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Critical Limb IschemiaPhase 3REVIVENCT01483898

An Efficacy and Safety Study of Ixmyelocel-T in Patients With Critical Limb Ischemia (CLI)

A Phase 3 study testing Ixmyelocel-T in people with Critical Limb Ischemia, run by Vericel Corporation at 86 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 efficacy and safety of ixmyelocel-T, a patient-specific expanded multicellular therapy, for the treatment of patients with critical limb ischemia (CLI). Read more about this study

Who is it for?
Ages 35 to 90 years
Conditions the study is for
Critical Limb Ischemia
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
41 participants
Where
86 sitesUnited States
Study dates
Feb 2012to 25 Mar 2014
Phase
Phase 3
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 35 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Males and nonpregnant, nonlactating females
  • Ages 35 to 90 years of age
  • Diagnosis of CLI with tissue loss (corresponding to Rutherford Category 5; see Appendix B) having an ulcer size of at least 0.5 cm2, a smaller sized ulcer penetrating into the subcutaneous tissue, and/or gangrene (dry). In addition, the subject must have ONE of the following documented at screening:
  • Ankle systolic pressure < 70 mm Hg
  • Toe systolic pressure < 50 mm Hg
  • TcPO2 < 30 mm Hg (in a supine position)
Show all 16Show fewer
  • Subjects must have no reasonable standard-of-care options for surgical or endovascular revascularization interventions
  • Subjects must have the following:
  • A narrative documenting the reasons why the site vascular specialist considers the subject "no option". A vascular specialist will be the principal investigator (PI) or subinvestigator and is defined as: vascular surgeon, interventional cardiologist, certified vascular medicine specialist, or interventional radiologist; AND
  • Secondary confirmation by an independent Eligibility Review Committee (ERC; see Section 8.1) after review of appropriate documents including, but not limited to: imaging results, medical records, surgical history, site vascular specialist narrative documenting reasons for "no option," and/or lab reports.
  • Major amputation in the index leg or death is not anticipated within 3 months of screening in the opinion of the vascular specialist (who must be the PI or subinvestigator)
  • In the opinion of the investigator, the subject is controlled on medical therapy indicated for CLI (unless there is a documented contraindication or intolerance)
  • Subject is current with all age-appropriate American Cancer Society (ACS) or similar (e.g., United States Preventative Service Task Force) screening guidelines
  • Given medical history and concurrent medication, the subject is an acceptable candidate for bone marrow aspiration and intramuscular injection procedures in the opinion of the Investigator
  • Subject is willing and able to comply with the scheduled visits, aspiration/injection procedure, wound care instructions treatment plan, and other study procedures for the duration of the study
  • Provide a personally-signed and dated informed consent document indicating that the subject (or a legally-acceptable representative, if permitted by the site's Investigational Review Board [IRB]) has been informed of all pertinent aspects of the study

