Mesenchymal Stem Cells Advances & Applications, 2019 – MSCs Appear to be an Exceptionally Promising Tool for Cell Therapy – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–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/7etdx4

Contacts

ResearchAndMarkets.com

Laura Wood, Senior Press Manager

[email protected]

For E.S.T Office Hours Call 1-917-300-0470

For U.S./CAN Toll Free Call 1-800-526-8630

For GMT Office Hours Call +353-1-416-8900

Related Topics: Stem Cells