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Mesenchymal Stem Cells – Advances & Applications

  • November 2015
  • -
  • BioInformant Worldwide, L.L.C.
  • -
  • 250 pages

Executive Summary
Mesenchymal stem cells (MSCs) are multipotent stem cells that can differentiate into a variety of cell types, including osteoblasts, chondrocytes, myocytes, adipocytes, beta-pancreatic islets cells, and potentially, other cell types. MSCs are of intense therapeutic interest, because they represent a population of cells with the potential to treat a range of acute and degenerative diseases. 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. Because of their unique capacity to form structural tissues, MSCs also being explored for use in 3D printing applications.
The report describes the current status of MSC research, ongoing clinical trials involving MSCs, late stage MSC clinical trials, and possible uses of MSCs in cell therapy. Because MSCs are a sub-segment of the broader cell therapy (CT) and regenerative medicine (RM) markets, it also gives an overview of the regenerative medicine (RM) and cell therapy (CT) industries.
It also explores recent advances in MSC products and technologies, identifies research priorities by market segment, and assesses 35 leading competitors within the MSC marketplace. For pharmaceutical companies, it reveals how advances in MSC research can reveal potential new drug targets, improve methods of drug delivery, and provide personalized treatment strategies.
There is substantial potential for growth within the MSC market, with more than 30,000 scientific publications published about the cell type, more than 400 clinical trials underway worldwide, and Google Trend data showing MSC searches to be approximately twice as common as the next most common adult stem cell type.
Therefore, the main objectives of the report are to consider the following:
Current status of global regenerative medicine (RM) industry in the utilization of stem cells in general and MSCs in particular
Current status of global cell therapy (CT) industry, the application of cell therapy in various disease indications, and the total number of clinical trials involving the different types of stem cells
Current status of MSCs in clinical trials, the dominance of MSCs in the ongoing clinical trials involving stem cells, the various applications of MSCs in different disease indications, and the number of clinical trials involving MSCs for different disease types
The number of companies involved in the development of MSCs, the clinical trials sponsored by major companies, and their ongoing search for MSCs-based cell therapy products
Analysis of traditional market metrics (grant rates, clinical trial rates, patent rates, scientific publication rates) and social analytics (metrics from social media sites, search engines, Google Trends, Google Adwords, and more)
Key questions answered in the report are:
(Regenerative Medicine = RM; Cell Therapy= CT)
How many companies are currently supporting the regenerative medicine (RM) industry?
What is the current regional breakdown of RM industry?
How many RM products have been approved?
What are the types of diseases are currently being pursued by RM companies?
What are the major financial events, partnerships and acquisitions in RM sector?
How do the large pharma companies perceive the value and long-term prospects of RM and cell therapy (CT)?
What are the major anticipated RM clinical events in 2015-16?
What are the major therapeutic opportunities for the big pharma in RM and CT?
How many CT product candidates have reached the Phase IIIstage and what are they?
What are the CT product candidates being developed for cardiovascular diseases, central nervous system, wounds, spine and orthopedics, diabetes and autoimmune diseases?
What are the major commercially available CT products?
What is the total number of CT clinical trials at the global level?
What are the major cell types used in CT clinical trials?
What are the major indications addressed by CT clinical trials?
What are the major CT clinical trials that have reached Phase III?
How many CT clinical trials failed in the past year and what are they?
What are the contributions of MSCs to the cell therapy industry?
What are the biological properties of MSCs?
What do MSCs get differentiated into?
What bioactive molecules do the MSCs secrete?
What are the immunomodulatory functions of MSCs?
What are the factors impacting the acquisition of MSCs?
What are the various sources of MSCs?
What are the ongoing clinical trials using bone marrow-derived MSCs (BMMSCs) for kidney diseases?
What are the major clinical trials focusing on diabetes using BMMSCs?
What are the major clinical trials involving BMMSCs for cardiovascular diseases?
What are the major clinical trials focusing on liver diseases by BMMSCs?
