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

Primary Purpose

Chronic Heart Failure

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Allogeneic Mesenchymal Precursor Cells (MPCs)

Sham Comparator

About this trial

This is an interventional treatment trial for Chronic Heart Failure focused on measuring Chronic Heart Failure, CHF, Left Ventricular Systolic Dysfunction, Ischemic Heart Failure, Nonischemic Heart Failure, Stem Cells, Allogeneic Mesenchymal Precursor Cells

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

The patient is 18 to 80 years of age, inclusive; both men and women will be enrolled.
The patient has a diagnosis of chronic HF of ischemic or nonischemic etiology for at least 6 months
The patient 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 patient is on a stable, outpatient, oral diuretic dosing regimen in which the patient remains clinically stable during screening.
Other Criteria apply, please contact the investigator

Exclusion Criteria:

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

Sites / Locations

Mesoblast Investigational Site 10757 - Cardiology, P.C.
Mesoblast Investigational Site 13262 - University of Alabama at Birmingham Hospital
Mesoblast Investigational Site 10779 - Mercy Gilbert Medical Center
Mesoblast Investigational Site 10786 - Cardiovascular Associates of Mesa
Mesoblast Investigational Site 10756 - Mayo Clinic
Mesoblast Investigational Site 13023 - University of Arizona Medical Center
Mesoblast Investigational Site 10754 - University of California, San Diego
Mesoblast Investigational Site 10759 - Scripps Clinic
Mesoblast Investigational Site 13265 - University of California, Los Angeles
Mesoblast Investigational Site 10775 - Cedars-Sinai Medical Care Foundation
Mesoblast Investigational Site 10778 - Orange County Cardiology
Mesoblast Investigational Site 13031 - St. John's Regional Medical Center
Mesoblast Investigational Site 13275 - Stanford University Hospital
Mesoblast Investigational Site 13267 - Bethesda Heart Hospital
Mesoblast Investigational Site 10780 - Morton Plant Hospital
Mesoblast Investigational Site 10760 - Shands Hospital, University of Florida
Mesoblast Investigational Site 13273 - University of Florida Health
Mesoblast Investigational Site 10768 - University of Miami
Mesoblast Investigational Site 13280
Mesoblast Investigational Site 13264 - Florida Hospital Pepin Heart Institute
Mesoblast Investigational Site 13027 - Emory University School of Medicine
Mesoblast Investigational Site 10765 - Georgia Regents University
Mesoblast Investigational Site 10772 - University Cardiologist, Rush University Medical Center
Mesoblast Investigational Site 13030 - University of Iowa
Mesoblast Investigational Site 10783 - Gill Heart Institute, University of Kentucky
Mesoblast Investigational Site 13022 - University of Louisville
Mesoblast Investigational Site 13266
Mesoblast Investigational Site 10782
Mesoblast Investigational Site 10766 - Michigan Cardiovascular Institute
Mesoblast Investigational Site 10762 - Minneapolis Heart Institute
Mesoblast Investigational Site 10761 - Mayo Clinic
Mesoblast Investigational Site 13281
Mesoblast Investigational Site 13263 - RWJ Barnabas Heart Center
Mesoblast Investigational Site 10776 - Columbia University Medical Center
Mesoblast Investigational Site 13026 - Sanger Heart and Vascular Institute, Carolinas Healthcare System
Mesoblast Investigational Site 10781 - Duke University
Mesoblast Investigational Site 10758 - The Christ Hospital
Mesoblast Investigational Site 10770 - University of Cincinnati
Mesoblast Investigational Site 10773
Mesoblast Investigational Site 13278 - OhioHealth Research Institute
Mesoblast Investigational Site 10785 - Lehigh Valley Hospital
Mesoblast Investigational Site 13261 - University of Pennsylvania
Mesoblast Investigational Site 10767 - Temple University Hospital
Mesoblast Investigational Site 13277
Mesoblast Investigational Site 10774 - University of Pittsburgh
Mesoblast Investigational Site 10777 - Stern Cardiovascular Foundation
Mesoblast Investigational Site 13024 - Austin Heart, PLLC
Mesoblast Investigational Site 13274 - Soltero CV Research Center, Baylor Scott & White Research Institute
Mesoblast Investigational Site 10755 - Texas Heart Institute
Mesoblast Investigational Site 13268 - Houston Methodist Hospital
Mesoblast Investigational Site 10763 - University Hospital
Mesoblast Investigational Site 10771 - Heart & Vascular Research, Swedish Medical Center
Mesoblast Investigational Site 10764 - University of Wisconsin
Mesoblast Investigational Site 10769 - Aurora Healthcare
Mesoblast Investigational Site 13279
Mesoblast Investigational Site 10789 - Aspirus Research Institute
Mesoblast Investigational Site 11027
Mesoblast Investigational Site 11024 - Victoria Heart Institute Foundation
Mesoblast Investigational Site 11025 - St. Michael's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Allogeneic Mesenchymal Precursor Cells

