ACP-01 in Patients With Critical Limb Ischemia

Inclusion Criteria

• Subject is diagnosed with critical limb ischemia.
• Subject has hemodynamic indicators of severe peripheral arterial occlusive disease.
• Subject is not a candidate for standard revascularization treatment options for peripheral arterial disease.
• Subject must be on standard of care medical therapy for peripheral vascular disease.
• Male or female age 18 and above.
• Non-pregnant, non-lactating female.
• Subject is able to understand and provide voluntary signed informed consent.

Exclusion Criteria

• Uncorrected aorto-iliac occlusive disease.
• Subjects who, in the opinion of the investigator, have a vascular disease prognosis that indicates they would require a major amputation in a time frame shortly after administration of the IMP (investigational drug or placebo).
• Advanced Critical Limb Ischemia (CLI) presenting as severe ischemic or dry gangrene.
• Lower extremity non-treated active infection.
• Hypercoagulable state.
• Subject received a blood transfusion during the previous 4 weeks (to exclude the potential of non-autologous ACPs in the harvested blood).
• Inability to communicate that may interfere with clinical evaluation.
• Recent major non-vascular operation.
• Myocardial infarction or uncontrolled myocardial ischemia or persistent severe heart failure.
• Severe aortic stenosis.
• Renal failure.
• Hepatic failure.
• Anemia.
• Major stroke.
• Diagnosis of malignancy.
• Concurrent chronic or acute infectious disease and uncontrolled infectious symptoms.
• Severe concurrent disease (other than Peripheral Vascular Disease (PAD)).
• Bleeding diathesis.
• Participation at the same time in another investigational product or device study.
• Chronic cytotoxic drug treatment.
• Life expectancy of less than 6 months.
• Subject unlikely to be available for follow-up.
• Acute worsening of CLI.