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

Mayo Clinic

Status and phase: Invitation-only; Phase 1

Conditions: Pressure Ulcer

Treatments: Drug: Adipose-derived stromal cells

Study type: Interventional

Funder types: Other

Identifiers

NCT02375802

14-002855

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

12 participants in 1 patient group

Experimental

Experimental group

Description:

Liposuction will be done to extract 50-100 cc of adipose tissue which will be processed to obtain the stromal cells. The adipose-derived stromal cells will be injected into a fibrin sealant applicator and applied to the wound (intervention), Patients will receive 5.0x106 ASCs per cubic centimeter of wound area. The wound will be dressed with an occlusive dressing and soft silicone dressing. The dressing will remain in place for one week (minimally, 3 days). Follow-up will occur weekly for 6 weeks.

Treatment:

Drug: Adipose-derived stromal cells

Drug: Adipose-derived stromal cells