Fat Grafting for Facial Defect

Overseen By Eleanor Shirley, MA, CCRC

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Must not be taking: Immunosuppressants, Steroids, Chemotherapy, others

Disqualifiers: Active infection, Radiation history, Coagulopathy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

22 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a two-step approach to improve facial appearance and tissue health in service members and veterans with facial injuries. It uses a person's own fat, taken from one part of the body, to fill areas of the face needing extra volume. Initially, the trial employs fresh fat (autologous fresh fat grafting) and, three months later, uses fat that has been frozen and stored (autologous cryopreserved fat grafting). The study seeks participants with facial injuries who have sufficient fat in other body areas for both treatments and have healed from any recent surgeries or injuries. As an unphased trial, it offers a unique opportunity to contribute to innovative treatment approaches for facial injuries.

Do I need to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on medications that significantly impact wound healing, like immunosuppressive agents, chronic steroids, or chemotherapy, you may not be eligible to participate.

What prior data suggests that this two-stage fat grafting approach is safe for craniofacial reconstruction?

Research has shown that using a person's own fat for grafting is generally safe and well-tolerated. Studies highlight its benefits for correcting facial deformities. Most people do not experience serious side effects, and common minor issues like swelling or bruising usually resolve on their own.

In a study with 53 patients, fat stored at very low temperatures for later use proved safe for facial procedures. The patients did not report any major problems. This suggests that both fresh and stored fat grafting are safe options for those considering joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional reconstructive methods for facial defects, which often involve synthetic implants or skin grafts, autologous fresh fat grafting uses the patient's own fat tissue to restore facial contours. This approach is unique because it employs freshly harvested adipose tissue, reducing the risk of rejection and providing a more natural look and feel. Researchers are particularly excited about the two-stage process, with an initial graft followed by a cryopreserved fat graft at three months, which may enhance the sustainability and integration of the grafts over time. This technique not only offers a personalized treatment option but also holds promise for improved long-term outcomes in repairing craniofacial deformities.

What evidence suggests that this two-stage fat grafting approach is effective for craniofacial reconstruction?

This trial will evaluate the effectiveness of two-stage autologous fat grafting for facial defects. Studies have shown that using a patient's own fat to fill in areas can correct facial deformities and improve appearance. Research indicates that fresh fat, which participants will receive in the first stage, can effectively enhance the shape and look of faces with injuries. Initial findings suggest that a second treatment using frozen fat, administered in the second stage, can also be effective. Evidence shows that both fresh and frozen fat maintain their volume, meaning they stay in place and retain their shape over time. A review of various studies confirms that these procedures often succeed in reconstructive surgeries. Therefore, using both fresh and frozen fat appears promising for improving the health and appearance of facial tissue. ^{1 2 3 4 6}

Who Is on the Research Team?

J. Peter Rubin

Principal Investigator

University of Pittsburgh

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

Principal Investigator

Director, Operations and Administration

Are You a Good Fit for This Trial?

This trial is for wounded service members and veterans with post-traumatic craniofacial deformities. Participants must be willing to undergo two fat grafting procedures: one with fresh fat and another with previously harvested and cryopreserved fat. They should also agree to provide medical and demographic data.

Inclusion Criteria

Willing and able to comply with follow up examinations, including radiographic studies (i.e. CT scans)

I have enough donor fat tissue for grafting and storage.

My facial injury can be treated with fat grafting.

Exclusion Criteria

I have a condition that increases my risk of bleeding.

I am under 18 years old.

Inability to provide informed consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Treatment

Participants undergo an initial fat grafting procedure using freshly harvested adipose tissue.

1 day

1 visit (in-person)

Second Treatment

Participants receive a second fat grafting procedure 3 months after the first, using cryopreserved adipose tissue.

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the second treatment.

3 months

Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Autologous Cryopreserved Fat Grafting
• Autologous Fresh Fat Grafting

Trial Overview The study tests a two-stage facial reconstruction technique using autologous (from the patient) fat grafts. The first stage involves fresh fat grafting, followed by a second treatment after 3 months using cryopreserved (-80°C) fat, aiming to improve tissue regeneration and appearance.

How Is the Trial Designed?

Group I: Clinical Intervention Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

Armed Forces Institute of Regenerative Medicine

Collaborator

Trials

7

Recruited

220+

Published Research Related to This Trial

A review of 396 patients undergoing autologous fat grafting from January 2015 to July 2018 showed that this technique is effective for volumization of the breasts and face, with an average of 124.4 grams of fat grafted per procedure.

While 27.8% of patients experienced complications, most were minor, and no life-threatening issues were reported, indicating that fat grafting is generally safe despite some risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Safety of Fat Grafting: An Institutional Retrospective Review. Fang, HA., Soto, E., Pigg, R., et al.[2023]

Doppler-ultrasound (DUS) imaging was successfully used in a study of 20 female patients (average age 57.9 years) to safely guide the harvesting and injection of autologous fat for facial lipofilling, helping to visualize and avoid the temporal artery during the procedure.

The study reported only one case of edema and nodules, indicating a favorable safety profile for DUS-guided lipofilling, suggesting that DUS should be considered an essential part of the procedure to enhance safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound to Improve the Safety and Efficacy of Lipofilling of the Temples. Kadouch, J., Schelke, LW., Swift, A.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06747715

NCT06747715 | Autologous Fresh Fat Grafting Followed by ... Will treating subjects with post-traumatic craniofacial deformities using fresh fat grafts, followed by a second treatment 3 months later with cryopreserved fat ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7061561/

A systematic review of the effectiveness and complications of ... Discussion. Autologous fat grafting has many beneficial qualities that make it advantageous for correcting contour deformities or augmenting ...

3. trialstoday.org trialstoday.org/trial/NCT06747715

Autologous Fresh Fat Grafting Followed by ... The main questions it aims to answer are: 1. Will treating subjects with post-traumatic craniofacial deformities using fresh fat grafts, ...

4. oaepublish.com oaepublish.com/articles/2347-9264.2024.70

Cell-supplemented autologous fat grafting: a review from ... Autologous fat grafting is routinely used in plastic and reconstructive surgery to improve contour deformities and appearance.

5. e-acfs.org e-acfs.org/journal/view.php?doi=10.7181/acfs.2019.00612

acfs :: Archives of Craniofacial Surgery In this study, we present an analysis of our clinical results from facial lipofilling, with a comparison between fresh fat and cryopreserved fat ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5876814/

Efficacy and Safety of Autologous Fat Transfer in Facial ... Is autologous fat transfer (lipofilling) a safe and effective treatment for soft-tissue deformities in the face? Findings. This systematic ...