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NCT00587990 · ClinicalTrials.gov registry record · Phase 1
Prospective Randomized Study of Mesenchymal Stem Cell Therapy in Patients Undergoing Cardiac Surgery (PROMETHEUS)
A Phase 1 study, sponsored by Joshua M Hare.
- Terminated
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
NCT00587990: Clinical Trial Phase 1 study, sponsored by Joshua M Hare.
NCT00587990 is a Phase 1 study that was terminated before completion, run by Joshua M Hare. The registered enrollment target is 9 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00587990, a Phase 1 study, was terminated before completion, sponsored by Joshua M Hare.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
Study Summary
Heart attacks are a leading cause of death in both men and women in the United States. When a person has a heart attack, blood is unable to reach a certain area of the heart, and if the blood supply is not re-established quickly, that area of the heart can suffer permanent damage. While recovery from a heart attack can be managed through medications and lifestyle changes, these treatments can not reverse the original damage to the heart. Current research is focusing on the development of cell-based therapies using stem cells to repair organs that have been irreversibly damaged by disease. A specific form of stem cells, called adult mesenchymal stem cells (MSCs), has shown promise for heart repair. This study will evaluate the safety and effectiveness of injecting MSCs into the heart to repair and restore heart function in people who have had a heart attack and who are having heart surgery for coronary artery bypass grafting (CABG).
Primary Outcome
Six-month post-CABG surgery serious adverse event (SAE) proportion of patients experiencing a composite of sustained ventricular arrhythmias, (lasting longer than 15 seconds), with hemodynamic compromise, sudden unexpected death at six months, ectopic tissue formation at 12 months by chest/abdomen/pelvis CT exam.
Interventions
- GENETIC Placebo
- BIOLOGICAL Lower dose mesenchymal stem cell (MSC) injection
- BIOLOGICAL Higher dose MSC injection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2007-11 |
| Est. Completion | 2011-06 |
| Phase | Phase 1 |
Why NCT00587990 stopped before completion
NCT00587990 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00587990 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00587990 about?
NCT00587990 is a clinical study titled "Prospective Randomized Study of Mesenchymal Stem Cell Therapy in Patients Undergoing Cardiac Surgery (PROMETHEUS)". Heart attacks are a leading cause of death in both men and women in the United States. When a person has a heart attack, blood is unable to reach a certain area of the heart, and if the blood supply is not re-established quickly, that area of the heart can suffer permanent damage. While recovery fro...
What is the current status of trial NCT00587990?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2007-11. Estimated completion is 2011-06.
What interventions are being tested in trial NCT00587990?
The interventions under investigation include: Placebo (GENETIC), Lower dose mesenchymal stem cell (MSC) injection (BIOLOGICAL), Higher dose MSC injection (BIOLOGICAL).
Who is sponsoring clinical trial NCT00587990?
This trial is sponsored by Joshua M Hare, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00587990's enrollment target sits among peer trials
9 1955th of 2000 higher than 42 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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