Chronic Heart FailurePhase 3DREAM HF-1NCT02032004

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

A Phase 3 study testing Rexlemestrocel-L in people with Chronic Heart Failure, run by Mesoblast, Inc. at 59 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Chronic Heart Failure
What is being tested?: Rexlemestrocel-L
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 565 participants
Where: 59 sitesin 2 countries
Study dates: 3 Mar 2014to 30 Jan 2020
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

59 sites in 2 countries.

Country

City, postcode or hospital

59 sites in 2 countries

United States56 sites

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

Other trials in United States

Canada3 sites

Mesoblast Investigational Site 11027
Edmonton, Alberta
Mesoblast Investigational Site 11025 - St. Michael's Hospital
Toronto, Ontario, M5B 1W8
Mesoblast Investigational Site 11024 - Victoria Heart Institute Foundation
Victoria, British Columbia, V8R 4R2

Other trials in Canada

About this study

Official title: 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

Read the 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.

Conditions: Chronic Heart Failure
Being tested: Rexlemestrocel-L, Sham Comparator
Keywords: Chronic Heart Failure, CHF, Left Ventricular Systolic Dysfunction, Ischemic Heart Failure, Nonischemic Heart Failure, Stem Cells, Allogeneic Mesenchymal Precursor Cells, Inflammation
Medical subject headings: Ventricular Dysfunction, Left, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Rexlemestrocel-LBiological
Also called Allogeneic Mesenchymal Precursor Cells
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.
Sham ComparatorOther
The sham procedure was staged to script and did not include actual cardiac mapping or delivery of rexlemestrocel-L.

Study groups in NCT02032004
Study group	Role	What they receive
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. Receives: 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. Receives: Biological: Rexlemestrocel-L

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Up to 71 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Mar 201430 Jan 2020

First posted9 Jan 2014 (estimated)
Study start3 Mar 2014
Primary completion30 Jan 2020
Study completion30 Jan 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 565 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02032004
Sponsor's protocol ID: MSB-MPC-CHF001
Acronym: DREAM HF-1
Status last verified: Oct 2025
First submitted: 8 Jan 2014
Last updated: 23 Mar 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes

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.
PubMed 31318648

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Chronic Heart Failure trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT02032004
Acronym / sponsor ID: DREAM HF-1 / MSB-MPC-CHF001
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
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 565 participants (actual)
Lead sponsor: Mesoblast, Inc.Industry (pharma, biotech, devices)
Study start: 3 Mar 2014 (actual)
Primary completion: 30 Jan 2020 (actual)
Study completion: 30 Jan 2020 (actual)
First posted: 9 Jan 2014 (estimated)
Results: Posted 23 Mar 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Sham Control	Sham comparator	Other: Sham ComparatorParticipants 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.
Rexlemestrocel-L	Experimental	Biological: Rexlemestrocel-LParticipants 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.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Rexlemestrocel-LAlso: Allogeneic Mesenchymal Precursor CellsRexlemestrocel-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.	Biological	Rexlemestrocel-L
Sham ComparatorThe sham procedure was staged to script and did not include actual cardiac mapping or delivery of rexlemestrocel-L.	Other	Sham Control

Primary outcome

Time to Recurrent Non-fatal Decompensated Heart Failure Major Adverse Cardiac Events (HF-MACE) That Occur Prior to the First Terminal Cardiac Event (TCE)
Time frame: Up to 71 months
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.

Results and safety

Results posted to the registry on 23 Mar 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sham Control	282	193
Rexlemestrocel-L	283	192

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

Time frame: Up to 71 months. Median (Full Range). Unit: months

Measure	Sham Control n = 282	Rexlemestrocel-L n = 283
Value	29.70 (0.0 to 68.3)	27.53 (-0.3 to 65.2)

Population analysed: ITT Population included all participants randomly assigned to treatment (active or sham).

Adverse events

Time frame: From Day 0 up to end of study (Up to 71 months). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sham Control	191 of 276 (69.2%)	260 of 276 (94.2%)	74 of 282
Rexlemestrocel-L	170 of 261 (65.1%)	244 of 261 (93.5%)	79 of 283

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31318648Borow 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.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: Yes

Related trials for Chronic Heart Failure

Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
Not yet recruiting
Community Health Worker Nutrition Self-Management Support for Cardio-Kidney-Metabolic Health
Hypertension (HTN), CKD - Chronic Kidney Disease
RecruitingPhase 4
The Effects of Low-Dose Versus High-Dose Intravenous IRON Therapy With Ferric DerisomaltOSE in Patients With Chronic Heart Failure and Iron Deficiency
Heart Failure, Iron Deficiency
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
RecruitingObservational study
Norepinephrine in the Management of General Anesthesia-Induced Arterial Hypotension in Chronic Heart Failure Patients
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Eric Rose, MD study director

Mesoblast, Ltd.

59 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rexlemestrocel-L in people with Chronic Heart Failure, run by Mesoblast, Inc. at 59 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 59 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Recurrent Non-fatal Decompensated Heart Failure Major Adverse Cardiac Events (HF-MACE) That Occur Prior to the First Terminal Cardiac Event (TCE) (time frame: Up to 71 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02032004, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026; AzTrials last refreshed its copy on 7 Nov 2026.