Control Treatment

Arm Description

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

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

Outcomes

Primary Outcome Measures

Time to recurrent non-fatal decompensated heart failure major adverse cardiac events (HF-MACE) that occur prior to the first terminal cardiac event (TCE).

Secondary Outcome Measures

Time-to-first terminal cardiac event (TCE)

Time-to-hospital admissions for non-fatal decompensated HF events

Time-to-urgent care outpatient HF visits

Time-to-successfully resuscitated cardiac death (RCD) events

Total length of in-hospital stay in intensive care unit for non-fatal decompensated HF events

Time-to-first HF-MACE (composite of hospital admissions for decompensated HF, urgent care outpatient HF visit, and successfully RCD events)

Time-to-first HF-MACE (composite of hospital admissions for decompensated HF, urgent care outpatient HF visit, successfully RCD events or TCE)

Time-to-cardiac death

Time-to-all-cause death

Time-to-first non-fatal MI (myocardial infarction), non-fatal CVA (cerebrovascular attack) or coronary artery revascularization

Left Ventricular (LV) remodeling in LVESV determined by 2-D echocardiography

Correlations between baseline LVESV <=100 mL and LVESV >100 mL and clinical outcomes

Correlations between baseline LVESV <=100 mL and LVESV >100 mL and change in Month 6 to baseline LVESV and clinical outcomes

LV remodeling in LVEDV determined by 2-D echocardiography

Overall Left Ventricular systolic performance as assessed by left ventricular ejection fraction (LVEF [radionuclide ventriculography {RVG} or echocardiogram])

Functional exercise capacity as assessed by 6 Minute Walk Test

Functional status by New York Heart Association (NYHA) class

Quality of Life Measure - Minnesota Living With Heart Failure (MLHF) questionnaire

Quality of Life Measure - European Quality of Life (EuroQoL) 5-dimensional (EQ-5D) questionnaire

Safety as assessed by occurrence of adverse events related to the index cardiac catheterization on Day 0

Safety as assessed by occurrence of treatment-emergent adverse events

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)

Safety as assessed by urinalysis (blood, glucose, ketones, total protein)

Safety as assessed by vital signs (pulse, systolic blood pressure [BP], diastolic BP)

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.

Safety as assessed by telemetry monitoring findings (clinically significant arrhythmias)

Safety as assessed by rhythm analysis (specifically, ventricular arrhythmias) by interrogation of any implanted device capable of defibrillation

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)

Safety as assessed by physical examination findings judged as clinically significant changes from baseline by the investigator or newly occurring abnormalities (including weight)

Safety as assessed by important cardiovascular events from adjudicated data

Full Information

NCT ID

NCT02032004

First Posted

January 8, 2014

Last Updated

January 5, 2022

Sponsor

Mesoblast, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02032004

Brief Title

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

Acronym

DREAM HF-1

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Completed

Study Start Date

February 14, 2014 (Actual)

Primary Completion Date

May 29, 2020 (Actual)

Study Completion Date

May 29, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mesoblast, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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 patients with chronic HF due to LV systolic dysfunction of either ischemic or nonischemic etiology who have received optimal medical/revascularization therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Heart Failure

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

566 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Allogeneic Mesenchymal Precursor Cells

Arm Type

Experimental

Arm Description

Arm Title

Control Treatment

Arm Type

Sham Comparator

Arm Description

Intervention Type

Biological

Intervention Name(s)

Allogeneic Mesenchymal Precursor Cells (MPCs)

Other Intervention Name(s)

MPCs, rexlemestrocel-L

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Sham Comparator

Intervention Description

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

Primary Outcome Measure Information:

Title

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

6 Month minimum

Secondary Outcome Measure Information:

Title

Time-to-first terminal cardiac event (TCE)

Time Frame

6 Month minimum

Title

Time-to-hospital admissions for non-fatal decompensated HF events

Time Frame

6 Month minimum

Title

Time-to-urgent care outpatient HF visits

Time Frame

6 Month minimum

Title

Time-to-successfully resuscitated cardiac death (RCD) events

Time Frame

6 Month minimum

Title

Total length of in-hospital stay in intensive care unit for non-fatal decompensated HF events

