Clinical Trials – The Expanding Landscape of Regenerative Medicine

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Regenerative Medicine Clinical Trials Market Overview

Regenerative medicine can be defined as the development and application of treatments that promote the process of replacing, engineering, or regenerating human or animal tissues to restore or establish normal function lost due to aging and disease. Regenerative medicine in GlobalData’s Pharma Intelligence Center is derived based on the FDA’s regenerative medicine advanced therapy (RMAT) designation or designated as such per regulatory authorities. As technology advancement continues to grow each year, so does the usage of regenerative medicine. This report provides an analysis of regenerative medicine clinical trial data and trends through the years.

The greatest number of regenerative medicine clinical trials occurred in 2020. This increase could be because of an improvement in funding for cell and gene therapy. North America and the US-dominated regenerative medicine clinical trials by geography. However, for industry-sponsored trials, Mesoblast topped regenerative medicine trials.

Key Regions North America, Asia-Pacific, Europe, South and Central America, and The Middle East And Africa
Key Therapy Areas Cardiovascular, Central Nervous System, Oncology, Gastrointestinal, Infectious Disease, Immunology, Metabolic Disorders, and Ophthalmology
Key Termination Reasons Low Accrual Rate, Business/Strategic Decisions, Financial, Product Discontinuation, and Lack of Efficacy
Leading Industry Sponsors Mesoblast, Novartis, Anterogen, Pharmicell, Helixmith, and Anges
Leading Non-Industry Sponsors The Foundation for Orthopaedics And Regenerative Medicine, University of Pennsylvania, Samsung Medical Center, University of Miami, Mayo Clinic, And Standford University
Key Drugs Novartis’s Tisagenlecleucel, Fludarabine, ISN-001, Stempeucel, and Allorx Stem Cell Therapy
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Regenerative Medicine Clinical Trials by Regions

Most regenerative clinical trials have been conducted in North America. This is followed by Asia-Pacific, Europe, South and Central America, and the Middle East and Africa. In Asia-Pacific, South Korea has conducted the highest number of regenerative medicine clinical trials.

Many countries such as Germany, Austria, and Ireland have a ban on regenerative medicine studies such as embryonic stem cell research, leading to a greater number of single-country trials. Regenerative medicine is a major challenge in developing countries. Due to financial limitations and ethical beliefs in the benefits of out-of-date therapies.

Regenerative Medicine Clinical Trials Analysis by Regions, 2022 (%)

Regenerative Medicine Clinical Trials Analysis, by Regions

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Regenerative Medicine Clinical Trials by Therapy Areas

Cardiovascular is the most researched therapy area when looking at regenerative medicine clinical trials. This is followed by central nervous system and oncology. Other key therapy areas of regenerative medicine clinical trials are gastrointestinal, infectious disease, immunology, metabolic disorders, and ophthalmology among others.

Regenerative Medicine Clinical Trials Analysis by Therapy Areas, 2022 (%)

Regenerative Medicine Clinical Trials Analysis, by Therapy Areas

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Regenerative Medicine Clinical Trials by Termination Reasons

Low accrual rate is the primary cause of termination for regenerative medicine clinical trials. This may be due to the notion of it having the highest risk of failure due to the increase in unapproved regenerative medicine. The other significant termination reasons are business/strategic decisions, financial, and product discontinuation. Lack of efficacy is number five for regenerative medicine.

Regenerative Medicine Clinical Trials Analysis, by Termination Reasons, 2022 (%)

Regenerative Medicine Clinical Trials Analysis, by Termination Reasons

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Regenerative Medicine Clinical Trials by Top Industry Sponsors

Mesoblast is the top industry sponsor with the most regenerative medicine clinical trials, followed by Novartis and Anterogen. Mesoblast has the most completed trials while Anterogen has the most ongoing and Novartis has the most planned trials. Other leading industry sponsors are Pharmicell, Helixmith, and AnGes among others.

