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Stem Cell Therapies in CVMD

Stem Cell Therapies in CVMD

Summary

Regenerative medicine could potentially cure diseases and may replace palliative treatments for chronic diseases. Stem cells in particular have been studied for their regenerative properties: their potential to repair or replace damaged or diseased human cells or tissues to restore normal function. Stem cells are able to develop into different cell types in the body during early the early stages of life and growth. They have a role in repairing many types of damaged tissue.

The FDA has put out a comprehensive policy framework for the development and oversight of regenerative medicine products through the 21st Century Cures Act, legislation for an expedited approval path for cellular medicines designated as regenerative medicine advanced therapies (RMATs) to patients who need them faster and more efficiently.

Studies of stem cell therapies targeting cardiovascular indications such as heart failure (HF), myocardial infarction (MI), cardiomyopathy (CM), and left ventricular dysfunction (LVD) aim to demonstrate that stem cells injected into the circulation or directly into the injured heart tissue improve cardiac function and/or induce the formation of new capillaries.

The majority of CVMD pipeline candidates are in preclinical development, with ~73% of CVMD stem cell pipeline therapies specifically targeting cardiovascular indications. Representative stem cell types that are being investigated in clinical trials towards CV indications include mesenchymal precursor, ischemia-tolerant mesenchymal, myoblast, immunomodulatory progenitor, and heart-derived stem cells.

Currently, there is an absence of big pharma investment in cardiovascular stem cell therapy clinical development, with the majority of the R&D efforts in this space being undertaken by small biotech companies.

The report Stem Cell Therapies in CVMD, provides an assessment of the pipeline, clinical, and commercial landscape of stem cell therapies in CVMD. Overall, it is expected that new stem cell therapy approvals will drive CVMD market growth from 2018-2025.

Companies Mentioned: Mesoblast, U.S. Stemcell, Celixir, Capricor, Stemedica, Healios, Athersys, SanBio.

Scope

Components of the slide deck include -

  • Overview of CVMD and Stem Cells: epidemiology and regulatory oversight
  • Pipeline Assessment: regional breakdown, promising late-stage products, early-stage pipeline by molecule type
  • Clinical Trials Assessment: trial breakdown by phase, leading industry and non-industry sponsors
  • Market Access: considerations for reimbursement, pricing, and unmet needs
  • Market Outlook: competitive assessment and key market events (2018-2025).
Reasons to buy
  • Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline.
  • Develop business strategies by understanding the trends shaping and driving the global CVMD stem cell therapy market.
  • Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global CVMD stem cell therapy market in the future.
  • Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various competitors.
  • Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
  • Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments, and strategic partnerships.


1. Introduction
1.1 Related Reports
1.2 Upcoming Related Reports
2. Executive Summary
2.1 Key Findings
2.2 CVMD Stem Cell Therapy Competitive Landscape Insights
3. Overview - Stem Cells, CVMD, Epidemiology
3.1 Regenerative Medicine
3.2 Stem Cells and Cardiovascular Disease
3.3 Stem Cell Therapies
3.4 Overview of Heart Disease and Epidemiology
3.5 Overview of Other CV Indications and Epidemiology
3.6 Overview of Metabolic Disorders and Epidemiology
4. Regulatory Oversight of Stem Cell Therapies
4.1 Regulatory Agencies in the US and EU
4.2 The FDA and Stem Cell Therapy
4.3 Oversight of Stem Cell Therapy in Japan and China
4.4 Marketed Heart Failure Therapy in Japan
5. Pipeline Assessment, Profiled Stem Cell Therapies
5.1 Pipeline Stem Cell Therapies Targeting CVMD
5.2 Stem Cell Therapies for Heart Failure
5.3 HF Pipeline: Mesoblast’s Revascor
5.4 HF Pipeline: U.S. Stemcell’s MyoCell
5.5 HF Pipeline: Celixir’s Heartcel
5.6 HF Pipeline: Capricor’s CAP-1002
5.7 HF Pipeline: Stemedica’s Stemedyne-MSC
5.8 Stroke Pipeline: Healios’/Athersys’ Multistem
5.9 Stroke Pipeline: SanBio’s SB623
6. Clinical Trials and Key Developers
6.1 Overview of Clinical Trials
6.2 CVMD Stem Cell Therapy Development
6.3 Clinical Trial Mapping
6.4 Key Players
7. Market Access: Reimbursement, Pricing, Unmet Need
7.1 Market Access
7.2 Stem Cell Therapy Reimbursement
7.3 Unmet Need within CVD
7.4 CVD Stem Cell Therapy Reimbursement and Pricing
7.5 Reimbursement for HF Stem Cell Pipeline Therapies
7.6 Reimbursement for Stroke Stem Cell Pipeline Therapies
7.7 MD (Diabetes) Stem Cell Therapy Reimbursement
8. Market Outlook
8.1 Market Outlook for Mesoblast’s Revascor
8.2 Market Outlook for U.S. StemCell’s MyoCell
8.3 Market Outlook for Celixir’s Heartcel
8.4 Market Outlook for Capricor’s CAP-1002
8.5 Market Outlook for Stemedica’s Stemedyne-MSC
8.6 Market Outlook for Healios’/Athersys’ Multistem
8.7 Market Outlook for SanBio’s SB623
8.8 Anticipated Key Events for Stem Cell Therapies in CVD
9. Appendix
9.1 Sources
9.2 Methodology
9.3 Primary Research
9.4 About the Authors
9.5 About GlobalData
9.6 Contact Us
9.7 Disclaimer

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