Who cannot join

  • Patients presenting with any of the following will not be randomized:
  • Disease-specific:
  • Failed open surgical revascularization (on index leg) within 4 weeks of screening Visit 1
  • Acute limb-threatening ischemia, trauma, known non-atherosclerotic vascular disease (e.g., temporal/giant cell arteritis, Takayasu's arteritis, Raynaud's occlusive disease, Buerger's disease), embolic disease, aortoiliac disease with > 50% stenosis, or history of hypercoagulable states
  • Advanced CLI (i.e., nonsalvageable) defined as Rutherford Category 6
  • Clinical evidence of invasive infection in index leg (e.g., cellulitis, osteomyelitis, wet gangrene)
Show all 27Show fewer
  • At screening, non-heel wound size of > 20 cm2 (excluding toe gangrene); or wounds on the heel > 10 cm2 on the index leg as measured by the Wound Core Lab (WCL) from photographs (and/or acetates) provided by the site
  • Previous amputation at or above the talus in the index leg Medical History
  • Hemoglobin A1c (HbA1c) ≥ 10% at screening
  • Diabetic subjects with uncontrolled or untreated proliferative retinopathy as determined by dilated eye exam (by qualified eye care professional as per American Diabetes Association guidelines)
  • Blood clotting disorder not caused by medication (e.g., thrombophilia)
  • Active non-basal cell cutaneous malignancy requiring surgery, chemotherapy, and/or radiation in the past 12 months
  • Current documented drug or alcohol abuse that would interfere with the subject's compliance with study procedures
  • Known allergies to any equine, porcine, or bovine products
  • Body mass index (BMI) ≥ 50 kg/m2 at screening
  • Established chronic kidney disease (CKD) requiring dialysis (Stage 5); estimated creatinine clearance < 15 mg/mL/min at screening
  • Systolic blood pressure (SBP) > 200 mm Hg or diastolic blood pressure (DBP) > 120 mm Hg or papilledema noted via ophthalmoscope at screening physical exam
  • Within 3 months prior to screening, a clinically significant history of cardiac disease
  • Laboratory Parameters:
  • Abnormal laboratory values (performed at central lab) at screening:
  • Platelets < 50,000 μL
  • Aspartate aminotransferase/alanine aminotransferase (AST/ALT) > 3 times the upper limit of normal (ULN)
  • Human immunodeficiency virus 1 (HIV 1), HIV 2, or syphilis positive (rapid plasma reagin [RPR])
  • Active hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV); Exclusionary Procedures, Devices, or Medication
  • Exposure to immunosuppressive therapy for oncologic or chronic non-oncologic reasons in the prior 12 months or expected requirement over the course of the study (e.g., chemotherapy, radiation therapy, methotrexate)
  • Concurrent participation in another clinical trial or receiving experimental medication within 30 days of screening or having previously been exposed to Aastrom's ixmyelocel T product [previously known as tissue repair cells (TRC), cardiac repair cells (CRC), vascular repair cells (VRC)]
  • On the index leg, use of concomitant wound treatments not currently approved for ischemic wound-healing within 30 days prior to screening or plans to initiate new, nonstandard-of-care treatments to the index leg during the study

Trial locations and contacts

86 sites in 1 country.

86 sites in 1 country

United States86 sites

  • VA Ann Arbor Healthcare System

    Ann Arbor, Michigan, 48105

  • University of Colorado Denver - Anschutz Medical Campus

    Aurora, Colorado, 80045

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • Union Memorial Hospital

    Baltimore, Maryland, 21218

  • Cardiology and Vascular Associates, P.C.

    Berkley, Michigan, 48072

  • Cardiology PC

    Birmingham, Alabama, 35211

  • Cardio-Thoracic Surgeons, P.C.

    Birmingham, Alabama, 35243

  • University Of Alabama At Birmingham

    Birmingham, Alabama, 35294

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • Bethesda Memorial Hospital - Clinical Research Center

    Boynton Beach, Florida, 33435

  • University of Buffalo Surgeons Inc.

    Buffalo, New York, 14203

  • University of North Carolina Hospital

    Chapel Hill, North Carolina, 27599

  • Charleston Area Medical Center - Memorial Hospital

    Charleston, West Virginia, 25304

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • University of Illinois at Chicago - Clinical Sciences North

    Chicago, Illinois, 60612

  • University Hospitals Case Medical Center

    Cleveland, Ohio, 44106

  • John Muir Medical Center - Concord Campus

    Concord, California, 94520

  • DFW Vascular Group, LLP

    Dallas, Texas, 75208

  • Oakwood Hospital and Medical Center

    Dearborn, Michigan, 48124

  • John D. Dingell VA Medical Center

    Detroit, Michigan, 48201

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Michigan Vascular Research Center

    Flint, Michigan, 48507

  • Holy Cross Hospital

    Fort Lauderdale, Florida, 33308

  • Indiana/Ohio Heart

    Fort Wayne, Indiana, 46804

  • Florida Research Network, LLC

    Gainesville, Florida, 32605

  • Malcom Randall Veterans Affairs Medical Center

    Gainesville, Florida, 32608

  • Integrated Vascular Vein Center of Michigan

    Grand Blanc, Michigan, 48439

  • Hattiesburg Clinic, P.A.

