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
  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


Estimated Enrollment: 152
Study Start Date: June 2010
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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)
Sham bone marrow aspiration, sham delivery to 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) 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).

  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
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01049919

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

Locations
United States, Arkansas
Central Arkansas Veterans Healthcare System Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Sandra Brock    501-257-6906    brocksandraj@uams.edu   
Principal Investigator: Mohammed Moursi, MD         
United States, California
University of California-Davis Medical Center Recruiting
Sacramento, California, United States, 95817
Contact: Christy Pifer    916-734-4156      
Principal Investigator: John R. Laird, MD         
United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Lynne Sparling    305-243-7298    lsparlin@med.miami.edu   
Principal Investigator: Omaida Velazquez, MD         
United States, Georgia
Piedmont Hospital Recruiting
Atlanta, Georgia, United States, 30309
Contact: Jennifer Jacobs, RN    404-605-3118    Jennifer.Jacobs@piedmont.org   
Principal Investigator: Charles B Ross, MD         
United States, Indiana
Indiana University School of Medicine Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Kristen Wanczyk, RN    317-988-9548    keevans@iu.edu   
Principal Investigator: Michael P. Murphy, MD         
United States, Iowa
University of Iowa Hospitals and Clinics Recruiting
Iowa City, Iowa, United States, 52242
Contact: Judith Pena-Quevedo, RN    319-353-8736    judith-pena-quevedo@uiowa.edu   
Principal Investigator: Melhem J. Sharafuddin, MD         
United States, Kentucky
University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact: Shari Williams, RN    502-407-3259    slwill06@louisville.edu   
Principal Investigator: Marvin E. Morris, MD         
United States, Massachusetts
UMass Memorial Health Care Recruiting
Worcester, Massachusetts, United States, 01655
Contact: Shauneen Valliere    508-856-1767    shauneen.valliere@umassmed.edu   
Principal Investigator: Louis Messina, MD         
United States, Michigan
Spectrum Health Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Jeanine Holen    616-391-5067    jeanine.holen@spectrumhealth.org   
Principal Investigator: Christopher M. Chambers, MD, PhD         
United States, New York
Weill Cornell Medical College / New York-Presbyterian Hospital Recruiting
New York, New York, United States, 10065
Contact: Ruchita Mehta    212-746-5949    rum2006@med.cornell.edu   
Principal Investigator: John Karwowski, MD         
United States, Ohio
The Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Jennifer Seaber    216-445-8063    seaberj@ccf.org   
Principal Investigator: Rebecca L. Kelso, MD         
University Hospitals Case Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Lori Hammer    216-983-4719    lori.hammer@uhhospitals.org   
Principal Investigator: Vikram S Kashyap, MD, F.A.C.S.         
Remington-Davis Recruiting
Columbus, Ohio, United States, 43215
Contact: Jennifer M Botte, BS, RN    614-487-2560    jbotte@remdavis.com   
Principal Investigator: Lucy M Laperna, D.O., RVT, RPVI         
United States, Pennsylvania
VA Pittsburgh Healthcare System Recruiting
Pittsburgh, Pennsylvania, United States, 15240
Contact: Jennifer Carrick, RN    412-360-3653    Jennifer.Carrick@va.gov   
Principal Investigator: Edith Tzeng, MD         
United States, Washington
Providence Sacred Heart Medical Center Recruiting
Spokane, Washington, United States, 99204
Contact: Claudia Flores    509-474-4306    claudia.flores@providence.org   
Principal Investigator: Joseph Davis, MD         
United States, Wisconsin
Aurora St. Luke's Medical Center Recruiting
Milwaukee, Wisconsin, United States, 53215
Contact: Valerie Williams, RN, CCRC    414-649-6853    valerie.williams@aurora.org   
Principal Investigator: Tanvir Bajwa, MD         
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: March 4, 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 Vascular Diseases
Peripheral Arterial Disease
Pathologic Processes
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on April 20, 2014