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Stem cells aim to tame heart failure in landmark trial

NCT ID NCT02032004

Disease control Sponsor: Mesoblast, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a single injection of special stem cells (Rexlemestrocel-L) into the heart for people with chronic heart failure. The goal was to see if it could reduce serious heart events like hospitalizations or death. The trial involved 565 adults and compared the stem cell treatment to a sham (fake) procedure. While not a cure, this approach aims to better control the disease and improve outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

565 people

The number who actually took part.

Started

Mar 2014

Finished

Jan 2020

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * The participant is 18 to 80 years of age, inclusive; both men and women will be enrolled. * The participant has a diagnosis of chronic HF of ischemic or nonischemic etiology for at least 6 months * The participant is on stable, optimally tolerated dosages of HF therapies including beta-blockers (approved for country-specific usage), angiotensin-converting enzyme (ACE) inhibitors or angiotensin-receptor blockers (ARBs), and/or aldosterone antagonists, without change in dose for at least 1 month before study intervention * The participant is on a stable, outpatient, oral diuretic dosing regimen in which the participant remains clinically stable during screening. * Other Criteria apply, please contact the investigator Exclusion Criteria: * The participant has NYHA Functional Class I or Functional Class IV symptoms. * Other Criteria apply, please contact the investigator

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Conditions

The condition(s) this trial relates to.

congestive heart failure Inflammation systolic heart failure Ventricular Dysfunction, Left

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic heart failure

Contacts and locations

Locations

  • Mesoblast Investigational Site 10754 - University of California, San Diego

    La Jolla, California, 92037, United States

  • Mesoblast Investigational Site 10755 - Texas Heart Institute

    Houston, Texas, 77030, United States

  • Mesoblast Investigational Site 10756 - Mayo Clinic

    Phoenix, Arizona, 85054, United States

  • Mesoblast Investigational Site 10757 - Cardiology, P.C.

    Birmingham, Alabama, 35211, United States

  • Mesoblast Investigational Site 10758 - The Christ Hospital

    Cincinnati, Ohio, 45219, United States

  • Mesoblast Investigational Site 10759 - Scripps Clinic

    La Jolla, California, 92037, United States

  • Mesoblast Investigational Site 10760 - Shands Hospital, University of Florida

    Gainesville, Florida, 32610, United States

  • Mesoblast Investigational Site 10761 - Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Mesoblast Investigational Site 10762 - Minneapolis Heart Institute

    Minneapolis, Minnesota, 55407, United States

  • Mesoblast Investigational Site 10763 - University Hospital

    Salt Lake City, Utah, 84132, United States

  • Mesoblast Investigational Site 10764 - University of Wisconsin

    Madison, Wisconsin, 53792, United States

  • Mesoblast Investigational Site 10765 - Georgia Regents University

    Augusta, Georgia, 30912, United States

  • Mesoblast Investigational Site 10766 - Michigan Cardiovascular Institute

    Saginaw, Michigan, 48602, United States

  • Mesoblast Investigational Site 10767 - Temple University Hospital

    Philadelphia, Pennsylvania, 19140, United States

  • Mesoblast Investigational Site 10768 - University of Miami

    Miami, Florida, 33215, United States

  • Mesoblast Investigational Site 10769 - Aurora Healthcare

    Milwaukee, Wisconsin, 53215, United States

  • Mesoblast Investigational Site 10770 - University of Cincinnati

    Cincinnati, Ohio, 45267, United States

  • Mesoblast Investigational Site 10771 - Heart & Vascular Research, Swedish Medical Center

    Seattle, Washington, 98122, United States

  • Mesoblast Investigational Site 10772 - University Cardiologist, Rush University Medical Center

    Chicago, Illinois, 60612, United States

  • Mesoblast Investigational Site 10773

    Cleveland, Ohio, United States

  • Mesoblast Investigational Site 10774 - University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213, United States

