15
Participants
Start Date
June 21, 2018
Primary Completion Date
September 30, 2026
Study Completion Date
September 30, 2026
Acellular Adipose Tissue (AAT)
"Participants (n=15) will be administered between 5cc and 20cc of AAT, depending on their assigned treatment group, via sterile subcutaneous injection into the target defect. The injection is intended to be permanent. After the 3-month study follow-up visit, participants will have the option to undergo additional AAT injection (up to 20cc per treatment) in order to fully correct the defect. Total injected AAT volume per patient will not exceed 40cc. Additional injection is dependent upon study- and patient-specific adverse / unanticipated events to date.~Each vial contains a 2 milliliter (mL) dose of the injectable AAT. This volume is similar to other commonly used injectable filler materials intended for soft tissue correction."
Johns Hopkins University School of Medicine, Baltimore
U.S. Army Medical Research and Development Command
FED
Armed Forces Institute of Regenerative Medicine
FED
Johns Hopkins University
OTHER