Autologous Fresh Fat Grafting Followed by Autologous Cryopreserved Fat Grafting

Conditions

• Facial Defect

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

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.

Study Details

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.

Key Dates

Start date

Oct 1, 2025

Status verified

Sep 2025

Primary completion

Dec 31, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

22 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

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.

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

• Eleanor Shirley, MA, CCRC
  412-624-2376
  [email protected]

Locations (1)

Find similar trials in Pittsburgh, PA

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