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NCT02032004 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study, sponsored by Mesoblast.

Completed
Registry status
Phase 3
Development phase
565
Enrollment target

NCT02032004: Completed Phase 3 study, sponsored by Mesoblast.

NCT02032004 is a Phase 3 study that has completed, run by Mesoblast. The registered enrollment target is 565 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (27% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02032004, a Phase 3 study, has completed, sponsored by Mesoblast.

COMPLETED
Registry status
Phase 3
Development phase
565 participants
Enrollment target

Study 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.

Primary Outcome

Non-fatal decompensated heart failure (HF) event was adjudicated when the diagnosis of a nonfatal decompensated HF event demonstrated the presence of signs and symptoms consistent with clinical decompensation of the participant's HF state requiring an in-hospital stay or intravenous (IV) diuretic therapy or aquapheresis during an urgent care outpatient HF visit. TCEs were defined as a composite of cardiac death, left ventricular assist device (LVAD) placement, heart transplant, or artificial hea

Interventions

  • OTHER Sham Comparator
  • BIOLOGICAL Rexlemestrocel-L

Trial Details

FieldValue
Enrollment Target 565 participants
Start Date 2014-03-03
Est. Completion 2020-01-30
Phase Phase 3
Mesoblast

25 total trials

What the finished NCT02032004 record still lists

NCT02032004 is an interventional study that assigns participants to a tested intervention. The registered 565 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (27% lower).

The record links to 0 conditions, and to 2 interventions - of which Sham Comparator is the first listed.

NCT02032004 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02032004 about?

NCT02032004 is a clinical study titled "Efficacy and Safety of Allogeneic Mesenchymal Precursor Cells (Rexlemestrocel-L) for the Treatment of Heart Failure". 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.

What is the current status of trial NCT02032004?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 565 participants. The study started on 2014-03-03. Estimated completion is 2020-01-30.

What interventions are being tested in trial NCT02032004?

The interventions under investigation include: Sham Comparator (OTHER), Rexlemestrocel-L (BIOLOGICAL).

Who is sponsoring clinical trial NCT02032004?

This trial is sponsored by Mesoblast, which has 25 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02032004's enrollment target sits among peer trials

565 667th of 2000 higher than 1,333 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02032004, the US trial registry maintained by the National Library of Medicine. NCT02032004 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.