Time Frame

6 Month minimum

Title

Time-to-first HF-MACE (composite of hospital admissions for decompensated HF, urgent care outpatient HF visit, and successfully RCD events)

Time Frame

6 Month minimum

Title

Time-to-first HF-MACE (composite of hospital admissions for decompensated HF, urgent care outpatient HF visit, successfully RCD events or TCE)

Time Frame

6 Month minimum

Title

Time-to-cardiac death

Time Frame

6 Month minimum

Title

Time-to-all-cause death

Time Frame

6 Month minimum

Title

Time-to-first non-fatal MI (myocardial infarction), non-fatal CVA (cerebrovascular attack) or coronary artery revascularization

Time Frame

6 Month minimum

Title

Left Ventricular (LV) remodeling in LVESV determined by 2-D echocardiography

Time Frame

Screening, day 0 (post-procedure), months 3, 6, and 12, and every 12 months thereafter during study conduct (6 Month minimum)

Title

Correlations between baseline LVESV <=100 mL and LVESV >100 mL and clinical outcomes

Time Frame

6 Month minimum

Title

Correlations between baseline LVESV <=100 mL and LVESV >100 mL and change in Month 6 to baseline LVESV and clinical outcomes

Time Frame

6 Month minimum

Title

LV remodeling in LVEDV determined by 2-D echocardiography

Time Frame

Screening, day 0 (post-procedure), months 3, 6, and 12, and every 12 months thereafter during study conduct (6 Month minimum)

Title

Overall Left Ventricular systolic performance as assessed by left ventricular ejection fraction (LVEF [radionuclide ventriculography {RVG} or echocardiogram])

Time Frame

Screening, day 0 (post-procedure), months 3, 6, and 12, and every 12 months thereafter during study conduct (6 Month minimum)

Title

Functional exercise capacity as assessed by 6 Minute Walk Test

Time Frame

Screening, months 3, 6, and 12, and every 12 months thereafter during study conduct (6 Month minimum)

Title

Functional status by New York Heart Association (NYHA) class

Time Frame

Screening, months 3, 6, and 12, and every 12 months thereafter during study conduct (6 Month minimum)

Title

Quality of Life Measure - Minnesota Living With Heart Failure (MLHF) questionnaire

Time Frame

Screening, months 3, 6, and 12, and every 6 months thereafter during study conduct (6 Month minimum)

Title

Quality of Life Measure - European Quality of Life (EuroQoL) 5-dimensional (EQ-5D) questionnaire

Time Frame

Screening, months 3, 6, and 12, and every 6 months thereafter during study conduct (6 Month minimum)

Title

Safety as assessed by occurrence of adverse events related to the index cardiac catheterization on Day 0

Time Frame

Day 0 through discharge from Day 0 hospitalization

Title

Safety as assessed by occurrence of treatment-emergent adverse events

Time Frame

Screening through 6 Month minimum

Title

Description

Time Frame

Screening, day 0 (post-procedure), day 10, months 1, 3, 6, and 12, and every 6 months thereafter during study conduct (6 Month minimum)

Title

Safety as assessed by urinalysis (blood, glucose, ketones, total protein)

Time Frame

Screening, day 10, months 1, 3, 6, and 12, and every 6 months thereafter during study conduct (6 Month minimum)

Title

Safety as assessed by vital signs (pulse, systolic blood pressure [BP], diastolic BP)

Time Frame

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)

Title

Time Frame

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)

Title

Safety as assessed by telemetry monitoring findings (clinically significant arrhythmias)

Time Frame

Day 0 through Day 0 overnight post-procedure

Title

Safety as assessed by rhythm analysis (specifically, ventricular arrhythmias) by interrogation of any implanted device capable of defibrillation

Time Frame

Day 10, months 1, 3, 6, and 12, and every 6 months thereafter during study conduct (6 Month minimum)

Title

Time Frame

Screening, day 0 (post-procedure), day 10, months 1 and 3

Title

Safety as assessed by physical examination findings judged as clinically significant changes from baseline by the investigator or newly occurring abnormalities (including weight)

Time Frame

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)

Title

Safety as assessed by important cardiovascular events from adjudicated data

Time Frame

6 Month minimum

Other Pre-specified Outcome Measures:

