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.
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.
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
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There are 49 Locations for this study
Birmingham Alabama, 35211, United States
Birmingham Alabama, 35233, United States
Gilbert Arizona, 85297, United States
Mesa Arizona, 85206, United States
Phoenix Arizona, 85054, United States
Tucson Arizona, 85724, United States
La Jolla California, 92037, United States
La Jolla California, 92037, United States
Los Angeles California, 90045, United States
Los Angeles California, 90211, United States
Orange California, 92868, United States
Oxnard California, 93030, United States
Stanford California, 94305, United States
Boynton Beach Florida, 33435, United States
Clearwater Florida, 33756, United States
Gainesville Florida, 32610, United States
Jacksonville Florida, 32209, United States
Miami Florida, 33215, United States
Orlando Florida, , United States
Tampa Florida, 33613, United States
Atlanta Georgia, 30322, United States
Augusta Georgia, 30912, United States
Chicago Illinois, 60612, United States
Iowa City Iowa, 52242, United States
Lexington Kentucky, 40536, United States
Louisville Kentucky, 40202, United States
New Orleans Louisiana, , United States
Boston Massachusetts, , United States
Saginaw Michigan, 48602, United States
Minneapolis Minnesota, 55407, United States
Rochester Minnesota, 55905, United States
Las Vegas Nevada, , United States
Newark New Jersey, 07112, United States
New York New York, 10032, United States
Charlotte North Carolina, 28203, United States
Durham North Carolina, 27710, United States
Cincinnati Ohio, 45219, United States
Cincinnati Ohio, 45267, United States
Cleveland Ohio, , United States
Columbus Ohio, 43214, United States
Allentown Pennsylvania, 18103, United States
Philadelphia Pennsylvania, 19104, United States
Philadelphia Pennsylvania, 19140, United States
Philadelphia Pennsylvania, , United States
Pittsburgh Pennsylvania, 15213, United States
Germantown Tennessee, 38125, United States
Austin Texas, 78756, United States
Dallas Texas, 75226, United States
Houston Texas, 77030, United States
Houston Texas, 77030, United States
Salt Lake City Utah, 84132, United States
Seattle Washington, 98122, United States
Madison Wisconsin, 53792, United States
Milwaukee Wisconsin, 53215, United States
Milwaukee Wisconsin, , United States
Wausau Wisconsin, 54401, United States
Edmonton Alberta, , Canada
Victoria British Columbia, V8R 4, Canada
Toronto Ontario, M5B 1, Canada
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