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

January 14, 2010
July 10, 2014
June 2010
May 2016   (final data collection date for primary outcome measure)
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
Not Provided
Complete list of historical versions of study NCT01049919 on ClinicalTrials.gov Archive Site
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
Not Provided
  • 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
Not Provided
 
Safety and Efficacy Study of Autologous Concentrated Bone Marrow Aspirate (cBMA) for Critical Limb Ischemia (CLI)
MarrowStim PAD Kit for the Treatment of Critical Limb Ischemia (CLI) in Subjects With Severe Peripheral Arterial Disease (PAD)

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).

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).

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
  • Critical Limb Ischemia
  • Peripheral Arterial Disease
  • Peripheral Vascular Disease
  • 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
  • Procedure: Placebo procedure (sham)
    Sham bone marrow aspiration, sham delivery to affected limb
  • 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
    Intervention: Device: Bone marrow concentration device
  • Sham Comparator: Placebo control (sham)
    Placebo procedure (sham) consists of simulated bone marrow aspiration followed by simulated intramuscular injections into the affected limb
    Intervention: Procedure: Placebo procedure (sham)
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
152
May 2020
May 2016   (final data collection date for primary outcome measure)

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.
Both
21 Years and older
No
Contact: Hillary Overholser 574-371-1087 hillary.overholser@biomet.com
United States
 
NCT01049919
BB-IDE 13996, BBIO.CR.CT002
Yes
Biomet, Inc. ( Biomet Biologics, LLC )
Biomet Biologics, LLC
Not Provided
Principal Investigator: Michael P. Murphy, MD Indiana University School of Medicine
Biomet, Inc.
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP