Autologous Fresh Fat Grafting Followed by Autologous Cryopreserved Fat Grafting (NCT06747715)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Pittsburgh — Pittsburgh, Pennsylvania
Age range: 18 Years
🧪 Interventions in This Study
- Serial Fat Grafting Fresh followed by Cryopreserved Fat (PROCEDURE)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- University of Pittsburgh — Pittsburgh, Pennsylvania
📞 Contact the Study Coordinator
Phone: (412) 624-2376
Email: shirleye@upmc.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
Explore by condition: All Facial Defect clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.