Inclusion/exclusion criteria

Critical Limb Ischemia

Critical Limb Ischemia

Critical limb ischemia occurs due to arterial occlusive disease, which is the obstruction of large arteries in the body. Symptoms include ulcers, gangrene and pain in one or both legs. It is a chronic disease, therefore it lasts a long time. About 500 to 1000 million people suffer with critical limb ischemia per year. Diabetes, old age and smoking increase the risk of this condition. 10% to 40% of people with critical limb ischemia need to have a limb amputated.

Inclusion Criteria

• Age ≥ 18 years
• Existence of critical limb ischemia, with clinical presentation corresponding to Rutherford Categories 4 or 5,2 as defined in the reporting standards adopted by the Society of Vascular Surgeons, or corresponding to the Leriche–Fontaine Classification, stages III or IV
• Stable and on optimal medical management for > 60 days as follows:
o Clopidogrel/aspirin therapy or other anticoagulation therapy, cholesterollowering agent, and⁄or antihypertensive medication
o Hematocrit ≥ 28.0%, White Blood Cell count ≤14,000, Platelet count ≥ 50,000
o Creatinine ≤ 2.0 mg/dL, and INR ≤ 1.6 (unless taking warfarin) or PTT < 1.5°¡ control (to avoid bleeding complications). INR values for patients taking warfarin will be corrected prior to the procedure • Patient meets at least one of the following diagnostic criteria for the index limb: o Ankle artery occlusion pressure absolute < 50 mm Hg or ABI <0.4 o Toe artery occlusive pressure < 40 mm Hg or TBI <0.4 o TcpO2 <20 mm Hg when lying down and breathing room air, if available • Need for open surgical or endovascular revascularization established • At least one non-healing distal extremity ulcer and concomitant ineligibility for revascularization as confirmed by a vascular surgeon

Exclusion Criteria

At the time of the screening/enrollment visit #1, patients meeting ANY ONE of the following criteria will be excluded from the study.
• Female who is pregnant or nursing, or is of childbearing potential and not using a reliable method of contraception
• Inability to undergo a liposuction procedure
• Any medical problems contraindicating liposuction
• Life expectancy < 6 months • Severe cardiovascular disease • Patient determined to be inoperable due to reasons such as o Anatomical considerations o No distal vascular outflow target o No appropriate autologous conduit available and patient unwilling or unable to tolerate an anticoagulation regimen deemed to be required following implantation of a synthetic conduit o Long-segment occlusions or calcified lesions within native vasculature that predict poor outcome with endovascular approaches o High-risk medical conditions o Unstable cardiac disease o Renal insufficiency • Inability to perform a walking test on a treadmill due to physical limitations other than HF including: o Severe peripheral vascular disease, including aortic aneurysms, leading to limiting claudication o Severe pulmonary disease or chronic obstructive pulmonary disease (COPD) limiting exercise o Dependence on chronic oral steroid therapy o Dependence on chronic continuous oxygen therapy, or previously required mechanical ventilation o Stroke or transient ischemic attack leading to limitations in lower extremities or occurring within 180 days prior to the initial screening visit o Severe arthritis or other musculoskeletal disorder. • Patients with severe coagulation disorders including thromobophilia • Systolic blood pressure (supine) ≤ 90 mmHg • Resting heart rate > 100 bpm
• Severe uncontrolled HF, including any evidence of severe fluid overload such as peripheral edema > +2, rales encroaching the upper 2/3 of either lung field, need for intravenous therapy for HF within 60 days of the initial screening visit, or hospitalization for HF within 90 days of the initial screening visit
• Known allergic reaction to cephalexin, clindamycin or vancomycin
• History of bone marrow diseases (especially NHL, MDS) that prohibit transplantation
• Terminal renal failure with existing dependence on dialysis
• Poorly controlled diabetes mellitus (HgbA1c > 10%)
• Active proliferative diabetic retinopathy
• Creatinine > 2.0 mg/dL
• Medical risk that precludes anesthesia (conscious sedation), or ASA Class v
• Life‐threatening complications of limb ischemia necessitating immediate amputation
• Uncorrected iliac artery occlusion on index side unless corrected with stent
• Extensive necrosis of the index limb or other conditions that make amputation inevitable (Rutherford Category 6)
• Prior lower extremity amputation of any extent within 3 months of study entry
• Active clinical infection being treated by antibiotics within one week of enrollment
• Treatment with immunosuppressant drugs
• Major open vascular or cardiovascular surgical procedure (carotid endarterectomy, arterial aneurysm, bypass surgery, or coronary artery bypass surgery) within 3 months preceding study entry
• Cerebrovascular accident within 6 months prior to study entry
• Known drug or alcohol dependence, or any other factors which will interfere with the study conduct or interpretation of the results
• Not suitable to participate in the opinion of the principal investigator
• COPD or severe asthma that would contraindicate surgery
• History of thromboangiitis obliterans (Buerger’s Disease), cancer (other than nonmelanoma skin cancer or in situ cervical cancer) within two years preceding study entry
• Unwilling and/or not able to give written informed consent