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

Overview

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. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Adults greater than 18 years old
  • 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)
      • Using Rutherford Scale: Stage 0-4 will be included    
        • Stage 0 – Asymptomatic
        • Stage 1 – Mild claudication
        • Stage 2 – Moderate claudication – The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters.
        • Stage 3 – Severe claudication
        • Stage 4 – Rest pain
        • Stage 5 – Ischemic ulceration not exceeding ulcer of the digits of the foot
        • Stage 6 – Severe ischemic ulcers or frank gangrene
    • Coronary Artery Disease (CAD)
    • Chronic Renal Disease (CRD)
      • Can be stages 1-5 (and based on clinical judgment of the physician)
    • Chronic Liver Disease (CLD)
      • MELD* score  < 11
    • Hypertension (HTN)
      • Normal, Prehypertensive, Hypertensive Stage 1 and 2 are included.  Hypertensive crisis ( >180/ >110mmHg) is excluded from the study and subject may be re-eligible when adequate BP control is maintained
    • Diabetes
      • HbA1c < 9
  • 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
  • *Note: Link is for calculator to determine MELD score:  http://www.mayoclinic.org/medical-professionals/model-end-stage-liver-disease/meld-score-90-day-mortality-rate-alcoholic-hepatitis

Exclusion Criteria

  • Patients with allergies to TISSEEL, Tegaderm, or silicon
  • Diabetics with poor glucose metabolic control exhibited by an 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)
  • Osteomyelitis
  • Wound abscess
  • BMI of < 16
  • Clinical signs of critical colonization or local infection
  • Pregnancy
  • Prolonged (> 6 months) use of steroids
  • Patients on active regimen of chemotherapy
  • Patients receiving radiation in proximity of wound
  • Decompensated chronic liver disease; i.e., patients who have experienced hepatic encephalopathy, ascites,  bleeding due to portal hypertension and jaundice or in patients with chronic liver disease with a Model for End-stage Liver Disease (MELD) scores > 11 will not be included
  • End of life

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Houssam Farres, M.D.

Open for enrollment

Contact information:

Mauricia Buchanan R.N.

Buchanan.Mauricia@mayo.edu

More information

Publications

  • To identify the impact of pressure ulcers (PUs) and PU interventions on health-related quality of life (HRQL). Read More on PubMed
  • To identify the independent effect of pressure ulcers on excess length of stay and control for all observable factors that may also contribute to excess length of stay. Hospitalized patients who develop a pressure ulcer during their hospital stay are at a greater risk for increased length of stay as compared with patients who do not. Read More on PubMed

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20144029

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