During the execution of this project the following technologies have been developed:
- The technologies to process into specific tri-dimensional forms a biocompatible and biodegradable semi-synthetic class of polymers.
- The development of technologies to cultivate and grow cells to be used for tissue engineering purposes.
In particular, we applied FAB's know-how for the modification of a highly biocompatible but otherwise not mechanically workable material, such as the gel-like hyaluronic acid, to obtain a solid and modifiable material, which maintains all the biological characteristics of the native molecule and, additionally, becomes conveniently modifiable in pre-determined physical structures. First, we developed the knowledge and the tools to transform hyaluronic acid-based fibres (HYAFF 11) into tridimensional devices of variable thickness (HYAFF 11 non woven meshes). We then coupled the technology for the production of these devices with newly developed technologies to either silicon-coat or cell-seed these devices. In the first case, we acquired the ability to manufacture a composite prototype which marries the biocompatibility and bioactivity of hyaluronic acid with the impermeability and mechanic resistance of silicon. In the second case we specifically adapted standard cell culture methods to the production of human derma.
During the scaling up process of the newly acquired technologies and devices, specific efforts were made to engineer and realise a new piece of equipment:
- Prototype carding machine.
Although the carding technology can be transferred from the textile industry, we needed to build a new carding machine, especially projected to produce non woven fleece based on hyaluronic acid derivatives. The carding machine developed by the Consortium, based on HDB's experience in textile machine engineering, is designed to process hyaluronic acid-based fibres, characterised by a very low tensile strength, and to produce only a few kilograms of fleece per day, in order to minimise the expenses of the starting material. Very important for the manufacture of material intended for clinical use, this prototype machine does not need the use of lubricating materials such as oil, enzyme or heat.
It could be realistically envisaged to utilise these newly developed technologies and the carding machine, separately or together, for new applications. For instance:
- During this project we acquired the knowledge needed to overcome some relevant obstacles to tissue engineering technology such as the realisation of tailor-made scaffolds, the seeding and proliferation of primary cells, their culture in a tridimensional structure rather than a flat surface, the organisation of a tissue-like structure in vitro. This knowledge is exploited independently by several partners in new projects, some of them EC funded, aiming to develop new human engineered tissues or organs.
- The use of the carding machine, so far limited to the production of scaffolds for fibroblasts tridimensional expansion, could be extended to the manufacture of other fabric-like materials intended for medical use and thus requiring high standard quality and special production care. For example, within the frame of some of the EC funded projects in which it is presently participating, FAB is already testing the production feasibility of new hyaluronic acid-based scaffolds with the carding machine.
- An immediate application of all the above detailed technologies and of the carding machine prototype is finalised at the realisation of the one-step skin graft. Indeed, FAB is currently completing the pre-clinical and clinical testing of a single device, composed of a hyaluronic-based scaffold able to support the proliferation of fibroblasts in its core and of keratinocytes on top. The aim is to obtain an autologous cell-seeded device to be used as complete skin substitute for acute or chronic wounds of small size. This new product, the first of its kind, is expected to be launched in the next 12 months. Based on its past experience and on the niche market already occupied with its own partial skin substitute devices, FAB is confident that this unique complete skin substitute device will quickly gain a large portion of the European and possibly American market.