Autologous Fat-Based Therapy for Scar Tissue

Not yet recruiting at 1 trial location

Overseen By Eleanor Shirley

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Active infection, Pregnancy, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day (surgery)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if using a person's own fat can effectively treat scar tissue from severe burns or injuries. It compares a new method, fat grafting (autologous point-of-care adipose therapy), with traditional skin grafting to assess improvements in healing, scarring reduction, and infection risk. The trial seeks adults who require surgery to release and reconstruct scar tissue and are open to receiving a fat graft. Participants will receive fat grafting during their scar revision, along with a skin graft for full tissue reconstruction. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance future treatment options.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this autologous fat-based therapy is safe for treating scar tissue?

Research has shown that using a person's own fat for treatment, known as autologous fat grafting, is generally safe and well-tolerated. Studies have found that it can significantly improve the appearance and texture of scars. For instance, one study found that this method reduced pain and enhanced the appearance of scars after an injury. Another study demonstrated its effectiveness in treating thick, scar-like tissue, known as fibrosis, and similar conditions without causing major side effects.

While the results are promising, individual experiences can vary. This treatment has been successfully used for similar conditions, suggesting it might be a safe option for those seeking to improve scars from burns or injuries. It is essential to consult healthcare professionals to understand the potential risks and benefits before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatment for scar tissue, which often involves skin grafts like Full Thickness Skin Grafts (FTSGs), Autologous Point-of-Care Adipose Therapy uses the patient's own fat to help heal and reconstruct scarred areas. This approach is particularly exciting because fat grafting can offer a more natural integration with existing tissue, potentially leading to better cosmetic outcomes and improved skin texture. Additionally, using the patient's own fat minimizes the risk of rejection and can be done in a single procedure, making it a more efficient and personalized treatment option. Researchers are keen to explore these benefits, as they could significantly enhance the quality of life for individuals with burn scars on the face, neck, or extremities.

What evidence suggests that autologous fat-based therapy is effective for treating scar tissue?

Research shows that using a patient's own fat to treat scars can improve their appearance and feel. This trial will compare two reconstruction methods after burn scar revision: the Autologous Layered Composite Graft, which uses the patient's own fat, and the Full Thickness Skin Graft (FTSG). The fat-based method can make scars softer and less noticeable. Participants have reported less pain and itching after the treatment, common issues with scars. Studies suggest that this technique improves the texture and thickness of scars, aiding in better healing. It not only enhances the appearance of scars but also increases comfort, which is crucial for overall satisfaction. Overall, using a patient's own fat for scar treatment appears to be a promising option. ^{2 4 6 7 8}

Who Is on the Research Team?

Francesco Egro

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for individuals with severe burns or soft-tissue loss leading to contracted scars. Participants should have delayed wound healing, scar tissue complications, or need incision treatment. The study excludes those who don't meet specific health criteria set by the researchers.

Inclusion Criteria

I am open to receiving a fat graft if chosen.

Civilian, military, active duty or retired veterans

I am seeking treatment for scar tightening that needs surgical correction.

Exclusion Criteria

Candidates that are pregnant or plan to become pregnant in the next year

Medical co-morbidities or anatomic configuration deemed by the physician to be a concern for safety

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive fat grafting and simultaneous split-thickness skin grafting for full soft-tissue reconstruction

1 day (surgery)

1 visit (in-person)

Follow-up

Participants are monitored for safety, effectiveness, and healing outcomes after treatment

9 months

Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Autologous Point-of-Care Adipose Therapy

Trial Overview The study tests if fat grafting combined with split-thickness skin grafting (Autologous Layered Composite Grafting) can be as effective as full-thickness skin grafts in treating burn-related scarring and improving healing outcomes.

How Is the Trial Designed?

Group I: Delayed Base of wound fat graft with STSG Reconstruction (Autologous Layered Composite Graft) Experimental Treatment 1 Intervention

In this Arm, the investigators will assess Autologous Layered Composite Grafting for reconstruction of defects after burn scar revision of the face, neck, or extremities. Participants will receive any release and/or preparation of the scar/wound bed as would be standard of care and will then receive reconstruction with a Autologous Layered Composite Graft.

Group II: Delayed Full Thickness Skin Graft (FTSG) Reconstruction Active Control 1 Intervention

In this Arm, the investigators will assess FTSGs for reconstruction of defects after burn scar revision of the face, neck, or extremities. Participants will receive any release and/or preparation of the scar/wound bed as would be standard of care and will then receive reconstruction with a FTSG.

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

The study evaluated the safety and efficacy of autologous adipose-derived stem cell (ASC) therapies in 17 patients with severe conditions, finding no serious adverse events over a follow-up period of up to 54 months.

Both ASC-derived products—a scaffold-free osteogenic graft for bone non-union and a biological dressing for chronic wounds—were successfully manufactured and implanted without contamination or genomic issues, demonstrating their feasibility for clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human Adipose-Derived Mesenchymal Stem Cells in Cell Therapy: Safety and Feasibility in Different "Hospital Exemption" Clinical Applications. Vériter, S., André, W., Aouassar, N., et al.[2022]

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]

In a study involving 11 patients with persistent incisional pain, autologous fat injections led to a significant reduction in pain, with a mean decrease of 3.5 points on the Visual Analog Scale (VAS).

The treatment was well-received, with 74.5% of patients reporting satisfaction and no complications observed, indicating that autologous fat grafting is a safe and effective option for managing painful scars resistant to conventional treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Autologous fat grafting in the surgical management of painful scar: preliminary results]. Baptista, C., Iniesta, A., Nguyen, P., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11352477/

Autologous Fat Grafting—A Panacea for Scar Tissue ... AFG has demonstrated efficacy in improving the aesthetic appearance of scars, while also reducing pain and pruritus, among other advantageous ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1748681520303533

Review Autologous fat transfer to treat fibrosis and scar ... AFT appears to be a safe and effective treatment for fibrosis and scar-related conditions as demonstrated by a significant improvement in patient and surgeon ...

3. stemcellres.biomedcentral.com stemcellres.biomedcentral.com/articles/10.1186/s13287-018-0782-8

Autologous chyle fat grafting for the treatment of hypertrophic ... In this study, we investigated the ability of autologous chyle fat injection to normalize the fibroblasts and collagen of scar tissue in 80 adult patients with ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5965331/

Autologous fat grafting for scars, healing and pain: a review A positive outcome was reported with increased softness and, improved texture and thickness of scar tissue. Histological staining also demonstrated tissue ...

5. withpower.com withpower.com/trial/phase-wounds-and-injuries-5-2025-21d9c

Autologous Fat-Based Therapy for Scar Tissue Research shows that autologous fat injections can significantly reduce pain in patients with painful scars, with most patients reporting satisfaction and ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06857448

Autologous Point-of-Care Adipose Therapy: Recent Injury The goal of this study is to explore if an adipose-based therapeutic strategy can treat full-thickness soft-tissue trauma wounds in injured individuals, ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2352320423001505

Minimally invasive scar release by autologous adipose ... Results from this study show that autologous fat transfer, alone or in combination with neuroma surgery, is effective to improve post traumatic neuropathic pain ...

8. jprasurg.com jprasurg.com/article/S1748-6815(20)30353-3/fulltext

Autologous fat transfer to treat fibrosis and scar-related ... AFT appears to be a safe and effective treatment for fibrosis and scar-related conditions as demonstrated by a significant improvement in ...