What are the brain-related diseases addressed by clinical trials using BMMSCs?
How many clinical trials are conducted for intestinal diseases using MSCs?
What are the details of clinical trials conducted for musculoskeletal diseases using MSCs?
Number of clinical trials using MSCs derived from Wharton’s jelly for various diseases?
What are the disease indications addressed by umbilical cord blood-derived MSCs (UCBMSCs) in current clinical trials?
What is the current number of clinical trials using MSCs?
How many major clinical trials using MSCs have reached the Phase III?
What are the MSCs-based cell therapy products available in the market?
What is the current size of the MSC marketplace?
35 leading MSC companies are profiled in this report, including:
American Type Culture Collection Inc. (ATCC)
Anterogen Co., Ltd.
Apceth GmbH & Co. KG
BioCardia Inc.
BioRestorative Therapies Inc.
Bone Therapeutics SA
BrainStorm Cell Therapeutics Inc.
CellGenix Technologie Transfer GmbH
Celprogen Inc.
CellTherapies P/L
Cesca Therapeutics Inc.
Cyagen Biosciences Inc.
Cynata Therapeutics Ltd.
Cytori Therapeutics Inc.
Escape Therapeutics
Kite Pharma Inc.
Life Technologies Corporation
Lonza Group Ltd.
Medipost Co. Ltd.
Mesoblast Ltd.
NuVasive Inc.
Ocata Therapeutics Inc.
Organogenesis Inc.
Orthofix International N.V.
Osiris Therapeutics Inc.
Pluristem Therapeutics Inc.
Regeneus Ltd.
ScienCell Research Laboratories
STEMCELL Technologies Inc.
Stemedica Cell Technologies Inc.
Stempeutics Research Pvt. Ltd.
TiGenix N.V.
Vericel Corporation

Table Of Contents

Mesenchymal Stem Cells - Advances and Applications
11 Statement of the Report10
12 Executive Summary12
21 Regenerative Medicine (RM) and Advanced Therapies Industry: A Brief Overview16
22 Global Breakdown of Major RM Industries by Region17
23 Breakdown of Global RM Companies by Type18
24 Number of Therapeutic Companies, Approved Products and Clinical Trials in RM Sector 18
25 Number of RM Clinical Trials by Phase of Development 19
26 Number of RM Companies by Disease Focus Area20
27 Major Financial Events in RM Industry 21
28 Major Partnerships and Acquisitions in RM Industry21
29 Total Financings in RM Industry by Segment22
210 Type of Financing for RM Industry 23
211 Major Regulatory Milestones in RM Industry23
212 Major Data and Technology Events in RM Industry 24
213 Major Pharma and Biotech Companies Active in Advanced Therapies 25
214 Major Corporate Partnerships in RM Industry 26
215 Anticipated Major RM Clinical Events28
216 Notable Deals and Acquisitions in RM, Cell and Gene Therapy Space 29
217 Big Pharma's Perception of RM 30
2181 Major Therapeutic Opportunities for Big Pharma in Cell Therapy and RM 31
21811 Current Opportunities 31
21812 Near-Term Opportunities31
21813 Long-Term Opportunities 32
31 Types of Stem Cells Used in Cell Therapy33
311 Human Embryonic Stem Cells (hESCs) 33
312 Induced Pluripotent Stem Cells (iPSCS)33
313 Hematopoietic Stem Cells (HSCs)34
314 Mesenchymal Stem Cells (MSCs) 34
315 Adipose Stem Cells (ASCs) 34
316 Neural Stem Cells (NSCs) 34
32 Cell Therapy Product Candidates in Late-Stage Clinical Development 35
33 Cell Therapy Product Candidates in Early-Stage Clinical Development36
34 Cell Therapy Products Being Developed for Cardiovascular Indication38
35 Cell Therapy Products Being Developed for Central Nervous System Indication40
36 Cell Therapy Products Developed and Being Developed for Wound Care41
37 Cell Therapy Products Developed and Being Developed for Spine and Orthopedics 42
38 Cell Therapy Products Being Developed for Diabetes 45
39 Cell Therapy Products Being Developed for Autoimmune Diseases 45
310 Combination of Cell and Gene Therapy Products in Development46
311 Cancer Programs Utilizing the Combination of Cell and Immunotherapy 47
312 Major Commercially Available Cell Therapy Products 49
313 Cell Therapy Products Approved in South Korea51
314 Cell Therapy Clinical Trials: An Overview 52
3141 Cell Therapy Clinical Trials by Geography 52
3142 Top Eight Countries in Cell Therapy Clinical Trials 53
3143 Major Cell Types in Cell Therapy Clinical Trials 54
3144 Major Disease Indications Addresses by Cell Therapy Clinical Trials54
315 Fifteen Major Cell Therapies in Phase III 55
3151 Prochymal 55
3152 Mesenchymal Precursor Cell (MPC)56
3153 MyoCell 56
3154 Ixmyelocel-T56
3155 ELAD57
3156 HP802 57
3157 StemEx (Carlecortemcel-L)57
3158 LaViv 57
3159 GSK 269627358
31510 Renew58
31511 NT-501 (Renexus) 58
31512 Neocart 58
31513 DeNovo ET 59
31514 MACI59
316 Clinical Trial Failures in Cell Therapy in 2014 59
3161 Failure of Phase II for MultiStem59
3162 Failure of Cardio 133 Trial 59
3163 Termination of AlloCure's ACT-AKI Trial 60
3164 Failed Stroke Trial in India 60
3165 Failure of HeartiCellGram-AMI Trial60
3166 Failure of Adipose MSCs in ARDS 60
3167 CD133+ in CLI Not Feasible 60
3168 Failed MSC Trial for Multiple Sclerosis 60
3169 Failure of Chinese Diabetes Trial61
31610 Failed Efficacy Trial in AMI by Stempeucel 61
317 A Sampling of Stem and Progenitor Cell-Based Trials with 2014 Clinical Readouts 61
318 Major Cell Therapy Companies and their Locations 62
319 Involvement of Multinational Companies (MNCs) in Cell Therapy Sector 67
41 Biological Properties of MSCs Contributing to their Therapeutic Effects 69
411 MSCs' Capacity to Migrate and Engraft69
412 MSCs' Differentiation Potential 70
413 MSCs' Potential to Secrete Multiple Bioactive Molecules70
414 MSCs' Potential for Immunomodulatory Functions71
415 Variable Immunophenotype of MSCs 72
42 Factors Impacting MSCs Acquisition73
43 Major Clinical Sources of MSCs 74
431 Bone Marrow-Derived Mesenchymal Stem Cells (BMMSCs) 74
4311 BMMSCs and Kidney75
4312 BMMSCs and Pancreas 75
4313 BMMSCs and Heart76
4314 BMMSCs and Liver76
4315 BMMSCs and Brain 77
4316 BMMSCs and Intestine 77
4317 BMMSCs and Bone 78
432 Adipose-Derived Mesenchymal Stem Cells79
4321 Selected ADSC Secretomes and their Functions80
433 Mesenchymal Stem Cells (MSCs) Derived from Wharton's Jelly81
4331 Clinical Application Properties of WJ-MSCs81
4332 Immunoprivileged Status of WJ-MSCs81
4333 Clinical Applications of WJ-MSCs 81
434 Umbilical Cord Blood-Derived MSCs (UCBMSCs)83
44 Dominance of MSCs in Cell Therapy Clinical Trials 84
45 Major Diseases Addressed by MSCs in Current Clinical Trials86
451 MSCs for Treating Liver Diseases 87
452 MSCs for Neurodegenerative Diseases88
453 Clinical Trials Using MSCs for Autoimmune Diseases 88
