Autologous Fat-Based Therapy for Scar Tissue

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)

40 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this study is to explore if an adipose-based therapeutic strategy can treat contracted scars secondary to soft-tissue burn wounds in injured individuals, especially those with severe burns or soft-tissue loss. The main question it aims to answer are: - Can autologous layered composite grafting demonstrate non-inferiority compared to full-thickness skin grafting for delayed reconstruction of post-burn or trauma scar contracture? Researchers will compare the single-stage autologous layered composite grafting method to traditional methods to see if it improves healing outcomes, minimizes scarring, and reduces infection risk. Participants will: * Receive fat grafting at time of scar revision. * Undergo simultaneous split-thickness skin grafting for full soft-tissue reconstruction.

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 data supports the effectiveness of this treatment?

Research shows that autologous fat injections can significantly reduce pain in patients with painful scars, with most patients reporting satisfaction and improved quality of life. Additionally, fat grafting has been shown to reduce wound size in chronic wounds, suggesting its potential for scar tissue treatment. ^{1 2 3 4 5}

Is autologous fat-based therapy generally safe for humans?

Autologous fat-based therapy is generally considered safe, with studies showing no serious adverse events in patients treated for various conditions, including wound healing and soft tissue repair. However, complications can occur, such as vascular issues, so it's important to discuss potential risks with a healthcare provider. ^{4 6 7 8 9}

How is Autologous Point-of-Care Adipose Therapy different from other treatments for scar tissue?

Autologous Point-of-Care Adipose Therapy is unique because it uses a patient's own fat, which contains regenerative cells, to improve scar quality and function. This approach not only fills the scar area but also promotes healing and tissue remodeling through the action of stem cells, making it different from traditional treatments that may not have these regenerative properties. ^{3 5 7 10 11}

Research Team

Francesco Egro

Principal Investigator

University of Pittsburgh

Eligibility Criteria

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 18 years old or older.

Civilian, military, active duty or retired veterans

I am open to receiving a fat graft if chosen.

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. France pubmed.ncbi.nlm.nih.gov

[Autologous fat grafting in the surgical management of painful scar: preliminary results]. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Long-term Results After Autologous Fat Transfer for Treatment of Chronic Lower Extremity Wounds. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Autologous fat injection therapy including a high concentration of adipose-derived regenerative cells in a vocal fold paralysis model: animal pilot study. [2017]

4. United States pubmed.ncbi.nlm.nih.gov

A Systematic Review of Autologous Fat Grafting in the Treatment of Acute and Chronic Cutaneous Wounds. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Autologous Fat Transfer for Scar Prevention and Remodeling: A Randomized, Blinded, Placebo-controlled Trial. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Ultrasound to Improve the Safety and Efficacy of Lipofilling of the Temples. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Protocol for a systematic review of autologous fat grafting for wound healing. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Human Adipose-Derived Mesenchymal Stem Cells in Cell Therapy: Safety and Feasibility in Different "Hospital Exemption" Clinical Applications. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Study on the Application of Concentrated Growth Factor Combined With Adipose Transplantation in Repairing Depressed Deformities of Soft Tissue in the Face. [2023]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Autologous fat transfer to treat fibrosis and scar-related conditions: A systematic review and meta-analysis. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Autologous platelet-rich plasma as an adipocyte in vivo delivery system: case report. [2022]