Phase 3 N=565 Randomized Triple-blind Treatment

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

Chronic Heart Failure

Bottom Line

View on ClinicalTrials.gov: NCT02032004 ↗

Enrolled (actual)

565

Serious AEs

67.2%

Results posted

Mar 2026

Primary outcome: Primary: Time to Recurrent Non-fatal Decompensated Heart Failure Major Adverse Cardiac Events (HF-MACE) That Occur Prior to the First Terminal Cardiac Event (TCE) — 29.70; 27.53 months

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Rexlemestrocel-L (Biological); Sham Comparator (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Mesoblast, Inc.
Primary completion: Jan 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Time to Recurrent Non-fatal Decompensated Heart Failure Major Adverse Cardiac Events (HF-MACE) That Occur Prior to the First Terminal Cardiac Event (TCE)	29.70; 27.53	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02032004). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.