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

Wound healing for Stage III and IV pressure 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-induced ulcers. However, there is limited research
completed on use of stem cells or ASCs with pressure ulcers. The goal is to heal pressure
ulcers faster and prevent further complications using the patient's own natural ASCs.

Inclusion Criteria

- Males and females

- Stage III or Stage IV 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

- 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