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Mesenchymal Stem Cells - Advances & Applications (2018)

MESENCHYMAL STEM CELLS – ADVANCES & APPLICATIONS (2018)

Executive Summary

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-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. 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 as social 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, BioInformant is first and only market research firm to specialize in the stem cell industry. Unlike other publishers that hire analysts from foreign countries, BioInformant is an American-based company with more than a decade of experience with tracking the stem cell market (2006 to present). BioInformant compiled this global strategic report using interviews with more than 90 individuals from across the stem cell industry.
BioInformant conducted interviews with representatives from Cynata Therapeutics (first company to bring a iPSC-derived MSC therapeutic product into a clinical trial), RoosterBio (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), BioEden (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.

About BioInformant

BioInformant research has been cited by major news outlets that include the Wall Street Journal, Nature Biotechnology, Medical Ethics, Vogue Magazine, and more. Serving Fortune 500 leaders that include GE Healthcare, Pfizer, and Goldman Sachs, BioInformant is your global leader in stem cell industry data.


  • REPORT OVERVIEW
    • Statement of the Report
    • Executive Summary
  • INTRODUCTION
  • ADVANCED THERAPY MEDICINAL PRODUCTS (ATMPs)
    • Table Categories of Advanced Therapy Medicinal Products (ATMPs)
    • Major Therapeutic Areas of Interests in ATMPs Sector
    • Price of Market-Stage ATMPs
      • Table List Prices of Market-Authorized ATMPs
    • FDA-Approved ATMPs
      • Table FDA-Approved ATMPs as of 2nd Quarter 2017
    • EC-Approved ATMPs
      • Table EC-Approved ATMPs as of March 2017
  • STEM CELLS: A BRIEF OVERVIEW
    • Embryonic Stem Cells (ESCs)
    • Induced Pluripotent Stem Cells (iPSCs)
    • Types of Specialized Cells Derived from Stem Cells
    • Types of Stem Cells in Human Body
      • Human Embryonic Stem Cells (hESCs)
      • Embryonic Germ Cells (EG-Cells)
      • Fetal Stem Cells
      • Umbilical Cord Stem Cells
    • Adult Stem Cells
      • Hematopoietic Stem Cells (HSCs)
      • Mesenchymal Stem Cells (MSCs)
      • Neural Stem Cells (NSCs)
    • Characteristics of Different Types of Stem Cells
      • Table Characteristics of Different Types of Stem Cells
    • Applications of Stem Cells in Medicine
  • MESENCHYMAL STEM CELLS (MSCs): A DETAILED OVERVIEW
    • A New Name for MSCs
      • History and Timeline of MSCs Nomenclature
        • Table History and Timeline of MSC Nomenclature
    • Functions of MSCs
      • Table Functions of MSCs
    • Sources of MSCs
      • Table Sources of hMSCs
    • Isolation and Culturing of hMSCs
      • Table Isolation Methods and Culture Media for MSCs
      • Cell Surface Markers in MSCs
        • Table Positive and Negative Markers for MSCs Derived from Different
      • In Vitro Differentiation Potential of MSCs
        • Table In Vitro Differentiation Potential of hMSCs
    • Key Features of Different Types of MSCs
      • Table Comparison of Characteristics of MPC, BMMSC, ATMSC and UCMSC
    • Chronic Diseases Treatable by hMSCs
      • Table Chronic Diseases Treatable by hMSCs in Animal Studies
      • Table Human Clinical Trials using MSCs for Chronic Diseases
    • Common Diseases Registered for MSC-Based Cell Therapy
      • Table Types of Common Diseases Registered for MSC-Based Cell Therapy
    • Advantages of MSCs in Cell Therapy
      • Table Advantages of MSCs over other Stem Cell Types
    • Comparison of MSCs with Other Stem Cell Types
      • Table Comparison of MSCs with other Stem Cell Types
    • Drawbacks of Autologous MSCs and Advantages of Allogeneic MSCs
