An immunologically active, adipose-derived extracellular matrix biomaterial for soft tissue reconstruction: concept to clinical trial.

Several human studies show positive signals, while research methods and sample sizes continue to develop.

• Level A · Stronger Clinical Evidence
• Level B · Emerging clinical evidence with positive signals
• Level C · Early human research exploring benefits
• Level D · Scientific groundwork from lab and animal studies
• Emerging · Emerging topic under active research

Abstract (original English)

ABSTRACT Soft tissue reconstruction remains an intractable clinical challenge as current surgical options and synthetic implants may produce inadequate outcomes. Soft tissue deficits may be surgically reconstructed using autologous adipose tissue, but these procedures can lead to donor site morbidity, require multiple trips to the operating room, and have highly variable outcomes. To address the clinical need for soft tissue reconstruction, we developed an “off-the-shelf” adipose matrix from allograft human adipose tissue (acellular adipose tissue, AAT). We applied physical and chemical processing methods to remove lipids and create an injectable matrix that mimicked the properties of fat grafting materials. Biological activity was assessed using cell migration and stem cell adipogenesis assays. Characterization of the regenerative immunology properties in a murine muscle injury model revealed allograft and xenograft AAT induced pro-regenerative CD4 + T cells and macrophages with xenograft AAT attracting additional eosinophils secreting interleukin 4 (Il4). In immunocompromised mice, AAT injections retained similar tissue volumes as human fat grafts but did not have the cysts and calcifications that formed in the human fat graft implants. Combination of AAT with human adipose-derived stem cells (ASCs) resulted in lower implant volumes. However, tissue remodeling and new adipose

Evidence level

Several human studies show positive signals, while research methods and sample sizes continue to develop.

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