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Training network for developing innovative (bio)artificial devices for treatment of kidney and liver disease

Final Report Summary - BIOART (Training network for developing innovative (bio)artificial devices for treatment of kidney and liver disease)

Renal and liver diseases are global public health problems, with the incidences of end-stage renal disease (ESRD) and end-stage liver disease (ESLD) rising annually. Due to the lack of donor kidneys, most of ESRD patients depend on dialysis treatment using either an artificial kidney or the peritoneal membrane. Both modes are inefficient in removing uremic waste molecules and inadequately remove excess body fluids, potassium and phosphate contributing significantly to severe patient health problems, poor life quality and high mortality (15-20% per year). The impairment of liver functions has also serious implications and it is responsible for high rates of patient morbidity and mortality. Presently, liver transplantation remains the treatment of choice for ESLD patients but it is limited by both the high costs and severe shortage of donor organs.

The main objective of BIOART ITN was to provide state-of-the-art multidisciplinary training for a cohort of 16 young researchers in order to equip them with the skills required to make a significant impact in the treatment of kidney and liver diseases. To achieve this, fourteen individual RTD Projects were performed and more than thirty-five scientific training courses were offered by the host organizations to the recruited young researchers.

The achievements of BIOART are:

Work package 1: A prototype artificial kidney device enabling prolonged / continuous removal of uremic toxins from human plasma, in vitro was developed. The device combining diffusion and adsorption techniques could achieve, in vitro, 3 times higher removal of toxins from human plasma compared to the current membranes used in the clinic. Besides, it has very good blood compatibility (tests performed following the ISO norms). In this WP, experimental and modelling studies allowed optimisation of the the first prototype. However, further research would be required for upscaling of the device and for the preparation of in vivo studies.

Work Package 2: A prototype bioartificial kidney device that utilizes human renal epithelial cells for removal of uremic toxins was developed. The device, using billions of well characterised kidney epithelial cells, was tested successfully, in vitro, for the removal of uremic toxins from human plasma. The products / therapies / devices containing biological material have to follow strict regulatory guidelines, therefore in a follow up project, the device needs to be tested thoroughly for safety and immune reaction before it enters in vivo studies. Nevertheless, the device combines unique features: a well characterised cell line and FDA approved biomaterials, therefore it has great promise for achieving an improved patient therapy.

It is also important to note that the above two devices developed in WP1 and WP 2 can be combined for achieving complete removal of toxins mimicking the natural kidney function. The artificial kidney device of WP1 would achieve removal of toxins (much better than the current membranes) from blood, mimicking the kidney glomerulus whereas the bioartificial kidney device of WP2 would achieve removal of protein bound toxins, reabsorption of valuable components, mimicking the proximal tube of the natural kidney.

Work package 3: Several laboratory scale prototypes bioreactor devices to ensure viability and functions of hepatocyte cells were developed. In specific, different types of bioreactors: with hollow fiber membranes, aggregates and combinations were tested and compared. Besides, several key modelling studies were performed for optimising the systems. The results are very promising indicating that combination of devices is required to achieve improved therapies. As in the case of the Bioartificial kidney due to the use of biological material, the devices needs to be tested thoroughly for safety and immune response before entering in vivo studies.

All the above innovative results were included in eleven PhD theses, in one textbook, and resulted at 19 research publications in scientific journals. Besides, all fellows gave numerous presentations at scientific conferences and public events, including outreach activities at the host institutions and abroad.

The network organised two workshops, one summer school and a final event. The final event (took place in Warsaw on September 15, 2016) was actually a BIOART symposium organized within the annual meeting of the European society for Artificial Organs (ESAO): ESAO 2016. Several BIOART fellows presented there the results of their work actually attracted lots of attention of researchers outside of the BIOART network as well as of companies. This provided the opportunity to the BIOART fellows to promote their work and increase the employability. In fact, all the BIOART fellows after the completion of their training in BIOART have quickly found new jobs in academia (the majority of the them) and in industry, proving the significant value of the training provided within the BIOART network.

The impact of the results to the young researchers, to their supervisors and to the society in general are very significant. The network addressed several key problems of the current kidney and liver therapies. The research performed was mostly in the fundamental phase, however, it provided new insights for potentially better therapies and could pave the way for future developments of new therapeutic products.

The technologies developed within BIOART would also form the basis for follow-up research initiatives and programs. Finally, the synergy between the research teams, achieved with the numerous events proposed by the Network, created an efficient and reference scientific community, well visible at European level in the domain of (bio)artificial organs and contributed to build a European leadership in this research topic. In the end of the project, both senior and younger researchers actually formed a core network that will continue collaborating and growing through further research projects as well as through academic and industrial collaborative projects.

Project website: Project coordinator: Prof Dr. D. Stamatialis, e-mail: