Using your own fresh and frozen fat to restore facial volume after injury
Official title: 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
Run by University of Pittsburgh · NCT06747715 · Data updated 2026-11-12
This trial will try taking extra fat at one operation, freezing it, and reusing it three months later to restore facial volume in adults with post‑traumatic craniofacial defects.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 22 (estimated) |
| Sponsor | University of Pittsburgh Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Status | Recruiting |
| Started | October 1, 2025 |
| Main results expected | December 31, 2028 |
| Study ends | December 31, 2028 |
| Registry record updated | October 7, 2026 |
| Trial ID | NCT06747715 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) at least three months past their craniofacial injury or surgery with intact skin covering a facial volume defect treatable with 3–150 cc of lipoaspirate and who have enough donor fat to harvest and cryostore an equal amount are ideal candidates.
✕Probably not a fit
Patients who lack sufficient donor fat, have defects that communicate with the oral cavity or sinuses, active infection, or medical conditions that severely impair healing may not benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a two‑stage autologous fat grafting approach in which extra lipoaspirate is harvested and used fresh, then matched cryopreserved fat stored at -80°C is reapplied about three months later. Researchers will compare volume retention, tissue health, and recovery between the initial fresh grafts and the subsequent cryopreserved grafts. They will also analyze how graft cellular composition and patient factors (age, BMI, diabetes, tobacco use, medications) influence outcomes. The work builds on prior DoD‑funded trials showing safety and effectiveness of fresh autologous fat grafting in craniofacial reconstruction.
Why it matters
Potential benefit: If successful, patients could get needed touch‑ups without another liposuction, lowering pain, time, and cost while improving long‑term facial volume retention.
How similar studies have gone: Previous DoD‑funded trials demonstrated safety and effectiveness of fresh autologous fat grafting, but systematic reuse of cryopreserved autologous fat in humans remains relatively novel and less well established.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged 18 years or older and able to provide informed consent, * Have suffered injury resulting in craniofacial volume defects which could be treated with a graft volume of between 3 and 150 cc of lipoaspirate (the patient's own fat, collected through liposuction). This may include patients who have not had craniofacial surgical procedures, as well as those who have undergone surgical procedures and have remaining deformities (post-surgical deformities). * Be at least 3 months post-injury or most recent surgery, so that acute edema (swelling) is resolved. * Volume defects (facial injury) are covered by intact skin and do not communicate with oral cavity or sinuses. * The three-dimensional geometry of the volume defects (facial injury) would allow for treatment with fat grafting. * Has sufficient donor tissue, as assessed on physical exam, to graft deformity and cryostore an equal amount of adipose (fat) tissue. * Willing and able to comply with follow up examinations, including radiographic studies (i.e. CT scans) Exclusion Criteria: * Age less than 18 years. * Inability to provide informed consent. * Craniofacial defects intended for treatment have open wounds or communicate with oral cavity or sinus (note: A second facial injury, that will not be treated by the study, that includes this type of defect, will not necessarily exclude the patient from participating). * Active infection anywhere in the body. * Systemic disease or medical condition that would render the fat harvest and injection procedure, along with associated anesthesia, unsafe to the patient. * History of radiation to the areas intended for treatment or the graft harvest site * Medications that would significantly impact wound healing, such as immunosuppressive agents, chronic steroid treatment, or chemotherapy, or medications/allergies that would pose a risk to anesthesia or the planned procedures. * Active narcotic abuse (presents a variable for pain logs). * Known coagulopathy (increased risk of bleeding/delay in forming blood clots).
Where it's running
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University of Pittsburgh
Pittsburgh, Pennsylvania, United States Recruiting
Study contacts
- Principal investigator: J. Peter Rubin — University of Pittsburgh
- Study coordinator: Eleanor Shirley, MA, CCRC
- Email: shirleye@upmc.edu
- Phone: 412-624-2376
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.