Title

Pharmacodynamics Measures (N-terminal (NT)-pro hormone BNP [NT-proBNP] and high-sensitivity C-reactive protein [hs-CRP])

Time Frame

Screening, months 3, 6, 12 and every 12 months thereafter until study conclusion

Title

Pharmacogenomics (PGx) Analysis

Time Frame

Screening (only from those subjects who provide consent to participate in PGx sample collection)

Title

Immunogenicity Measures (panel reactive antibodies, donor specific antibody, if panel-reactive antibody (PRA) test is positive, antibodies against bovine and murine products)

Time Frame

Screening, day 10, months 1, 3, 6, and 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: The patient is 18 to 80 years of age, inclusive; both men and women will be enrolled. The patient has a diagnosis of chronic HF of ischemic or nonischemic etiology for at least 6 months The patient 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 patient is on a stable, outpatient, oral diuretic dosing regimen in which the patient remains clinically stable during screening. Other Criteria apply, please contact the investigator Exclusion Criteria: The patient has NYHA Functional Class I or Functional Class IV symptoms. Other Criteria apply, please contact the investigator

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fred Grossman, DO

Organizational Affiliation

Mesoblast, Ltd.

Official's Role

Study Director

Facility Information:

Facility Name

Mesoblast Investigational Site 10757 - Cardiology, P.C.

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35211

Country

United States

Facility Name

Mesoblast Investigational Site 13262 - University of Alabama at Birmingham Hospital

