Actively Recruiting
Autologous Fresh Fat Grafting Followed by Autologous Cryopreserved Fat Grafting
Led by University of Pittsburgh · Updated on 2025-10-22
22
Participants Needed
1
Research Sites
117 weeks
Total Duration
On this page
Sponsors
U
University of Pittsburgh
Lead Sponsor
A
Armed Forces Institute of Regenerative Medicine
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Autologous Fresh Fat Grafting Followed by Autologous Cryopreserved Fat Grafting
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older and able to provide informed consent
- Have suffered injury resulting in craniofacial volume defects treatable with 3 to 150 cc of lipoaspirate
- At least 3 months post-injury or most recent surgery with swelling resolved
- Facial volume defects covered by intact skin without communication to oral cavity or sinuses
- Three-dimensional geometry of defects allows treatment with fat grafting
- Sufficient donor fat tissue available to graft deformity and cryostore an equal amount
- Willing and able to comply with follow-up examinations including CT scans
You will not qualify if you...
- Age less than 18 years
- Unable to provide informed consent
- Craniofacial defects with open wounds or communication with oral cavity or sinus (except untreated second injury)
- Active infection anywhere in the body
- Medical conditions making fat harvest and injection unsafe
- History of radiation to treatment or harvest sites
- Medications that impair wound healing or pose anesthesia risks
- Active narcotic abuse
- Known bleeding disorders (coagulopathy)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15261
Actively Recruiting
Research Team
E
Eleanor Shirley, MA, CCRC
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here