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Autologous Fresh Fat Grafting Followed by Autologous Cryopreserved Fat Grafting

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Dec 31, 2027 → Dec 31, 2028
See other at-risk trials from University of Pittsburgh

Record History

  1. Primary and study completion pushed from Dec 31, 2027 to Dec 31, 2028 Eligibility criteria expanded, about 16 words · Secondary endpoints: details revised at 1 of 2 entries Show 2 more changesShow less
    • Eligibility criteria expanded, about 16 words
    • Secondary endpoints: details revised at 1 of 2 entries
  2. Trial status: Not Yet Recruiting to Recruiting Site details revisedv4 Show 1 more changeShow less
    • Site details revised
  3. Start date: Sep 1, 2025 to Oct 1, 2025v3
  4. Start date: Jun 15, 2025 to Sep 1, 2025 Site contact updatedv2 Show 1 more changeShow less
    • Site contact updated
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06747715
Lead Sponsor University of Pittsburgh
Collaborators: Armed Forces Institute of Regenerative Medicine
Conditions Facial Defect
Enrollment 22 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov