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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.
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
| Field | Value |
|---|---|
| Enrollment Target | 135 participants |
| Start Date | 2012-11-13 |
| Est. Completion | 2019-02-28 |
| Phase | Phase 1 |
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.
Learn More About Clinical Trials
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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