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Autologous Fresh Fat Grafting Followed by Autologous Cryopreserved Fat Grafting

NCT06747715 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2025-10-22

No results posted yet for this study

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

Interventions

PROCEDURE

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.

Sponsors & Collaborators

  • Armed Forces Institute of Regenerative Medicine

    collaborator FED

  • University of Pittsburgh

    lead OTHER

Principal Investigators

  • J. Peter Rubin · University of Pittsburgh

  • Patsy Simon, BS, RN, CCRC, CCRA, ACRP-PM · Director, Operations and Administration

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-01
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06747715 on ClinicalTrials.gov