      • Application Strategies for Allogeneic MSCs
        • Table Application Strategies for Allogeneic MSCs
    • Mechanism of Action of MSCs in Treating Diseases
    • Tissue Regeneration
    • Immune Modulation
      • Table Immunomodulatory Effects of MSCs on Immune Cells
      • Table Important Bioactive Molecules Secreted by MSCs and their Functions
    • Manufacture of MSCs
      • Safety and Potency Assays
        • Table Basic Assays for MSC-Based Products
      • Surface Markers of MSC
        • Table Comparison of MSC and Fibroblast Characteristics
      • BM-MNC Isolation and Plating
      • Passaging and Harvesting
        • Table Supplies/Reagents used in the Manufacture of MSCs
      • Cryopreservation of MSCs
      • Donor Eligibility and Cell Collection
      • Regulatory Framework of MSC Therapies
      • Contract Development and Manufacturing Organizations (CDMO)
        • Table A Partial List of CDMOs
  • CLINICAL APPLICATIONS OF MSCs
    • MSCs for GvHD
    • MSCs for Cardiovascular Repair
    • MSCs for Liver Disease
    • MSC for Bone/Cartilage Disease
    • Approved MSC-Based Products
      • Cartistem
      • Stempeucel
      • Mesenchymal Precursor Cells (MPCs) from Mesoblast
        • Table Approved Allogeneic and Autologous Mesenchymal Stem Cell-Based Products
      • Cupistem
      • Prochymal
      • AlloStem
      • Cellgram-AMI
      • Osteocel Plus
      • Trinity Evolution
      • CardioRel
      • Temcell
    • Bone Matrices Containing MSCs
      • Table Features of Currently Available Bone Matrices
      • Cost of Bone Matrices Containing MSCs
        • Table Prices of Cellular Bone Matrices Compared with Prices of other Bone Graft Substitutes
      • Tissue Engineered Orthopedic Product Candidates Containing MSCs
        • Table Tissue Engineered Orthopedic Product Candidates Containing MSCs
    • Pricing of Approved Cell Therapy Products
      • Table The Expensive Price Tags of Cell Therapies
  • STEM CELL RESEARCH PUBLICATIONS, FUNDING AND PATENTS
    • Table Stem Cell Research Publications Landscape
    • Volume of Scientific Papers Published on MSCs
      • Number of Publications on MSCs by Major Applications
    • Stem Cell Research around the World
      • Table Organizations Providing Funds for Stem Cell Research
    • NIH Funding for MSCs Research
      • Table NIH Funding for Mesenchymal Stem Cell Research in 2017
    • Stem Cell Patents Landscape
      • Table MSCs Patents Filed in 2015 and 2016
  • CLINICAL TRIALS INVOLVING MSCS: AN OVERVIEW
    • Current Clinical Trial Scenario
    • Geographical Share of MSC Clinical Trials
      • Number of Clinical Trials using MSCs by Geography/Country
        • Table Number of Clinical Trials using MSCs by Geography/Country, 2016
    • Sources of MSCs for Current Clinical Trials
    • Diseases Addressed by MSCs in the Ongoing Clinical Trials
    • Active Clinical Trials using MSCs
      • Table Number of Active Clinical Trials using MSCs by Major Indications
    • MSC Clinical Trial Outcomes, 2011-2016
      • Table Highlights of MSC Therapy Outcomes from Clinical Trials between 2011 and 2016
    • Selected Clinical Trials Sponsored by Universities
      • Celal Bayar University (NCT02824393)
      • University of Jordan (NCT02118519)
      • Ankara University (NCT03106662)
      • University Hospital of Liege (NCT00504803)
      • Acibadem University (NCT02285673)
      • University of Sao Paulo (NCT01297972)
      • Cairo University (NCT02387749)
        • Table Universities Involved in Clinical Trials using MSCs
    • Selected Clinical Trials Sponsored by Cell Therapy Companies
      • Scinow Biotechnology Co., Ltd. (NCT03184935)
      • Mesoblast Ltd. (NCT00294112)
      • Cellular Biomedicine Group Ltd. (NCT01809769)
      • Alliancells Bioscience Corporation Ltd. (NCT01573923)
      • Pharmicell Co., Ltd. (NCT01676441)
      • Shenzhen Hometcorn Biotechnology Co., Ltd.
      • Sclnow Biotechnology Co., Ltd. (NCT03180450)
        • Table Companies Involved in Clinical Trials using MSCs
    • Clinical Trials using MSCs for Cardiovascular Diseases
      • Table Selected Clinical Trials Involving MSCs in Cardiovascular Disorders
      • Corporate Investment in Cardiovascular Diseases using MSC Therapy
        • Table Commercial Clinical Stage MSC Therapy Approaches for Cardiovascular Diseases
    • MSCs for Osteoarthritis
      • Table Currently Available Therapies for Osteoarthritis
      • Table Clinical Trials using MSCs for Osteoarthritis
      • Table Ongoing Clinical Trials using MSCs for OA Sponsored by Universities and Companies
    • MSCs in Wound Healing
      • Table Clinical Trials Using MSCs for Wound Healing
    • MSCs for Liver Diseases
      • Table Select Clinical Trials using MSCs for Liver Diseases
    • MSCs for Lung Disorders
      • Table Select Clinical Trials using MSCs for Lung Diseases
    • Clinical Trials using MSCs for Eye Disorders
      • Table Clinical Trials using MSCs for Eye Disorders
    • MSCs for Kidney Disorders
      • Table Clinical Trials using MSCs for Kidney Transplantation
    • MSCs for Diabetes
      • Table Companies Developing Cell Therapies for Diabetes
      • Table Selected Clinical Trials using MSCs for Diabetes
    • MSCs for Graft vs. Host Disease (GvHD)
      • Table A Sample of Clinical Trials using MSCs for GvHD
    • MSCs for Inflammatory Bowel Diseases
      • Table A Partial List of Clinical Trials using MSCs for IBD
    • MSCs for Multiple Sclerosis
      • Table A Partial List of Clinical Trials using MSCs for MS
    • Status of MSC Clinical Research in Specific Diseases
      • Graft v. Host Disease (GvHD)
      • OA & RA
      • Inflammatory Airway and Pulmonary Diseases
      • Multiple Sclerosis (MS)
      • Inflammatory Bowel Disease (IBD)
      • Genetically Engineered MSCs
        • Table Pre-Clinical Studies using Genetically Engineered MSCs in Cancer
  • PARTNERING ACTIVITIES IN CELL THERAPY SECTOR
    • Table Major Deals within the Cell Therapy Sector
    • Collaboration between Lonza and Nikon
    • Hitachi's Purchase of PCT from Caladrius Biosciences
    • Collaboration between Regeneus Ltd. and Asahi Glass. Co. on Progenza
    • Collaboration between RepliCel Life Sciences and Shiseido Co., Ltd.
    • Collaboration between SanBio Life Sciences and Sumitomo
    • Partnership and License Agreement between Healios K.K. and Athersys Inc.
    • Cell Therapy Ltd.' s License to Daiichi Sankyo
    • TiGenix's License to Takeda Pharmaceuticals
    • Celyad's License to Ono Pharmaceuticals
    • Collaboration Kolon Life Sciences and Mitsubishi Tanabe
    • Collaboration between Steminent Biotherapeutics and ReproCELL Inc.
    • Kite Pharma's Partnership with Daiichi Sankyo
    • Acquisition of Cellular Dynamics by Fujifilm Holdings
    • License Agreement between Cynata Therapeutics and Fujifilm
    • Gilead to Acquire Kite Pharma
    • Big Pharma's Strategy in Advanced Therapy Sector
      • Table Big Pharma's Strategies in Advanced Therapies Sector, 2016/2017
      • Collaboration between Sangamo and Pfizer
      • Acquisition of 3D Printing Systems from Tissue Regeneration Systems by DePuy Synthes Products (J&J)
      • New JLABS Opened by J&J
      • Collaboration between GSK and Miltenyl Biotec
    • Big Pharma's Interest in Cell Therapy
      • Table Big Pharma's Interest in Cell Therapy
      • GlaxoSmithKline (GSK)
      • Pfizer
      • Novartis
      • AstraZeneca
      • Roche
      • Johnson & Johnson
      • Sanofi
    • Big Pharma Strategy in Advanced Therapies
      • Table Big Pharma's Involvement in Advanced Therapies
      • Value of Big Pharma Deals in Cell and Gene Therapy
    • Recent Events in Advanced Therapies Sector
      • Table Recent Events in Advanced Therapies Industry
    • Geographical Distribution of Cell Therapy Companies
      • Table A Comprehensive List of Cell Therapy Companies
  • MARKET ANALYSIS
  • COMPANY PROFILES
    • AdiCyte
    • AdiSave
    • Allo Source Inc.
      • AlloStem
    • American CryoStem Corporation
      • Clinical Adipose-Tissue Platform
    • Anterogen Co., Ltd.
      • Cupistem Injection
    • Apceth Biopharma GmbH
      • Apceth's Allogeneic MSC Platform
      • Apceth's Genetically-Engineered MSCs
        • Table Apceth's Product Pipeline
    • Athersys Inc.
      • MultiStem
        • Table Athersy's MultiStem Programs
    • Astarte Biologics Inc.
    • BioCardia Inc.
      • Product Pipeline
        • Table BioCardia's Product Pipeline
    • BioRestorative Therapies Inc.
      • brtxDISC
      • ThermoStem Program
    • Bone Therapeutics SA
      • Collaborators
        • Table Bone Therapeutics' Products in Development
    • Brainstorm Cell Therapeutics
      • NurOwn Technology
    • Caladrius Biosciences Inc.
      • CLBS03
      • CLBS12
    • Capricor Therapeutics Inc.
      • Table Capricor's Product Pipeline
      • CAP-1002
      • CAP-2003
    • Cell Applications Inc.
    • Cell Cure Neurosciences Ltd.
      • OpRegen
    • CellGenix Technologie Transfer GmbH
      • Cell Types Offered
      • CellGro Cytokines
      • Serum-Free Media
      • Supplements and Cells
    • CellProthera SAS
      • ProtheraCytes
    • Celltex Therapeutics Corporation
    • Cellular Dynamics International Inc.
    • Celprogen Inc.
      • Table Celprogen's Therapeutic Product Pipeline
    • Cell Therapies Pty Ltd.
      • Contract Manufacturing Services
      • Apheresis Management Services
      • Clinical Trial Support Services
      • Consultancy & Advisory Services
    • Celvive Inc.
      • The StemCell Bag
    • Cesca Therapeurics Inc.
      • CAR-TXpress
      • AutoXpress (AXP)
      • Point-of-Care Solutions for Cell-Based Therapies (PXP)
      • CellXpress
    • Celyad SA
      • Table Celyad's Programs in Immuno-Oncology
    • Cyagen Biosciences Inc.
      • Cells
      • Media
    • Cynata Therapeucics Ltd.
      • Cymerus Platform Technology
    • Cytori Therapeutics Inc.
      • Cytori Cell Therapy
    • Escape Therapeutics Inc.
      • Table Escape Therapeutic's Product Pipeline
    • Future Health BioBank
    • Gamida Cell Ltd.
      • NAM Technology
        • Table Gamida Cell's Clinical Pipeline Products
      • NiCord
      • CordIn
      • NAM-NK Cells
    • Intercytex Ltd.
      • ICH-RHY
    • International Stem Cell Corp.
      • Table International Stem Cell Corporation's Pipeline
    • Invitrx Therapeutics Inc.
      • Therapeutic Procedures
      • Invitra ECM Suspension
      • Cosmetic Procedures
    • JCR Pharmaceuticals Co., Ltd.
      • Temcell HS Inj.
    • Kadimastem Ltd.
      • Solution for Diabetes
      • Solution for Neurodegenerative Diseases
    • Kiadis Pharma N.V.
      • ATIR101
      • ATIR201
    • Kite Pharma Inc.
      • Kite Pharma's Research
        • Table Kite Pharma's Product Candidates
    • Life Sciences Inc.
      • Technology
        • Table RepliCel's Product Pipeline
      • RCT-01
      • RCS-01
      • RCH-01
      • RCI-02
    • Living Cell Technologies Ltd.
      • NTCELL
    • Lonza Group Ltd.
    • Magenta Therapeutics Inc.
      • Magenta's Stem Cell Platform
    • Medeor Therapeutics Inc.
      • MDE-10X
    • Medipost Co., Ltd.
      • Cartistem
      • Pneumostem
      • Neurostem
    • Mesoblast Inc.
      • Table Mesoblast's Late Stage Product Candidates
      • MPC-150-IM
      • MPC-300-IV
      • MPC-06-ID
      • MSC-100-IV
      • Temcell HS Injection
    • NuVasive Inc.
      • Osteocel
    • Neuralstem Inc.
      • Table Neuralstem's Product Pipeline
      • NSI-189
    • Octane Biotech Inc.
      • Turn-Key Production System for Cell and Tissue Therapy
      • Automated Bioreactors
      • Atomically Enhanced Implants
      • Drug-Enhanced Implants
      • Cell-Enhanced Implants
    • Organogenesis Inc.
      • Apligraf
      • Dermagraft
    • Orthofix International N.V.
      • BioStim
      • Biologics
    • Osiris Therapeutics Inc.
      • Grafix
      • BIO4
      • Stravix
      • Cartiform
    • OxStem Ltd.
      • Table OxStem's Project Pipeline
    • PharmaCell B.V.
    • Pharmicell Co. Ltd.
      • Cellgram-AMI
        • Table Pharmicell's Product Pipeline
    • Pluristem Therapeutics Inc.
      • PLX Products
      • PLX-PAD
      • PLX-R18
      • Prochymal
    • Precious Cells International Ltd.
    • Promethera Biosciences S.A.
      • Table Promethera's Development Pipeline
      • HepaStem for ACLF
      • HepaStem for NASH
      • H2Stem
      • Heparesc
    • Provia Laboratories, LLC
    • Regen BioPharma Inc.
      • HemaXellerate (Phase I/II)
    • Regeneus Ltd.
      • Table Regeneus' Human Health Pipeline
      • Progenza
      • RGSH4K
      • Secretions
    • Reliance Life Sciences Pvt. Ltd.
      • CardioRel
    • Reneuron Group plc
      • Table ReNeuron's Product Pipeline
      • CTX Cell Line
      • hRPC
      • Exosome Platform
    • Stemedica Cell Technologies Inc.
      • BioSmart Technology
      • Clinical Pipeline
        • Table Stemedica's Clinical Pipeline
    • StemGen Therapeutics
      • Lipokraft
      • Lipokraft Advance
      • Amniokraft
    • Stempeutics Research Pvt. Ltd.
      • Stempeucel
        • Table Clinical Trials for Stempeucel
      • Stempeucare
        • Table Clinical Trials for Stempuecare
      • Stempeutron
    • Stratatech Corp.
      • StrataGraft
      • ExpressGraft
        • Table Stratatech's Product Pipeline
    • ThermoFischer Scientific Inc.
    • TiGenix N.V.
      • TiGenix's Pipeline
        • Table TiGenix's Product Candidates
    • U.S. Stem Cell Inc.
      • MyoCell
      • MyoCell SDF-1
      • AdipoCell
    • Vericel Corporation
      • Ixmyelocel-T
      • MACI
      • Epicel
      • Carticel
    • ViaCyte Inc.
      • Table ViaCyte's Product Pipeline
      • VC-01
      • VC-02
    • Xintea AB
      • XINMARK
    • Zen-Bio Inc.

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