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

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ClinicalTrials.gov Identifier: NCT01049919
Recruitment Status : Active, not recruiting
First Posted : January 15, 2010
Last Update Posted : June 23, 2017
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Critical Limb Ischemia Peripheral Arterial Disease Peripheral Vascular Disease Device: Bone marrow concentration device Procedure: Placebo procedure (sham) Not Applicable

Detailed Description:
This is a prospective, randomized, double-blind, placebo controlled, multicenter trial intended for subjects with critical limb ischemia (CLI) that are unsuitable for revascularization. The investigational treatment utilizes autologous concentrated bone marrow aspirate (cBMA) at the point of care. The bone marrow aspirate is obtained from the subject's hip, concentrated with a bone marrow concentration device, and delivered intramuscularly to the affected limb. Subjects meeting the inclusion/exclusion criteria will be randomized to receive either the investigational treatment (cBMA) or a placebo control (sham treatment).

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 152 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: MarrowStim PAD Kit for the Treatment of Critical Limb Ischemia (CLI) in Subjects With Severe Peripheral Arterial Disease (PAD)
Study Start Date : June 2010
Actual Primary Completion Date : June 2016
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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
Device: Bone marrow concentration device
Concentration of autologous bone marrow aspirate for intramuscular delivery to affected limb
Other Names:
  • Bone marrow concentrate
  • Bone marrow mononuclear cells
  • MarrowStim

Sham Comparator: Placebo control (sham)
Placebo procedure (sham) consists of simulated bone marrow aspiration followed by simulated intramuscular injections into the affected limb
Procedure: Placebo procedure (sham)
Sham bone marrow aspiration, sham delivery to affected limb




Primary Outcome Measures :
  1. Time to treatment failure [ Time Frame: 52 weeks ]
    "Treatment failure" defined as the composite of major amputation of the index limb or death


Secondary Outcome Measures :
  1. Perfusion and quality of life measurements [ Time Frame: Throughout 52 week follow-up ]
    ABI, TBI, rest pain, 6 Minute Walk Test, VascuQol, minor amputations, time to major amputation of the index limb, time to death


Other Outcome Measures:
  1. Long-term treatment failure [ Time Frame: 5 years ]
    Evaluations of long-term amputation-free survival will be assessed for a period of 5 years.

  2. Long-term perfusion and quality of life measurements [ Time Frame: 3 years ]
    ABI, TBI, rest pain, 6 Minute Walk Test, VascuQol, SF-36, wound assessment, minor amputations, time to major amputation of the index limb, time to death



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01049919


  Hide Study Locations
Locations
United States, Arkansas
Central Arkansas Veterans Healthcare System
Little Rock, Arkansas, United States, 72205
United States, California
University of California-Davis Medical Center
Sacramento, California, United States, 95817
United States, District of Columbia
Medstar Health Research Institute
Washington, D.C., District of Columbia, United States, 20010
United States, Florida
University of Miami
Miami, Florida, United States, 33136
United States, Georgia
Piedmont Hospital
Atlanta, Georgia, United States, 30309
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Southern Illinois University
Springfield, Illinois, United States, 62702
United States, Indiana
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202
United States, Massachusetts
Tuft's Medical Center
Boston, Massachusetts, United States, 02111
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
UMass Memorial Health Care
Worcester, Massachusetts, United States, 01655
United States, Michigan
Spectrum Health
Grand Rapids, Michigan, United States, 49503
United States, Missouri
Saint Luke's Hospital
Kansas City, Missouri, United States, 64111
United States, Nebraska
Nebraska-Western Iowa VA Healthcare System
Omaha, Nebraska, United States, 68105
United States, New Jersey
Holy Name Medical Center
Teaneck, New Jersey, United States, 07666
United States, New York
The Mount Sinai Hospital
New York, New York, United States, 10029
Weill Cornell Medical College / New York-Presbyterian Hospital
New York, New York, United States, 10065
United States, Ohio
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
The Cleveland Clinic
Cleveland, Ohio, United States, 44195
Remington-Davis
Columbus, Ohio, United States, 43215
United States, Pennsylvania
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
VA Pittsburgh Healthcare System
Pittsburgh, Pennsylvania, United States, 15240
United States, Texas
The Methodist Hospital
Houston, Texas, United States, 77030
United States, Virginia
University of Virginia Hospital
Charlottesville, Virginia, United States, 22908
United States, Washington
Providence Sacred Heart Medical Center
Spokane, Washington, United States, 99204
United States, Wisconsin
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
Sponsors and Collaborators
Zimmer Biomet
Investigators
Principal Investigator: Michael P. Murphy, MD Indiana University School of Medicine

Additional Information:
Publications:
Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT01049919     History of Changes
Other Study ID Numbers: BB-IDE 13996
BBIO.CR.CT002 ( Other Identifier: Biomet )
First Posted: January 15, 2010    Key Record Dates
Last Update Posted: June 23, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes

Keywords provided by Zimmer Biomet:
Peripheral Arterial Disease
PAD
Critical Limb Ischemia
Peripheral Vascular Disease
CLI
PVD
Angiogenesis
Stem Cells
Cell Therapy
Limb Salvage
Amputation
Leg Pain

Additional relevant MeSH terms:
Ischemia
Vascular Diseases
Peripheral Arterial Disease
Peripheral Vascular Diseases
Pathologic Processes
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases