This global strategic report is produced for:
- Management of stem cell companies
- Management of regenerative therapy companies
- Stem cell industry investors
It is designed to increase your efficiency and effectiveness in:
- Commercializing mesenchymal stem cell (MSC) products, technologies, and therapies
- Making intelligent investment decisions
- Launching high-demand products
- Selling effectively to your client base
- Increasing revenue from MSC products and services
- Taking market share from your competition
Mesenchymal stem cells (MSCs) are multipotent stem cells that can differentiate into a variety of cell types, including osteoblasts, chondrocytes, myocytes, adipocytes, beta-pancreatic 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 MSC research applications, research priorities by market segment, and the competitive environment for MSC 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 MSC market, this report also presents a range of topics that apply to these companies, including how advances in MSC 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 MSC gene therapy. In addition, MSCs possess strong immunosuppressive 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:
- Migrate to sites of inflammation caused by tissue injury when injected intravenously
- To get differentiated into different cell types
- To release different bioactive molecules having the potential of stimulating recovery of injured cells and preventing inflammation
- 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 Research’s 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 Crohn’s 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 for some conditions.
The majority of cell therapy products currently being marketed are meant to address musculoskeletal conditions, and most of these products use MSCs as a component.
The purpose of this report is to describe the current status of mesenchymal stem cells (MSCs) research, the ongoing clinical trials involving MSCs, late stage MSCs clinical trials, and the possible uses of MSCs in cell therapy. As MSC cell therapy is an integrated component of other cell therapies and regenerative medicines (RM), the report also gives a brief overview of the RM industry and overall cell therapy (CT) industry.
Thus, the main objectives are to consider the following:
- Current status of global regenerative medicine (RM) industry in the utilization of stem cells in general and MSCs in particular.
- Current status of global cell therapy (CT) industry, the application of cell therapy in various disease indications, and the total number of clinical trials involving the different types of stem cells.
- Current status of MSCs in clinical trials, the dominance of MSCs in the ongoing clinical trials involving stem cells, the various applications of MSCs in different disease indications, and the number of clinical trials involving MSCs for different disease types.
- The number of companies involved in the development of MSCs, the clinical trials sponsored by major companies, and their sustained search for MSCs-based cell therapy products.
Key questions answered in this global strategic report are:
- How many companies are currently supporting the RM industry?
- What is the current regional breakdown of RM industry?
- How many RM products have been approved?
- What are the types of diseases are currently being pursued by RM companies?
- What are the major financial events, partnerships and acquisitions in RM sector?
- How do the large pharma companies perceive the value and long-term prospects of RM and CT?
- What are the major anticipated RM clinical events in 2015-16?
- What are the major therapeutic opportunities for the big pharma in RM and CT?
- How many CT product candidates have reached the Phase III stage and what are they?
- What are the CT product candidates being developed for cardiovascular diseases, central nervous system, wounds, spine and orthopedics, diabetes and autoimmune diseases?
- What are the major commercially available cell therapy products?
- What is the total number of cell therapy clinical trials at the global level?
- What are the major cell types used in cell therapy clinical trials?
- What are the major indications addressed by cell therapy clinical trials?
- What are the major cell therapy clinical trials that have reached Phase III?
- How many cell therapy clinical trials failed in the past year and what are they?
- What are the contributions of MSCs to the cell therapy industry?
- What are the biological properties of MSCs?
- What do MSCs get differentiated into?
- What bioactive molecules do the MSCs secrete?
- What are the immunomodulatory functions of MSCs?
- What are the factors impacting the acquisition of MSCs?
- What are the various sources of MSCs?
- What are the ongoing clinical trials using bone marrow-derived MSCs (BMMSCs) for kidney diseases?
- What are the major clinical trials focusing on diabetes using BMMSCs?
- What are the major clinical trials involving BMMSCs for cardiovascular diseases?
- What are the major clinical trials focusing on liver diseases by BMMSCs?
- What are the brain-related diseases addressed by clinical trials using BMMSCs?
- How many clinical trials are conducted for intestinal diseases using MSCs?
- What are the details of clinical trials conducted for musculoskeletal diseases using MSCs?
- Number of clinical trials using MSCs derived from Wharton’s jelly for various diseases?
- What are the disease indications addressed by umbilical cord blood-derived MSCs (UCBMSCs) in current clinical trials?
- What is the current number of clinical trials using MSCs?
- How many major clinical trials using MSCs have reached the Phase III?
- What are the MSCs-based cell therapy products available in the market?