Efficacy and Safety of Allogeneic Mesenchymal Precursor Cells (Rexlemestrocel-L) for the Treatment of Heart Failure (DREAM HF-1)

Double-blind, Randomized, Sham-procedure-controlled, Parallel-Group Efficacy and Safety Study of Allogeneic Mesenchymal Precursor Cells (Rexlemestrocel-L) in Chronic Heart Failure Due to LV Systolic Dysfunction (Ischemic or Nonischemic) Dream HF-1

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.

Study Overview

• Status: Completed
• Conditions: Chronic Heart Failure
• Intervention / Treatment: Other: Sham Comparator; Biological: Rexlemestrocel-L

Detailed Description

The purpose of this study is to evaluate the efficacy and safety of a single transendocardial delivery in the cardiac catheterization laboratory of human bone marrow-derived allogeneic MPCs (rexlemestrocel-L) for improvement in clinical outcomes (heart failure major adverse cardiac events [HF-MACE]), preventing further adverse cardiac remodeling (left ventricular end systolic volume [LVESV] and left ventricular end-diastolic volume [LVEDV]), and increasing exercise capacity (six-minute walking test [6MWT]) in participants with chronic HF due to LV systolic dysfunction of either ischemic or nonischemic etiology who have received optimal medical/revascularization therapy.

