Safety and Efficacy Study of Autologous Concentrated Bone Marrow Aspirate (cBMA) for Critical Limb Ischemia (CLI)
NCT ID: NCT01049919
Last Updated: 2021-05-28
Study Results
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View full resultsBasic Information
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TERMINATED
NA
153 participants
INTERVENTIONAL
2010-06-30
2020-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Concentrated bone marrow aspirate (cBMA)
Collection of autologous bone marrow aspirate and point-of-care concentration using the bone marrow concentration device, followed by intramuscular injection of concentrated bone marrow aspirate (cBMA) into the affected limb
Bone marrow concentration device
Concentration of autologous bone marrow aspirate for intramuscular delivery to affected limb
Placebo control (sham)
Placebo procedure (sham) consists of simulated bone marrow aspiration followed by simulated intramuscular injections into the affected limb
Placebo procedure (sham)
Sham bone marrow aspiration, sham delivery to affected limb
Interventions
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Bone marrow concentration device
Concentration of autologous bone marrow aspirate for intramuscular delivery to affected limb
Placebo procedure (sham)
Sham bone marrow aspiration, sham delivery to affected limb
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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.
21 Years
ALL
No
Sponsors
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Zimmer Biomet
INDUSTRY
Responsible Party
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Principal Investigators
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Michael P. Murphy, MD
Role: PRINCIPAL_INVESTIGATOR
Indiana University School of Medicine
Locations
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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
Countries
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References
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Murphy MP, Lawson JH, Rapp BM, Dalsing MC, Klein J, Wilson MG, Hutchins GD, March KL. Autologous bone marrow mononuclear cell therapy is safe and promotes amputation-free survival in patients with critical limb ischemia. J Vasc Surg. 2011 Jun;53(6):1565-74.e1. doi: 10.1016/j.jvs.2011.01.074. Epub 2011 Apr 22.
Other Identifiers
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BBIO.CR.CT002
Identifier Type: OTHER
Identifier Source: secondary_id
BB-IDE 13996
Identifier Type: -
Identifier Source: org_study_id
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