE 6.5: Global Cell Therapy Manufacturing Capacity 76
 TABLE 6.6: Major CDMOs and CMOs in North America 76
 TABLE 6.7: Major CDMOs and CMOs in Europe 77
 TABLE 7.1: Cost of MSCs per Patient in Clinical Trials by Indication 83
 TABLE 8.1: Number of Published Papers on MSCs between 2010 and 2020 84
 TABLE 8.2: Number of Papers on MSCs & iPSCs Compared between 2010 and 2020 86
 TABLE 8.3: Number of Papers on MSCs by Source 87
 TABLE 8.4: Number of Papers on Clinical Trials Involving MSCs, 2010-2020 88
 TABLE 8.5: Number of Papers on Trials using MSCs for Specific Diseases, 2010-2020 90
 TABLE 9.1: Number of Clinical Trials Involving MSCs by Region as of Apr. 2020 91
 TABLE 9.2: Clinical Trials Involving MSCs by Source 93
 TABLE 9.3: Clinical Trials Involving Autologous vs. Allogeneic MSCs 94
 TABLE 9.4: Distribution of MSC-Based Clinical Trials by Geography, 2020 95
 TABLE 9.5: Number of MSC-Based Clinical Trials by Country as of 2020 96
 TABLE 9.6: Type of Funding for MSC-Based Clinical Trials, 2020 97
 TABLE 9.7: The Three Types of Ongoing MSC-Based Clinical Trials, 2020 98
 TABLE 9.8: MSC-Based Clinical Trials by Phase of Development, 2020 99
 TABLE 9.9: Number of COVID-19 Clinical Trials by Country 101
 TABLE 9.10: Examples of Clinical Trials involving MSC-Derived Exosomes 102
 TABLE 9.11: NIH Funding for Research on MSCs, 2020 103
 TABLE 9.11: (CONTINUED) 104
 TABLE 9.12: CIRM-Funded MSC Projects 105
 TABLE 9.13: MSC-Based Clinical Trials Funded by CIRM 106
 TABLE 10.1: Examples of Bioengineered MSCs Loaded with Therapeutics 110
 TABLE 10.2: Examples of Bioengineered MSCs used as Anti-Cancer Trojan Horses 111
 TABLE 11.1: Select Cases of Modified MSC Applications and Therapeutic Outcome 121
 TABLE 12.1: Select MSC-Based Clinical Trials for Autoimmune Diseases 123
 TABLE 12.2: Select MSC-Based Clinical Trials for Cardiovascular Diseases 124
 TABLE 12.3: Select MSC-Based Clinical Trials for Neurodegenerative Diseases 125
 TABLE 12.4: Select MSC-Based Clinical Trials for Bone and Cartilage Diseases 126
 TABLE 13.1: Examples of Completed Clinical Trials involving MSCs 129
 TABLE 13.2: MSC Products with Marketing Approval 130
 TABLE 13.3: Marketed Products Containing MSCs in Matrices 135
 TABLE 13.4: Disease Conditions Studied using Stem Cell Conditioned Medium (CM) 145
 TABLE 13.5: List of Stem Cell-Based Cosmetics 146
 TABLE 13.5: (CONTINUED) 147
 TABLE 13.5: (CONTINUED) 148
 TABLE 13.5: (CONTINUED) 149
 TABLE 13.5: (CONTINUED) 150
 TABLE 13.5: (CONTINUED) 151
 TABLE 13.5: (CONTINUED) 152
 TABLE 14.1: Price Tags of MSC-Based Approved CT Products 155
 TABLE 14.2: Price Tags for Select MSC Progenitor-Based Products 156
 TABLE 14.3: Global Market for MSC-Based Cell Therapy by Geography, 2020-2027 158
 TABLE 14.4: Global Market for Mesenchymal Stem Cells by Geography, 2020-2027 161
 TABLE 15.1: Alexerion’s Exosome-Based Pipeline 169
 TABLE 15.2: BrainStorm’s Product Pipeline 190
 TABLE 15.3: Celltex Therapeutics’ Clinical Trials 195
 TABLE 15.4: The Cellgram Pipeline from Pharmicell 239
 TABLE 15.5: Pluristem’s Clinical Pipeline 242
 TABLE 15.6: Sentien’s Pipeline 253
 TABLE 15.7: Stemedica’s Clinical Pipeline 256
  


