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Completed Phase 2 Interventional

Use of Ixmyelocel-T (Formerly Vascular Repair Cells [VRC]) in Patients With Peripheral Arterial Disease to Treat Critical Limb Ischemia

ClinicalTrials.gov ID: NCT00468000

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.

ClinicalTrials.gov public records Last synced Oct 19, 2026, 9:08 AM EDT

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
Lead sponsor
Vericel Corporation
Industry
Enrollment
86 participants

Conditions and interventions

Interventions

Biological

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
Apr 2007 (Type not available)
Primary completion
Mar 2011 (Actual)
Completion
Mar 2011 (Actual)
Last update posted
May 20, 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.

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 20, 2020 · Synced Oct 19, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00468000 live on ClinicalTrials.gov.

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