Injection of Autologous CD34-Positive Cells for Critical Limb Ischemia

Injection of Autologous CD34-Positive Cells for Improved Symptomatic Relief and Ischemic Wound Healing in Subjects With Moderate or High-Risk Critical Limb Ischemia

The purpose of this study is to evaluate the safety and efficacy of intramuscular injections of adult stem cells in patients with Critical Limb Ischemia (CLI).

Inclusion Criteria:

• 21-80 years of age
• moderate or high-risk Critical Limb Ischemia (Rutherford Clinical Severity Score 4 or 5)
• unsuitable for conventional revascularization

Exclusion Criteria:

• advanced CLI (Rutherford Clinical Severity Score 6) characterized by extensive tissue loss or gangrene
• advance AV block or NYHA Class III or Class IV heart failure
• myocardial infarction within 3 months of treatment
• successful coronary or lower extremity revascularization within 3 months of study enrollment
• arterial insufficiency in the lower extremity is the result of a non-atherosclerotic disorder with the exception of thromboangitis obliterans (Buerger's Disease)
• co-morbidity associated with life expectancy of less than 1 year