Facial DefectNCT06747715
Autologous Fresh Fat Grafting Followed by Autologous Cryopreserved Fat Grafting
A study testing Serial Fat Grafting Fresh followed by Cryopreserved Fat in people with Facial Defect, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Facial Defect
- What is being tested?
- Serial Fat Grafting Fresh followed by Cryopreserved Fat
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2025to 31 Dec 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
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- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261
Eleanor Shirley, MA, CCRC, 412-624-2376, shirleye@upmc.edu
J. Peter Rubin
About this study
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
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:
- 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?
- How do volume retention and tissue health change between fresh and cryopreserved grafts in humans?
- 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?
Read more
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.
Read the 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
- Being tested
- Serial Fat Grafting Fresh followed by Cryopreserved Fat
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serial Fat Grafting Fresh followed by Cryopreserved FatProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Clinical Intervention | Experimental | 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. Receives: Procedure: Serial Fat Grafting Fresh followed by Cryopreserved Fat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Facial volume and appearance scale
This is a validated visual 3-point grading scale that will be scored by 4 blinded observers (2 physicians and 2 lay-observers) from standardized photographs The definitions for each of three points on the scale are listed here: a score of 1 means: for baseline grading of a given facial aesthetic region assessed there is an obvious contour defect that would benefit from volume fill. For post-treatment grading, no discernable improvement from baseline. A score of 2 means: for a given facial aesthetic region with a history of a traumatic deformity and treatment of the deformity according to the study protocol, there is a discernable improvement in the contour defect from baseline which does not yet approximate the contralateral side (if uninjured) or represent a normal appearance. A score of 3 means: for a given facial aesthetic region there is a normal appearance and/or close to matching contralateral structure (if uninjured).
Measured: 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.
Secondary outcomes (2)
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Incidence of adverse events will be counted, as well as a subscore for those adverse events that are considered related to the study intervention.
Measured: From intervention to the final study visit (3 months post 2nd treatment, or approximately 6 months after initial intervention)
Change in facial injury volume from Pre to Post CT Scans- within each subject- High resolution Computed Tomography with 3D reconstruction (CT) will be performed.
Craniofacial fine cut CT with 3D reconstruction \& volume analysis. 5 CTs of the face will be done on each subject. The first scan will be pre-procedural and will serve as a baseline. All CT scans will be done on a 64-slice scanner (LightSpeed, GE Healthcare), using collimation of 0.625mm and slice interval of 0.3mm, resulting in approximately 50% overlap between adjacent slices. kVp, mA, and FOV will be optimized to the subject, but will approximately be kVp=120; mA=320, FOV=18cm. Soft tissue and bone kernels will be employed. These images will be volumetrically reformatted into coronal and sagittal planes for confirmation of findings. Additionally, surface-rendered volumetric reformats will be created emphasizing both bony structures and soft tissues. Images will be reviewed by a dedicated head and neck radiologist with 25 years of experience in CT of the face.
Measured: Facial volume analysis of the injured area will be calculated from the individual CTs, comparing from each subject's pretreatment baseline to the final study visit (3 months post 2nd treatment, or approximately 6 months after initial intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study start1 Oct 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial DefectStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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. Facial volume and appearance will be scored by 4 blinded observers (2 physicians and 2 lay-observers) from standardized photographs.
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Armed Forces Institute of Regenerative Medicine
- Responsible party
- Principal investigator, J. Peter Rubin, MD, University of Pittsburgh
- Investigators
- J. Peter Rubin, Principal investigator, University of PittsburghPatsy Simon, BS, RN, CCRC, CCRA, ACRP-PM, Study director, Director, Operations and Administration
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06747715
- Sponsor's protocol ID
- STUDY24080145
- Status last verified
- Oct 2026
- First submitted
- 21 Nov 2024
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No