Abdominal wall defects are often the consequence of severe trauma, cancer treatment and burns. These defects involve a significant loss of tissue, and often require surgical reconstruction where tissue is lifted from the patient's donor site and moved to his injured site with an intact blood supply (autologous muscle free flap). The current transfer surgery is complicated and involved with donor site morbidity after tissue harvesting, and scant availability. We proposed a robust engineered transplant performed by a novel reconstruction technique to overcome these disadvantages. The proposed transplant uses an alternative biomaterial implantation, offering the possibility to repair a full-thickness defect of the abdominal wall without the need to transfer tissue from another site and minimal postoperative scarification. We name this technique "an Engineered Autologous Vascularized Axial Flap". The key idea of this approach is the use of a polymeric scaffold upon which human cells will be seeded. The engineered tissue cultured in vitro will contain also a network of blood vessels. Then, this engineered construct will be implanted around large blood vessels adjacent to the injured site. Once highly vascularized, it will be possible to transfer the implanted engineered vascularized construct as a flap for covering the defects.
We performed a set of feasibility studies in rat model using adipose-derived human cells (which could later be isolated from the patient = autologous cells). First, we optimized the vascularization of polymeric scaffolds seeded with different combinations of such cells. We managed to create a complex, well-organized microvessels network in our engineered constructs within just 7 days post seeding.
Then, we transplanted these vascularized constructs around femoral blood vessels adjacent to abdominal wall and exposed bone and tendon of an ankle defects of rats.
We showed that our vascularized engineered tissue promoted formation of highly vascularized axial flaps, which were better integrated in both defect-models. These data are a significant step in creating a well vascularized engineered axial flap using autologous cells.
A detailed market research & initial business modelling for the commercialization and future development of our product was conducted by Ernst & Young (Israel) Ltd. (EY). Its purpose was to identify relevant application for further development's focus, and to set high level go-to-market roadmap, in regards to regulatory and commercial aspects.
Post abdominal surgery dehiscence was defined as the Go-to-market application, due to its estimated unmet market need and lack of current solutions.
Such autologous engineered tissue product may improve the patients’ quality of life and reduce surgical costs and risks.
