Clinical trialNCT00468000CompletedPhase 2Interventional

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

SponsorVericel CorporationEnrollment86Peripheral Arterial Disease

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Anthony J Comerota, MD
Jobst Vascular Center
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

20 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Cardiology, P.C.
Birmingham, Alabama, United States
Arizona Heart Institute
Phoenix, Arizona, United States
University of California, San Francisco
San Francisco, California, United States
Malcolm Randall Veterans Administration Medical Center, Part of the North Florida/south Georgia Veterans Health System
Gainesville, Florida, United States
University of Miami/miller School of Medicine
Miami, Florida, United States
Loyola University Stritch School of Medicine
Maywood, Illinois, United States
Southern Illinois University School of Medicine
Springfield, Illinois, United States
the Care Group, Llc
Indianapolis, Indiana, United States
St. Joseph Mercy Hospital
Ann Arbor, Michigan, United States
Va Ann Arbor Healthcare System
Ann Arbor, Michigan, United States
Michigan Vascular Research Center
Flint, Michigan, United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States
Dartmouth-Hitchcock Memorial Center
Lebanon, New Hampshire, United States
University of North Carolina Hospitals
Chapel Hill, North Carolina, United States
Jobst Vascular Center
Toledo, Ohio, United States
Oklahoma University
Oklahoma City, Oklahoma, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Peripheral Vascular Associates
San Antonio, Texas, United States
Scott and White Hospital
Temple, Texas, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Ixmyelocel-TPlacebo

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 30 Apr 2007
Primary completion: 31 Mar 2011
Completion: 31 Mar 2011
Last update posted: 20 May 2020
Registered enrollment: 86
Registry id: NCT00468000

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.