Use of Ixmyelocel-T (Formerly Vascular Repair Cells [VRC]) in Patients With Peripheral Arterial Disease to Treat Critical Limb Ischemia
Public ClinicalTrials.gov record NCT00468000. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Use of Ixmyelocel-T (Formerly TRC Autologous Bone Marrow Cells) in Patients With Peripheral Arterial Disease to Treat Critical Limb Ischemia
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00468000
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 86 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 90 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 31, 2007
- Primary completion
- Feb 28, 2011
- Completion
- Feb 28, 2011
- Last update posted
- May 19, 2020
2007 – 2011
United States locations
- U.S. sites
- 20
- U.S. states
- 15
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Cardiology, P.C. | Birmingham | Alabama | 35211 | — |
| Arizona Heart Institute | Phoenix | Arizona | 85006 | — |
| University of California, San Francisco | San Francisco | California | 94143 | — |
| Malcolm Randall Veterans Administration Medical Center, part of the North Florida/South Georgia Veterans Health System | Gainesville | Florida | 32608 | — |
| University of Miami/Miller School of Medicine | Miami | Florida | 33136 | — |
| Loyola University Stritch School of Medicine | Maywood | Illinois | 60153 | — |
| Southern Illinois University School of Medicine | Springfield | Illinois | 62702 | — |
| The Care Group, LLC | Indianapolis | Indiana | 46260 | — |
| VA Ann Arbor Healthcare System | Ann Arbor | Michigan | 48105 | — |
| St. Joseph Mercy Hospital | Ann Arbor | Michigan | 48106 | — |
| Michigan Vascular Research Center | Flint | Michigan | 48507 | — |
| Minneapolis Heart Institute Foundation | Minneapolis | Minnesota | 55407 | — |
| Dartmouth-Hitchcock Memorial Center | Lebanon | New Hampshire | 03756 | — |
| University of North Carolina Hospitals | Chapel Hill | North Carolina | 27514 | — |
| Jobst Vascular Center | Toledo | Ohio | 43606 | — |
| Oklahoma University | Oklahoma City | Oklahoma | 73104 | — |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232-2735 | — |
| Peripheral Vascular Associates | San Antonio | Texas | 78205 | — |
| Scott and White Hospital | Temple | Texas | 76508 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
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About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00468000, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 19, 2020 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00468000 live on ClinicalTrials.gov.