Safety and Efficacy Study of Autologous Concentrated Bone Marrow Aspirate (cBMA) for Critical Limb Ischemia (CLI)

Stopped early · Not applicable · Has a placebo group

Conditions studied: Critical Limb Ischemia, Peripheral Arterial Disease, Peripheral Vascular Disease

In brief

This trial will evaluate the safety and efficacy of concentrated bone marrow aspirate (cBMA) to prevent or delay major amputation and/or death in subjects with critical limb ischemia (CLI) due to severe peripheral arterial disease (PAD).

Key facts

Study ID

NCT01049919

Run by

Zimmer Biomet

People needed

153

Starts

2010-06-01

Expected to finish

2020-02-01

Last updated by the study team

2021-05-28

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Unilateral or bilateral lower extremity ischemia due to advanced peripheral arterial disease
• Unsuitable for revascularization
• Minor tissue loss (Rutherford Category 5) or ischemic rest pain (Rutherford Category 4) with ABI ≤ 0.6, or TBI ≤ 0.4, or TcPO2 ≤ 50 mm Hg
• Competent to give consent
• No current malignancy or history of previous malignancy within the last five years, with the exception of adequately treated non-melanoma skin cancer (evidence of standard preventative cancer screenings required)

You may not qualify if…

• Major tissue loss (Rutherford Category 6)
• Diabetics on oral or insulin therapy with uncontrolled or untreated proliferative retinopathy (evidence of retinal exam required)
• Poorly controlled diabetes mellitus with HbA1C > 10% (evidence of HbA1C test required)
• Uncompensated congestive heart failure (New York Heart Association Class IV) and/or other conditions that preclude general anesthesia
• Myocardial infarction or stroke within last 90 days
• Elevated liver function tests (AST or ALT more than twice normal upper limit)
• Renal disease (creatinine > 2.5 mg/dl) or chronic hemodialysis
• White blood cell count < 3,000/µL or > 15,000/µL, platelet count < 100,000/µL, or hematocrit < 32%
• Topical growth hormone therapy within last 90 days, or injected growth hormone therapy within last 180 days
• Disease of central nervous system and/or other conditions that impair cognitive function
• Two or more episodes of pulmonary embolus with a documented DVT in index leg or history of DVT in index leg without evidence of clot resolution
• Current infection of index leg
• Pregnant women (negative urine pregnancy test required)
• Lower extremity venous disease with pitting edema in index leg
• Recent history (in the 6 months prior to screening) of bone marrow disease or treatment with any medication or procedure which adversely affects the bone marrow and would prohibit transplantation
• Current osteomyelitis in index leg
• Existing HIV diagnosis
• Organ transplant recipients
• Known terminal disease process with life expectancy less than one year
• Severe concomitant disease(s) or any additional condition(s) which the investigator feels constitute(s) criteria for exclusion of a particular subject
• Major amputation required within 30 days
• Inclusion in any other clinical study that may affect the outcome of this study
• Uncorrected stenosis(es) of greater than 50% in the common and/or external iliac artery and/or common femoral artery of the index leg.

Where it is running

• Central Arkansas Veterans Healthcare System — Little Rock, Arkansas, United States
• University of California-Davis Medical Center — Sacramento, California, United States
• University of Miami — Miami, Florida, United States
• Piedmont Hospital — Atlanta, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• Indiana University School of Medicine — Indianapolis, Indiana, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• University of Louisville — Louisville, Kentucky, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• UMass Memorial Health Care — Worcester, Massachusetts, United States
• Spectrum Health — Grand Rapids, Michigan, United States
• Saint Luke's Hospital — Kansas City, Missouri, United States
• Nebraska-Western Iowa VA Healthcare System — Omaha, Nebraska, United States
• Holy Name Medical Center — Teaneck, New Jersey, United States
• The Mount Sinai Hospital — New York, New York, United States
• Weill Cornell Medical College / New York-Presbyterian Hospital — New York, New York, United States
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
• The Cleveland Clinic — Cleveland, Ohio, United States
• Remington-Davis — Columbus, Ohio, United States
• Temple University Hospital — Philadelphia, Pennsylvania, United States
• VA Pittsburgh Healthcare System — Pittsburgh, Pennsylvania, United States
• The Methodist Hospital — Houston, Texas, United States
• University of Virginia Hospital — Charlottesville, Virginia, United States
• Providence Sacred Heart Medical Center — Spokane, Washington, United States
• Aurora St. Luke's Medical Center — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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