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

Overview

  • Study type

    Interventional
  • Study phase

    I
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Jacksonville, Florida: 14-002855
    NCT ID: NCT02375802
    Sponsor Protocol Number: 14-002855

About this study

This pilot study of 12 patients (6 control, 6 experimental) will test the safety and efficacy of applying autologous, adipose-derived stromal cells (ASCs), uncultured, on a Stage III or IV pressure ulcer. Patients in both groups would 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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

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

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Houssam Farres, M.D.

Open for enrollment

Contact information:

Michael Burke