• Study Type: Interventional
• Enrollment (Actual): 565
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada
      • Mesoblast Investigational Site 11027
  • British Columbia
    • Victoria, British Columbia, Canada, V8R 4R2
      • Mesoblast Investigational Site 11024 - Victoria Heart Institute Foundation
  • Ontario
    • Toronto, Ontario, Canada, M5B 1W8
      • Mesoblast Investigational Site 11025 - St. Michael's Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35211
      • Mesoblast Investigational Site 10757 - Cardiology, P.C.
    • Birmingham, Alabama, United States, 35233
      • Mesoblast Investigational Site 13262 - University of Alabama at Birmingham Hospital
  • Arizona
    • Gilbert, Arizona, United States, 85297
      • Mesoblast Investigational Site 10779 - Mercy Gilbert Medical Center
    • Mesa, Arizona, United States, 85206
      • Mesoblast Investigational Site 10786 - Cardiovascular Associates of Mesa
    • Phoenix, Arizona, United States, 85054
      • Mesoblast Investigational Site 10756 - Mayo Clinic
    • Tucson, Arizona, United States, 85724
      • Mesoblast Investigational Site 13023 - University of Arizona Medical Center
  • California
    • La Jolla, California, United States, 92037
      • Mesoblast Investigational Site 10754 - University of California, San Diego
    • La Jolla, California, United States, 92037
      • Mesoblast Investigational Site 10759 - Scripps Clinic
    • Los Angeles, California, United States, 90045
      • Mesoblast Investigational Site 13265 - University of California, Los Angeles
    • Los Angeles, California, United States, 90211
      • Mesoblast Investigational Site 10775 - Cedars-Sinai Medical Care Foundation
    • Orange, California, United States, 92868
      • Mesoblast Investigational Site 10778 - Orange County Cardiology
    • Oxnard, California, United States, 93030
      • Mesoblast Investigational Site 13031 - St. John's Regional Medical Center
    • Stanford, California, United States, 94305
      • Mesoblast Investigational Site 13275 - Stanford University Hospital
  • Florida
    • Boynton Beach, Florida, United States, 33435
      • Mesoblast Investigational Site 13267 - Bethesda Heart Hospital
    • Clearwater, Florida, United States, 33756
      • Mesoblast Investigational Site 10780 - Morton Plant Hospital
    • Gainesville, Florida, United States, 32610
      • Mesoblast Investigational Site 10760 - Shands Hospital, University of Florida
    • Jacksonville, Florida, United States, 32209
      • Mesoblast Investigational Site 13273 - University of Florida Health
    • Miami, Florida, United States, 33215
      • Mesoblast Investigational Site 10768 - University of Miami
    • Orlando, Florida, United States
      • Mesoblast Investigational Site 13280
    • Tampa, Florida, United States, 33613
      • Mesoblast Investigational Site 13264 - Florida Hospital Pepin Heart Institute
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Mesoblast Investigational Site 13027 - Emory University School of Medicine
    • Augusta, Georgia, United States, 30912
      • Mesoblast Investigational Site 10765 - Georgia Regents University
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Mesoblast Investigational Site 10772 - University Cardiologist, Rush University Medical Center
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • Mesoblast Investigational Site 13030 - University of Iowa
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • Mesoblast Investigational Site 10783 - Gill Heart Institute, University of Kentucky
    • Louisville, Kentucky, United States, 40202
      • Mesoblast Investigational Site 13022 - University of Louisville
  • Louisiana
    • New Orleans, Louisiana, United States
      • Mesoblast Investigational Site 13266
  • Massachusetts
    • Boston, Massachusetts, United States
      • Mesoblast Investigational Site 10782
  • Michigan
    • Saginaw, Michigan, United States, 48602
      • Mesoblast Investigational Site 10766 - Michigan Cardiovascular Institute
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Mesoblast Investigational Site 10762 - Minneapolis Heart Institute
    • Rochester, Minnesota, United States, 55905
      • Mesoblast Investigational Site 10761 - Mayo Clinic
  • Nevada
    • Las Vegas, Nevada, United States
      • Mesoblast Investigational Site 13281
  • New Jersey
    • Newark, New Jersey, United States, 07112
      • Mesoblast Investigational Site 13263 - RWJ Barnabas Heart Center
  • New York
    • New York, New York, United States, 10032
      • Mesoblast Investigational Site 10776 - Columbia University Medical Center
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • Mesoblast Investigational Site 13026 - Sanger Heart and Vascular Institute, Carolinas Healthcare System
    • Durham, North Carolina, United States, 27710
      • Mesoblast Investigational Site 10781 - Duke University
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Mesoblast Investigational Site 10758 - The Christ Hospital
    • Cincinnati, Ohio, United States, 45267
      • Mesoblast Investigational Site 10770 - University of Cincinnati
    • Cleveland, Ohio, United States
      • Mesoblast Investigational Site 10773
    • Columbus, Ohio, United States, 43214
      • Mesoblast Investigational Site 13278 - OhioHealth Research Institute
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • Mesoblast Investigational Site 10785 - Lehigh Valley Hospital
    • Philadelphia, Pennsylvania, United States, 19104
      • Mesoblast Investigational Site 13261 - University of Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Mesoblast Investigational Site 10767 - Temple University Hospital
    • Philadelphia, Pennsylvania, United States
      • Mesoblast Investigational Site 13277
    • Pittsburgh, Pennsylvania, United States, 15213
      • Mesoblast Investigational Site 10774 - University of Pittsburgh
  • Tennessee
    • Germantown, Tennessee, United States, 38125
      • Mesoblast Investigational Site 10777 - Stern Cardiovascular Foundation
  • Texas
    • Austin, Texas, United States, 78756
      • Mesoblast Investigational Site 13024 - Austin Heart, PLLC
    • Dallas, Texas, United States, 75226
      • Mesoblast Investigational Site 13274 - Soltero CV Research Center, Baylor Scott & White Research Institute
    • Houston, Texas, United States, 77030
      • Mesoblast Investigational Site 10755 - Texas Heart Institute
    • Houston, Texas, United States, 77030
      • Mesoblast Investigational Site 13268 - Houston Methodist Hospital
