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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Biomet, Inc.
Sponsor:
Information provided by (Responsible Party):
Biomet, Inc. ( Biomet Biologics, LLC )
ClinicalTrials.gov Identifier:
NCT01049919
First received: January 14, 2010
Last updated: July 10, 2014
Last verified: July 2014
  Purpose

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 Intervention
Critical Limb Ischemia
Peripheral Arterial Disease
Peripheral Vascular Disease
Device: Bone marrow concentration device
Procedure: Placebo procedure (sham)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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)

Resource links provided by NLM:


Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:
  • Time to treatment failure [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
    "Treatment failure" defined as the composite of major amputation of the index limb or death


Secondary Outcome Measures:
  • Perfusion and quality of life measurements [ Time Frame: Throughout 52 week follow-up ] [ Designated as safety issue: Yes ]
    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:
  • Long-term treatment failure [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Evaluations of long-term amputation-free survival will be assessed for a period of 5 years.

  • Long-term perfusion and quality of life measurements [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 152
Study Start Date: June 2010
Estimated Study Completion Date: May 2020
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01049919

Contacts
Contact: Hillary Overholser 574-371-1087 hillary.overholser@biomet.com

  Show 21 Study Locations
Sponsors and Collaborators
Biomet Biologics, LLC
Investigators
Principal Investigator: Michael P. Murphy, MD Indiana University School of Medicine
  More Information

Additional Information:
Publications:
Responsible Party: Biomet, Inc. ( Biomet Biologics, LLC )
ClinicalTrials.gov Identifier: NCT01049919     History of Changes
Other Study ID Numbers: BB-IDE 13996, BBIO.CR.CT002
Study First Received: January 14, 2010
Last Updated: July 10, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Biomet, Inc.:
Critical Limb Ischemia
Peripheral Arterial Disease
Peripheral Vascular Disease
CLI
PAD
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

ClinicalTrials.gov processed this record on September 18, 2014