Autologous Fresh Fat Grafting Followed by Autologous Cryopreserved Fat Grafting

The goal of this clinical trial is to validate the safety and effectiveness of a two-stage approach for minimally invasive craniofacial soft tissue reconstruction using autologous fat grafting in wounded service members and veterans. The main questions it aims to answer are: 1. Will treating subjects with post-traumatic craniofacial deformities using fresh fat grafts, followed by a second treatment 3 months later with cryopreserved fat stored at -80°C, improve facial tissue regeneration and appearance? 2. How do volume retention and tissue health change between fresh and cryopreserved grafts in humans? 3. How do factors such as cellular composition of the graft, patient demographics, and medical conditions (including diabetes, tobacco use, medications, age, and BMI) affect fat graft volume retention and overall outcomes? Researchers will compare results from the second-stage cryopreserved fat grafting to fresh fat grafting to assess outcomes like volume retention, patient recovery, and cost reduction. Participants will: Undergo an initial fat grafting procedure. Have additional fat harvested and cryo-stored for use in a second-stage procedure. Receive the cryopreserved fat in a later stage without the need for a second fat harvest. Receive small test injections behind each ear for later analysis. Provide data on demographics and medical conditions for correlation with outcomes.

NCT Number	NCT06747715
Lead Sponsor	University of Pittsburgh Collaborators: Armed Forces Institute of Regenerative Medicine
Conditions	Facial Defect
Enrollment	22 participants
Start Date	2025-10-01
Primary Completion	2027-12-31 (estimated)
Study Completion	2027-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-10-22