Mesenchymal Stem Cells / Medicinal Signaling Cells (MSCs) - Advances & Applications, 2023

Table of Contents

1. REPORT OVERVIEW 
1.1 Statement of the Report 
1.2 Target Demographic 
1.3 Report Sources 
1.4 Purpose of the Report 
1.4.1  Survey Recent MSC Advancements 
1.4.3  Assess Opportunities for Commercialization 
1.4.4  Identify Major Market Players & Assess the Competitive Environment 
1.4.5  Identify Existing and Emerging Trends 
1.4.6  Identify Critical Opportunities and Threats within the MSC Market 
1.5 Executive Summary 
1.6 Introduction 

2. MESENCHYMAL STEM CELLS (MSCS): AN OVERVIEW 
2.1 Stabilization of hMSCs as a Technology 
2.2 The Impact of MSCs on Regenerative Medicine 
2.3 Timeline of MSC Nomenclature 
2.4 Sources of MSCs 
2.4.1  Bone Marrow-Derived MSCs (BM-MSCs) 
2.4.2  Adipose-Derived MSCs (AD-MSCs) 
2.4.3  Umbilical Cord-Derived MSCs 
2.5 Cell Surface Markers in MSCs 
2.6 In Vitro Differentiation Potentials of MSCs 
2.7 Soluble Factors Secreted by MSCs 
2.8 Stemness Genes Present in MSCs 

3. PUBLISHED SCIENTIFIC PAPERS ON MSCS 
3.1 Number of Papers on MSCs & iPSCs Compared 
3.2 Number of Papers Published on MSC-based Clinical Trials 
3.3 Number of Papers on Clinical Trials using MSCs for Specific Diseases 
3.4 Published Papers on Modified MSCs 
3.5 Published Papers on MSC-Derived Exosomes 

4. STEM CELLS PATENT LANDSCAPE: AN OVERVIEW 

4.1 Geographical Distribution of Stem Cell Patent Filing 
4.1.1  Leading Players in Stem Cell Patent Arena 
4.1.2  Types of Patent Document Holders in Stem Cell Arena 
4.1.3  Top Ten Stem Cell Patent Owners by Size of Patent Portfolio 
4.2 MSC Patents 
4.2.1 Top Ten MSC Patent Applicants 
4.2.2  Status of MSC Patent Applications 
4.2.3  MSC Patent Jurisdictions 
4.2.4  Top Ten MSC Patent Inventors 
4.2.5  Top Ten MSC Patent Owners 
4.2.6  Patent Landscape of MSC-Derived Exosomes 
4.2.7  Number of Patent Applications by Year 
4.2.8  MSC-Exosomes Patent Jurisdiction 
4.2.9  Top Ten Patent Inventors 

5. MSCS: CLINICAL TRIAL LANDSCAPE 

5.1 Analysis of Data from ClinicalTrials.gov 
5.1.1  Sources of MSCs for Clinical Trials 
5.1.2  Autologous vs. Allogeneic MSCs in Clinical Studies 
5.1.3  Types of Funding for MSC-based Clinical Trials 
5.1.4  Types of MSC-based Clinical Trials 
5.1.5  MSC-based Clinical Trials by Phase of Development 
5.2 Administration of MSCs in Clinical Trials 
5.3 MSC Clinical Trials by Disease Category 
5.3.1  MSC-based Clinical Trials for Musculoskeletal Disorders 
5.3.2  MSC-based Clinical Trials for Neurological Disorders 
5.3.3  Clinical Trials involving MSC-derived Exosomes 

6. BIOENGINEERING SOLUTIONS TO BOOST MSC’S FUNCTIONS 
6.1 Small-Molecule Priming 
6.2 Particle Engineering 
6.3 Genetic Engineering 
6.3.1  Engineering MSCs to Go Beyond their Innate Functions 
6.3.2  Engineered MSCs for Neurological Conditions 
6.3.3  Engineered MSCs for Cardiovascular Diseases 
6.3.4  Engineered MSCs for Lung Injury 
6.3.5  Engineered MSCs for Diabetes 
6.4 Bioengineering Approaches to Improve MSC Administration 

7. MANUFACTURING OF MSCS 
7.1 Autologous and Allogeneic MSCs 
7.2 Methods of Isolation of MSCs 
7.3 Cell Expansion: Conventional Cultures to Bioreactors 
7.3.1  Monolayer Culture Systems 
7.3.2  Bioreactor-Based Cell Expansion 
7.3.2.1  Stirred Tank Bioreactor 
7.3.2.2  Rocking Bioreactor 
7.3.2.3  Hollow Fiber Bioreactors 
7.3.2.4  Fixed-Bed Bioreactors 
7.4 Bioreactors in Current Use 
7.4.1  Miniaturized Bioreactors 
7.4.2  Alternative Mixing Mechanisms 
7.5 Main Features of Commercial Bioreactors 
7.6 Number of Cells per Batch by Technologies 
7.7 Microcarriers for the Expansion of MSCs 
7.8 Downstream Processing of MSCs 
7.8.1  Cell Detachment and Separation 
7.8.2  Cell Washing and Concentration 
7.8.3  Safety & Potency Assays 
7.8.4  Surface Markers for Identification during MSC Manufacture 
7.9 Autologous & Allogeneic MSC Manufacturing: A Comparison 
7.9.1  Manufacturing Cost: Autologous and Allogeneic MSCs 
7.9.2  Cost of Manufacturing Autologous MSCs 
7.9.3  Cost of Donor Screening & Testing 
7.9.4  Cost for Release Testing 
7.10 Cost Breakdown in MSC Manufacturing 
7.10.1  Strategies for Cost Reduction 
7.10.1.1 Cost of Manufacture in Partial Automation vs. Full Automation 
7.10.1.2 CoG Breakdown in Partially-Automated MSC Manufacturing 
7.10.1.3 CoG Breakdown in Fully Automated MSC Manufacturing 
7.10.1.4 Higher Throughput in Partially Automated Facilities 

8. SMALL SCALE PROCESSING OF MSCS 
8.1 Model Design 
8.2 Culture Media 

9. LARGE-SCALE MANUFACTURING OF MSCS 
9.1 The Four Common Bioprocessing Strategies for Large-Scale Expansion of MSCs 
9.2 Commonly Used Sources of MSCs for Large-Scale Expansion 
9.3 Commonly used Culture Media for Large-Scale Expansion of MSCs 
9.3.1  Expansion Ratios Achieved with Different Culture Media 
9.4 Comparison between the Four Large-Scale MSC Expansion Strategies 