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • Mesoblast Investigational Site 10763 - University Hospital
  • Washington
    • Seattle, Washington, United States, 98122
      • Mesoblast Investigational Site 10771 - Heart & Vascular Research, Swedish Medical Center
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • Mesoblast Investigational Site 10764 - University of Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • Mesoblast Investigational Site 10769 - Aurora Healthcare
    • Milwaukee, Wisconsin, United States
      • Mesoblast Investigational Site 13279
    • Wausau, Wisconsin, United States, 54401
      • Mesoblast Investigational Site 10789 - Aspirus Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Sham Control; 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; The sham procedure was staged to script and did not include actual cardiac mapping or delivery of rexlemestrocel-L.
Experimental: Rexlemestrocel-L; 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; 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.; Other Names: Allogeneic Mesenchymal Precursor Cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time-to-first terminal cardiac event (TCE)		6 Month minimum
Time-to-hospital admissions for non-fatal decompensated HF events		6 Month minimum
Time-to-urgent care outpatient HF visits		6 Month minimum
Time-to-successfully resuscitated cardiac death (RCD) events		6 Month minimum
Total length of in-hospital stay in intensive care unit for non-fatal decompensated HF events		6 Month minimum
Time-to-first HF-MACE (composite of hospital admissions for decompensated HF, urgent care outpatient HF visit, and successfully RCD events)		6 Month minimum
Time-to-first HF-MACE (composite of hospital admissions for decompensated HF, urgent care outpatient HF visit, successfully RCD events or TCE)		6 Month minimum
Time-to-cardiac death		6 Month minimum
Time-to-all-cause death		6 Month minimum
Time-to-first non-fatal MI (myocardial infarction), non-fatal CVA (cerebrovascular attack) or coronary artery revascularization		6 Month minimum
Left Ventricular (LV) remodeling in LVESV determined by 2-D echocardiography		Screening, day 0 (post-procedure), months 3, 6, and 12, and every 12 months thereafter during study conduct (6 Month minimum)
Correlations between baseline LVESV <=100 mL and LVESV >100 mL and clinical outcomes		6 Month minimum
Correlations between baseline LVESV <=100 mL and LVESV >100 mL and change in Month 6 to baseline LVESV and clinical outcomes		6 Month minimum
LV remodeling in LVEDV determined by 2-D echocardiography		Screening, day 0 (post-procedure), months 3, 6, and 12, and every 12 months thereafter during study conduct (6 Month minimum)
Overall Left Ventricular systolic performance as assessed by left ventricular ejection fraction (LVEF [radionuclide ventriculography {RVG} or echocardiogram])		Screening, day 0 (post-procedure), months 3, 6, and 12, and every 12 months thereafter during study conduct (6 Month minimum)
Functional exercise capacity as assessed by 6 Minute Walk Test		Screening, months 3, 6, and 12, and every 12 months thereafter during study conduct (6 Month minimum)
Functional status by New York Heart Association (NYHA) class		Screening, months 3, 6, and 12, and every 12 months thereafter during study conduct (6 Month minimum)
Quality of Life Measure - Minnesota Living With Heart Failure (MLHF) questionnaire		Screening, months 3, 6, and 12, and every 6 months thereafter during study conduct (6 Month minimum)
Quality of Life Measure - European Quality of Life (EuroQoL) 5-dimensional (EQ-5D) questionnaire		Screening, months 3, 6, and 12, and every 6 months thereafter during study conduct (6 Month minimum)
Safety as assessed by occurrence of adverse events related to the index cardiac catheterization on Day 0		Day 0 through discharge from Day 0 hospitalization
Safety as assessed by occurrence of treatment-emergent adverse events		Screening through 6 Month minimum
Safety as assessed by clinical laboratory tests (serum chemistry - ALT, AST, alkaline phosphate, GGT, LDH, BUN, creatinine, uric acid, total bilirubin - and hematology - hematocrit, hemoglobin, WBCs, eosinophils, ANC, platelet count)	ALT (alanine transaminase), AST (aspartate aminotransferase), GGT (gamma-glutamyl transferase), LDH (lactate dehydrogenase), BUN (blood urea nitrogen), WBCs (white blood cells), ANC (absolute neutrophil count)	Screening, day 0 (post-procedure), day 10, months 1, 3, 6, and 12, and every 6 months thereafter during study conduct (6 Month minimum)
Safety as assessed by urinalysis (blood, glucose, ketones, total protein)		Screening, day 10, months 1, 3, 6, and 12, and every 6 months thereafter during study conduct (6 Month minimum)
Safety as assessed by vital signs (pulse, systolic blood pressure [BP], diastolic BP)		Screening, day 0 (pre and post-procedure), day 1, day 10, months 1, 3, 6, and 12, and every 6 months thereafter during study conduct (6 Month minimum)
Safety as assessed by 12-lead electrocardiogram (ECG) findings - QT interval with Fridericia's correction (QTcF), heart rate-corrected QT interval (QTcB), QT, Q wave, R wave and S wave (QRS) complex, HR and T waves.		Screening, day 0 (pre and post-procedure), day 1, day 10, months 1, 3, 6, and 12, and every 6 months thereafter during study conduct (6 Month minimum)
Safety as assessed by telemetry monitoring findings (clinically significant arrhythmias)		Day 0 through Day 0 overnight post-procedure
Safety as assessed by rhythm analysis (specifically, ventricular arrhythmias) by interrogation of any implanted device capable of defibrillation		Day 10, months 1, 3, 6, and 12, and every 6 months thereafter during study conduct (6 Month minimum)
Safety as assessed by 24-hr Holter monitoring (HR, rate & duration of arrhythmias, a-fib average rate, supra- & ventricular ectopy singles/couplets/runs/totals, sustained & non-sustained ventricular tachycardia, longest pauses RR duration, total pauses)		Screening, day 0 (post-procedure), day 10, months 1 and 3
Safety as assessed by physical examination findings judged as clinically significant changes from baseline by the investigator or newly occurring abnormalities (including weight)		Screening, month 12 and every 12 months thereafter until study conclusion (weight measured at screening, day 0 - pre and post-procedure, day 1, day 10, months 1, 3, 6 and 12 and every 6 months thereafter)
Safety as assessed by important cardiovascular events from adjudicated data		6 Month minimum

Other Outcome Measures

Outcome Measure	Time Frame
Pharmacodynamics Measures (N-terminal (NT)-pro hormone BNP [NT-proBNP] and high-sensitivity C-reactive protein [hs-CRP])	Screening, months 3, 6, 12 and every 12 months thereafter until study conclusion
Pharmacogenomics (PGx) Analysis	Screening (only from those subjects who provide consent to participate in PGx sample collection)
Immunogenicity Measures (panel reactive antibodies, donor specific antibody, if panel-reactive antibody (PRA) test is positive, antibodies against bovine and murine products)	Screening, day 10, months 1, 3, 6, and 12

Collaborators and Investigators

• Sponsor: Mesoblast, Inc.
• Investigators: Study Director: Eric Rose, MD, Mesoblast, Ltd.

Publications and helpful links

General Publications

• 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2014
• Primary Completion (Actual): January 30, 2020
• Study Completion (Actual): January 30, 2020

Study Registration Dates

• First Submitted: January 8, 2014
• First Submitted That Met QC Criteria: January 8, 2014
• First Posted (Estimated): January 9, 2014

Study Record Updates

• Last Update Posted (Actual): March 23, 2026
• Last Update Submitted That Met QC Criteria: March 2, 2026
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Inflammation; Stem Cells; CHF; Chronic Heart Failure; Ischemic Heart Failure; Left Ventricular Systolic Dysfunction; Nonischemic Heart Failure; Allogeneic Mesenchymal Precursor Cells
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Ventricular Dysfunction; Pathological Conditions, Signs and Symptoms; Inflammation; Ventricular Dysfunction, Left
• Other Study ID Numbers: MSB-MPC-CHF001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No