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NCT00468000 · ClinicalTrials.gov registry record · Phase 2
Use of Ixmyelocel-T (Formerly Vascular Repair Cells [VRC]) in Patients With Peripheral Arterial Disease to Treat Critical Limb Ischemia
A Phase 2 study of Peripheral Arterial Disease, sponsored by Vericel Corporation.
- Completed
- Registry status
- Phase 2
- Development phase
- 86
- Enrollment target
- 20
- Study locations
NCT00468000 is a Phase 2 study of Peripheral Arterial Disease that has completed, run by Vericel Corporation. The registered enrollment target is 86 participants, below the 4,205-participant average among 79 other Peripheral Arterial Disease trials with a reported enrollment target (98% lower). The trial reports 20 study locations across 15 states.
The verdict
NCT00468000, a Phase 2 study of Peripheral Arterial Disease, has completed, sponsored by Vericel Corporation.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 86 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study is designed to evaluate the safety and efficacy of autologous Vascular Repair Cells (VRC) for patients with peripheral arterial disease as a treatment for critical limb ischemia. The double-blind study is expected to enroll 150 patients, randomized into two patient groups. The treatment group will receive intramuscular (IM) injections of the VRCs into the affected limb; the control group will receive intramuscular injections with an electrolyte solution (without cells). Both groups will receive the standard of care appropriate for their medical condition.
Conditions Studied
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL Ixmyelocel-T
Study Locations (20)
Michigan
- VA Ann Arbor Healthcare System - Ann Arbor
- St. Joseph Mercy Hospital - Ann Arbor
- Michigan Vascular Research Center - Flint
Florida
- Malcolm Randall Veterans Administration Medical Center, part of the North Florida/South Georgia Veterans Health System - Gainesville
- University of Miami/Miller School of Medicine - Miami
Illinois
- Loyola University Stritch School of Medicine - Maywood
- Southern Illinois University School of Medicine - Springfield
Texas
- Peripheral Vascular Associates - San Antonio
- Scott and White Hospital - Temple
Alabama
- Cardiology, P.C. - Birmingham
Arizona
- Arizona Heart Institute - Phoenix
California
- University of California, San Francisco - San Francisco
Indiana
- The Care Group, LLC - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 86 participants |
| Start Date | 2007-04 |
| Est. Completion | 2011-03 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00468000
The ClinicalTrials.gov registry entry for NCT00468000 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 86 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,205-participant average among 79 other Peripheral Arterial Disease trials with a reported enrollment target (98% lower). The listed sponsor is Vericel Corporation, which has 11 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Peripheral Arterial Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00468000 reports 20 study locations spanning 15 distinct geographic areas - top geographies include Michigan, Florida, Illinois.
Frequently Asked Questions
What is clinical trial NCT00468000 about?
NCT00468000 is a clinical study titled "Use of Ixmyelocel-T (Formerly Vascular Repair Cells [VRC]) in Patients With Peripheral Arterial Disease to Treat Critical Limb Ischemia". This study is designed to evaluate the safety and efficacy of autologous Vascular Repair Cells (VRC) for patients with peripheral arterial disease as a treatment for critical limb ischemia. The double-blind study is expected to enroll 150 patients, randomized into two patient groups. The treatment ...
What is the current status of trial NCT00468000?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 86 participants. The study started on 2007-04. Estimated completion is 2011-03.
What conditions does trial NCT00468000 study?
This clinical trial studies the following conditions: Peripheral Arterial Disease.
What interventions are being tested in trial NCT00468000?
The interventions under investigation include: Placebo (BIOLOGICAL), Ixmyelocel-T (BIOLOGICAL).
Who is sponsoring clinical trial NCT00468000?
This trial is sponsored by Vericel Corporation, which has 11 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00468000 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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