An Efficacy and Safety Study of Ixmyelocel-T in Patients With Critical Limb Ischemia (CLI)
REVIVE
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
1 other identifier
interventional
41
1 country
86
Brief 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). 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Feb 2012
86 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 30, 2011
CompletedFirst Posted
Study publicly available on registry
December 2, 2011
CompletedStudy Start
First participant enrolled
February 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 25, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 25, 2014
CompletedMay 27, 2021
May 1, 2021
2.1 years
November 30, 2011
May 25, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (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).
12 months
Secondary Outcomes (3)
Percent of patients with adverse events
18 months
Percent of patients with complete wound closure by Month 12
12 months
Percent of patients experiencing a major cardiac event (MACE) by Months 6, 12, and 18
6, 12 and 18 months
Study Arms (2)
ixmyelocel-T
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
On Day 14, 20 intramuscular injections of ixmyelocel-T on pre-identified index leg.
On Day 14, 20 intramuscular injections of vehicle control on pre-identified index leg.
Eligibility Criteria
You may qualify if:
- 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)
- 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
- +1 more criteria
You may not qualify if:
- 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)
- 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
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (86)
Cardiology PC
Birmingham, Alabama, 35211, United States
Cardio-Thoracic Surgeons, P.C.
Birmingham, Alabama, 35243, United States
University Of Alabama At Birmingham
Birmingham, Alabama, 35294, United States
Arizona Heart Institute
Phoenix, Arizona, 85006, United States
Carl T. Hayden VA Medical Center
Phoenix, Arizona, 85012, United States
University of Arizona
Tucson, Arizona, 85724, United States
Arkansas Primary Care Clinic, P.A.
Little Rock, Arkansas, 72204, United States
Central Arkansas Veteran's Healthcare System
Little Rock, Arkansas, 72205, United States
John Muir Medical Center - Concord Campus
Concord, California, 94520, United States
VA Loma Linda Healthcare
Loma Linda, California, 92357, United States
UCLA Gonda Venous Center & Ambulatory Procedure Unit
Los Angeles, California, 90095, United States
Sutter Medical Group - Cardiology
Sacramento, California, 95819, United States
University of California San Diego Medical Center
San Diego, California, 92103, United States
Kaiser Permanente Medical Center
San Diego, California, 92120, United States
University of California San Francisco - Division of Vascular and Endovascular Surgery
San Francisco, California, 94143-0222, United States
University of Colorado Denver - Anschutz Medical Campus
Aurora, Colorado, 80045, United States
Yale School of Medicine
New Haven, Connecticut, 06520, United States
Bethesda Memorial Hospital - Clinical Research Center
Boynton Beach, Florida, 33435, United States
Holy Cross Hospital
Fort Lauderdale, Florida, 33308, United States
Florida Research Network, LLC
Gainesville, Florida, 32605, United States
Malcom Randall Veterans Affairs Medical Center
Gainesville, Florida, 32608, United States
First Coast Cardiovascular Institute, P.A.
Jacksonville, Florida, 32216, United States
University of Miami Hospital
Miami, Florida, 33136, United States
Orlando Health
Orlando, Florida, 32806, United States
Baptist Hospital
Pensacola, Florida, 32501, United States
Cardiology Consultants
Pensacola, Florida, 32501, United States
Grove Place Surgery Center
Vero Beach, Florida, 32960, United States
Vascular Surgical Associates, P.C.
Marietta, Georgia, 30060, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
University of Illinois at Chicago - Clinical Sciences North
Chicago, Illinois, 60612, United States
Memorial Medical Center
Springfield, Illinois, 62702, United States
Indiana/Ohio Heart
Fort Wayne, Indiana, 46804, United States
St. Vincent Medical Group, Inc.
Indianapolis, Indiana, 46290, United States
Heartland Vascular Medicine and Surgery
Windsor Heights, Iowa, 50324, United States
Ochsner Clinic foundation
New Orleans, Louisiana, 70121, United States
University of Maryland Medical Center
Baltimore, Maryland, 21201, United States
Union Memorial Hospital
Baltimore, Maryland, 21218, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
UMASS Memorial Health Care
Worcester, Massachusetts, 01655, United States
VA Ann Arbor Healthcare System
Ann Arbor, Michigan, 48105, United States
Cardiology and Vascular Associates, P.C.
Berkley, Michigan, 48072, United States
Oakwood Hospital and Medical Center
Dearborn, Michigan, 48124, United States
John D. Dingell VA Medical Center
Detroit, Michigan, 48201, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Michigan Vascular Research Center
Flint, Michigan, 48507, United States
Integrated Vascular Vein Center of Michigan
Grand Blanc, Michigan, 48439, United States
Michigan CardioVascular Institutue at Covenant Medical Center
Saginaw, Michigan, 48602, United States
Saint Joseph Mercy Hospital
Ypsilanti, Michigan, 48197, United States
Abbott Northwestern Hospital / Minneapolis Heart Institute-Vascular Clinic
Minneapolis, Minnesota, 55407, United States
Minneapolis VA Health Care System
Minneapolis, Minnesota, 55417, United States
University of Minnesota Medical School
Minneapolis, Minnesota, 55455, United States
Hattiesburg Clinic, P.A.
Hattiesburg, Mississippi, 39401, United States
Saint Luke's Hospital
Kansas City, Missouri, 64111, United States
Omaha VAMC
Omaha, Nebraska, 68105, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Vascular Access Center of West Orange
West Orange, New Jersey, 07052, United States
University of Buffalo Surgeons Inc.
Buffalo, New York, 14203, United States
Mount Sinai Medical Center
New York, New York, 10029, United States
Stony Brook University Medical Center
Stony Brook, New York, 11794, United States
University of North Carolina Hospital
Chapel Hill, North Carolina, 27599, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157, United States
University Hospitals Case Medical Center
Cleveland, Ohio, 44106, United States
Jobst Vascular Institute
Toledo, Ohio, 43606, United States
University of Toledo Medical Center
Toledo, Ohio, 43614, United States
University of Oklahoma Health Science Center
Oklahoma City, Oklahoma, 73104, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
Veterans' Administration Medical Center
Pittsburgh, Pennsylvania, 15232, United States
VA Pittsburgh Healthcare System
Pittsburgh, Pennsylvania, 15240, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37212, United States
DFW Vascular Group, LLP
Dallas, Texas, 75208, United States
Texas Heart Institute at St. Luke's Episcopal Hospital
Houston, Texas, 77030, United States
The Methodist Hospital
Houston, Texas, 77030, United States
Audie L Murphy VA Hospital - Pathology Laboratory
San Antonio, Texas, 78229, United States
University of Utah
Salt Lake City, Utah, 84132, United States
Swedish Medical Center
Seattle, Washington, 98122, United States
University of Washington
Seattle, Washington, 98195, United States
Cascade Vascular Associates, P.S.
Tacoma, Washington, 98405, United States
Charleston Area Medical Center - Memorial Hospital
Charleston, West Virginia, 25304, United States
University of Wisconsin
Madison, Wisconsin, 53792, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53203, United States
Columbia Saint Mary's
Milwaukee, Wisconsin, 53211, United States
Wheaton Franciscan Medical Group, Inc.
Milwaukee, Wisconsin, 53217, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 30, 2011
First Posted
December 2, 2011
Study Start
February 1, 2012
Primary Completion
March 25, 2014
Study Completion
March 25, 2014
Last Updated
May 27, 2021
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will not share