NCT06747715

Autologous Fresh Fat Grafting Followed by Autologous Cryopreserved Fat Grafting

Minimally Invasive Post-Traumatic Craniofacial Soft Tissue Regeneration: Validation of Safety and Efficacy of Staged Approach Using Autologous Fresh Fat Grafting Followed by Autologous Cryopreserved Fat Grafting

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (estimated)
• Sponsor: University of Pittsburgh · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Craniofacial injuries are common among wounded service members, with 22.7% to 39% of battle injuries affecting the cranio-maxillofacial region. Restoring appearance requires precise soft tissue reconstruction. This proposal aims to address that need using a minimally invasive approach that uses the patient's own tissue, building on previous successful DoD-funded clinical trials. Autologous fat grafting (AFG) is a common, minimally invasive procedure used in plastic surgery to restore facial volume. In a prior department of defense funded trial, the study investigators demonstrated its safety and effectiveness for repairing traumatic craniofacial deformities. However, about 37% of the grafted fat is reabsorbed during early healing, requiring multiple procedures for optimal results. The donor site harvest is the main source of discomfort, time, and cost in these procedures. The study investigators propose improving this process by harvesting extra fat during the first procedure, cryo-storing it, and using the preserved fat for a second stage without needing another harvest. This approach will be validated using outcome measures from prior work. Additionally, the investigators are working with a commercial partner to advance a low-cost kit for cryo-storing fat at medical facilities, including military treatment centers.

Conditions

• Facial Defect

Interventions

Type	Name	Description
PROCEDURE	Serial Fat Grafting Fresh followed by Cryopreserved Fat	The therapeutic intervention is a two stage surgical procedure (with a third stage biopsy for research purposes in this trial) in which a primary traumatic or post-surgical craniofacial deformity is treated first with autologous fat grafting using freshly harvested adipose tissue. A second fat grafting procedure is performed at 3.0 months after the first procedure using autologous adipose tissue that had been cryopreserved during the first procedure.

Timeline

• Start date: 2025-10-01
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2024-12-24
• Last updated: 2025-10-22

Locations

1 site across 1 country: United States