List Of Figures

 FIGURE 3.1: Monolayer Culture Systems 36
 FIGURE 3.2: Stirred Tank Bioreactor 37
 FIGURE 3.3: Rocking Bioreactor 38
 FIGURE 3.4: Hollow Fiber Bioreactors 39
 FIGURE 3.5: Fixed-Bed Bioreactors 39
 FIGURE 3.6: Single-Use Harvestainer for Small Scale Application 49
 FIGURE 3.7: Single-Use Harvestainer for Large Scale Application 49
 FIGURE 4.1: CoG in MSC Manufacturing 56
 FIGURE 4.2: Impact of Head Count on Overall CoG per Batch 57
 FIGURE 4.3: CoG Breakdown in Partially-Automated MSC Manufacturing 58
 FIGURE 4.4: Cost Breakdown in Fully Automated MSC Manufacturing 59
 FIGURE 4.5: Higher Throughput in Partially Automated Facilities 60
 FIGURE 5.1: Diagrammatic Representation of SelecT Automated Platform by Sartorius 65
 FIGURE 5.2: Model of a Clean Room in a Small-Scale Manufacturing Facility 66
 FIGURE 6.1: The Four Common Bioprocessing Strategies 69
 FIGURE 6.2: Large-Scale Expansion of MSCs by Source 69
 FIGURE 6.3: Commonly used Culture Media in the Large-Scale Expansion of MSCs 70
 FIGURE 6.4: Major Services Offered by CMOs 74
 FIGURE 6.5: Regional Distribution of CMOs 75
 FIGURE 7.1: Share of Published Papers by Type 78
 FIGURE 7.2: Consumption of MSCs in Academic and Preclinical Settings 79
 FIGURE 7.3: MSC Consumption in Clinical Settings 80
 FIGURE 7.4: Consumption of MSCs by Target Indications in Clinical Trials 80
 FIGURE 8.1: Number of Published Papers on MSCs between 2010 and 2020 85
 FIGURE 8.2: Number of Published Papers for MSCs and iPSCs Compared, 2010-2020 86
 FIGURE 8.3: Number of Papers on MSCs by Source 88
 FIGURE 8.4: Number of Papers on Clinical Trials Involving MSCs 89
 FIGURE 8.5: Percent Share of Specific Diseases in Clinical Trials 90
 FIGURE 9.1: Distribution of Clinical Trials involving MSCs across the World, 2020 92
 FIGURE 9.2: Clinical Trials Involving MSCs by Source 93
 FIGURE 9.3: Clinical Trials Involving Autologous and Allogeneic MSCs 94
 FIGURE 9.4: Distribution of MSC-Based Clinical Trials by Geography, 2020 95
 FIGURE 9.5: Type of Funding for MSC-Based Clinical Trials 97
 FIGURE 9.6: The Three Types of Ongoing MSC-Based Clinical Trials, 2020 98
 FIGURE 9.7: MSC-Based Clinical Trials by Phase of Development, 2020 99
 FIGURE 9.8: MSC-Based COVID-19 Clinical Trials by Geography 100
 FIGURE 10.1: Bioengineering Solutions to Boost the Function of MSC 109
 FIGURE 10.2: Bioengineering Solutions for Improving Administration of MSCs 113
 FIGURE 10.3: Solutions to Overcome Host Factors 114
 FIGURE 11.1: Four Focal Points of Enhancement of MSC’s Properties during Modification 115
 FIGURE 11.2: The Cycle of Naïve MSCs to Modified MSCs for Clinical Application 119
 FIGURE 12.1: Major Diseases Addressed by MSCs in Clinical Trials 122
 FIGURE 12.2: Percent Share of Autoimmune Diseases in Clinical Trials using MSCs 123
 FIGURE 12.3: Percent Share of MSC by Source in Trials for Cardiovascular Diseases 124
 FIGURE 12.4: Percent Shares of Neurodenerative Diseases in Clinical Trials using MSCs 125
 FIGURE 12.5: Percent Share of MSC by Source in Trials for Bone & Cartilage Diseases 126
 FIGURE 14.1: Percent Share of Marketed CT, GT and TE Products 153
 FIGURE 14.2: Percent Share of CT Products by Indication 154
 FIGURE 14.3: Market for MSC-Based Cell Therapy Products by Geography, 2020-2027 158
 FIGURE 14.4: Global Market for Mesenchymal Stem Cells by Geography, 2020-2027 161
 FIGURE 14.5: Market Share of MSCc by Business Segments 163


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