Open Label Single Arm Proof of Concept Trial to Evaluate the Efficacy and Safety of Cytori Celution System in Chronic Non-Healing Venous Leg Ulcers

Exclusion Criteria

• •1. More than 20% change in surface area of target ulcer between screening and enrollment visit.
• •2. There is bone involvement in case of ulcer
• •3. Patient with a history of bleeding disorder
• •4. Therapy for anticoagulation
• •5. Patient receiving corticosteroids, immunosuppressive or cytotoxic agents, and all systemic agents that can affect wound repair
• •6. Patient with any treatment that might interfere with the assessment of the study treatment
• •7. Pregnant or likely to become pregnant or lactating women
• •8. Participation in any type of clinical investigation concurrently or in the last 6 months
• •9. Positive for HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV) and syphilis (results within 1 month are acceptable)
• •10. Any concurrent disease or condition that, in the opinion of the investigator, would make the patient unsuitable for the participation in the study.
• •11. Active cancer during chemotherapy or radiotherapy, or recent cancer, if the remission had place less than 5 years before joining the study (except basal cell skin cancer)
• •12. Patient currently undergoing dialysis for renal insufficiency (serum creatinine ≥2 mg/dL)
• •13. In the opinion of treating physician, patient not expected to survive beyond 30 days
• •14. Subjects with psychiatric conditions that are anticipated to result in protocol noncompliance
• •15. Uncontrolled chronic disease
• •16. Patient with history of severe alcohol or drug abuse
• •17. Lack of patient's cooperation
• •18. Use with blood thinners within 8 weeks of enrollment
• •19. Systemic treatments with a possible effect on ulcers within 4 weeks prior to enrollment with the following exceptions:
• •1. Ustekinumab (within 16 weeks prior to enrollment)
• •2. Adalimumab, infliximab, alefacept (within 8 weeks prior to enrollment)