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NCT01458405 · ClinicalTrials.gov registry record · Phase 1

Allogeneic Heart Stem Cells to Achieve Myocardial Regeneration

A Phase 1 study, sponsored by Capricor.

Terminated
Registry status
Phase 1
Development phase
135
Enrollment target

NCT01458405: Clinical Trial Phase 1 study, sponsored by Capricor.

NCT01458405 is a Phase 1 study that was terminated before completion, run by Capricor. The registered enrollment target is 135 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (125% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01458405, a Phase 1 study, was terminated before completion, sponsored by Capricor.

TERMINATED
Registry status
Phase 1
Development phase
135 participants
Enrollment target

Study Summary

The purpose of this study is to determine whether Allogeneic Cardiosphere-Derived Cells (CAP-1002) is safe and effective in decreasing infarct size in patients with a myocardial infarction.

Primary Outcome

Adjudicated Events reported included: Acute myocarditis; Death due to ventricular tachycardia (VT) or ventricular fibrillation (VF); Sudden unexpected death (defined as occurring within one hour of symptom onset, or un- witnessed death); and Major adverse cardiac event (MACE) (defined as the composite incidence of death, non- fatal recurrent MI, hospitalization for heart failure, emergency room treatment for heart failure, left ventricular assist device \[LVAD\] placement or heart transplant).

Interventions

  • DRUG Placebo
  • BIOLOGICAL CAP-1002 Allogeneic Cardiosphere-Derived Cells

Trial Details

FieldValue
Enrollment Target 135 participants
Start Date 2012-11-13
Est. Completion 2019-02-28
Phase Phase 1
Capricor

9 total trials

Why NCT01458405 stopped before completion

NCT01458405 is an interventional study that assigns participants to a tested intervention. The registered 135 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (125% higher).

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

NCT01458405 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01458405 about?

NCT01458405 is a clinical study titled "Allogeneic Heart Stem Cells to Achieve Myocardial Regeneration". The purpose of this study is to determine whether Allogeneic Cardiosphere-Derived Cells (CAP-1002) is safe and effective in decreasing infarct size in patients with a myocardial infarction.

What is the current status of trial NCT01458405?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 135 participants. The study started on 2012-11-13. Estimated completion is 2019-02-28.

What interventions are being tested in trial NCT01458405?

The interventions under investigation include: Placebo (DRUG), CAP-1002 Allogeneic Cardiosphere-Derived Cells (BIOLOGICAL).

Who is sponsoring clinical trial NCT01458405?

This trial is sponsored by Capricor, which has 9 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01458405's enrollment target sits among peer trials

135 425th of 2000 higher than 1,574 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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 NCT01458405, the US trial registry maintained by the National Library of Medicine. NCT01458405 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.