10. CONTRACT MANUFACTURING FOR CELL & GENE THERAPIES 
10.1 The Need for Staff with Expertise 
10.2 Capacity Constraints 
10.3 CDMO Platforms Showing Greatest Growth Potential 
10.4 Outsourcing Trends for Cell & Gene Therapies (CGT) 
10.4.1  Number of CDMOS Utilized by Biotechs 
10.5 CMOs/CDMOs 
10.5.1  Contract Manufacturing Organizations (CMOs) 
10.5.1.1 Major Services offered by CMOs 
10.5.2  Contract Development and Manufacturing Organizations (CDMOs) 
10.6 Global Bioprocessing Capacity 
10.6.1  Capacity Growth over Time 
10.6.2  Current Distribution of Capacity by Facility Size 
10.6.3  Global Bioprocessing Capacity by Region 
10.7 Top Global CDMOs in 2022 
10.7.1  Major Cell & Gene Therapy CDMOs in the U.S 
10.7.2  Major Cell & Gene Therapy Contract Manufacturers in Europe 
10.8 U.K.’s Domination in European Cell & Gene Therapy Contract Manufacturing 
10.8.1  Cell & Gene Therapy GMP Manufacturing in U.K. 
10.8.2  U.K. Cleanroom Footprint for CGT Manufacturing, 20018-2022 
10.8.3  Cell Therapy Process Capabilities in the U.K. by Types of Process 
10.8.4  Gene Therapy Process Capabilities in the U.K. by Types of Process 
10.8.5  Countries Importing Cell & Gene Therapy Services from U.K. 

11. MAJOR DISEASES ADDRESSED BY MSCS 
11.1 Studies using MSCs for Autoimmune Diseases 
11.2 Studies using MSCs for Cardiovascular Diseases 
11.3 Studies using MSCs for Neurodegenerative Diseases 
11.4 Studies using MSCs for Bone & Cartilage Diseases 
11.5 Studies using MSCs in GvHD 
11.6 Studies using MSCs in Crohn’s Disease 
11.7 Studies using MSCs in Type 1 Diabetes 
11.8 Studies using MSCS in Systemic Lupus Erythematosus (SLE) 
11.9 Studies using MSCs in Parkinson’s disease (PD) 
11.10 Studies using MSCs in Alzheimer’s Disease (AD) 
11.11 Studies using MSCs in Kidney Failure 
11.12 Studies using MSCs in Spinal Cord Injury (SCI) 
11.13 MSCs for Chronic Wounds 

12. CURRENT STATUS OF MESENCHYMAL STEM CELL INDUSTRY 
12.1 Brief Account of Modified MSCs 
12.1.1  Genetic Modification of MSCs 
12.1.2  Priming of MSCs 
12.1.2.1 Primed MSCs in Clinical Trials 
12.1.3  Biomaterial Strategies 
12.1.4  MSC Secretomes 
12.1.5  MSCs in Topical Cosmetics 
12.1.5.1 Cosmetic Effects of Secretomes 
12.1.5.2 Secretome-Based Formulations for Skincare 
12.2 MSC-Based Products with Marketing Approval 
12.2.1  Alofisel 
12.2.2  Stemirac 
12.2.3  Stempeucel 
12.2.4  Temcell HS 
12.2.5  Neuronata-R 
12.2.6  Prochymal 
12.2.7  Cupistem 
12.2.8  Cartistem 
12.2.9  Cellgram-AMI 
12.2.10  Queencell 
12.3 Currently Marketed MSC-Based Bone Matrices 
12.3.1  Osteocel 
12.3.2  AlloStem 
12.3.3  Cellentra VCBM 
12.3.4  HiQCell 
12.3.5  Trinity ELITE 
12.3.6  Map3 
12.3.7  Trinity Evolution 
12.3.8  Carticel 
12.3.9  Chondron 
12.3.10  DeNovo 
12.3.11  Chondrocelect 
12.3.12  Ossron 
12.3.13  JACC 
12.3.14  MACI 
12.3.15  Ortho-ACI 
12.3.16  Spherox 
12.3.17  Ossgrow 
12.3.18  Cartigrow 
12.3.19  ViviGen 
12.3.20  Bio4 
12.3.21  Cartiform 

13. RECENT COLLABORATIONS IN MSC SECTOR 
13.1 RoosterBio’s Partnership with AGC Biologics 
13.2 RoosterBio’s Partnership with ShiftBio 
13.3 Pluristem’s Collaboration with Tnuva Group 
13.4 RoosterBio’s Partnership with Univercells Technologies 
13.5 Partnership between Cynata & Fujifilm 
13.6 Collaboration between American CryoStem Corp. & BioTherapeutic Labs Corp 
13.7 RoosterBio’s Partnership with Sartorius 
13.8 Research & Development Agreement between American CryoStem and CRADA 
13.9 RoosterBio’s Partnership with Sartorius Korea Biotech 
13.10 Partnership between Catalent and BrainStorm 
13.11 Collaboration between Cipla & Stempeutics 
13.12 Aethlon’s Collaboration with University of Pittsburgh 
13.13 RoosterBio’s Partnership with Senti Biosciences 

14. MARKET ANALYSIS 
14.1 Price Tags of MSC-Based CT Treatment 
14.2 Price Tags of MSC-Based Matrices 
14.3 Market Size of MSC-Based Therapies 
14.4 Global Market for MSC-Based Therapeutics 
14.5 Global Demand for Mesenchymal Stem Cells (MSCs) 
14.5.1  Global Demand for MSCs in Academic and Preclinical Studies 
14.5.2  Global Demand for MSCs in Clinical Trials 
14.5.3  Global Demand for MSCs for the Development of Therapeutics 
14.5.4  Global Demand for MSCs to Develop Exosome Products 
14.5.5  Global Demand for MSCs in Emerging Industries 
14.5.6  Global Market for MSCs 
14.5.7  Market Share of MSC-Based Business Segments 

