CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 565 enrolled
Drug / intervention
Rexlemestrocel-L +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02032004
NCT02032004Phase 3Completed
CompareCT.gov

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

Mesoblast, Inc.·interventional·Posted Jan 9, 2014·Updated Mar 23, 2026

In Brief

A Phase 3 clinical trial evaluating Rexlemestrocel-L and Sham Comparator for Chronic Heart Failure. Completed, enrolled 565 participants across 59 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Heart Failure
CountriesCanada, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJan 9, 2014
Enrollment StartMar 3, 2014
Primary CompletionJan 30, 2020
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 12.5 years ago

Interventions

Rexlemestrocel-Lbiological

Rexlemestrocel-L consists of human bone marrow-derived allogeneic mesenchymal precursor cells (MPCs) isolated from bone mononuclear cells with anti-STRO-3 antibodies, expanded ex vivo, and cryopreserved.

Sham Comparatorother

The sham procedure was staged to script and did not include actual cardiac mapping or delivery of rexlemestrocel-L.