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

NCT00468000 | Completed Phase 2 DMC

• 1 other identifier: ABI-55-0610-1
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 20

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.

Conditions

Peripheral Arterial Disease

Keywords

Peripheral Arterial Disease; Critical Limb Ischemia; Ischemia; Peripheral Vascular Disease; ixmyelocel-T

Outcome Measures

Primary Outcomes (1)

• Safety of TRCs in patients with CLI(key safety parameters include vital signs, physical exams, laboratory results, assessment of aspiration and injection sites, adverse events, major amputations, wounds presence(size and grading using the Wagner scale)

  throughout trial

Secondary Outcomes (12)

• Composite efficacy endpoint assessing time to treatment failure(failure defined as major amputation, doubling of wound size, and new gangrene)

  Day 7 and Months 3, 6, 9, 12

• Percentage of patients failing treatment

  Day 7, and Months 3,6,9, and 12

• Time to major amputation

  Day 7 and Month 3, 6, 9, and 12

• Percentage of patients undergoing major amputation

  Day 7 and Months 3, 6, 9, 12

• Incidence of revascularization interventions throughout duration of study

  Day 7 and Months 3,6,9,12

Study Arms (2)

Ixmyelocel-T

EXPERIMENTAL

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

Biological: Ixmyelocel-T

Placebo

PLACEBO COMPARATOR

The control arm of the study will receive placebo injections.

Biological: Placebo

Interventions

Ixmyelocel-T BIOLOGICAL

IM injection

Ixmyelocel-T

Placebo BIOLOGICAL

IM Injection

Placebo

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Vericel Corporation: lead

Study Sites (20)

Cardiology, P.C.

Birmingham, Alabama, 35211, United States

Location

Arizona Heart Institute

Phoenix, Arizona, 85006, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Malcolm Randall Veterans Administration Medical Center, part of the North Florida/South Georgia Veterans Health System

Gainesville, Florida, 32608, United States

Location

University of Miami/Miller School of Medicine

Miami, Florida, 33136, United States

Location

Loyola University Stritch School of Medicine

Maywood, Illinois, 60153, United States

Location

Southern Illinois University School of Medicine

Springfield, Illinois, 62702, United States

Location

The Care Group, LLC

Indianapolis, Indiana, 46260, United States

Location

VA Ann Arbor Healthcare System

Ann Arbor, Michigan, 48105, United States

Location

St. Joseph Mercy Hospital

Ann Arbor, Michigan, 48106, United States

Location

Michigan Vascular Research Center

Flint, Michigan, 48507, United States

Location

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, 55407, United States

Location

Dartmouth-Hitchcock Memorial Center

Lebanon, New Hampshire, 03756, United States

Location

University of North Carolina Hospitals

Chapel Hill, North Carolina, 27514, United States

Location

Jobst Vascular Center

Toledo, Ohio, 43606, United States

Location

Oklahoma University

Oklahoma City, Oklahoma, 73104, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232-2735, United States

Location

Peripheral Vascular Associates

San Antonio, Texas, 78205, United States

Location

Scott and White Hospital

Temple, Texas, 76508, United States

Location

Related Publications (3)

• 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.

  PMID: 22453769 RESULT

• 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.

  PMID: 21684715 RESULT

• 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.

  PMID: 35802393 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease; Chronic Limb-Threatening Ischemia; Ischemia; Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Anthony J Comerota, MD

  Jobst Vascular Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2007
• First Posted: May 1, 2007
• Study Start: April 1, 2007
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: May 20, 2020

Record last verified: 2020-05

Locations

US (20)