Acellular Adipose Tissue (AAT) for Soft Tissue Reconstruction

PHASE2Enrolling by invitationINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

June 21, 2018

Primary Completion Date

September 30, 2026

Study Completion Date

September 30, 2026

Conditions
Soft Tissue InjuriesTrauma
Interventions
DRUG

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."

Trial Locations (1)

21287

Johns Hopkins University School of Medicine, Baltimore

All Listed Sponsors
collaborator

U.S. Army Medical Research and Development Command

FED

collaborator

Armed Forces Institute of Regenerative Medicine

FED

lead

Johns Hopkins University

OTHER