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Mesenchymal Stem Cells Advances & Applications, 2019 - Opportunities for MSC Equipment and Media System Developers

DUBLIN, July 12, 2019 /PRNewswire/ -- The "Mesenchymal Stem Cells - Advances & Applications, 2019" report has been added to ResearchAndMarkets.com's offering.

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. MSCs are also well-suited for use in the exponential growth field 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 exploring 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 and difficulties of administering the cells to patients.

As the most common stem cell type being used within regenerative medicine, there is huge potential for growth within the MSC market. There are more than one-hundred thousand scientific publications published about MSCs, as well as 900+ MSC clinical trials underway worldwide, including trials within 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 have reached Phase III, indicating that a limited number of MSC products have near-term market potential and the therapeutic market for MSCs remains early-stage.

As of 2019, ten MSC-based products have received regulatory approvals, including nine cell therapy approvals and one tissue engineering approval. Population aging and increasing prevalence of chronic disease are also driving interest in MSC-based therapies, with Google Trend data revealing that MSC searches are more than twice as common as the next most common stem cell type.

Key Topics Covered:

1. REPORT OVERVIEW
1.1 Statement of the Report
1.2 Executive Summary

2. MESENCHYMAL STEM CELLS (MSCS): AN INTRODUCTION
2.1 The Various Names for MSCs
2.3 Timeline of MSC Nomenclature
2.4 Functions of MSCs
2.5 Sources of MSCs
2.5.1 Bone Marrow-Derived MSCs (BM-MSCs)
2.5.2 Adipose-Derived MSCs (AD-MSCs)
2.5.2.1 Comparison of Yield by Isolation Method
2.5.3 Umbilical Cord-Derived MSCs (UC-MSCs)
2.6 Cell Surface Markers in MSCs
2.7 In Vitro Differentiation Potential of MSCs
2.8 Soluble Factors Secreted by MSCs

3. MANUFACTURE OF MESENCHYMAL STEM CELLS
3.1 Methods of Isolation of MSCs
3.2 From Conventional Cultures to Bioreactors
3.2.1 Monolayer Culture Systems
3.2.2 Bioreactor-Based Cell Expansion
3.2.2.1 Stirred Tank Bioreactor
3.2.2.2 Rocking Bioreactor
3.2.2.3 Hollow Fiber Bioreactors
3.2.2.4 Fixed-Bed Bioreactors
3.2.3 Main Features of the Commercial Bioreactors
3.2.4 Microcarriers used for the Expansion of MSCs
3.3 Downstream Processing of hMSCs
3.3.1 Cell Detachment and Separation
3.3.2 Cell Washing and Concentration
3.3.3 Safety and Potency Assays
3.4 Surface Markers for Identification
3.4 MSC Manufacturing Bottlenecks and Solutions

4. COMPARISON OF AUTOLOGOUS & ALLOGENEIC CELL MANUFACTURING
4.1 Manufacturing of Allogeneic Cells
4.2 Cost Differential
4.3 Donor Screening and Testing
4.4 Release Testing
4.5 Comparison of the Two Business Models
4.5.1 Risk of Immune Reaction
4.5.2 Risk of Cross Contamination
4.5.3 Commercially Attractive Option

5. COST OF CELL MANUFACTURING
5.1 Cost Breakdown
5.2 Opportunities for Cost Reduction
5.3 Partial Automation vs. Full Automation
5.4 Partial Automation: Most Attractive Option

6. CONTRACT MANUFACTURING OF MSCs
6.1 CMOS
6.2 CDMOs
6.2.1 Opportunities for MSC Equipment and Media System Developers
6.3 Leading Cell Therapy CMOS
6.4 Global Cell Manufacturing Capacity

7. DISEASES ADDRESSED BY MSCS IN CLINICAL TRIALS
7.1 MSCs in Hematological Diseases and Graft-versus-Host Diseases (GvHD)
7.2 MSCs in Cardiovascular Diseases
7.3 MSCs in Neurological Diseases
7.4 MSCs in Bone and Cartilage Diseases
7.5 MSCs in Lung, Liver, and Kidney Diseases

8. CLINICAL TRIALS LANDSCAPE OF MSCS
8.1 Phases of Studies
8.2 Sources of Cells for Clinical Trials using MSCs
8.3 Share of Autologous vs. Allogeneic Transfusions of MSCs in Clinical Trials
8.4 MSC-Based Clinical Trial Location by Geography

