Adipose Derived Regenerative Cellular Therapy of Chronic Wounds

In an attempt to explore the contribution of Adipose Derived Stem Cells (ASCs) to chronic
wound healing, we will investigate the effects of injecting ASCs into the periphery and
debrided surfaces of chronic wounds. Our goal is to achieve healing in two months, and for
the wounds to stay healed for the following two weeks.

Inclusion Criteria:

- Female or male patient aged ≥ 18

- With diagnosis of diabetic or other chronic wound

- Grade 1 or 2 wound on the Wagner Scale

- Ulcer with a surface area comprised greater than 4 cm2 included (after mechanical
debridement of the ulcer)

- For subjects with more than one wound that meet these criteria, all qualifying wounds
may be treated

- Patient's wound has been refractory to standard of care (no measureable signs of
healing for at least 30 days)

- Patient has adequate (>200cc) abdominal or other subcutaneous adipose tissue
accessible by syringe-based lipoharvest

- Patient has activated platelet thromboplastin time (aPTT) of < 1.6x the mean normal
reference interval at the time of the lipoharvest procedure and no contraindication
to lipoharvest

Exclusion Criteria:

- Typical Charcot's foot

- Presence of osteitis (eq Br osteomyelitis) at the inclusion visit (evidenced with a
radiological lesion facing the wound [bone erosion or disappearance of the cortical
bone]) as determined by MRI

- Clinical evidence of uncontrolled infection at the inclusion visit

- Patient not eligible for syringe-based lipoharvest of at least 200cc of subcutaneous
adipose tissue

- Subjects with cancerous or pre-cancerous lesions in the area to be treated

- Patient with working activity who cannot be on sick-leave during the study period

- Patient suffering from a psychiatric disorder not treated

- Clinical evidence of gangrene on any part of the affected foot

- Patient receiving corticosteroids, NSAIDs, immunosuppressive or cytotoxic agents, all
systemic agents that can affect wound repair or any treatment that might interfere
with the assessment of the study treatment

- Pregnant or nursing females

- Patient receiving dialysis for renal insufficiency or who have severe renal
dysfunction

- Patient who cannot have an off-loading method

- Participation in any other clinical research study that has not reached the primary
efficacy endpoint or otherwise would interfere with the patient's participation in
this study

- Any concurrent disease or condition that, in the opinion of the investigator, would
make the patient unsuitable for participation in the study