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

Vericel

Status and phase

Completed

Phase 2

Conditions

Peripheral Arterial Disease

Treatments

Biological: Ixmyelocel-T

Biological: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00468000

ABI-55-0610-1

Details and patient eligibility

About

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.

Full description

The study will assess the safety and ability of Aastrom TRC autologous bone marrow cells to restore peripheral blood flow affected by critical limb ischemia.

Peripheral arterial disease (PAD), also known as Peripheral Vascular Disease (PVD), occurs when peripheral arteries are damaged by arterial hypertension and/or by the formation of atherosclerotic plaques. PAD is a chronic disease that progressively constricts arterial circulation of limbs. The term critical limb ischemia (CLI) is used for all patients with chronic ischemia rest pain, ulcers, or gangrene in limbs attributable to objectively proven PAD. These sequelae represent the end stage of PAD. PAD is associated with several other clinical conditions, i.e. hypertension, cardiovascular disease, hyperlipidemia, diabetes, tobacco use, obesity and stroke.

The double-blind study is expected to enroll 150 patients, randomized into two patient groups. The treatment group will receive intramuscular injections of the TRC product 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.

Enrollment

86 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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