9. CONSUMPTION OF MSCS
9.1 Consumption of MSCs within Cardiac Applications
9.2 Dosing of MSCs within Cell Therapy and Tissue Engineering
9.3 Rates of MSCs Scientific Publications
9.4 Frequency of MSC Online Searches (Google Trends)
9.5 Pricing of MSCs
9.6 Disruptive Technologies to Threaten the Demand for MSCs)

10. APPROVED CELL-BASED MEDICINAL PRODUCTS
10.1 Approved Cell-Based Medicinal Products by Region/Country
10.2 Approved Cell-Based Medicinal Products by Therapy Type
10.3 Major Cell Types used in Approved Cell-Based Medicinal Products
10.4 Price of Cell-Based Therapies
10.5 MSC-Based Medicinal Products
10.5.1 Alofisel
10.5.2 Chondrocytes-T-Ortho-ACI
10.5.3 Spherox
10.5.4 Ossgrow
10.5.5 Stempeucel
10.5.6 Prochymal (remestemcel-L)
10.5.7 Temcell HS
10.5.8 Neuronata-R
10.5.9 Cupistem
10.5.10 Cellgram-AMI

11. RECENT BUSINESS DEVELOPMENTS IN MSCS AND RELATED SECTORS
11.1 Novartis to Acquire CELLforCURE
11.2 Novartis' Agreement with Cellular Biomedicine Group
11.3 AveXis to Acquire a Biologics Manufacturing Campus in Longmont
11.4 The Leasing of Hoofddorp Facility by Kite Pharma
11.4.1 Other Additions to Kite Pharma
11.5 Celgene's New Manufacturing Center
11.6 Roche to Acquire Spark Therapeutics
11.7 Astella Pharma's New Facilities
11.8 Novo Nordisk to have a New Facility in Fremont
11.9 Catalent to Acquire Paragon Bioservices
11.10 Paragon's New Facility
11.11 Thermo Fisher Scientific to Acquire the CDMO, Brammer Bio
11.12 Lonza's Acquisition of Octane Biotech
11.13 Lonza Installing Multiple Cell Therapy Suites
11.14 Fujifilm's New GMP Production Facility
11.15 Bluebird bio's New Facility in Durham
11.16 Allogene Therapeutics' Facility in Newark
11.17 Rubius Therapeutics' Facility in Rhode Island
11.18 Hitachi Chemical to Acquire Apceth Biopharma

12. MARKET ANALYSIS
12.1 Global Market for Mesenchymal Stem Cells (MSCs)
12.2 Global Market for MSCs and MSC-Based Therapeutics

