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

Enrolling by invitation · Phase 1

Conditions studied: Pressure Ulcer

In brief

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.

Key facts

Study ID

NCT02375802

Run by

Mayo Clinic

People needed

12

Starts

2015-07-01

Expected to finish

2027-12-01

Last updated by the study team

2026-01-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Mayo Clinic in Florida — Jacksonville, Florida, United States

Full record on ClinicalTrials.gov

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