Summary

for people ages 18-80 (full criteria)
at La Jolla, California and other locations
study started
estimated completion:
Eric Adler

Description

Summary

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

Details

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.

Keywords

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) Sham Comparator

Eligibility

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

Locations

  • Mesoblast Investigational Site 10754 - University of California, San Diego accepting new patients
    La Jolla California 92037 United States
  • Mesoblast Investigational Site 10759 - Scripps Clinic accepting new patients
    La Jolla California 92037 United States

Lead Scientist

  • Eric Adler
    Clinical Professor, Medicine. Authored (or co-authored) 42 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Mesoblast, Inc.
ID
NCT02032004
Phase
Phase 3
Study Type
Interventional
Last Updated