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

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.