BIO
In the BIO section, personalised implants are developed on the basis of the materials and technologies developed in the FABRICATION section and are then applied to specific areas of medicine. To achieve this, innovative approaches with high translation potential are generated in the areas of tissue engineering and infection-resistant solid implants. Patient-specific approaches are developed that are consistent with industrial and medical manufacturing standards.
The modules “Tissue Engineering” and “Implant-Associated Infections” cooperate closely with the module “Clinical Translation”. This accelerates both prospective clinical use and economic exploitation, thus providing optimal conditions for timely implementation.
Tissue Engineering
The work in this module pursues the objective of in vitro generation of bioartificial tissue and organ systems. These are not regarded as foreign by the recipient organism and are completely integrated in the course of endogenous repair mechanisms (remodelling), in order to maintain its ability to grow and regenerate over long periods. Several different bioartificial tissue constructs are generated, such as a bioartificial three dimensional tissue substitute made of bone and fat tissue, or a patient-specific vascular prosthesis using the patient's own blood samples.
Implant-Associated Infections and Immune Reactions
As a result of progress in biomedical technology, it is now possible in many medical disciplines to replace the function of damaged or missing organs and tissues by using implants, thus considerably improving the patient's quality of life. However, implant-associated infections are still one of the most important challenges in modern medicine. These infections may lead to the loss of implant function, to the loss of the implant itself, or even - in some medical disciplines - to potentially fatal complications. These infections are caused when the implant surfaces are colonised by bacteria organised in complex communities - the so-called “biofilms”. This results in inflammation, accompanied by destructive changes in the surrounding tissue. It has not yet been possible to treat this effectively, as the bacteria in the biofilm are specifically organised within a protective matrix and their metabolism is modified.
Clinical Translation
Once results have been obtained from studies on tissue engineering and sold body implants they must be applied in the clinic. However, this is an immense challenge. The European Registration Procedure lays down a complex procedure consisting of laboratory studies and graduated clinical testing, in order to apply a medical device or a medical device with cellular components (ATMP) in man. In addition, the individual steps must comply with specific quality standards with respect to the investigations and facilities. This is very similar to drug registration. Thus an objective or qualitative error in the development of new implants can lead to years of development in the clinical implementation and make it necessary to repeat studies relevant to registration.
Biocompatibility and Cell Test Systems
In the module ”Biocompatibility and Cell Test Systems”, a novel biotesting procedure is to be developed. This procedure is intended to permit the high throughput screening of the materials relevant to implant research and biomedical technology - for example, with respect to biocompatibility, toxicity and immunological effects. For this purpose, standard initial tests will be developed, that allow rapid pre-screening of large numbers of samples. The tests used will first be tested on commercially available cell lines with respect to their suitability for the test material.
