Heart Failure Clinical Trial

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

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.

View Full Description

Full 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.

View Eligibility Criteria

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

Study is for people with:

Heart Failure

Phase:

Phase 3

Estimated Enrollment:

566

Study ID:

NCT02032004

Recruitment Status:

Completed

Sponsor:

Mesoblast, Inc.

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 49 Locations for this study

See Locations Near You

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

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Phase:

Phase 3

Estimated Enrollment:

566

Study ID:

NCT02032004

Recruitment Status:

Completed

Sponsor:


Mesoblast, Inc.

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider