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

Sponsor:	Biomet Biologics, LLC
Information provided by (Responsible Party):	Biomet, Inc. ( Biomet Biologics, LLC )
ClinicalTrials.gov Identifier:	NCT01049919

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	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:

MedlinePlus related topics: Peripheral Arterial Disease

U.S. FDA Resources

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 2014
Estimated Primary Completion Date:	May 2014 (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

Contacts and Locations

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

Locations

United States, Alabama
The University of Alabama at Birmingham	Recruiting
Birmingham, Alabama, United States, 35294
Contact: Juli Burks 205-934-7279 Juli.Burks@ccc.uab.edu
Principal Investigator: Marc A. Passman, MD
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: John F. Eidt, 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: Jagajan Karmacharya, MD
United States, Indiana
Indiana University School of Medicine	Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Pat G'Sell 317-278-6585 pgsell@iupui.edu
Principal Investigator: Michael P. Murphy, MD
United States, Iowa
University of Iowa Hospitals and Clinics	Recruiting
Iowa City, Iowa, United States, 52242
Contact: Anas Eid, MD 319-356-1304 anas-eid@uiowa.edu
Principal Investigator: Melhem J. Sharafuddin, MD
United States, Kentucky
University of Louisville	Recruiting
Louisville, Kentucky, United States, 40202
Contact: Diane DeLong 502-852-2604 ddelong@louisville.edu
Principal Investigator: Charles B. Ross, 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
United States, Texas
Austin Heart Hospital	Recruiting
Austin, Texas, United States, 78756
Contact: Paige Musick 512-421-3896 pmusick@austinheart.com
Principal Investigator: Roger Gammon, MD
Dallas Veterans Affairs Medical Center	Recruiting
Dallas, Texas, United States, 75216
Contact: Eric Rosero, MD 214-857-0336 eric.rosero@utsouthwestern.edu
Principal Investigator: Carlos H. Timaran, MD
University of North Texas Health Science Center	Recruiting
Fort Worth, Texas, United States, 76107
Contact: Bonnie Wicklund 817-735-0304 Bonnie.Wicklund@unthsc.edu
Principal Investigator: Albert H. Olivencia-Yurvati, DO
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

Sponsors and Collaborators

Biomet Biologics, LLC

Investigators

Principal Investigator:

Michael P. Murphy, MD

Indiana University School of Medicine

More Information

Additional Information:

Click here for more information about this study: MarrowStim™ PAD Kit for the Treatment of Critical Limb Ischemia (CLI) in Subjects with Severe Peripheral Arterial Disease (PAD) This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Click here if you think you may qualify for this study to obtain further information about participation: Clinical Trial Spotlight This link exits the ClinicalTrials.gov site

Publications:

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. Epub 2011 Apr 22.

Responsible Party:	Biomet, Inc. ( Biomet Biologics, LLC )
ClinicalTrials.gov Identifier:	NCT01049919 History of Changes
Other Study ID Numbers:	BB-IDE 13996
Study First Received:	January 14, 2010
Last Updated:	October 17, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Ischemia
Peripheral Arterial Disease
Peripheral Vascular Diseases
Pathologic Processes
Atherosclerosis

Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on February 21, 2012