13. COMPANY PROFILES
13.1 AlloSource, Inc
13.1.1 ProChondrix CR
13.1.2 AlloFuse (Cellular Allograft Matrix)
13.2 American Type Culture Collection (ATCC)
13.2.1 Stem Cell Products
13.3 Anterogen, Co., Ltd
13.3.1 Cupistem Injection
13.3.2 Queencell
13.4 Athersys, Inc
13.4.1 MultiStem
13.5 BioCardia, Inc.
13.6 Brainstorm Cell Therapeutics, Inc.
13.6.1 Autologous MSC-NTF Cells
13.7 CellGenix Technologie Transfer GmbH
13.7.1 Products
13.8 Celltex Therapeutics Corporation
13.8.1 Banking Services
13.8.2 Therapies
13.9 Cesca Therapeutics, Inc.
13.9.1 CellXpress (CXP)
13.9.2 CXP + BioArchive
13.9.3 PXP
13.9.4 AutoXpress (AXP)
13.9.5 CAR-TXpress
13.10 Cynata Therapeutics Ltd.
13.10.1 Cymerus Platform
13.11 CO.DON AG
13.11.1 Spherox
13.12 Corestem, Inc
13.12.1 NeuroNATA-R
13.13 Cytori Therapeutics, Inc
13.13.1 Cytori Cell Therapy
13.14 Escape Therapeutics, Inc
13.15 HemaCare Corporation
13.15.1 Products
13.16 Invitrx Therapeutics, Inc
13.16.1 Invitra CBSC
13.16.2 Invitra WJ-C
13.17 iXCells Biotechnologies
13.17.1 Products
13.18 JCR Pharmaceuticals, Co., Ltd.
13.18.1 STEMCELL HS Inj
13.19 MEDIPOST, CO., Ltd.
13.19.1 CARTISTEM
13.19.2 PNEUMOSTEM
13.19.3 NEUROSTEM
13.20 Mesoblast Ltd
13.20.1 Product Candidates
13.21 NuVasive, Inc
13.21.1 Osteocel Plus
13.22 Orthocell, Ltd
13.22.1 Ortho-ATI
13.22.2 Ortho-ACI
13.22.3 CelGro
13.23 Osiris Therapeutics, Inc
13.23.1 Grafix PRIME & GrafixPL PRIME
13.23.2 Stravix
13.23.3 Cartiform
13.23.4 BIO
13.23.5 Prochymal
13.24 Pharmicell, Co., Ltd
13.24.1 Cellgram-AMI
13.25 Pluristem Therapeutics, Inc.
13.25.1 PLX Products
13.26 Regeneus, Ltd.
13.27 Reliance Life Sciences
13.27.1 Products
13.28 RoosterBio, Inc.
13.28.1 Products
13.29 San-Bio, Inc.
13.30 ScienCell Research Laboratories, Inc
13.30.1 Products
13.31 StemBioSys, Inc
13.31.1 CELLvo Matrix Technology
13.31.2 CELLvo Cells Technology
13.32 STEMCELL Technologies Canada, Inc
13.32.1 Products
13.33 Stempeutics Research Pvt., Ltd.
13.33.1 Stempeucel
13.33.2 Stempeutron
13.33.3 Stempeucare (Cutisera)
13.34 Takeda Pharmaceuticals U.S.A. Inc
13.34.1 Alofisel

14. MSC-DERIVED EXOSOMES AND EVs
14.1. Characteristics of MSC-Derived Exosomes
14.2 Advantages of MSC-Derived Exosomes
14.3 Therapeutic Effects of MSC-Derived Exosomes
14.4 Characterization of MSC-Derived Exosomes
14.5 Patent Analysis for MSC-Derived Exosomes

15. REGULATORY OVERSIGHT OF MSC THERAPEUTICS

Companies Mentioned

  • Allogene Therapeutics
  • AlloSource, Inc
  • American Type Culture Collection (ATCC)
  • Anterogen, Co., Ltd
  • Apceth Biopharma
  • Astella Pharma
  • Athersys, Inc
  • AveXis
  • BioCardia, Inc.
  • Bluebird bio
  • Brainstorm Cell Therapeutics, Inc.
  • Brammer Bio
  • Catalent
  • Celgene
  • CELLforCURE
  • CellGenix Technologie Transfer GmbH
  • Celltex Therapeutics Corporation
  • Cellular Biomedicine Group
  • Cesca Therapeutics, Inc.
  • CO.DON AG
  • Corestem, Inc
  • Cynata Therapeutics Ltd.
  • Cytori Therapeutics, Inc
  • Escape Therapeutics, Inc
  • Fujifilm
  • HemaCare Corporation
  • Hitachi Chemical
  • Invitrx Therapeutics, Inc
  • iXCells Biotechnologies
  • JCR Pharmaceuticals, Co., Ltd.
  • Kite Pharma
  • Lonza
  • MEDIPOST, CO., Ltd.
  • Mesoblast Ltd
  • Novartis
  • Novo Nordisk
  • NuVasive, Inc
  • Octane Biotech
  • Orthocell, Ltd
  • Osiris Therapeutics, Inc
  • Paragon Bioservices
  • Pharmicell, Co., Ltd
  • Pluristem Therapeutics, Inc.
  • Regeneus, Ltd.
  • Reliance Life Sciences
  • Roche
  • RoosterBio, Inc.
  • Rubius Therapeutics
  • San-Bio, Inc.
  • ScienCell Research Laboratories, Inc
  • Spark Therapeutics
  • StemBioSys, Inc
  • STEMCELL Technologies Canada, Inc
  • Stempeutics Research Pvt., Ltd.
  • Takeda Pharmaceuticals U.S.A. Inc
  • Thermo Fisher Scientific

For more information about this report visit https://www.researchandmarkets.com/r/905rtb

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