  • Mesoblast Investigational Site 10775 - Cedars-Sinai Medical Care Foundation

    Los Angeles, California, 90211, United States

  • Mesoblast Investigational Site 10776 - Columbia University Medical Center

    New York, New York, 10032, United States

  • Mesoblast Investigational Site 10777 - Stern Cardiovascular Foundation

    Germantown, Tennessee, 38125, United States

  • Mesoblast Investigational Site 10778 - Orange County Cardiology

    Orange, California, 92868, United States

  • Mesoblast Investigational Site 10779 - Mercy Gilbert Medical Center

    Gilbert, Arizona, 85297, United States

  • Mesoblast Investigational Site 10780 - Morton Plant Hospital

    Clearwater, Florida, 33756, United States

  • Mesoblast Investigational Site 10781 - Duke University

    Durham, North Carolina, 27710, United States

  • Mesoblast Investigational Site 10782

    Boston, Massachusetts, United States

  • Mesoblast Investigational Site 10783 - Gill Heart Institute, University of Kentucky

    Lexington, Kentucky, 40536, United States

  • Mesoblast Investigational Site 10785 - Lehigh Valley Hospital

    Allentown, Pennsylvania, 18103, United States

  • Mesoblast Investigational Site 10786 - Cardiovascular Associates of Mesa

    Mesa, Arizona, 85206, United States

  • Mesoblast Investigational Site 10789 - Aspirus Research Institute

    Wausau, Wisconsin, 54401, United States

  • Mesoblast Investigational Site 11024 - Victoria Heart Institute Foundation

    Victoria, British Columbia, V8R 4R2, Canada

  • Mesoblast Investigational Site 11025 - St. Michael's Hospital

    Toronto, Ontario, M5B 1W8, Canada

  • Mesoblast Investigational Site 11027

    Edmonton, Alberta, Canada

  • Mesoblast Investigational Site 13022 - University of Louisville

    Louisville, Kentucky, 40202, United States

  • Mesoblast Investigational Site 13023 - University of Arizona Medical Center

    Tucson, Arizona, 85724, United States

  • Mesoblast Investigational Site 13024 - Austin Heart, PLLC

    Austin, Texas, 78756, United States

  • Mesoblast Investigational Site 13026 - Sanger Heart and Vascular Institute, Carolinas Healthcare System

    Charlotte, North Carolina, 28203, United States

  • Mesoblast Investigational Site 13027 - Emory University School of Medicine

    Atlanta, Georgia, 30322, United States

  • Mesoblast Investigational Site 13030 - University of Iowa

    Iowa City, Iowa, 52242, United States

  • Mesoblast Investigational Site 13031 - St. John's Regional Medical Center

    Oxnard, California, 93030, United States

  • Mesoblast Investigational Site 13261 - University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • Mesoblast Investigational Site 13262 - University of Alabama at Birmingham Hospital

    Birmingham, Alabama, 35233, United States

  • Mesoblast Investigational Site 13263 - RWJ Barnabas Heart Center

    Newark, New Jersey, 07112, United States

  • Mesoblast Investigational Site 13264 - Florida Hospital Pepin Heart Institute

    Tampa, Florida, 33613, United States

  • Mesoblast Investigational Site 13265 - University of California, Los Angeles

    Los Angeles, California, 90045, United States

  • Mesoblast Investigational Site 13266

    New Orleans, Louisiana, United States

  • Mesoblast Investigational Site 13267 - Bethesda Heart Hospital

    Boynton Beach, Florida, 33435, United States

  • Mesoblast Investigational Site 13268 - Houston Methodist Hospital

    Houston, Texas, 77030, United States

  • Mesoblast Investigational Site 13273 - University of Florida Health

    Jacksonville, Florida, 32209, United States

  • Mesoblast Investigational Site 13274 - Soltero CV Research Center, Baylor Scott & White Research Institute

    Dallas, Texas, 75226, United States

  • Mesoblast Investigational Site 13275 - Stanford University Hospital

    Stanford, California, 94305, United States

  • Mesoblast Investigational Site 13277

    Philadelphia, Pennsylvania, United States

  • Mesoblast Investigational Site 13278 - OhioHealth Research Institute

    Columbus, Ohio, 43214, United States

  • Mesoblast Investigational Site 13279

    Milwaukee, Wisconsin, United States

  • Mesoblast Investigational Site 13280

    Orlando, Florida, United States

  • Mesoblast Investigational Site 13281

    Las Vegas, Nevada, United States

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