Efficacy and Safety of Allogeneic Mesenchymal Precursor Cells (Rexlemestrocel-L) for the Treatment of Heart Failure

NCT02032004 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: MSB-MPC-CHF001
• Study Type: interventional
• Target: 565
• Locations: 2 countries
• Sites: 59

Brief Summary

The primary objective of this study is to determine whether transendocardial delivery of allogeneic human bone marrow-derived mesenchymal precursor cells (MPCs \[rexlemestrocel-L\]) is effective in the treatment of chronic heart failure (HF) due to left ventricular (LV) systolic dysfunction.

Conditions

Chronic Heart Failure

Keywords

Chronic Heart Failure; CHF; Left Ventricular Systolic Dysfunction; Ischemic Heart Failure; Nonischemic Heart Failure; Stem Cells; Allogeneic Mesenchymal Precursor Cells; Inflammation

Outcome Measures

Primary Outcomes (1)

• Time to Recurrent Non-fatal Decompensated Heart Failure Major Adverse Cardiac Events (HF-MACE) That Occur Prior to the First Terminal Cardiac Event (TCE)

  Non-fatal decompensated heart failure (HF) event was adjudicated when the diagnosis of a nonfatal decompensated HF event demonstrated the presence of signs and symptoms consistent with clinical decompensation of the participant's HF state requiring an in-hospital stay or intravenous (IV) diuretic therapy or aquapheresis during an urgent care outpatient HF visit. TCEs were defined as a composite of cardiac death, left ventricular assist device (LVAD) placement, heart transplant, or artificial heart implantation. Adjudication of all potential non-fatal HF-MACE or TCEs was performed by an independent, blinded Clinical Endpoints Adjudication Committee (CEC) based on the cardiac adjudication manual. Negative number in the time to event range indicates that event occurred to the subject before treatment.

  Up to 71 months

Study Arms (2)

Sham Control

SHAM COMPARATOR

Participants randomly assigned to control treatment underwent a single cardiac catheterization involving a scripted sham cardiac mapping and cell delivery procedure at a cell injection center at Day 0 by an interventional cardiology team not involved with review or assessment of subsequent study results.

Other: Sham Comparator

Rexlemestrocel-L

EXPERIMENTAL

Participants randomly assigned to treatment underwent a single index cardiac catheterization involving transendocardial delivery of rexlemestrocel-L into the myocardium at a cell injection center at Day 0 by an interventional cardiology team not involved with review or assessment of subsequent study results.

Biological: Rexlemestrocel-L

Interventions

Rexlemestrocel-L BIOLOGICAL

Rexlemestrocel-L consists of human bone marrow-derived allogeneic mesenchymal precursor cells (MPCs) isolated from bone mononuclear cells with anti-STRO-3 antibodies, expanded ex vivo, and cryopreserved.

Also known as: Allogeneic Mesenchymal Precursor Cells

Rexlemestrocel-L

Sham Comparator OTHER

The sham procedure was staged to script and did not include actual cardiac mapping or delivery of rexlemestrocel-L.

Sham Control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• The participant has NYHA Functional Class I or Functional Class IV symptoms.
• Other Criteria apply, please contact the investigator

Sponsors & Collaborators

• Mesoblast, Inc.: lead

Study Sites (59)

Mesoblast Investigational Site 10757 - Cardiology, P.C.

Birmingham, Alabama, 35211, United States

Location

Mesoblast Investigational Site 13262 - University of Alabama at Birmingham Hospital

