for people ages 18-80 (full criteria)
study started
estimated completion



The primary objective of this study is to determine whether transendocardial delivery of allogeneic human bone marrow-derived MPCs (rexlemestrocel-L) is effective in the treatment of chronic heart failure due to LV systolic dysfunction.

Official Title

Double-blind, Randomized, Sham-procedure-controlled, Parallel-Group Efficacy and Safety Study of Allogeneic Mesenchymal Precursor Cells (Rexlemestrocel-L) in Chronic Heart Failure Due to LV Systolic Dysfunction (Ischemic or Nonischemic) Dream HF-1


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 (HF-MACE), preventing further adverse cardiac remodeling (LVESV and LVEDV), and increasing exercise capacity (6MWT) in patients with chronic HF due to LV systolic dysfunction of either ischemic or nonischemic etiology who have received optimal medical/revascularization therapy.


Chronic Heart Failure CHF Left Ventricular Systolic Dysfunction Ischemic Heart Failure Nonischemic Heart Failure Stem Cells Allogeneic Mesenchymal Precursor Cells Heart Failure Allogeneic Mesenchymal Precursor Cells (MPC)


You can join if…

Open to people ages 18-80

  • 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

You CAN'T join if...

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


  • Mesoblast Investigational Site 10754 - University of California, San Diego
    La Jolla California 92037 United States
  • Mesoblast Investigational Site 13265 - University of California, Los Angeles
    Los Angeles California 90045 United States
  • Mesoblast Investigational Site 10759 - Scripps Clinic
    La Jolla California 92037 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


in progress, not accepting new patients
Start Date
Completion Date
Mesoblast, Inc.
Phase 3
Study Type
Last Updated