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Mesenchymal stem cells (MSCs) are multipotent stem cells that can differentiate into a
variety of cell types, including osteoblasts, chondrocytes, myocytes, adipocytes, betapancreatic islets cells, and potentially, neuronal cells. MSCs are of intense therapeutic
interest because they represent a population of cells with the potential to treat a wide
range of acute and degenerative diseases.
MSCs are advantageous over other stem cells types for a variety of reasons: they avoid
the ethical issues that surround embryonic stem cell research, and repeated studies
have found MSCs to be immuno-privileged, which make them an advantageous cell type
for allogenic transplantation. MSCs reduce both the risks of rejection and complications
of transplantation. Recently, there have been advances in the use of autologous
mesenchymal stem cells to regenerate human tissues, including cartilage, meniscus,
tendons, bone fractures, and more.
This global strategic report explores recent advances in mesenchymal stem cells
research applications, research priorities by market segment, and the competitive
environment for Mesenchymal Stem Cells research products. It also identifies trend and
growth patterns within the MSC industry. Because it is important for pharmaceutical
companies interested to understand underlying forces affecting the Mesenchymal Stem
Cells market, this report also presents a range of topics that apply to these companies,
including how advances in mesenchymal stem cells research can reveal potential new
drug targets, improve methods of drug delivery, and provide personalized treatment
strategies.
Literature and data concerning the biology and differentiation potential of
mesenchymal stem cells (MSCs) has expanded rapidly over the past 10 years, with
more than 13,000 publications now exploring aspects of MSC biology, behavior, and
applications. In particular, MSCs appear to be an exceptionally promising tool for cell
therapy because of their unusual characteristics, which partially mimic those of
embryonic stem cells, while having advantages in terms of 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 from their ability to migrate to sites of
tissue injury/inflammation or tumor growth. These localization properties present a
promising strategy for targeted introduction of therapeutic agents through
Mesenchymal Stem Cell therapy. In addition, MSCs possess strong immunosuppressive
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properties that medical researchers are exploiting for both autologous as well as
heterologous therapies.
Clinical Progress with MSCs
As mentioned, mesenchymal stem cells (MSCs) have inspired a lot of activity over the
past ten years as a novel therapeutic model for a wide range of diseases. Presently,
MSCs-based clinical trials are being conducted for twelve types of disease conditions,
with many completed trials showing their safety and efficacy.
The clinical utility of MSCs are mostly attributed to their four key biological
properties, which are their potential to:
1. Migrate to sites of inflammation caused by tissue injury when injected intravenously
2. To get differentiated into different cell types
3. To release different bioactive molecules having the potential of stimulating recovery
of injured cells and preventing inflammation
4. To accomplish immunomodulatory functions
Currently, there are 128 clinical trials involving MSCs are in progress in different parts
of the world, including China, the European Union, the United States, the Middle East,
and South Korea. Among these trials, 45 (35%) are exploiting MSCs for various disease
indications. Currently, four major clinical trials using MSCs have reached Phase III.
Stempeutics Researchs product candidate Stempeucel is being evaluated in two
centers for treating critical leg ischemia. Prochymal is the product candidate from
Osiris Therapeutics and it is being used for treating graft vs. host disease (GvHD). The
company is also testing Prochymal for treating Crohns disease in another Phase III
trial. The Australian company Mesoblast is testing an off-the-shelf mesenchymal
precursor product candidate for treating patients with hematological malignancies.
Since 1968, bone marrow transplantation (BMT) has been the gold standard treatment
for blood cancer patients and others with genetic blood disorders. Each year more than
60,000 bone marrow transplantations are performed worldwide, and 58% of these
procedures use autologous bone marrow and 42% of the cases use allogeneic bone
marrow. Currently, the use of bone marrow is being replaced by the utilization of MSCs
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How many major clinical trials using MSCs have reached the Phase III?
What are the MSCs-based cell therapy products available in the market?
Table of Contents
1. REPORT OVERVIEW 10
1.1 Statement of the Report 10
1.2 EXECUTIVE SUMMARY 12
2. INTRODUCTION 14
2.1 Regenerative Medicine (RM) and Advanced Therapies Industry: A Brief Overview
16
2.2 Global Breakdown of Major RM Industries by Region 17
2.3 Breakdown of Global RM Companies by Type 18
2.4 Number of Therapeutic Companies, Approved Products and Clinical Trials in RM
Sector 18
2.5 Number of RM Clinical Trials by Phase of Development 19
2.6 Number of RM Companies by Disease Focus Area 20
2.7 Major Financial Events in RM Industry 21
2.8 Major Partnerships and Acquisitions in RM Industry 21
2.9 Total Financings in RM Industry by Segment 22
2.10 Type of Financing for RM Industry 23
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List Of Tables
TABLE 2.1: Global Breakdown of Major RM Industries by Region 17
TABLE 2.2: Global Breakdown of RM Companies by Type, 2014 18
TABLE 2.3: Number of Therapeutic Companies, Approved Products and Clinical Trials,
2014 19
TABLE 2.4: Number of RM Clinical Trials by Phase in 2014 .19
TABLE 2.5: Number of RM Companies by Disease Focus Area.20
TABLE:2.6: Major Financial Events in RM Industry in 2014.21
TABLE 2.7: Major Partnerships and Acquisitions in RM Industry in 2014 22
TABLE 2.8: Total Financings in RM Industry by Segment in 2014 22
TABLE 2.9: Type of Financing for RM Industry in 2013 and 2014 23
TABLE 2.10: Major Regulatory Milestones in RM Industry in 201424
TABLE 2.11: Major Data and Technology Events in RM Industry in 201425
TABLE 2.12: Major Pharma and Biotech Companies Active in Advanced Therapies in
2014 26
TABLE 2.13: Major Corporate Partnerships in RM Industry in 2014 27
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List Of Figures
FIGURE 3.1: Number of Cell Therapy Clinical Trials, 2011-2014 52
FIGURE 3.2: Cell Therapy Clinical Trials (%) by Geography in 2014 53
FIGURE 3.3: Top Eight Countries in Cell Therapy Clinical Trials (%) in 2014 53
FIGURE 3.4: Major Cell Types in Cell Therapy Clinical Trials (Numbers) in 2014 54
FIGURE 3.5: Major Cell Therapy Clinical Trials (Numbers) by Indication in 2014 55
FIGURE 4.1: Schematic of Factors Impacting MSC Acquisition 73
FIGURE 4.2: Number of Clinical Trials Using MSCs, 2004-2014 86
FIGURE 4.3: Increasing Focus on the Immunological Properties of MSCs 99
FIGURE 4.4: Percentage of MSCs Clinical Trials by Different Phases 100
FIGURE 5.1: Global Market for Stem Cells, Stem Cell Services, Cord Blood Banking, Stem
Cell Therapies and Bone Marrow Transplants, Through 2021 104
FIGURE 5.2: Global Market for Stem Cells by Disease Indication, Through 2021 106
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