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

January 12, 2026 updated by: Houssam Farres, M.D., Mayo Clinic

A Pilot Study: Evaluating the Safety and Feasibility of Using Autologous Adipose-Derived Stromal Cells From Stromal Vascular Fraction (SVF) on Adults With Pressure Ulcers or Diabetic Foot Ulcers

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Estimated)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic in Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental
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.
Biological: Adipose-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.
Other Names:
  • ASC's
Drug: Adipose-derived stromal cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Free of wound infection
Time Frame: one week
Symptoms include fever along with new or increasing pain, erythema, local warmth, swelling, purulent discharge, and/or malodor
one week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Liposuction procedure without complication
Time Frame: 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.
one week
Improved wound healing
Time Frame: 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
weekly observation for 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Houssam Farres, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

February 18, 2015

First Submitted That Met QC Criteria

February 24, 2015

First Posted (Estimated)

March 3, 2015

Study Record Updates

Last Update Posted (Estimated)

January 14, 2026

Last Update Submitted That Met QC Criteria

January 12, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-002855

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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