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ENROLLING BY INVITATION
NCT02375802
PHASE1

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

Sponsor: Mayo Clinic

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

12

Start Date

2015-07

Completion Date

2027-12

Last Updated

2026-01-14

Healthy Volunteers

No

Conditions

Interventions

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.

DRUG

Adipose-derived stromal cells

Locations (1)

Mayo Clinic in Florida

Jacksonville, Florida, United States