Adipose Derived Regenerative Cellular Therapy of Chronic Wounds

Phase 2

Completed

• Conditions: Pressure Ulcer; Diabetic Foot; Venous Ulcer
• Interventions: Drug: Adipose derived stem cells

• Registration Number: NCT02092870
• Lead Sponsor: Tower Outpatient Surgical Center

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2014-03-18
• Study First Submitted QC: 2014-03-19
• Study First Posted: 2014-03-20
• Primary Completion: 2015-09
• Status Verified: 2019-09
• Study Completion: 2019-09-09
• Last Update Submitted: 2019-09-09
• Last Update Posted: 2019-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment of Chronic Wound	Adipose derived stem cells	Patients will receive a single treatment with ASCs in the form of multiple injections of cells within and immediately surrounding the wound. Cells will be delivered using a 1 cc syringe with an appropriate gauge and length needle. Each injection will have a volume less than 250 micro-liters. The number of injections will be determined by the surgeon as a function of total wound volume.

Primary Outcome Measures

Name	Time	Method
Percent change in wound size from baseline at 12 weeks	12 weeks

Trial Locations

Locations (1)

Tower Outpatient Surgical Center; 🇺🇸 Los Angeles, California, United States