Mayo Clinic
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.
Wound healing for Stage III and IV pressure ulcers or diabetic foot ulcers can take four to six weeks or longer and cost upwards of $40,000 to treat. Past studies have shown that adipose tissue contains progenitor cells or regenerative cells that can release multiple angiogenic growth factors and cytokines including vascular endothelial growth factor (VEGF), hepatocyte growth factor (HGF) and chemokine stromal cell-derived factor-1 (SDF-1). A current literature review revealed that there is research related to use of stem cells to enhance wound healing, in particular with ischemic or radiation…
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…
Adipose-derived stromal cells contain stem cells which have been successful in enhancing wound healing. The product used as the carrier is a fibrin sealant called TISSEEL. Pre-pilot testing was done to verify viability of the stromal cells for up to 72 hours in the fibrin sealant.
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