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Peripheral Arterial DiseasePhase 2RESTORE-CLINCT00468000

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

A Phase 2 study testing Ixmyelocel-T in people with Peripheral Arterial Disease, run by Vericel Corporation at 20 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Peripheral Arterial Disease
What is being tested?
Ixmyelocel-T
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
86 participants
Where
20 sitesUnited States
Study dates
Apr 2007to Mar 2011
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 19Show fewer
  • 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

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

United States20 sites

  • VA Ann Arbor Healthcare System

    Ann Arbor, Michigan, 48105

  • St. Joseph Mercy Hospital

    Ann Arbor, Michigan, 48106

  • Cardiology, P.C.

    Birmingham, Alabama, 35211

  • University of North Carolina Hospitals

    Chapel Hill, North Carolina, 27514

  • Michigan Vascular Research Center

    Flint, Michigan, 48507

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

    Gainesville, Florida, 32608

  • The Care Group, LLC

    Indianapolis, Indiana, 46260

  • Dartmouth-Hitchcock Memorial Center

    Lebanon, New Hampshire, 03756

  • Loyola University Stritch School of Medicine

    Maywood, Illinois, 60153

  • University of Miami/Miller School of Medicine

    Miami, Florida, 33136

  • Minneapolis Heart Institute Foundation

    Minneapolis, Minnesota, 55407

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232-2735

  • Oklahoma University

    Oklahoma City, Oklahoma, 73104

  • Arizona Heart Institute

    Phoenix, Arizona, 85006

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

  • Peripheral Vascular Associates

    San Antonio, Texas, 78205

  • University of California, San Francisco

    San Francisco, California, 94143

  • Southern Illinois University School of Medicine

    Springfield, Illinois, 62702

  • Scott and White Hospital

    Temple, Texas, 76508

  • Jobst Vascular Center

    Toledo, Ohio, 43606

Other trials in United States

About this study

Official title: Use of Ixmyelocel-T (Formerly TRC Autologous Bone Marrow Cells) in Patients With Peripheral Arterial Disease to Treat Critical Limb Ischemia

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.

Read the 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.

Being tested
Ixmyelocel-T, Placebo
Keywords
Peripheral Arterial Disease, Critical Limb Ischemia, Ischemia, Peripheral Vascular Disease, ixmyelocel-T
Medical subject headings
Peripheral Arterial Disease, Chronic Limb-Threatening Ischemia, Ischemia, Peripheral Vascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ixmyelocel-TBiological

    IM injection

  • PlaceboBiological

    IM Injection

Study groups in NCT00468000
Study groupRoleWhat they receive
Ixmyelocel-TExperimentalThe treatment arm of the study will receive injections of the study cellular product.
Receives: Biological: Ixmyelocel-T
PlaceboPlacebo comparatorThe control arm of the study will receive placebo injections.
Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: throughout trial

Secondary outcomes (12)

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

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

  2. Percentage of patients failing treatment

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

  3. Time to major amputation

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

  4. Percentage of patients undergoing major amputation

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

  5. Incidence of revascularization interventions throughout duration of study

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

  6. Incidence of bypass surgery for patients throughout duration of study

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

  7. Healing of all wounds in the target limb

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

  8. Ankle and/or toe pressure and ankle brachial pressure index and/or toe brachial index

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

  9. Pain, as measured by visual analog scale(VAS)

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

  10. The King's College Vascular Quality of Life Questionnaire

    Measured: Baseline and Months 6 and 12

  11. Walking distance as measured by six-minute walk test(with or without walking device)

    Measured: Baseline and Month 12

  12. Concurrent Meds for trends

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2007 (estimated)
  2. Study startApr 2007
  3. Primary completionMar 2011
  4. Study completionMar 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
86 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00468000
Sponsor's protocol ID
ABI-55-0610-1
Acronym
RESTORE-CLI
Status last verified
May 2020
First submitted
30 Apr 2007
Last updated
20 May 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 22453769

  • 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.

    PubMed 21684715

  • 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.

    PubMed 35802393

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ixmyelocel-T in people with Peripheral Arterial Disease, run by Vericel Corporation at 20 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00468000, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2020.

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