15. COMPANY PROFILES 
15.1 101 Bio 
15.1.2  Products 
15.1.3  Services 
15.2 AbbVie, Inc. 
15.2.1  SkinMedica Neck Correct Cream 
15.3 Abzena 
15.3.1  Services 
15.4 Adipomics, Inc. 
15.5 Advancells 
15.5.1  MSC-Derived Exosome Therapy 
15.6 Advent BioServices, Ltd. 
15.6.1  Ultra Cold Storage Services 
15.6.2  Quality Control Services 
15.7 Aegle Therapeutics 
15.7.1  Aegle’s Platform Technology 
15.7.2  Epidermolysis Bullosa 
15.8 Aethlon Medical, Inc. 
15.8.1  Hemopurifier in Infectious Disease 
15.8.2  Status of Clinical Studies 
15.8.3  Hemopurifier in Cancer 
15.9 AGC Biologics 
15.9.1  Offerings 
15.10 AgeX Therapeutics, Inc. 
15.10.1  Pluristem Technology 
15.10.2  Induced Tissue Generation 
15.10.3  UniverCyte 
15.10.4  HyStem Delivery Technology 
15.11 AlloSource, Inc. 
15.11.1  Allografts with Tissue-derived MSCs 
15.11.2  Products 
15.11.2.1 AlloConnex 
15.11.2.2 AlloFuse & AlloFuse Plus DBM 
15.11.2.3 AlloFlex Plus 
15.11.2.4 AlloFuse Cervical Grafts 
15.11.2.5 AlloFuse Fiber and Fiber Boats 
15.11.2.6 AlloFuse Select CM 
15.12 Ambulero 
15.12.1  Supercharged MSCs 
15.12.2  Ambulero’s Pipeline 
15.13 American CryoStem Corporation 
15.13.1  Products 
15.13.1.1 CELLECT Tissue Harvesting System 
15.13.1.2 ACSelerateMAX hMSC Medium 
15.13.1.3 ATCELL Mesenchymal Stem Cells (ADSCs) 
15.13.2  Services 
15.13.2.1 ATGRAFT Fat Storage 
15.13.2.2 Adult Stem Cell Program 
15.14 American Type Culture Collection (ATCC) 
15.14.1  Stem Cell Products 
15.15 AMS Biotechnology, Ltd. (AMSBIO) 
15.15.1  Products 
15.16 Andelyn Biosciences 
15.16.1  Andelyn’s Solutions 
15.17 Anemocyte S.r.l 
15.17.1  Total GMP Capacity 
15.17.2  Product Types 
15.17.3  Manufacturing Services 
15.18 Anterogen, Co., Ltd. 
15.18.1  Products 
15.18.1.1 Cupistem Injection 
15.18.1.2 Queencell Injection 
15.19 AQ Skin Solutions 
15.19.1  Products 
15.19.1.1 AQ Active Serum 
15.19.1.2 AQ Eye Serum 
15.19.1.3 AQ Lash 
15.19.1.4 AQ Vaginal Rejuvenation System 
15.20 Arranta Bio 
15.20.1  Services 
15.21 Aruna Bio 
15.21.1  AB126 
15.22 Avid Bioservices, Inc. 
15.22.1  Services 
15.23 Bacthera 
15.23.1  Services 
15.24 Baylx, Inc. 
15.24.1  Technology 
15.24.2  Rheumatoid Arthritis 
15.24.3  Metastatic Cancer 
15.24.4  FDA Clearance of IND Application 
15.25 BioCardia 
15.25.1  BioCardia’s Pipeline Overview 
15.25.1.1 CardiAMP Cell Therapy 
15.25.1.2 CardiALLO Cell Therapy 
15.26 BioCentriq 
15.26.1  Clinical Manufacturing Services 
15.26.2  Process Development Services 
15.27 BioEden, Inc. 
15.28 Bioinova s.r.o 
15.28.1  MSCs for Clinical Trials 
15.28.2  Novel Solution for Storage and Transportation of Cells 
15.29 BioRestorative Therapies 
15.29.1  BRTX-100 
15.29.2  ThermoStem 
15.30 Bioscience Institute S.p.A 
15.30.1  LIPOSKILL 
15.30.2  HAIRSKILL 
15.30.3  GYNSKILL 
15.30.4  LIPOSKILL PLUS 
15.31 Bio-Techne 
15.31.1  Mesenchymal Stem Cell Products 
15.32 Blue Horizon International, LLC 
15.32.1  BHI’s Stem Cell Division 
15.33 Boehringer Ingelheim BioXcellence 
15.33.1  Services 
15.33.2  Cell Line Development Services 
15.34 Bonus Biogroup, Ltd. 
15.34.1  BonoFill 
15.34.2  MesenCure 
15.35 BrainStorm Cell Therapeutics 
15.35.1  MSC-NTF Cells 
15.36 Caregen Nordic 
15.36.1  Dermaheal HSR 
15.36.2  Dermaheal HL 
15.36.3  Dermaheal SB 
15.36.4  Dermaheal Stem C’rum 
15.36.5  Dermaheal Stem C’rum SR 
15.37 CardioCell, LLC 
15.37.1  The itMSC Advantage 
15.37.2  Clinical Trials 
15.38 Catalent Pharma Solutions 
15.38.1  OneBio Integrated Suite 
15.38.2  Gene Therapy Services 
15.38.3  Cell Therapy Services 
15.39 CCRM 
15.39.1  CDMO Services 
15.40 Cellipont Bioservices 
15.40.1  Cellipont’s Capabilities 
15.40.2  Cellipont’s Cell Expertise 
15.41 Celprogen, Inc. 
15.41.1  Products 
15.41.1.1 FolliStem 
15.41.1.2 FolliStem Jawan 
15.42 CellResearch Corporation, Pte Ltd. 
15.42.1  Umbilical Cord Lining Stem Cells 
15.43 Celltex Therapeutics Corporation 
15.43.1  Therapy Services 
15.44 Cellular Biomedicine Group, Inc. 
15.45 Citius Pharmaceuticals, Inc. 
15.45.1  Stem Cell Platform 
15.46 Charles River Laboratories International, Inc. 
