Phase 3
Completed N=565
Efficacy and Safety of Allogeneic Mesenchymal Precursor Cells (Rexlemestrocel-L) for the Treatment of Heart Failure
Source: ClinicalTrials.gov NCT02032004 ↗Enrolled (actual)
565
Serious AEs
67.2%
Results posted
Mar 2026
Primary outcomePrimary: 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
◆ Published Evidence
Established
84citations · ~12 / year
Phase 3 DREAM-HF Trial of Mesenchymal Precursor Cells in Chronic Heart Failure.
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.
Linked Publications
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Phase 3 DREAM-HF Trial of Mesenchymal Precursor Cells in Chronic Heart Failure.
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 | — |
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
Data sourced from ClinicalTrials.gov (NCT02032004) and the linked publication. 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. Informational only — not medical advice.