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

This study is currently recruiting participants.
Verified March 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: March 4, 2014
Last verified: March 2014

January 14, 2010
March 4, 2014
June 2010
May 2015   (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
Not Provided
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) and no revascularization options. 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)
    Point-of-care collection and concentration of autologous bone marrow aspirate, followed by intramuscular delivery of cBMA to affected limb
    Intervention: Device: Bone marrow concentration device
  • Sham Comparator: Placebo control (sham)
    Sham bone marrow aspiration, sham delivery to 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 2015
May 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Unilateral or bilateral lower extremity ischemia due to advanced peripheral arterial disease
  • Non-candidates for surgical bypass or percutaneous angioplasty and stenting
  • Maximal medical therapy for critical limb ischemia
  • 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 active (or history of) 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
  • Infection of index leg
  • Pregnant women (negative urine pregnancy test required)
  • Lower extremity venous disease with pitting edema in index leg
  • History of bone marrow disease prohibiting transplantation
  • History of non-cancer chemotherapy or radiation affecting bone marrow
  • 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
  • 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.
March 2014

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