15.46.1  Products & Services 
15.47 Corestem, Inc. 
15.47.1  ALS (NeuroNata-R) 
15.48 Creative Bioarray 
15.48.1  MSC Services 
15.48.1.1 MSC Isolation and Expansion Services 
15.48.1.2 MSC Characterization Service 
15.48.1.3 MSC Differentiation Service 
15.49 Curia Global, Inc. 
15.49.1  Services 
15.50 Cynata Therapeutics, Ltd. 
15.50.1  Cymerus Platform 
15.50.1.1  Importance of Cymerus Technology 
15.50.2  Preclinical Development 
15.50.2.1 GvHD 
15.50.2.2 Critical Limb Ischemia 
15.50.2.3 Asthma 
15.50.2.4 Heart Attack 
15.50.2.5 Diabetic Wounds 
15.50.2.6 Coronary Artery Disease (CAD) 
15.50.2.7 Acute Respiratory Distress Syndrome (ARDS) 
15.50.2.8 Sepsis 
15.50.2.9 Osteoarthritis 
15.51 Cytovance Biologics 
15.51.1  CGMP Manufacturing 
15.52 Dendreon 
15.52.1  Provenge Immunotherapy 
15.52.2  Services 
15.53 Direct Biologics 
15.53.1  ExoFlo 
15.54 ElevateBio 
15.54.1  ElevateBio’s Enabling Technologies 
15.54.2  BaseCamp cGMP 
15.55 Exothera 
15.55.1  Exoscan Process Analysis Services 
15.55.2  Process Design & Development Services 
15.55.3  GMP Manufacturing Services 
15.56 EXOSOMEplus 
15.57 FUJIFILM Cellular Dynamics, Inc. 
15.57.1  iCell Mesenchymal Stem Cells 
15.58 Fujifilm Diosynth Biotechnologies 
15.58.1  Cell & Gene Therapy Services 
15.59 Future Cell Japan Co., Ltd. 
15.59.1  BABY STEM 
15.60 Genezen 
15.60.1  Genezen’s Capabilities 
15.61 Hope Biosciences, LLC 
15.61.1  Adult Stem Cell Banking 
15.61.2  Newborn Stem Cell Banking 
15.61.3  Hope Sponsored Clinical Trials 
15.62 Invitrx Therapeutics 
15.62.1  Reluma 
15.63 JCR Pharmaceuticals, Co., Ltd. 
15.63.1  TEMCELL HS Inj. 
15.64 Just-Evotec Biologics, Inc. 
15.64.1  J.POD Biomanufacturing Facility 
15.64.2  J.Design Solutions 
15.64.3  J.DISCOVERY - Molecule Discovery 
15.64.4  J.MD - Molecule Design 
15.64.5  JP3 - Process & Product Design 
15.64.6  J-POD - Manufacturing Design 
15.65 Kimera Labs, Inc. 
15.65.1  XoGlo 
15.65.2  XoGlo Pro 
15.65.3  Equisome HC 
15.65.4  Vive 
15.65.4.1 Effects of MSC Exosomes on Skin 
15.66 LifeCell 
15.66.1  Large-Scale Manufacturing of MSCs 
15.67 Longeveron 
15.67.1  Lomecel-B 
15.67.2  Focused Therapeutic Areas 
15.67.2.1 Hypoplastic Left Heart Syndrome (HLHS) Research Program 
15.67.2.2 Alzheimer’s disease (AD) Research Program 
15.67.2.3 Aging Frailty Research Program 
15.67.2.4 Metabolic Syndrome Research Program 
15.67.2.5 Acute Respiratory Distress Syndrome (ARDS) Research Program 
15.68 Lonza Group, Ltd. 
15.68.1  Product Overview 
15.68.1.1  Poietics 
15.68.1.2 MSCGM Growth Medium 
15.68.1.3 TheraPEAK Growth Medium 
15.68.1.4 hMSC Chondrogenic Differentiation Medium 
15.68.1.5 hMSC Adipogenic Differentiation Medium 
15.68.1.6 ReagentPack Subculture Reagents 
15.68.1.7 Trypsin/EDTA for Mesenchymal Stem Cells 
15.69 Lorem Cytori USA, Inc. 
15.69.1  Celution System 
15.70 Lykan Bioscience 
15.70.1  Process Development 
15.70.2  Analytical Development 
15.70.3  Manufacturing Science & Technology 
15.70.4  Clinical & Commercial Manufacturing 
15.70.5  Supply Chain & Logistics 
15.70.6  Quality & Compliance 
15.71 Matica Biotechnology, Inc. 
15.71.1  Cell Line Development Services 
15.71.2  Process Development Services 
15.71.3  Assay Development Services 
15.71.4  GMP Production Services 
15.71.5  Product Release & Stability Testing 
15.72 Medipost, Co., Ltd. 
15.72.1  Products 
15.72.1.1 Cartistem 
15.72.1.2 Pneumostem 
15.72.1.3 SMUP-IA-01 
15.72.1.4 SMUP-IV-01 
15.73 Mesoblast, Ltd. 
15.73.1  Product Candidates 
15.73.1.1 Remestemcel-L 
15.73.1.2 Rexlemestrocel-L 
15.74 MilliporeSigma 
15.74.1  Cell Culture & Analysis Products 
15.75 NecstGen 
15.75.1  Cell Therapy Development & Manufacturing 
15.75.2  Viral Vector Development & Manufacturing 
15.75.3  Cleanroom Rental 
15.76 Novus Biologicals, LLC 
15.77 NuVasive, Inc. 
15.77.1  Osteocel Family 
15.78 OCT Therapies & Research Pvt. Ltd. 
15.79 Orthofix Medical, Inc. 
15.79.1  Trinity ELITE 
15.79.2  TrinityEvolution 
15.80 Personal Cell Sciences, Corp. 
15.80.1  Autokine CM 
15.80.2  Products 
15.80.2.1  U Autologous Adult Stem Cell Regenerative Firming Serum 
15.80.2.2 U Autologous Adult Stem Cell Regenerative Eye Cream 
15.80.2.3 U Autologous Adult Stem Cell Regenerative Moisturizer 
15.81 Personalized Stem Cells, Inc. 
15.81.1  Personalized Stem Cell Study: Knee Osteoarthritis 
15.82 Porton Advanced 
15.82.1  Cell Therapy Services 
15.82.2  Portons LVV Services 
15.83 Pluristem Therapeutics, Inc. 
15.83.1  PLX Products 
15.83.2  PLX-PAD 
15.83.2.1 Mechanism of Action 
15.83.3  PLX-R18 
15.83.3.1 Mechanism of Action 
15.83.4  PLX-Immune 
15.83.4.1 Mechanism of Action 
15.84 PromoCell GmbH 
15.84.1  Human Stem & Blood Cell Culture Products 
15.85 Regeneus, Ltd. 
15.85.1  Technologies 
15.85.1.1 Progenza 
15.85.1.1.1  Mechanism of Action 
15.85.1.2 Sygenus 
15.85.1.2.1  Mechanism of Action 
15.85.2  Product Pipeline 
15.86 Reliance Life Sciences Pvt. Ltd. 
15.86.1  Regenerative Medicine Products 
15.87 Rentschler Biopharma 
15.87.1  Services 
15.88 Resilience 
15.88.1  Resilience’s Capabilities 
15.89 Richter-HELM 
15.89.1  Services 
15.90 RoosterBio, Inc. 
15.90.1  RoosterBio’s Technology 
15.90.2  Products 
15.90.2.1 Human Mesenchymal Stem Cells (hMSCs) 
15.90.3  Genetic Engineering Tools 
15.90.3.1 Genetic Engineering Media 
15.90.3.2 Cell Culture Media & Supplements 
15.90.4  Cell and Media Kits 
15.90.5  MSC-derived Exosomes 
15.90.6  cGMP CliniControl Products 
15.90.7  Process Development Services 
15.90.8  hMSC Analytical Services 
15.91 RoslinCT 
15.91.1  Services 
15.91.1.1 Process Development 
15.91.1.2 GMP Manufacturing 
15.91.1.3 Quality Control 
15.91.1.4 Quality & Regulations 
15.91.1.5 Product Storage & Logistics 
15.91.2  RoslinCT - Lykan Bioscience Combine 
15.92 Samsung Biologics 
15.92.1  Development Services 
15.92.2  Manufacturing Services 
15.93 Sentien Biotechnologies, Inc. 
15.93.1  SBI-101 
15.93.1.1 Prolonged Therapeutic Activity of MSCs in SBI-101 
15.93.1.2 Sentien’s Product Pipeline 
15.94 Smith & Nephew plc 
15.94.1  Grafix 
15.95 STEMCELL Technologies, Inc. 
15.95.1  Products 
15.95.1.1 Mesenchymal Stem Cells (MSCs) 
15.95.1.2 Mesenchymal Stem and Progenitor Cell Research Products 
15.96 Stemedica Cell Technologies, Inc. 
15.96.1  BioSmart Technology 
15.96.2  Clinical Pipeline 
15.97 Stemmatters 
15.98 Stempeutics Research Pvt. Ltd. 
15.98.1  Stempeucel 
15.98.1.1 Process Description 
15.98.2  Stempeucare 
15.98.3  Cutisera 
15.98.4  Trichosera 
15.98.5  Perioptisera 
15.99 Syngene International Ltd. 
15.99.1  Services 
15.100 TaiwanBio Therapeutics, Co., Ltd. 
15.101 Takeda Pharmaceutical Co., Ltd. 
15.101.1 Alofisel (Darvadstrocel) 
15.102 Symbiosis Pharmaceutical Services 
15.102.1 Vial Filling Capability 
15.102.2 Drug Product Testing 
15.102.3 Qualified Person Release 
15.102.4 Clinical Labeling & Packaging 
15.102.5 Product Development 
15.103 Tempo Bioscience 
15.103.1 Products 
15.103.1.1 Human Cell Models 
15.103.2 Services & Alliances 
15.104 Thermo Fisher Scientific 
15.104.1 Cell Culture Services 
15.104.2 Cell Therapy Solutions 
15.105 TranstoxBio 
15.105.1 Products 
15.105.1.1 CarcinogenSAFE 
15.105.1.2 CardioSight 
15.105.1.3 HeMOToX 
15.105.1.4 HepatoSight 
15.105.1.5 NeuroSAFE 
15.105.1.6 SkinIR System 
15.105.1.7 TransD System 
15.105.1.8 Human Umbilical Cord Blood Monocytes 
15.105.1.9 Human Peripheral Blood CD34 Positive Cells 
15.105.1.10 CD34+ Configured Cellular Platform 
15.105.1.11 Human Mesenchymal Stem Cells 
15.106 United Therapeutics Corporation 
15.106.1 Genetically-Enhanced Mesenchymal Stem Cells (GEM) 
15.107 Viralgen 
15.107.1 Service 
15.107.2 Viralgen’s Facilities 
15.108 VIVEbiotech 
15.109 Waisman Biomanufacturing 
15.109.1 GMP Cell Therapeutic Capabilities 
15.109.2 Cell Bank Specifics 
15.109.3 Waisman Products & Processes 
15.110 WuXi Biologics 
15.110.1 Manufacturing Services 
15.111 Yapan Bio 
15.111.1 Process Development Services 
15.111.2 Process Characterization Services 
15.111.3 GMP Manufacturing Services 
15.112 Yposkesi 
15.113 Zimmer Biomet Holdings, Inc. 
15.113.1 Cellentra VCBM 

LIST OF FIGURES
FIGURE 3.1: Number of Published Papers on MSCs between 2000 and 2022 
FIGURE 3.2: Number of Papers on MSCs & iPSCs Compared 
FIGURE 3.3: Number of Papers Published on MSC-based Clinical Trials, 2000-2022 
FIGURE 3.4: Percent Share of Papers on Clinical Trials for Specific Diseases, 2000-2022 
FIGURE 3.5: Number of Published Papers on Modified MSCs 
FIGURE 3.6: Number of PubMed Papers on MSC-Exosomes 
FIGURE 4.1: Number of Patent Documents in Stem Cell Therapies, 2011-2020 
FIGURE 4.2: Geographical/Country Distribution of Stem Cell Patents 
FIGURE 4.3: Types of Patent Document Holders in Stem Cell Arena 
FIGURE 4.4: Number of MSC Patent Filings by Year, 2000-January 5, 2023 
FIGURE 4.5: Number of MSC-Exosomes Patent Applications by Year, 2009 to Present 
FIGURE 5.1: Number of Clinical Trials involving MSCs by Region 
FIGURE 5.2: Sources of MSCs for Clinical Trials in 2022 
FIGURE 5.3: Clinical Trials involving Autologous and Allogeneic MSCs in 2022 
FIGURE 5.4: Types of Funding for MSC-based Clinical Trials 
FIGURE 5.5: Types of MSC-based Clinical Trials 
FIGURE 5.6: MSC-based Clinical Trials by Phase of Development 
FIGURE 5.7: MSC Administration Routes 
FIGURE 5.8: MSC Clinical Trials by Disease Category 
FIGURE 6.1: Bioengineering Solutions to Boost the Functions of MSCs 
FIGURE 6.2: Bioengineering Solutions for Improving Administration of MSCs 
FIGURE 7.1: Advantages & Disadvantages of Autologous & Allogeneic MSCs 
FIGURE 7.2: Monolayer Culture Systems 
FIGURE 7.3: Stirred Tank Bioreactor 
FIGURE 7.4: Rocking Bioreactor 
FIGURE 7.5: Hollow Fiber Bioreactors 
FIGURE 7.6: Fixed-Bed Bioreactors 
FIGURE 7.7: Number of Cells per Batch by Technologies 
FIGURE 7.8: Single-Use Harvestainer for Small Scale Application 
FIGURE 7.9: Single-Use Harvestainer for Large Scale Application 
FIGURE 7.10: Advantages & Disadvantages of Autologous and Allogeneic MSC 
FIGURE 7.11: Cost of Goods (CoG) in MSC Manufacturing 
FIGURE 7.12: Impact of Headcount on Overall CoG per Batch 
FIGURE 7.13: CoG Breakdown in Partially-Automated MSC Manufacturing 
FIGURE 7.14: CoG Breakdown in Fully Automated MSC Manufacturing 
FIGURE 7.15: Higher Throughput in Partially Automated Facilities 
FIGURE 8.1: Schematic of Sartorius’ SelectT Automated Platform 
FIGURE 8.2: Model of a Clean Room in a Small Scale Manufacturing Facility 
FIGURE 9.1: Four Common Bioprocessing Strategies for Large-Scale Expansion of MSCs 
FIGURE 9.2: Commonly Used Sources of MSCs for Large-Scale Expansion 
FIGURE 9.3: Commonly used Culture Media for Large-Scale Expansion of MSCs 
FIGURE 10.1: Outsourced Percent of CGT Manufacturing: Now and Five Years from Now 
FIGURE 10.2: Number of CDMOs Utilized 
FIGURE 10.3: Major Services offered by CMOs 
FIGURE 10.4: Percentage of Total Biomanufacturing Capacity by Platform 
FIGURE 10.5: Global Bioprocessing Capacity by Region/Country 
FIGURE 10.6: U.K. Cleanroom Footprint for CGT Therapy Manufacturing, 20018-2022 
FIGURE 10.7: Cell Therapy Process Capabilities in the U.K. by Types of Process, 2022 
FIGURE 10.8: Gene Therapy Process Capabilities in the U.K. by Types of Process 
FIGURE 11.1: Major Diseases Addressed by MSCs in Clinical Trials 
FIGURE 11.2: Percent Share of Autoimmune Diseases Using MSCs in Clinical Trials 
FIGURE 11.3: Percent Share of MSCs by Source in Trials for Cardiac Diseases 
FIGURE 11.4: Percent Shares of Neurodegenerative Diseases in Clinical Trials using MSCs 
FIGURE 11.5: % Shares of Studies using MSCs in Bone & Cartilage Diseases by Source 
FIGURE 12.1: The Four MSC Modification Techniques 
FIGURE 13.2: Priming Effects on MSCs 
FIGURE 14.1: Percent Share of Marketed CT, GT and TE Products 
FIGURE 14.2: Percent Market Share of CT Products by Indication 
FIGURE 14.3: Global Market for MSC-Based Therapeutics by Geography 
FIGURE14.4: Global Market for MSCs by Geography, 2022-2030 
FIGURE 14.5: Market Share of MSCs by Business Segments 

LIST OF TABLES
TABLE 2.1: Timeline of MSC Nomenclature 
TABLE 2.2: Sources of MSCs 
TABLE 2.3: Advantages and Disadvantages of BM-MSCs 
TABLE 2.4: Advantages and Disadvantages of AD-MSCs 
TABLE 2.5: Advantages and Disadvantages of UC-MSCs 
TABLE 2.6: Positive & Negative Markers in MSCs from different Sources 
TABLE 2.7: In Vitro Differentiation Potentials of MSCs 
TABLE 2.8: Soluble Factors Secreted by MSCs 
TABLE 2.8: (CONTINUED) 
TABLE 2.9: Some Typical Stemness Genes of MSCs 
TABLE 3.1: Number of Published Papers on MSCs between 2000 to Present 
TABLE 3.2: Number of Papers on MSCs & iPSCs Compared 
TABLE 3.3: Number of Papers Published on MSC-based Clinical Trials, 2000 to Present 
TABLE 3.4: Percent Share of Papers for Specific Diseases, 2000-2022 
TABLE 3.5: Published Papers on Modified MSCs 
TABLE 3.6: Number of PubMed Papers on MSC-Exosomes 
TABLE 4.1: Number of Patent Documents in Stem Cell Therapies 
TABLE 4.2: Top Ten Players in Stem Cell Patent Arena 
TABLE 4.3: Top Ten Stem Cell Patent Owners by Size of Patent Portfolio 
TABLE 4.4: Number of MSC Patent Filings by Year, 2000 to Present 
TABLE 4.5: Top Ten MSC Patent Applicants 
TABLE 4.6:  Status of MSC Patent Applications, 2000-2022 
TABLE 4.7: MSC Patent Jurisdictions 
TABLE 4.7: (CONTINUED) 
TABLE 4.8: Top Ten MSC Patent Inventors 
TABLE 4.9: Top Ten MSC Patent Owners 
TABLE 4.10: Top Ten MSC-Exosome Patent Applicants 
TABLE 4.11: MSC-Exosomes Patent Jurisdiction 
TABLE 4.12: Top Ten MSC-Exosome Patent Inventors 
TABLE 5.1: Number of Clinical Trials involving MSCs by Region 
TABLE 5.2: Sources of MSCs for Clinical Trials 
TABLE 5.3: Clinical Trials involving Autologous and Allogneic MSCs in 2022 
TABLE 5.4: Types of Funding for MSC-based Clinical Trials 
TABLE 5.5: Types of MSC-based Clinical Trials 
TABLE 5.6: MSC-based Clinical Trials by Phase of Development 
TABLE 5.7: Examples of MSC-based Clinical Trials for Musculoskeletal Disorders 
TABLE 5.7: (CONTINUED) 
TABLE 5.8: MSC-based Clinical Trials for Neurological Disorders 
TABLE 5.9: Clinical Trials involving MSC-derived Exosomes 
TABLE 6.1: Examples of Bioengineered MSCs as Living Drug Factories 
TABLE 6.2: Examples of Oncology Indications being studied using MSC Trojan Horses 
TABLE 6.3: Select Cases of Modified MSC Applications & Therapeutic Outcome 
TABLE 7.1: Methods of Isolation of MSCs & Corresponding Culture Media 
TABLE 7.2: A Snapshot of Commercially Available Culture Systems 
TABLE 7.3: Main Features of Commercially Available Bioreactors 
TABLE 7.4: Microcarriers for the Expansion of MSCs 
TABLE 7.5: Basic Assays for MSCs 
TABLE 7.6: Cell Surface Markers on MSCs and Fibroblasts 
TABLE 7.7: Cost of Manufacturing Allogeneic MSCs 
TABLE 7.8: Cost of Manufacturing Autologous MSCs 
TABLE 7.9: Cost of Goods (CoG) in MSC Manufacturing 
TABLE 7.10: CoG Breakdown in Partially-Automated MSC Manufacturing 
TABLE 7.11: CoG Breakdown in Fully Automated MSC Manufacturing 
TABLE 7.12: Higher Throughput in Partially Automated Facilities 
TABLE 8.1: Key Processes and Cost Assumptions 
TABLE 8.2: Quality Control Panels and Cost Assumptions 
TABLE 8.3: Additional Supporting Labor Cost Assessments 
TABLE 8.4: Additional Supporting Facility and Cost Assumptions 
TABLE 9.1: Large-Scale Expansion of MSCs by Method, Cell Source and Media 
TABLE 9.2: Expansion Ratios Achieved with Different Culture Media 
TABLE 9.3: Comparison between the Four Large-Scale MSC Expansion Strategies 
TABLE 10.1: Comparison of Capacity Trends, 2018-2021 
TABLE 10.2: Current Distribution of Capacity by Facility Size 
TABLE 10.3: Global Bioprocessing Capacity by Region/Country 
TABLE 10.4: Top Global CDMOs 
TABLE 10.5: GMP Capacities of U.S-based Contract Manufacturers 
TABLE 10.6: Major Cell & Gene Therapy Contract Manufacturers in Europe 
TABLE 10.7: GMP Manufacturing Facilities for Cell and Gene Therapies in U.K., 2022 
TABLE 10.8: U.K. Cleanroom Footprint for Cell & Gene Therapy Manufacturing, 20018-2022 
TABLE 10.9: Countries Outsourcing Cell & Gene Therapy Services from U.K. by Country 
TABLE 11.1: Select MSC-Based Clinical Trials for Autoimmune Diseases 
TABLE 11.2: Select MSC-Based Clinical Trials for Cardiovascular Studies 
TABLE 11.3: Select MSC-Based Studies using MSCs for Neurodegenerative Diseases 
TABLE 11.4: Select MSC-Based Studies for Bone & Cartilage Diseases 
TABLE 11.5: Ongoing Studies using MSCs for GvHD 
TABLE 11.6: Examples of Ongoing Clinical Trials using MSCs for Crohn’s Disease 
TABLE 11.7: Examples of Ongoing Clinical Trials using MSCs for Type 1 Diabetes 
TABLE 11.8: Examples of Currently Ongoing Clinical Trials using MSCs for SLE 
TABLE 11.9: Examples of Ongoing Clinical Trials using MSCs for PD 
TABLE 11.10: Examples of Currently Ongoing Clinical Trials using MSCs for AD 
TABLE 11.11: Examples of Ongoing Clinical Trials using MSCs for Kidney Failure 
TABLE 11.12: Examples of Ongoing Clinical Trials using MSCs for SCI 
TABLE 11.13: Examples of Currently Ongoing Clinical Trials using MSCs for SCI 
TABLE 12.1: Clinical Trials Involving Engineered MSCs 
TABLE 12.2: Primed MSCs in Clinical Trials 
TABLE 12.3: Scaffold-Based MSCs in Clinical Trials 
TABLE 12.4: Clinical Trials Involving MSC-Derived Exosomes 
TABLE 12.5: Commercially Available Products Incorporated with Secretomes 
TABLE 12.6: MSC Products with Marketing Approval 
TABLE 12.7: Marketed MSC-Containing Bone Matrices 
TABLE 14.1: Price Tags of MSC-Based Approved CT Products 
TABLE 14.2: Price Tags of Select MSC Progenitor-Based Products 
TABLE 14.3: Global Market for MSC-Based Therapeutics 
TABLE 14.4: Global Market for MSCs by Geography, 2022-2030 
TABLE 15.1: Ambulero’s Product Pipeline 
TABLE 15.2: BioCardia’s Advanced Pipeline 
TABLE 15.3: Bonus Biogroup’s Product Pipeline 
TABLE 15.4: BrainStorm’s Product Pipeline 
TABLE 15.5: CardioCell’s Clinical Development 
TABLE 15.6: Celltex’s Clinical Trials 
TABLE 15.7: Corestem’s Product Pipeline 
TABLE 15.8: Cynata’s Product Pipeline 
TABLE 15.9: Regulatory Proteins found in ExoFlo 
TABLE 15.10: Hope’s Clinical Trial Pipeline 
TABLE 15.11: Growth Factors in XoGlo and XoGlo Plus 
TABLE 15.12: Mesoblast’s Late-Stage Clinical Pipeline 
TABLE 15.13: Pluristem’s Clinical Pipeline 
TABLE 15.14: Regeneus’ Product Pipeline 
TABLE 15.15: Sentien’s Product Pipeline 
TABLE 15.16: Stemedica’s Clinical Pipeline 
TABLE 15.17: Stempeutics’ Product Candidates in Clinical Trial 

