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Adipose tissue engineering offers a promising alternative to current breast reconstruction options. However, the conventional approach of using a scaffold in combination with adipose-derived precursor cells poses several problems in terms of scalability and hence clinical feasibility. Following the body-as-a-bioreactor approach, this study proposes a unique concept of delayed fat injection into an additive biomanufactured and custom-made scaffold. Three study groups were evaluated: Empty scaffold, Scaffold containing 4 cm3 lipoaspirate and Empty scaffold +2-week prevascularisation period. In group 3, of prevascularisation, 4 cm3 of lipoaspirate was injected into scaffolds after 2 weeks. Using a well-characterised additive biomanufacturing technology platform, patient-specific scaffolds made of medical-grade-polycaprolactone were designed and fabricated. Scaffolds were implanted in subglandular pockets in immunocompetent minipigs (n = 4) for 24-weeks. Angiogenesis and adipose tissue regeneration were observed in all constructs. Histological evaluation showed that the prevascularisation + lipoaspirate group had the highest relative area of adipose tissue (47.32% ± 4.12) which was significantly higher than both lipoaspirate-only (39.67% ± 2.04) and empty control group (8.31% ± 8.94) and similar to native breast tissue (44.97% ± 14.12). This large preclinical animal study provides proof-of-principle that the clinically applicable prevascularisation and delayed fat-injection techniques can be used for regeneration of large volumes of adipose tissue.

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Breast reconstruction and augmentation are very common procedures, yet the prevailing current methods utilize silicone implants that may have significant local complications requiring reoperation. Lipofillling is increasingly used to contour and is considered safe, however, its utility is limited by significant volume loss. A new approach could offer an alternative and increase the scope of patient choice. A small number of teams around the world are investigating a breast tissue engineering (TE) paradigm. Conventional breast TE concepts are based on seeding a scaffold with the patients' own stem cells. However, the clinical viability of many of these approaches is limited by their costs in relevant volumes. In this article the state of the art of tissue-engineered breast reconstruction is reviewed and future perspectives are presented and discussed.

The application of additive biomanufacturing represents one of the most rapidly advancing areas of biomedical science, in which engineers, scientists, and clinicians are contributing to the future of health care. The combined efforts of a large number of groups around the globe have developed a strong research thrust that has resulted in a large number of publications. Reviewing this body of literature, there is an increasing trend of research groups inventing their own definitions and terminology. This has made it difficult to find and compare the results. Therefore, to move the field constructively forward, it is a conditio sine qua non to clarify various terminologies and standards. Based on this background, this article advocates tightening the terminology and has the objective of penning out definitions that will ultimately allow the development of official industry standard terms, such as American Society for Testing and Materials and or International Organization for Standardization for technologies developed for Tissue Engineering and Regenerative Medicine.