Efficacy and Safety of Allogeneic Mesenchymal Precursor Cells (Rexlemestrocel-L) for the Treatment of Heart Failure.
NCT ID: NCT02032004
Last Updated: 2022-01-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
566 participants
INTERVENTIONAL
2014-02-14
2020-05-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Allogeneic Mesenchymal Precursor Cells
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.
Allogeneic Mesenchymal Precursor Cells (MPCs)
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
Control Treatment
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.
Sham Comparator
The sham procedure will be staged to script and will not include actual cardiac mapping or delivery of rexlemestrocel-L.
Interventions
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Allogeneic Mesenchymal Precursor Cells (MPCs)
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
Sham Comparator
The sham procedure will be staged to script and will not include actual cardiac mapping or delivery of rexlemestrocel-L.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Other Criteria apply, please contact the investigator
18 Years
80 Years
ALL
No
Sponsors
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Mesoblast, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Fred Grossman, DO
Role: STUDY_DIRECTOR
Mesoblast, Ltd.
Locations
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Mesoblast Investigational Site 10757 - Cardiology, P.C.
Birmingham, Alabama, United States
Mesoblast Investigational Site 13262 - University of Alabama at Birmingham Hospital
Birmingham, Alabama, United States
Mesoblast Investigational Site 10779 - Mercy Gilbert Medical Center
Gilbert, Arizona, United States
Mesoblast Investigational Site 10786 - Cardiovascular Associates of Mesa
Mesa, Arizona, United States
Mesoblast Investigational Site 10756 - Mayo Clinic
Phoenix, Arizona, United States
Mesoblast Investigational Site 13023 - University of Arizona Medical Center
Tucson, Arizona, United States
Mesoblast Investigational Site 10754 - University of California, San Diego
La Jolla, California, United States
Mesoblast Investigational Site 10759 - Scripps Clinic
La Jolla, California, United States
Mesoblast Investigational Site 13265 - University of California, Los Angeles
Los Angeles, California, United States
Mesoblast Investigational Site 10775 - Cedars-Sinai Medical Care Foundation
Los Angeles, California, United States
Mesoblast Investigational Site 10778 - Orange County Cardiology
Orange, California, United States
Mesoblast Investigational Site 13031 - St. John's Regional Medical Center
Oxnard, California, United States
Mesoblast Investigational Site 13275 - Stanford University Hospital
Stanford, California, United States
Mesoblast Investigational Site 13267 - Bethesda Heart Hospital
Boynton Beach, Florida, United States
Mesoblast Investigational Site 10780 - Morton Plant Hospital
Clearwater, Florida, United States
Mesoblast Investigational Site 10760 - Shands Hospital, University of Florida
Gainesville, Florida, United States
Mesoblast Investigational Site 13273 - University of Florida Health
Jacksonville, Florida, United States
Mesoblast Investigational Site 10768 - University of Miami
Miami, Florida, United States
Mesoblast Investigational Site 13280
Orlando, Florida, United States
Mesoblast Investigational Site 13264 - Florida Hospital Pepin Heart Institute
Tampa, Florida, United States
Mesoblast Investigational Site 13027 - Emory University School of Medicine
Atlanta, Georgia, United States
Mesoblast Investigational Site 10765 - Georgia Regents University
Augusta, Georgia, United States
Mesoblast Investigational Site 10772 - University Cardiologist, Rush University Medical Center
Chicago, Illinois, United States
Mesoblast Investigational Site 13030 - University of Iowa
Iowa City, Iowa, United States
Mesoblast Investigational Site 10783 - Gill Heart Institute, University of Kentucky
Lexington, Kentucky, United States
Mesoblast Investigational Site 13022 - University of Louisville
Louisville, Kentucky, 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, United States
Mesoblast Investigational Site 10762 - Minneapolis Heart Institute
Minneapolis, Minnesota, United States
Mesoblast Investigational Site 10761 - Mayo Clinic
Rochester, Minnesota, United States
Mesoblast Investigational Site 13281
Las Vegas, Nevada, United States
Mesoblast Investigational Site 13263 - RWJ Barnabas Heart Center
Newark, New Jersey, United States
Mesoblast Investigational Site 10776 - Columbia University Medical Center
New York, New York, United States
Mesoblast Investigational Site 13026 - Sanger Heart and Vascular Institute, Carolinas Healthcare System
Charlotte, North Carolina, United States
Mesoblast Investigational Site 10781 - Duke University
Durham, North Carolina, United States
Mesoblast Investigational Site 10758 - The Christ Hospital
Cincinnati, Ohio, United States
Mesoblast Investigational Site 10770 - University of Cincinnati
Cincinnati, Ohio, United States
Mesoblast Investigational Site 10773
Cleveland, Ohio, United States
Mesoblast Investigational Site 13278 - OhioHealth Research Institute
Columbus, Ohio, United States
Mesoblast Investigational Site 10785 - Lehigh Valley Hospital
Allentown, Pennsylvania, United States
Mesoblast Investigational Site 13261 - University of Pennsylvania
Philadelphia, Pennsylvania, United States
Mesoblast Investigational Site 10767 - Temple University Hospital
Philadelphia, Pennsylvania, United States
Mesoblast Investigational Site 13277
Philadelphia, Pennsylvania, United States
Mesoblast Investigational Site 10774 - University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Mesoblast Investigational Site 10777 - Stern Cardiovascular Foundation
Germantown, Tennessee, United States
Mesoblast Investigational Site 13024 - Austin Heart, PLLC
Austin, Texas, United States
Mesoblast Investigational Site 13274 - Soltero CV Research Center, Baylor Scott & White Research Institute
Dallas, Texas, United States
Mesoblast Investigational Site 10755 - Texas Heart Institute
Houston, Texas, United States
Mesoblast Investigational Site 13268 - Houston Methodist Hospital
Houston, Texas, United States
Mesoblast Investigational Site 10763 - University Hospital
Salt Lake City, Utah, United States
Mesoblast Investigational Site 10771 - Heart & Vascular Research, Swedish Medical Center
Seattle, Washington, United States
Mesoblast Investigational Site 10764 - University of Wisconsin
Madison, Wisconsin, United States
Mesoblast Investigational Site 10769 - Aurora Healthcare
Milwaukee, Wisconsin, United States
Mesoblast Investigational Site 13279
Milwaukee, Wisconsin, United States
Mesoblast Investigational Site 10789 - Aspirus Research Institute
Wausau, Wisconsin, United States
Mesoblast Investigational Site 11027
Edmonton, Alberta, Canada
Mesoblast Investigational Site 11024 - Victoria Heart Institute Foundation
Victoria, British Columbia, Canada
Mesoblast Investigational Site 11025 - St. Michael's Hospital
Toronto, Ontario, Canada
Countries
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References
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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.
Other Identifiers
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MSB-MPC-CHF001
Identifier Type: -
Identifier Source: org_study_id
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