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

Inclusion Criteria:

1. Written informed consent
2. Males or females age ≥ 18
3. At least one venous chronic leg ulcer with the following condition 3.1. Ulcer ispresent beyond 2 months 3.2. Conservative treatment not leading to improvement 3.3.Wound size between ≥5 and ≤100 cm2
4. Ability to safely undergo tissue harvest that is anticipated to yield >100mL ofadipose tissue at a site that is free from infection and injury
5. Able and willing to work with the doctor, adhere to therapeutic prescriptions andappear on prescribed examinations
6. Normal or clinically not significant abnormal values based on investigator judgementon white blood cell count (WBC), C-reactive protein (CRP), Platelets, internationalnormalized ratio (INR), partial thromboplastin time (APTT), haemoglobin (Hgb), Renaland Liver function
7. Females of childbearing potential must have a negative pregnancy test at the ScreenVisit
8. Females of childbearing potential must agree to use a highly effective method of birthcontrol during the study. A highly effective method of birth control is defined as onewhich has a proven low failure rate of less than 1%

Exclusion Criteria:

1. More than 20% change in surface area of target ulcer between screening and enrollmentvisit.
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 allsystemic agents that can affect wound repair
6. Patient with any treatment that might interfere with the assessment of the studytreatment
7. Pregnant or likely to become pregnant or lactating women
8. Participation in any type of clinical investigation concurrently or in the last 6months
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, wouldmake the patient unsuitable for the participation in the study.
11. Active cancer during chemotherapy or radiotherapy, or recent cancer, if the remissionhad place less than 5 years before joining the study (except basal cell skin cancer)
12. Patient currently undergoing dialysis for renal insufficiency (serum creatinine ≥2mg/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 protocolnoncompliance
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 toenrollment with the following exceptions:
20. Ustekinumab (within 16 weeks prior to enrollment)
21. Adalimumab, infliximab, alefacept (within 8 weeks prior to enrollment)