Healing Chronic Venous Stasis Wounds With Autologous Cell Therapy

Inclusion Criteria:

- Males and females 18 years of age or older

- venous leg ulcers present for at least six months and not responding to

- standard wound therapy for at least one month prior to study treatment

- one wound size 10-25centimeters squared

- inpatient or outpatient treatment of chronic venous ulcers

- the ability of subjects to give appropriate consent or have an appropriate
representative available

Exclusion Criteria:

- Age < 18 years of age

- Patients who are pregnant or currently breast feeding

- for a female subject of childbearing potential, a pregnancy test must be performed
with negative results known within 7 days prior to the procedure

- Patient with a BMI less than or equal to 18.5 or an insufficient amount of
subcutaneous tissue to allow recovery of up to 100ml of lipoaspirate

- Patients with poor glucose metabolic control (HgbA1c > 9)

- history of local neoplasm and any history of local neoplasm and any history of local
neoplasm at site of administration

- History of systemic malignant neoplasms within last 5 years

- Patients who require Negative Pressure Wound Therapy (NPWT) or limb amputation at the
target wound at the time of screening

- Wounds which are unable to be staged or classified. For example, full thickness tissue
loss in which actual depth of the ulcer is completely obscured by slough and/or eschar
in the wound bed

- Wounds that have evidence of necrosis after debridement

- Severe vascular disease in the pathogenesis of the ulcer (ABI<0.6)

- Clinical signs of critical colonization or local infection

- Prolonged(>6 months) of use of steroids

- Patients on an active regimen of chemotherapy

- Patients who have received radiation in proximity of the wound

- Patients with a documented history of liver disease or an ALT value>400

- Allergy to sodium citrate of any "caine" type of local anesthetic

- Subject is in the opinion of the Investigator or designee, unable to comply with the
requirements of the study protocol or is unsuitable for the study for any reason. This
includes completion of the Patient Reported Outcome instruments.

- Subject is currently participating in another clinical trial that has not yet
completed its primary endpoint.

- Subject is part of a vulnerable population who, in the judgement of the investigator,
is unable to give Informed Consent for reasons of incapacity, immaturity, adverse
personal circumstances or lack of autonomy. This may include: Individuals with mental
disability, person in nursing homes, children, impoverished persons, persons in
emergency situations, homeless person, nomads, refugees, and those incapable of giving
informed consent. Vulnerable populations also may include members of a group with a
hierarchical structure such as university students, subordinate hospital and
laboratory personnel, employees of the Sponsor, members of the armed forces, and
persons kept in detention.