Adipose-Derived Stromal Cells (ASC's) for Pressure Ulcers
Launched by MAYO CLINIC · Feb 24, 2015
Trial Information
Current as of July 22, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
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 radiat...
Gender
ALL
Eligibility 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
About Mayo Clinic
Mayo Clinic is a renowned nonprofit medical practice and research institution dedicated to providing comprehensive healthcare and advancing medical knowledge through innovative research and education. With a commitment to patient-centered care, Mayo Clinic conducts numerous clinical trials aimed at exploring new therapies and improving treatment outcomes across various disciplines. Leveraging a multidisciplinary approach, the institution collaborates with leading experts and cutting-edge technology to ensure rigorous scientific standards and ethical practices in all its research endeavors. Through its trials, Mayo Clinic seeks to translate breakthroughs in science into tangible benefits for patients, fostering advancements in medicine that enhance health and quality of life.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Jacksonville, Florida, United States
Patients applied
Trial Officials
Houssam Farres, MD
Principal Investigator
Mayo Clinic
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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