Market Overview

Stem Cell Therapies in CVMD 2018-2025 - New Stem Cell Therapy Approvals will Drive CVMD Market Growth -


The "Stem
Cell Therapies in CVMD"
report has been added to's

This report 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.

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

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


  • 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
  • Market Outlook: competitive assessment and key market events

Companies Featured

  • Mesoblast
  • U.S. Stemcell
  • Celixir
  • Capricor
  • Stemedica
  • Healios
  • Athersys
  • SanBio

Key Topics Covered

1. Introduction

2. Executive Summary

3. Overview - Stem Cells, CVMD, Epidemiology

4. Regulatory Oversight of Stem Cell Therapies

5. Pipeline Assessment, Profiled Stem Cell Therapies

6. Clinical Trials and Key Developers

7. Market Access: Reimbursement, Pricing, Unmet Need

8. Market Outlook

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