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

NCT ID: NCT00468000

Last Updated: 2020-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-04-30
• Study Completion Date: 2011-03-31

Brief 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.

Detailed 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.

Conditions

Peripheral Arterial Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Ixmyelocel-T

The treatment arm of the study will receive injections of the study cellular product.

Group Type: EXPERIMENTAL

Ixmyelocel-T

Intervention Type: BIOLOGICAL

IM injection

Placebo

The control arm of the study will receive placebo injections.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

IM Injection

Interventions

Ixmyelocel-T

IM injection

Intervention Type: BIOLOGICAL

Placebo

IM Injection

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vericel Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anthony J Comerota, MD

Role: PRINCIPAL_INVESTIGATOR

Jobst Vascular Center

Locations

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

Countries

United States

References

Powell RJ, Marston WA, Berceli SA, Guzman R, Henry TD, Longcore AT, Stern TP, Watling S, Bartel RL. Cellular therapy with Ixmyelocel-T to treat critical limb ischemia: the randomized, double-blind, placebo-controlled RESTORE-CLI trial. Mol Ther. 2012 Jun;20(6):1280-6. doi: 10.1038/mt.2012.52. Epub 2012 Mar 27.

Reference Type: RESULT

PMID: 22453769 (View on PubMed)

Powell RJ, Comerota AJ, Berceli SA, Guzman R, Henry TD, Tzeng E, Velazquez O, Marston WA, Bartel RL, Longcore A, Stern T, Watling S. Interim analysis results from the RESTORE-CLI, a randomized, double-blind multicenter phase II trial comparing expanded autologous bone marrow-derived tissue repair cells and placebo in patients with critical limb ischemia. J Vasc Surg. 2011 Oct;54(4):1032-41. doi: 10.1016/j.jvs.2011.04.006. Epub 2011 Jul 31.

Reference Type: RESULT

PMID: 21684715 (View on PubMed)

Moazzami B, Mohammadpour Z, Zabala ZE, Farokhi E, Roohi A, Dolmatova E, Moazzami K. Local intramuscular transplantation of autologous bone marrow mononuclear cells for critical lower limb ischaemia. Cochrane Database Syst Rev. 2022 Jul 8;7(7):CD008347. doi: 10.1002/14651858.CD008347.pub4.

Reference Type: DERIVED

PMID: 35802393 (View on PubMed)

Other Identifiers

ABI-55-0610-1

Identifier Type: -

Identifier Source: org_study_id