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NCT00365326 · ClinicalTrials.gov registry record · Phase 1
Safety and Efficacy of Autologous, Intracoronary Stem Cell Injections in Total Coronary Artery Occlusions
A Phase 1 study, sponsored by Case Western Reserve University.
- Completed
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
NCT00365326: Completed Phase 1 study, sponsored by Case Western Reserve University.
NCT00365326 is a Phase 1 study that has completed, run by Case Western Reserve University. 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
NCT00365326, a Phase 1 study, has completed, sponsored by Case Western Reserve University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
Study Summary
This phase I clinical trial will evaluate the safety and efficacy of intra-coronary injection of AC133 selected autologous marrow-derived stem cells in patients with chronic coronary artery occlusion. A clinical study to determine the therapeutic potential of marrow-derived stem cells as an adjunct therapy to current standard therapies for CAD is warranted. The current initiative is to investigate a model of chronic myocardial ischemia and (1) to determine whether intra-coronary injection of selected autologous marrow-derived AC133 stem cells is reasonably safe for use in humans and (2) if this treatment shows any improvement in coronary perfusion, as assessed using non-invasive imaging. This study is structured to evaluate the feasibility and safety of autologous AC133+ bone marrow-derived stem cell via intra-coronary injection into documented ischemic but viable myocardial zones via established collateral vessels. The epicardial vessel that normally supplies the ischemic zone must be 100% chronically occluded and considered non-revascularizable by percutaneous means.
Primary Outcome
Determine whether intra-coronary injection of selected autologous marrow-derived AC133 stem cells is reasonably safe for use in humans
Interventions
- BIOLOGICAL Catheter-based intracoronary injection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2006-01 |
| Est. Completion | 2008-06 |
| Phase | Phase 1 |
What the finished NCT00365326 record still lists
NCT00365326 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 1 intervention - of which Catheter-based intracoronary injection is the first listed.
NCT00365326 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00365326 about?
NCT00365326 is a clinical study titled "Safety and Efficacy of Autologous, Intracoronary Stem Cell Injections in Total Coronary Artery Occlusions". This phase I clinical trial will evaluate the safety and efficacy of intra-coronary injection of AC133 selected autologous marrow-derived stem cells in patients with chronic coronary artery occlusion. A clinical study to determine the therapeutic potential of marrow-derived stem cells as an adjunct ...
What is the current status of trial NCT00365326?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2006-01. Estimated completion is 2008-06.
What interventions are being tested in trial NCT00365326?
The interventions under investigation include: Catheter-based intracoronary injection (BIOLOGICAL).
Who is sponsoring clinical trial NCT00365326?
This trial is sponsored by Case Western Reserve University, which has 141 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00365326'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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