Adipose-Derived Stromal Cells (ASC's) for Pressure Ulcers

• Status: Active, not recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This pilot study of 12 patients will test the safety and efficacy of applying autologous, adipose-derived stromal cells (ASCs), uncultured, on a Stage III or IV pressure ulcer or diabetic foot ulcers. Patients will undergo a minimal risk liposuction procedure to withdraw 50-100 cc of adipose tissue. The tissue would be processed to extract the stromal layer of cells that contain stem cells. The ASCs would be injected into a fibrin sealant to be applied to the wound. Patients would be followed for 6 weeks to assess wound healing and tolerance of the treatment.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Treatments: Fibrin Tissue Adhesive

Criteria

Inclusion Criteria

• Males and females

• Stage III pressure ulcers measuring 5 cc - 36 cc in volume (as measured by filling the wound with Normal Saline).

• Inpatient or outpatient treatment of pressure ulcers

• Diabetic Foot Ulcer Stage 1 or 2 of any size

• Co-morbidities may include:

• Peripheral Vascular Disease (PVD)

• Coronary Artery Disease (CAD)

• Chronic Renal Disease (CRD)

• Chronic Liver Disease (CLD)

• Hypertension (HTN)

• Diabetes

• The ability of subjects to give appropriate consent or have an appropriate representative available to do so

• The ability of subjects to return for weekly wound assessments

Exclusion Criteria

• Patients with allergies to TISSEEL, Tegaderm, or silicon

• Diabetics with poor glucose metabolic control (HbA1c > 9)

• Target wounds that are in close proximity to potential cancerous lesions

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

• Wounds located on the face

• Patients with Stage 5 or 6 Peripheral Vascular disease (specifically, wounds that are caused by peripheral vascular disease such as leg ulcers)

• Wounds caused by diabetes mellitus (diabetic foot ulcers).

• BMI of <16 Clinical signs of critical colonization or local infection

• Prolonged (> 6 months) use of steroids

• Patients on active regimen of chemotherapy

• Patients receiving radiation in proximity of wound

• Decompensated chronic liver disease