    Hattiesburg, Mississippi, 39401

  • Penn State Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • Texas Heart Institute at St. Luke's Episcopal Hospital

    Houston, Texas, 77030

  • The Methodist Hospital

    Houston, Texas, 77030

  • St. Vincent Medical Group, Inc.

    Indianapolis, Indiana, 46290

  • First Coast Cardiovascular Institute, P.A.

    Jacksonville, Florida, 32216

  • Saint Luke's Hospital

    Kansas City, Missouri, 64111

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Arkansas Primary Care Clinic, P.A.

    Little Rock, Arkansas, 72204

  • Central Arkansas Veteran's Healthcare System

    Little Rock, Arkansas, 72205

  • VA Loma Linda Healthcare

    Loma Linda, California, 92357

  • UCLA Gonda Venous Center & Ambulatory Procedure Unit

    Los Angeles, California, 90095

  • University of Wisconsin

    Madison, Wisconsin, 53792

  • Vascular Surgical Associates, P.C.

    Marietta, Georgia, 30060

  • University of Miami Hospital

    Miami, Florida, 33136

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53203

  • Columbia Saint Mary's

    Milwaukee, Wisconsin, 53211

  • Wheaton Franciscan Medical Group, Inc.

    Milwaukee, Wisconsin, 53217

  • Abbott Northwestern Hospital / Minneapolis Heart Institute-Vascular Clinic

    Minneapolis, Minnesota, 55407

  • Minneapolis VA Health Care System

    Minneapolis, Minnesota, 55417

  • University of Minnesota Medical School

    Minneapolis, Minnesota, 55455

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37212

  • Yale School of Medicine

    New Haven, Connecticut, 06520

  • Ochsner Clinic foundation

    New Orleans, Louisiana, 70121

  • Mount Sinai Medical Center

    New York, New York, 10029

  • University of Oklahoma Health Science Center

    Oklahoma City, Oklahoma, 73104

  • Omaha VAMC

    Omaha, Nebraska, 68105

  • Orlando Health

    Orlando, Florida, 32806

  • Baptist Hospital

    Pensacola, Florida, 32501

  • Cardiology Consultants

    Pensacola, Florida, 32501

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140

  • Arizona Heart Institute

    Phoenix, Arizona, 85006

  • Carl T. Hayden VA Medical Center

    Phoenix, Arizona, 85012

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • Veterans' Administration Medical Center

    Pittsburgh, Pennsylvania, 15232

  • VA Pittsburgh Healthcare System

    Pittsburgh, Pennsylvania, 15240

  • Sutter Medical Group - Cardiology

    Sacramento, California, 95819

  • Michigan CardioVascular Institutue at Covenant Medical Center

    Saginaw, Michigan, 48602

  • University of Utah

    Salt Lake City, Utah, 84132

  • Audie L Murphy VA Hospital - Pathology Laboratory

    San Antonio, Texas, 78229

  • University of California San Diego Medical Center

    San Diego, California, 92103

  • Kaiser Permanente Medical Center

    San Diego, California, 92120

  • University of California San Francisco - Division of Vascular and Endovascular Surgery

    San Francisco, California, 94143-0222

  • Swedish Medical Center

    Seattle, Washington, 98122

  • University of Washington

    Seattle, Washington, 98195

  • Memorial Medical Center

    Springfield, Illinois, 62702

  • Stony Brook University Medical Center

    Stony Brook, New York, 11794

  • Cascade Vascular Associates, P.S.

