Adipose Derived Regenerative Cellular Therapy of Chronic Wounds

This is an interventional treatment trial for Diabetic Foot focused on measuring Chronic Wounds, Diabetes, Adipose Derived Stem Cells, Diabetic Foot Read More

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