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

This study has been completed.
Information provided by (Responsible Party):
Vericel Corporation Identifier:
First received: April 30, 2007
Last updated: June 29, 2016
Last verified: June 2016

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.

Condition Intervention Phase
Peripheral Arterial Disease
Biological: Ixmyelocel-T
Biological: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Use of Ixmyelocel-T (Formerly TRC Autologous Bone Marrow Cells) in Patients With Peripheral Arterial Disease to Treat Critical Limb Ischemia

Resource links provided by NLM:

Further study details as provided by Vericel Corporation:

Primary Outcome Measures:
  • 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) [ Time Frame: throughout trial ]

Secondary Outcome Measures:
  • Composite efficacy endpoint assessing time to treatment failure(failure defined as major amputation, doubling of wound size, and new gangrene) [ Time Frame: Day 7 and Months 3, 6, 9, 12 ]
  • Percentage of patients failing treatment [ Time Frame: Day 7, and Months 3,6,9, and 12 ]
  • Time to major amputation [ Time Frame: Day 7 and Month 3, 6, 9, and 12 ]
  • Percentage of patients undergoing major amputation [ Time Frame: Day 7 and Months 3, 6, 9, 12 ]
  • Incidence of revascularization interventions throughout duration of study [ Time Frame: Day 7 and Months 3,6,9,12 ]
  • Incidence of bypass surgery for patients throughout duration of study [ Time Frame: Day 7 and Months 3,6,9,12 ]
  • Healing of all wounds in the target limb [ Time Frame: Day 7 and Months 3,6,9,12 ]
  • Ankle and/or toe pressure and ankle brachial pressure index and/or toe brachial index [ Time Frame: Day 7 and Months 3,6,9,12 ]
  • Pain, as measured by visual analog scale(VAS) [ Time Frame: Day 7 and Months 3,6,9,12 ]
  • The King's College Vascular Quality of Life Questionnaire [ Time Frame: Baseline and Months 6 and 12 ]
  • Walking distance as measured by six-minute walk test(with or without walking device) [ Time Frame: Baseline and Month 12 ]
  • Concurrent Meds for trends [ Time Frame: Day 7 and Months 3, 6, 9, 12 ]

Enrollment: 86
Study Start Date: April 2007
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ixmyelocel-T
The treatment arm of the study will receive injections of the study cellular product.
Biological: Ixmyelocel-T
IM injection
Placebo Comparator: Placebo
The control arm of the study will receive placebo injections.
Biological: Placebo
IM Injection

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.


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00468000

United States, Alabama
Cardiology, P.C.
Birmingham, Alabama, United States, 35211
United States, Arizona
Arizona Heart Institute
Phoenix, Arizona, United States, 85006
United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
United States, Florida
Malcolm Randall Veterans Administration Medical Center, part of the North Florida/South Georgia Veterans Health System
Gainesville, Florida, United States, 32608
University of Miami/Miller School of Medicine
Miami, Florida, United States, 33136
United States, Illinois
Loyola University Stritch School of Medicine
Maywood, Illinois, United States, 60153
Southern Illinois University School of Medicine
Springfield, Illinois, United States, 62702
United States, Indiana
The Care Group, LLC
Indianapolis, Indiana, United States, 46260
United States, Michigan
VA Ann Arbor Healthcare System
Ann Arbor, Michigan, United States, 48105
St. Joseph Mercy Hospital
Ann Arbor, Michigan, United States, 48106
Michigan Vascular Research Center
Flint, Michigan, United States, 48507
United States, Minnesota
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States, 55407
United States, New Hampshire
Dartmouth-Hitchcock Memorial Center
Lebanon, New Hampshire, United States, 03756
United States, North Carolina
University of North Carolina Hospitals
Chapel Hill, North Carolina, United States, 27514
United States, Ohio
Jobst Vascular Center
Toledo, Ohio, United States, 43606
United States, Oklahoma
Oklahoma University
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232-2735
United States, Texas
Peripheral Vascular Associates
San Antonio, Texas, United States, 78205
Scott and White Hospital
Temple, Texas, United States, 76508
Sponsors and Collaborators
Vericel Corporation
Principal Investigator: Anthony J Comerota, MD Jobst Vascular Center
  More Information

Responsible Party: Vericel Corporation Identifier: NCT00468000     History of Changes
Other Study ID Numbers: ABI-55-0610-1
Study First Received: April 30, 2007
Last Updated: June 29, 2016

Keywords provided by Vericel Corporation:
Peripheral Arterial Disease
Critical Limb Ischemia
Peripheral Vascular Disease

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Pathologic Processes
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases processed this record on May 22, 2017