Regenerative Medicine Clinical Trials Analysis, by Top Industry Sponsors, 2022 (%)

Regenerative Medicine Clinical Trials Analysis, by Top Industry Sponsors

To know more about the leading industry sponsors of regenerative medicine clinical trials, download a free report sample.

Regenerative Medicine Clinical Trials by Top Non-Industry Sponsors

The Foundation for Orthopaedics and Regenerative Medicine is the top non-industry sponsor for regenerative medicine clinical trials, followed by the University of Pennsylvania and Samsung Medical Center. Other leading non-industry sponsors are University of Miami, Mayo Clinic, and Standford University.

Regenerative Medicine Clinical Trials Analysis, by Top Non-Industry Sponsors, 2022 (%)

Regenerative Medicine Clinical Trials Analysis, by Top Non-Industry Sponsors

To know more about the leading non-industry sponsors of regenerative medicine clinical trials, download a free report sample.

Regenerative Medicine Clinical Trials by Drugs

Novartis’s tisagenlecleucel, also known as Kymriah, is the top drug being tested in regenerative medicine trials. Other key drugs are Fludarabine, ISN-001, Stempeucel, and AlloRx Stem Cell Therapy among others.

Regenerative Medicine Clinical Trials Analysis by Top Drugs, 2022 (%)

Regenerative Medicine Clinical Trials Analysis by Top Drugs

To know more about the key drugs of regenerative medicine clinical trials, download a free report sample.

Scope

The clinical trials data used for these analyses were extracted from GlobalData’s Clinical Trials Database. The data was captured in the database as of September 8, 2022. The data has been analyzed by trial start year, phase, status, sponsor type, geography, single-country vs. multinational, virtual components, therapy area, indication, reasons for discontinuation, endpoint status, sponsors, and drugs.

Reasons to Buy

  • Trends of regenerative medicine trials through the years
  • Comparison of trials by sponsor type
  • Can view top therapy areas, indications, geographies and sponsors
  • Focus on the usage of decentralized clinical trials/virtual components
  • Analysis of top drugs used

Table of Contents

Executive Summary

Introduction

The Expanding Landscape of Regenerative Medicine

2020 Has the Most Regenerative Medicine Clinical Trials

Phase II Trials Top Regenerative Medicine Trials

Industry-Sponsored Trials Dominate

North America and the US Saw the Most Trials

North America Has the Most Single-Country Trials While Europe Has the Most Multinational

Virtual Components Used Less in Regenerative Medicine Clinical Trials

Cardiovascular Is the Most Researched Therapy Area

Low Accrual Rate Is the Leading Cause of Trial Termination

Phase II and Industry-Sponsored Trials Achieved Their Endpoints More Frequently

Mesoblast Is the Top Industry Sponsor

Foundation for Orthopedics and Regenerative Medicine Is the Top Non-industry Sponsor

Tisagenlecleucel Is the Top Drug Used in Regenerative Medicine Clinical Trials

Key Findings

Appendix

Figures

Figure 1: Number of regenerative medicine clinical trials, by trial start year

Figure 2: Regenerative medicine clinical trials, by phase and status

Figure 3: Number of regenerative medicine clinical trials, by sponsor type and year

Figures 4 & 5: Number of regenerative medicine clinical trials, by region and country

Figure 6: Single-country and multinational regenerative clinical trials, by region

Figure 7: Virtual components used in regenerative medicine clinical trials, by trial status

Figures 8 & 9: Regenerative medicine clinical trials, by therapy area and indication

Figure 10: Regenerative medicine clinical trials, by termination reason

Figure 11: Endpoint status of completed regenerative medicine clinical trials, by phase and sponsor type

Figure 12: Top industry sponsors for regenerative medicine clinical trials, by trial status

Figure 13: Top non-industry sponsors for regenerative medicine clinical trials, by trial status

Figure 14: Top drugs for regenerative medicine clinical trials, by trial status

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