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

Completed · Phase 2 · Has a placebo group

Conditions studied: Peripheral Arterial Disease

In brief

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.

Key facts

Study ID

NCT00468000

Run by

Vericel Corporation

People needed

86

Starts

2007-04-01

Expected to finish

2011-03-01

Last updated by the study team

2020-05-20

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males and females, 18-90 years of age
• Diagnosis of CLI
• Infrainguinal occlusive disease, without options for revascularization
• No surgical interventions planned
• Life expectancy of 2 years
• Normal organ and marrow function
• Patients with controlled blood pressure (≤ 180/110 mmHg) and established anti-hypertensive therapy
• Established anti-platelet therapy

You may not qualify if…

• Poorly controlled diabetes mellitus (hemoglobin A1c [HbA1c] > 10%)
• Aortoiliac disease with > 50% stenosis
• Wounds with severity greater than Grade 3 on the Wagner Scale
• Any known failed ipsilateral revascularization within 2 weeks of enrollment
• Previous amputation of the talus, or above in the target limb
• Life-threatening ventricular arrhythmia; unstable angina; or, myocardial infarction within 4 weeks of enrollment
• Severe congestive heart failure (CHF) (i.e. New York Heart Association [NYHA] Stage IV)
• Receiving treatment with hematopoietic growth factors
• Infection of the involved extremity(ies)
• Active wet gangrenous tissue
• Require uninterruptible anticoagulation therapy
• Blood clotting disorder
• Cancer
• End stage renal disease requiring dialysis for more than 6 months prior to enrollment
• Pregnant or lactating
• Having received medication for thrombolytic therapy (e.g. rTPA or other enzymatic clot busters) within 30 days prior to enrollment
• Undergoing hyperbaric oxygen treatment within 2 weeks of enrollment
• Concomitant wound treatments with growth factors or tissue engineered products
• Receiving anti-angiogenic drugs

Where it is running

• 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
• VA Ann Arbor Healthcare System — Ann Arbor, Michigan, United States
• St. Joseph Mercy Hospital — 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

Full record on ClinicalTrials.gov

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