Autologous Fresh Fat Grafting Followed by Autologous Cryopreserved Fat Grafting

NCT06747715 | Recruiting

• 1 other identifier: STUDY24080145
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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. 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. 2.How do volume retention and tissue health change between fresh and cryopreserved grafts in humans?
3. 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?

Conditions

Facial Defect

Outcome Measures

Primary Outcomes (1)

• 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).

  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]

  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.

  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)

Study Arms (1)

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.

Procedure: Serial Fat Grafting Fresh followed by Cryopreserved Fat

Interventions

Serial Fat Grafting Fresh followed by Cryopreserved Fat PROCEDURE

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.

Clinical Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Pittsburgh: lead
• Armed Forces Institute of Regenerative Medicine: collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15261, United States

RECRUITING

Study Officials

• J. Peter Rubin

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Patsy Simon, BS, RN, CCRC, CCRA, ACRP-PM

  Director, Operations and Administration

  STUDY DIRECTOR

Central Study Contacts

Eleanor Shirley, MA, CCRC

CONTACT

412-624-2376; shirleye@upmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Endowed Chair of Plastic Surgery

Model Details: 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.

Study Record Dates

• First Submitted: November 21, 2024
• First Posted: December 24, 2024
• Study Start: October 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: October 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)