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



Status:Active, not recruiting
Conditions:Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:21 - Any
Updated:6/27/2018
Start Date:June 2010
End Date:May 2020

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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).

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.
We found this trial at
25
sites
9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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Boston, MA
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Miami, Florida 33124
(305) 284-2211
University of Miami A private research university with more than 15,000 students from around the...
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1968 Peachtree Rd NW
Atlanta, Georgia 30309
(404) 605-5000
Piedmont Hospital For more than a century, Piedmont Healthcare has been a recognized leader in...
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Charlottesville, Virginia 22908
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303 East Superior Street
Chicago, Illinois 60611
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Columbus, Ohio 43215
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Grand Rapids, Michigan 49503
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Houston, Texas 77030
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340 W 10th St #6200
Indianapolis, Indiana 46202
(317) 274-3772
Indiana University School of Medicine With more than 2,000 students in 2013, the Indiana University...
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Indianapolis, IN
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200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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Kansas City, Missouri 64111
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Little Rock, Arkansas 72205
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500 S Preston St
Louisville, Kentucky
(502) 852-5555
University of Louisville The University of Louisville is a state supported research university located in...
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2900 W Oklahoma Ave
Milwaukee, Wisconsin 53215
414-649-6000
Aurora St. Luke's Medical Center At Aurora St. Luke's Medical Center, you'll find remarkable treatment...
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New York, New York 10029
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3401 N Broad St
Philadelphia, Pennsylvania
(215) 707-2000
Temple University Hospital On January 18, 1892 a three-story house at 3403 North Broad Street...
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Pittsburgh, Pennsylvania 15240
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2315 Stockton Blvd.
Sacramento, California 95817
(916) 734-2011
University of California, Davis Medical Center UC Davis Medical Center serves a 65,000-square-mile area that...
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Spokane, Washington 99204
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Teaneck, New Jersey 07666
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Worcester, Massachusetts 01655
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