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35233

Country

United States

Facility Name

Mesoblast Investigational Site 10779 - Mercy Gilbert Medical Center

City

Gilbert

State/Province

Arizona

ZIP/Postal Code

85297

Country

United States

Facility Name

Mesoblast Investigational Site 10786 - Cardiovascular Associates of Mesa

City

Mesa

State/Province

Arizona

ZIP/Postal Code

85206

Country

United States

Facility Name

Mesoblast Investigational Site 10756 - Mayo Clinic

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85054

Country

United States

Facility Name

Mesoblast Investigational Site 13023 - University of Arizona Medical Center

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85724

Country

United States

Facility Name

Mesoblast Investigational Site 10754 - University of California, San Diego

City

La Jolla

State/Province

California

ZIP/Postal Code

92037

Country

United States

Facility Name

Mesoblast Investigational Site 10759 - Scripps Clinic

City

La Jolla

State/Province

California

ZIP/Postal Code

92037

Country

United States

Facility Name

Mesoblast Investigational Site 13265 - University of California, Los Angeles

City

Los Angeles

State/Province

California

ZIP/Postal Code

90045

Country

United States

Facility Name

Mesoblast Investigational Site 10775 - Cedars-Sinai Medical Care Foundation

City

Los Angeles

State/Province

California

ZIP/Postal Code

90211

Country

United States

Facility Name

Mesoblast Investigational Site 10778 - Orange County Cardiology

City

Orange

State/Province

California

ZIP/Postal Code

92868

Country

United States

Facility Name

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

City

Oxnard

State/Province

California

ZIP/Postal Code

93030

Country

United States

Facility Name

Mesoblast Investigational Site 13275 - Stanford University Hospital

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

Facility Name

Mesoblast Investigational Site 13267 - Bethesda Heart Hospital

City

Boynton Beach

State/Province

Florida

ZIP/Postal Code

33435

Country

United States

Facility Name

Mesoblast Investigational Site 10780 - Morton Plant Hospital

City

Clearwater

State/Province

Florida

ZIP/Postal Code

33756

Country

United States

Facility Name

Mesoblast Investigational Site 10760 - Shands Hospital, University of Florida

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32610

Country

United States

Facility Name

Mesoblast Investigational Site 13273 - University of Florida Health

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32209

Country

United States

Facility Name

Mesoblast Investigational Site 10768 - University of Miami

City

Miami

State/Province

Florida

ZIP/Postal Code

33215

Country

United States

Facility Name

Mesoblast Investigational Site 13280

City

Orlando

State/Province

Florida

Country

United States

Facility Name

Mesoblast Investigational Site 13264 - Florida Hospital Pepin Heart Institute

City

Tampa

State/Province

Florida

ZIP/Postal Code

33613

Country

United States

Facility Name

Mesoblast Investigational Site 13027 - Emory University School of Medicine

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

Facility Name

Mesoblast Investigational Site 10765 - Georgia Regents University

City

Augusta

State/Province

Georgia

ZIP/Postal Code

30912

Country

United States

Facility Name

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

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

Country

United States

Facility Name

Mesoblast Investigational Site 13030 - University of Iowa

City

Iowa City

State/Province

Iowa

ZIP/Postal Code

52242

Country

United States

Facility Name

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

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40536

Country

United States

Facility Name

Mesoblast Investigational Site 13022 - University of Louisville

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40202

Country

United States

Facility Name

Mesoblast Investigational Site 13266

City

New Orleans

State/Province

Louisiana

Country

United States

Facility Name

Mesoblast Investigational Site 10782

City

Boston

State/Province

Massachusetts

Country

United States

Facility Name

Mesoblast Investigational Site 10766 - Michigan Cardiovascular Institute

City

Saginaw

State/Province

Michigan

ZIP/Postal Code

48602

Country

United States

Facility Name

Mesoblast Investigational Site 10762 - Minneapolis Heart Institute

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55407

Country

United States

Facility Name

Mesoblast Investigational Site 10761 - Mayo Clinic

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Facility Name

Mesoblast Investigational Site 13281

City

Las Vegas

State/Province

Nevada

Country

United States

Facility Name

Mesoblast Investigational Site 13263 - RWJ Barnabas Heart Center

City

Newark

State/Province

New Jersey

ZIP/Postal Code

07112

Country

United States

Facility Name

Mesoblast Investigational Site 10776 - Columbia University Medical Center

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

Facility Name

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

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28203

Country

United States

Facility Name

Mesoblast Investigational Site 10781 - Duke University

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Facility Name

Mesoblast Investigational Site 10758 - The Christ Hospital

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45219

Country

United States

Facility Name

Mesoblast Investigational Site 10770 - University of Cincinnati

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45267

Country

United States

Facility Name

Mesoblast Investigational Site 10773

City

Cleveland

State/Province

Ohio

Country

United States

Facility Name

Mesoblast Investigational Site 13278 - OhioHealth Research Institute

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43214

Country

United States

Facility Name

Mesoblast Investigational Site 10785 - Lehigh Valley Hospital

City

Allentown

State/Province

Pennsylvania

ZIP/Postal Code

18103

Country

United States

Facility Name

Mesoblast Investigational Site 13261 - University of Pennsylvania

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

Mesoblast Investigational Site 10767 - Temple University Hospital

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19140

Country

United States

Facility Name

Mesoblast Investigational Site 13277

City

Philadelphia

State/Province

Pennsylvania

Country

United States

Facility Name

Mesoblast Investigational Site 10774 - University of Pittsburgh

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213

Country

United States

Facility Name

Mesoblast Investigational Site 10777 - Stern Cardiovascular Foundation

City

Germantown

State/Province

Tennessee

ZIP/Postal Code

38125

Country

United States

Facility Name

Mesoblast Investigational Site 13024 - Austin Heart, PLLC

City

Austin

State/Province

Texas

ZIP/Postal Code

78756

Country

United States

Facility Name

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

City

Dallas

State/Province

Texas

ZIP/Postal Code

75226

Country

United States

Facility Name

Mesoblast Investigational Site 10755 - Texas Heart Institute

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Mesoblast Investigational Site 13268 - Houston Methodist Hospital

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Mesoblast Investigational Site 10763 - University Hospital

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84132

Country

United States

Facility Name

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

City

Seattle

State/Province

Washington

ZIP/Postal Code

98122

Country

United States

Facility Name

Mesoblast Investigational Site 10764 - University of Wisconsin

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53792

Country

United States

Facility Name

Mesoblast Investigational Site 10769 - Aurora Healthcare

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53215

Country

United States

Facility Name

Mesoblast Investigational Site 13279

City

Milwaukee

State/Province

Wisconsin

Country

United States

Facility Name

Mesoblast Investigational Site 10789 - Aspirus Research Institute

City

Wausau

State/Province

Wisconsin

ZIP/Postal Code

54401

Country

United States

Facility Name

Mesoblast Investigational Site 11027

City

Edmonton

State/Province

Alberta

Country

Canada

Facility Name

Mesoblast Investigational Site 11024 - Victoria Heart Institute Foundation

City

Victoria

State/Province

British Columbia

ZIP/Postal Code

V8R 4R2

Country

Canada

Facility Name

Mesoblast Investigational Site 11025 - St. Michael's Hospital

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5B 1W8

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Yes

Citations:

PubMed Identifier

31318648

Citation

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. Erratum In: Circ Res. 2019 Aug 16;125(5):e28.

Results Reference

derived

Learn more about this trial

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

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