Birmingham, Alabama, 35233, United States

Location

Mesoblast Investigational Site 10779 - Mercy Gilbert Medical Center

Gilbert, Arizona, 85297, United States

Location

Mesoblast Investigational Site 10786 - Cardiovascular Associates of Mesa

Mesa, Arizona, 85206, United States

Location

Mesoblast Investigational Site 10756 - Mayo Clinic

Phoenix, Arizona, 85054, United States

Location

Mesoblast Investigational Site 13023 - University of Arizona Medical Center

Tucson, Arizona, 85724, United States

Location

Mesoblast Investigational Site 10754 - University of California, San Diego

La Jolla, California, 92037, United States

Location

Mesoblast Investigational Site 10759 - Scripps Clinic

La Jolla, California, 92037, United States

Location

Mesoblast Investigational Site 13265 - University of California, Los Angeles

Los Angeles, California, 90045, United States

Location

Mesoblast Investigational Site 10775 - Cedars-Sinai Medical Care Foundation

Los Angeles, California, 90211, United States

Location

Mesoblast Investigational Site 10778 - Orange County Cardiology

Orange, California, 92868, United States

Location

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

Oxnard, California, 93030, United States

Location

Mesoblast Investigational Site 13275 - Stanford University Hospital

Stanford, California, 94305, United States

Location

Mesoblast Investigational Site 13267 - Bethesda Heart Hospital

Boynton Beach, Florida, 33435, United States

Location

Mesoblast Investigational Site 10780 - Morton Plant Hospital

Clearwater, Florida, 33756, United States

Location

Mesoblast Investigational Site 10760 - Shands Hospital, University of Florida

Gainesville, Florida, 32610, United States

Location

Mesoblast Investigational Site 13273 - University of Florida Health

Jacksonville, Florida, 32209, United States

Location

Mesoblast Investigational Site 10768 - University of Miami

Miami, Florida, 33215, United States

Location

Mesoblast Investigational Site 13280

Orlando, Florida, United States

Location

Mesoblast Investigational Site 13264 - Florida Hospital Pepin Heart Institute

Tampa, Florida, 33613, United States

Location

Mesoblast Investigational Site 13027 - Emory University School of Medicine

Atlanta, Georgia, 30322, United States

Location

Mesoblast Investigational Site 10765 - Georgia Regents University

Augusta, Georgia, 30912, United States

Location

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

Chicago, Illinois, 60612, United States

Location

Mesoblast Investigational Site 13030 - University of Iowa

Iowa City, Iowa, 52242, United States

Location

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

Lexington, Kentucky, 40536, United States

Location

Mesoblast Investigational Site 13022 - University of Louisville

Louisville, Kentucky, 40202, United States

Location

Mesoblast Investigational Site 13266

New Orleans, Louisiana, United States

Location

Mesoblast Investigational Site 10782

Boston, Massachusetts, United States

Location

Mesoblast Investigational Site 10766 - Michigan Cardiovascular Institute

Saginaw, Michigan, 48602, United States

Location

Mesoblast Investigational Site 10762 - Minneapolis Heart Institute

Minneapolis, Minnesota, 55407, United States

Location

Mesoblast Investigational Site 10761 - Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Mesoblast Investigational Site 13281

Las Vegas, Nevada, United States

Location

Mesoblast Investigational Site 13263 - RWJ Barnabas Heart Center

Newark, New Jersey, 07112, United States

Location

Mesoblast Investigational Site 10776 - Columbia University Medical Center

New York, New York, 10032, United States

Location

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

Charlotte, North Carolina, 28203, United States

Location

Mesoblast Investigational Site 10781 - Duke University

Durham, North Carolina, 27710, United States

Location

Mesoblast Investigational Site 10758 - The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

Mesoblast Investigational Site 10770 - University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

Mesoblast Investigational Site 10773

Cleveland, Ohio, United States

Location

Mesoblast Investigational Site 13278 - OhioHealth Research Institute

Columbus, Ohio, 43214, United States

Location

Mesoblast Investigational Site 10785 - Lehigh Valley Hospital

Allentown, Pennsylvania, 18103, United States

Location

Mesoblast Investigational Site 13261 - University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Mesoblast Investigational Site 10767 - Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

Mesoblast Investigational Site 13277

Philadelphia, Pennsylvania, United States

Location

Mesoblast Investigational Site 10774 - University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Mesoblast Investigational Site 10777 - Stern Cardiovascular Foundation

Germantown, Tennessee, 38125, United States

Location

Mesoblast Investigational Site 13024 - Austin Heart, PLLC

Austin, Texas, 78756, United States

Location

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

Dallas, Texas, 75226, United States

Location

Mesoblast Investigational Site 10755 - Texas Heart Institute

Houston, Texas, 77030, United States

Location

Mesoblast Investigational Site 13268 - Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

Mesoblast Investigational Site 10763 - University Hospital

Salt Lake City, Utah, 84132, United States

Location

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

Seattle, Washington, 98122, United States

Location

Mesoblast Investigational Site 10764 - University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

Mesoblast Investigational Site 10769 - Aurora Healthcare

Milwaukee, Wisconsin, 53215, United States

Location

Mesoblast Investigational Site 13279

Milwaukee, Wisconsin, United States

Location

Mesoblast Investigational Site 10789 - Aspirus Research Institute

Wausau, Wisconsin, 54401, United States

Location

Mesoblast Investigational Site 11027

Edmonton, Alberta, Canada

Location

Mesoblast Investigational Site 11024 - Victoria Heart Institute Foundation

Victoria, British Columbia, V8R 4R2, Canada

Location

Mesoblast Investigational Site 11025 - St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Related Publications (1)

• Borow KM, Yaroshinsky A, Greenberg B, Perin EC. Phase 3 DREAM-HF Trial of Mesenchymal Precursor Cells in Chronic Heart Failure. Circ Res. 2019 Jul 19;125(3):265-281. doi: 10.1161/CIRCRESAHA.119.314951. Epub 2019 Jul 18.

  PMID: 31318648 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Ventricular Dysfunction, Left; Inflammation

Condition Hierarchy (Ancestors)

Ventricular Dysfunction; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Susan Sukovich, Senior Director, Regulatory Affairs
• Organization: Mesoblast

Susan.Sukovich@mesoblast.com

212-993-7950

Study Officials

• Eric Rose, MD

  Mesoblast, Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2014
• First Posted: January 9, 2014
• Study Start: March 3, 2014
• Primary Completion: January 30, 2020
• Study Completion: January 30, 2020
• Last Updated: March 23, 2026
• Results First Posted: March 23, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share

Locations

CA (3); US (56)