Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Use of Ixmyelocel-T (Formerly Vascular Repair Cells [VRC]) in Patients With Peripheral Arterial Disease to Treat Critical Limb Ischemia
NCT00468000 · View on ClinicalTrials.gov ↗
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 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 86 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vericel Corporation, which has 5 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00468000 reports 20 study locations spanning 15 distinct geographic areas — top geographies include Michigan, Florida, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00468000?
The interventions under investigation include: Placebo (BIOLOGICAL), Ixmyelocel-T (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00468000?
This trial is sponsored by Vericel Corporation, which has 5 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.