Efficacy and Safety of Allogeneic Mesenchymal Precursor Cells (Rexlemestrocel-L) for the Treatment of Heart Failure. (DREAM HF-1)

Mesoblast

Status and phase: Completed; Phase 3

Conditions: Chronic Heart Failure

Treatments: Biological: Allogeneic Mesenchymal Precursor Cells (MPCs); Other: Sham Comparator

Study type: Interventional

Funder types: Industry

Identifiers

NCT02032004

MSB-MPC-CHF001

Details and patient eligibility

About

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.

Enrollment: 566 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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566 participants in 2 patient groups

Allogeneic Mesenchymal Precursor Cells

Experimental group

Description:

Participants randomly assigned to treatment will undergo a single index cardiac catheterization involving transendocardial delivery of rexlemestrocel-L into the myocardium at a cell injection center by an interventional cardiology team not involved with review or assessment of subsequent study results.

Treatment:

Biological: Allogeneic Mesenchymal Precursor Cells (MPCs)

Control Treatment

Sham Comparator group

Description:

Participants randomly assigned to control treatment will undergo a single cardiac catheterization involving a scripted sham cardiac mapping and cell delivery procedure at a cell injection center by an interventional cardiology team not involved with review or assessment of subsequent study results.

Treatment:

Other: Sham Comparator