Adipose Derived Regenerative Cellular Therapy of Chronic Wounds

• Status: Completed
• Trial end date: 2019-09-09
• Target enrollment: 0
• Participant gender: All

Summary

Our study aims to explore the effects of Adipose Derived Stem Cells (ASCs) on chronic wounds.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tower Outpatient Surgical Center

Criteria

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