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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 is a Phase 1 study that has completed, run by Case Western Reserve University. The registered enrollment target is 9 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00365326
The ClinicalTrials.gov registry entry for NCT00365326 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Case Western Reserve University, which has 141 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Catheter-based intracoronary injection is the first listed.
NCT00365326 reports 0 study locations.
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.
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