    Tacoma, Washington, 98405

  • Jobst Vascular Institute

    Toledo, Ohio, 43606

  • University of Toledo Medical Center

    Toledo, Ohio, 43614

  • University of Arizona

    Tucson, Arizona, 85724

  • Grove Place Surgery Center

    Vero Beach, Florida, 32960

  • Vascular Access Center of West Orange

    West Orange, New Jersey, 07052

  • Heartland Vascular Medicine and Surgery

    Windsor Heights, Iowa, 50324

  • Wake Forest Baptist Health

    Winston-Salem, North Carolina, 27157

  • UMASS Memorial Health Care

    Worcester, Massachusetts, 01655

  • Saint Joseph Mercy Hospital

    Ypsilanti, Michigan, 48197

Other trials in United States

About this study

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy, Safety, And Tolerability Of Ixmyelocel-T In Subjects With Critical Limb Ischemia And No Options For Revascularization

This study is designed to evaluate the efficacy and safety of ixmyelocel-T, a patient-specific expanded multicellular therapy, for the treatment of patients with critical limb ischemia (CLI). The study is a randomized, vehicle controlled (placebo)study in CLI patients who have no option for revascularization procedures. All patients randomized will undergo a small volume bone marrow aspiration in a 15-minute outpatient or in-office procedure. All patients will receive injections of either ixmyelocel-T or vehicle-control into their pre-identified index leg. Patients will be followed for 18 months.

Being tested
Ixmyelocel-T, Placebo
Keywords
critical limb ischemia, REVIVE, peripheral vascular disease, CLI, PAD, MSC, stem cells, cell therapy
Medical subject headings
Chronic Limb-Threatening 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

    On Day 14, 20 intramuscular injections of ixmyelocel-T on pre-identified index leg.

  • PlaceboOther

    On Day 14, 20 intramuscular injections of vehicle control on pre-identified index leg.

Study groups in NCT01483898
Study groupRoleWhat they receive
ixmyelocel-TExperimentalNot described
Receives: Biological: Ixmyelocel-T
PlaceboPlacebo comparatorNot described
Receives: Other: Placebo

What is being measured

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

  1. Amputation free survival (AFS) at 12 months post-injection

    The primary objective will be to assess the efficacy of ixmyelocel-T compared to placebo (vehicle control) on AFS at 12 months post-injection in CLI patients with no options for revascularization. Amputation free survival is defined as time to the first occurrence of either major amputation (above the talus) in the index leg or all-cause mortality (death).

    Measured: 12 months

Secondary outcomes (3)

  1. Percent of patients with adverse events

    A secondary objective will be to evaluate the overall safety and tolerability of ixmyelocel-T versus placebo in patients with CLI from time of aspiration through 18 months post-treatment/follow-up by % of patients with adverse events.

    Measured: 18 months

  2. Percent of patients with complete wound closure by Month 12

    A secondary objective is to assess the percent of patients with at least 1 ischemic wound on the index leg that is present at Visit 3 (preinjection) having complete closure by Month 12.

    Measured: 12 months

  3. Percent of patients experiencing a major cardiac event (MACE) by Months 6, 12, and 18

    % of patients experiencing a MACE event defined as cardiovascular mortality, myocardial infarction, chest pain requiring hospitalization, or stroke.

    Measured: 6, 12 and 18 months

Timeline

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

  1. First posted2 Dec 2011 (estimated)
  2. Study startFeb 2012
  3. Primary completion25 Mar 2014
  4. Study completion25 Mar 2014

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01483898
Sponsor's protocol ID
ABI 55-1009-1
Acronym
REVIVE
Status last verified
May 2021
First submitted
30 Nov 2011
Last updated
27 May 2021
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ixmyelocel-T in people with Critical Limb Ischemia, run by Vericel Corporation at 86 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 16 inclusion and 27 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 27 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 86 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Amputation free survival (AFS) at 12 months post-injection (time frame: 12 months). 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 NCT01483898.

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 27 May 2021.

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