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

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.

Inclusion criteria

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

Exclusion criteria

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