454 Clinical Trials Using MSCs for Diabetes 89
455 MSCs for Cardiovascular Repair 90
456 MSCs for Musculoskeletal Diseases90
4561 Studies Using MSCs for Musculoskeletal Indications by Leading Countries 92
4552 Application of MSCs in Joint Diseases 93
457 MSCs in Neuron/Spinal Cord Diseases 95
458 MSC Infusion for GvHD 96
459 MSCs for Crohn's Disease97
4510 MSCs in Wound Healing97
4511 Increasing Focus on Immunological Properties of MSCs 99
4512 Percentage of MSCs Clinical Trials by Different Phases100
4513 Selected MSCs Late-Stage Pipeline Cell Therapies 100
51 Global Market for Stem Cells by Disease Indication 105
61 American Type Culture Collection Inc (ATCC)107
62 Anterogen Co, Ltd108
621 Cupistem Injection108
622 Queencell 108
63 Apceth GmbH and Co KG109
631 Apceth's Research Areas 109
64 BioCardia Inc 110
65 BioRestorative Therapies Inc111
651 brtxDISC111
652 ThermoStem 111
66 Bone Therapeutics SA112
661 PREOB112
662 ALLOB112
67 BrainStorm Cell Therapeutics Inc113
671 NurOwn 113
68 CellGenix Technologie Transfer GmbH114
69 Celprogen Inc 115
610 CellTherapies P/L 116
6101 Services 116
6102 Product117
611 Cesca Therapeutics Inc 117
6111 Surgwerks 118
6112 Cellwerks118
6113 AutoXress (AXP)118
6114 MarrowXpress (MXP)118
6115 Res-Q BMC118
612 Cyagen Biosciences Inc 119
6121 Mesenchymal Stem Cells from Cyagen119
6122 Adipose-Derived Mesenchymal Stem Cells from Cyagen120
6123 Mesenchymal Stem Cells with GFP from Cyagen120
6124 Adipose-Derived Mesenchymal Cells with GFP from Cyagen121
6125 Stem Cell Culture Media from Cyagen 121
6126 Stem Cell Differentiation Media from Cynagen122
6127 Primary Cells from Cynagen 122
6128 Cyagen's Cryopreservation Media123
6129 Cyagen's Primary Cell Culture Media124
61210 General Cell Culture Supplements and Specialty Reagents from Cyagen 124
613 Cynata Therapeutics Ltd125
6131 Cymerus Platform Technology125
614 Cytori Therapeutics Inc126
6141 Clinical Trial for Scleroderma126
6142 Clinical Trials for Osteoarthritis 126
615 Escape Therapeutics 127
616 Genlantis128
617 Kite Pharma Inc 129
6171 Engineered Autologous Cell Therapy (eACT) 129
6172 DC-Ad GM-CAIX129
618 Life Technologies Corporation130
619 Lonza Group Ltd 131
6191 Selected Products 131
620 Medipost Co Ltd132
6201 Cartistem133
6202 Neurostem133
6203 Pneumostem 133
621 Mesoblast Ltd 134
6211 Mesoblast's Product Pipeline Overview134
622 NuVasive Inc136
6221 Osteocel 136
623 Octa Therapeutics Inc136
624 Organogenesis Inc137
6241 Apligraf 137
6242 Dermagraft 138
625 Orthofix International NV 138
6251 Trinity Elite 138
6252 Trinity Evolution139
626 Osiris Therapeutics Inc 139
6261 Grafix139
6262 OvationOS139
6263 Cartiform 140
627 Pluristem Therapeutics Inc 140
6271 PLX Cells 140
628 PromoCell 141
629 Regeneus Ltd 142
6291 Products 142
630 ScienCell Research Laboratories 143
631 Stemcell Technologies Inc146
632 Stemedica Cell Technologies Inc 149
6321 Stemedyne MSC149
6322 Stemedyne NSC 149
6323 Stemedyne RPE149
633 Stempeutics Research Pvt Ltd 150
6331 Stempeucel 150
6332 Stempeutron150
6333 Stempeucare151
634 TiGenix NV151
6341 Cx601152
6342 Cx611152
6343 Cx621152
635 Vericel Corporation 153

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