Pressure Ulcer
Conditions
Keywords
Stem cells
Brief 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.
Detailed description
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-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.
Interventions
BIOLOGICALAdipose-derived stromal cells
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.
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Free of wound infection | one week | Symptoms include fever along with new or increasing pain, erythema, local warmth, swelling, purulent discharge, and/or malodor |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Liposuction procedure without complication | one week | Signs of adverse reactions to the liposuction procedure include an allergy to the Hunstad solution, infection at the puncture wound site or risk of bleeding at the puncture wound site. Risks include bleeding or infection at the site and bruising for approximately one week. No adverse consequences of fluid overload have been associated with low volume liposuction. |
| Improved wound healing | weekly observation for 6 weeks | Wound healing is greater than 20% healing within two weeks documented by measurement of the wound bed or wound healing to less than the dermal layer documented by photography and agreement of healing between research nurse and wound physician consultant. Would not expect deterioration to a more severe level of tissue injury |
Countries
United States
Outcome results
None listed