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Clinical Trial to Determine Safety of Allograft Adipose Matrix for Soft Tissue Reconstruction

Egro FM, Schusterman MA, Sivak WN, Grybowsky D, Mahoney C, Minteer D, Jacobs M, Chnari E, Brennan H, Coleman SR, Marra KG, Kokai LE, Rubin JP
University of Pittsburgh
2018-02-26

Presenter: Francesco M. Egro MBChB, MSc, MRCS

Affidavit:
Vu T. Nguyen

Director Name: Vu T. Nguyen

Author Category: Resident Plastic Surgery
Presentation Category: Clinical
Abstract Category: General Reconstruction

Introduction: Allograft Adipose Matrix (AAM) is a novel off-the-shelf decellularized adipose-derived injectable matrix, which represents a safe alternative for soft-tissue reconstruction. Animal studies have shown favorable volume retention, cellular infiltration, and de-novo adipogenesis from endogenous precursor cells, producing safe and long-lasting results. The aim of this study was to report the clinical safety of this product in human subjects.

Methods: A clinical trial was conducted at the University of Pittsburgh Medical Center between January 2017 and January 2018. Subjects were injected with 20cc of AAM into 6 individual abdominal subcutaneous sites within a predetermined area of pannus excision. Subjects were randomized to panniculectomy either 3 or 6 months after injection, and biopsies were taken at 1 and 2 months. Photos and abdominal wall ultrasound were performed at each clinic visit. Specimens obtained at biopsy and surgery underwent histology examination using H&E, Masson's Trichrome, CD31, perilipin, collagen 1, and collagen 3.

Results: A total of 10 subjects were enrolled and underwent panniculectomy at 3 or 6 months after the injections. AAM injections were tolerated well with no reactions. Clinical safety and graft retention were demonstrated at 6 months with histological evidence of adipogenesis and presence of endothelial cells. The only adverse event was surgical site infection in one out of 60 sites, which occurred after a biopsy.

Conclusion: This clinical trial demonstrates that AAM is safe for use in human subjects and that it generates native adipose tissue, making this a unique tool for use in soft tissue reconstruction.

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