Recruiting

Fresh & Cryopreserved Fat

Sponsor:

University of Pittsburgh

Code:

NCT06747715

Conditions

Facial Defect

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Serial Fat Grafting Fresh followed by Cryopreserved Fat

Study Details

Brief 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.

Conditions

Facial Defect

Study ID

NCT06747715

Start date

Oct 1, 2025

Status verified date

Sep, 2025

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

22 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Clinical Intervention

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.

Interventions

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.

Primary outcome measure

  • Facial volume and appearance scale [ Time Frame: The key timepoint is 3 months post-graft. The difference between the Facial Volume and Appearance Scale scores from the Pre-treatment baseline to the 3-months post-1st treatment, for each subject, will be generated. ]

Central Contacts and Locations

Central contacts

Eleanor Shirley, MA, CCRC

412-624-2376shirleye@upmc.edu

Locations

University of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15261

Contacts

Eleanor Shirley, MA, CCRC

412-624-2376shirleye@upmc.edu

Principal Investigator:

J. Peter Rubin

More Information

Sponsor

University of Pittsburgh

Last update posted

Oct 22, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Pittsburgh on 2025-10-22.