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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
565
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.
The sham procedure was staged to script and did not include actual cardiac mapping or delivery of rexlemestrocel-L.
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.
Time frame: Up to 71 months
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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
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