Companies Mentioned

• 101 Bio   
• AGC Biologics 
• AMS Biotechnology, Ltd. (AMSBIO)    
• AQ Skin Solutions 
• AbbVie, Inc. 
• Abzena    
• Adipomics, Inc. 
• Advancells 
• Advent Bio , Ltd.   
• Aegle Therapeutics 
• Aethlon Medical, Inc. 
• AgeX Therapeutics, Inc. 
• AlloSource, Inc.    
• Ambulero 
• American CryoStem Corporation 
• American Type Culture Collection (ATCC)   
• Andelyn Biosciences 
• Anemocyte S.r.l   
• Anterogen, Co., Ltd. 
• Arranta Bio   
• Aruna Bio 
• Avid Bioservices, Inc. 
• Bacthera   
• Baylx, Inc. 
• Bio-Techne 
• BioCardia 
• BioCentriq   
• BioEden, Inc. 
• BioRestorative Therapies 
• Bioinova s.r.o 
• Bioscience Institute S.p.A 
• Blue Horizon International, LLC 
• Boehringer Ingelheim BioXcellence  
• Bonus Biogroup, Ltd. 
• BrainStorm Cell Therapeutics 
• CCRM  
• CardioCell, LLC 
• Caregen Nordic 
• Catalent Pharma Solutions 
• CellResearch Corporation, Pte Ltd. 
• Cellipont Bioservices 
• Celltex Therapeutics Corporation 
• Cellular Biomedicine Group, Inc. 
• Celprogen, Inc. 
• Charles River Laboratories International, Inc. 
• Citius Pharmaceuticals, Inc. 
• Corestem, Inc. 
• Creative Bioarray 
• Cynata Therapeutics, Ltd. 
• Cytovance Biologics 
• Dendreon   
• Direct Biologics 
• EXOSOMEplus 
• ElevateBio 
• Exothera 
• FUJIFILM Cellular Dynamics, Inc. 
• Fujifilm Diosynth Biotechnologies   
• Future Cell Japan Co., Ltd. 
• Genezen 
• Hope Biosciences, LLC 
• Invitrx Therapeutics 
• JCR Pharmaceuticals, Co., Ltd. 
• Just-Evotec Biologics, Inc. 
• Kimera Labs, Inc.  
• LifeCell 
• Longeveron 
• Lonza Group, Ltd. 
• Lorem Cytori USA, Inc. 
• Lykan Bioscience 
• Matica Biotechnology, Inc. 
• Medipost, Co., Ltd. 
• Mesoblast, Ltd. 
• MilliporeSigma 
• NecstGen 
• Novus Biologicals, LLC 
• NuVasive, Inc. 
• Orthofix Medical, Inc. 
• Personal Cell Sciences, Corp. 
• Personalized Stem Cells, Inc. 
• Pluristem Therapeutics, Inc. 
• Porton Advanced 
• PromoCell GmbH    
• Regeneus, Ltd. 
• Reliance Life Sciences Pvt. Ltd.  
• Rentschler Biopharma   
• Resilience 
• Richter-HELM   
• RoosterBio, Inc.  
• RoslinCT 
• STEMCELL Technologies, Inc. 
• Samsung Biologics 
• Sentien Biotechnologies, Inc. 
• Smith & Nephew plc 
• Stemedica Cell Technologies, Inc. 
• Stemmatters 
• Stempeutics Research Pvt. Ltd. 
• Symbiosis Pharmaceutical   
• Syngene International Ltd. 
• TaiwanBio Therapeutics, Co., Ltd. 
• Takeda Pharmaceutical Co., Ltd. 
• Tempo Bioscience 
• Thermo Fisher Scientific 
• TranstoxBio 
• VIVEbiotech 
• Viralgen  
• Waisman Biomanufacturing 
• WuXi Biologics 
• Yapan Bio 
• Yposkesi 
• Zimmer Biomet Holdings, Inc. 

Methodology

The content and statistics contained within the publisher's reports are compiled using a broad range of sources, as described below.

Input Sources

• Clinical Trial Databases (ClinicalTrials.gov, International Clinical Trials Registry Platform, European Union Clinical Trials Register, Chinese Clinical Trial Registry, Others)
• Scientific Publication Databases (PubMed, Highwire Press, Google Scholar)
• Patent Databases (United States Patent and Trade Office, World Intellectual Property Organization, Google Patent Search)
• Grant Funding Databases (RePORT Database, CIRM, MRC, Wellcome Trust - UK, Others)
• Product Launch Announcements (Trade Journals, Google News)
• Industry Events (Google News, Google Alerts, Press Releases)
• Company News (SEC Filings, Investor Publications, Historical Performance)
• Social Analytics (Google Adwords, Google Trends, Twitter, Topsy.com, Hashtagify.me, BuzzSumo.com)
• Interviews with Stem Cell Industry Leaders

Research & Analysis Methodologies

The publisher employs the following techniques for deriving its market research:

• Historical Databases: As the first and only market research firm to specialize in the stem cell industry, the publisher has 13+ years of historical data on each segment of the stem cell the industry. This provides an extremely rare and robust database for establishing market size determinations, as well as making future market predictions.
• Prolific Interviews with Industry Leaders: As the global leader in stem cell industry data, the publisher has interviewed hundreds of leaders from across the stem cell industry, including the CEO of FUJIFILM CDI, FUJIFILM Irvine Scientific, Pluristem Therapies, Celularity, and many others.
• Industry Relationships: The research team and its President/Founder, Cade Hildreth, Chair and present at a wide range of stem cell industry events, including Phacilitate's Advanced Therapies Week, World Stem Cell Summit (WSCS), Perinatal Stem Cell Society Congress, AABB's International Cord Blood Symposium (ICBS), and other events hosted within the U.S. and worldwide.
• Global Integrated Feedback: Because the publisher maintains the world's largest stem cell industry news site that is read by nearly a million unique readers per year and the company has large social media audiences (25.7K+ followers on Linked, 21.2K+ followers on Twitter, and 4.3K+ followers on Facebook), the publisher is able to publish content relevant to the industry and receive immediate feedback/input from a global community of readers. In short, the publisher's data is crowd-sourced from market participants worldwide, including those in diverse geographic regions.
• Preliminary Research: In addition to the interviews described above, the publisher conducts market surveys, executes social media polls, and aggregates market data from stem cell industry announcements, press releases, and corporate filings/presentations.
• Secondary Research: The publisher summarizes, collects and synthesizes existing market research that is relevant to the market area of interest.
• Future Projections: Using the resources described above, the publisher is uniquely positioned to make future projections about market size, market growth by segment, market trends, technology evolution, funding activities (financing rounds, M&A, and IPOs), and importantly, market leadership (market share by company).