Jun 28, 2022, 1:50 PM
Room: S4 B

Room: S4 B


Lewandowska-Szumiel, Malgorzata (Medical University of Warsaw)


"Almost 160 clinical trials of tissue engineered products (TEPs) currently registered in ClinicalTrials.gov databases as well as the continuously growing record for TEPs under clinical investigations starting from the year 2006, can be taken as one of the many measures of success of tissue engineering as an applied science discipline. On the other hand, the number of TEPs on the medical market remains at a level that can be considered below expectations. Obviously, the road of the medicinal products to the market is costly and time consuming. Extremely complicated, unstable and demanding regulatory issues concerning advanced therapy medicinal products make it even more difficult. Nevertheless, it is hard to disagree that - so far - TEP-based therapies have failed to bring medical breakthroughs. Among the substantive reasons, one of the most important seems to be the multiplicity of variables at all stages of design and validation of TEPs. On one hand it opens more possibilities, but on the other one, it often limits repeatability of results. The reproducibility of the active substance of TEPs, i.e. the cells, is already extremely difficult to achieve. Even when the requirements of pharmaceutical law are met, the donor-dependent biological diversity of the cells makes it difficult to obtain reproducible results. Advanced preclinical studies of TEPs in vitro, repeated on material from many donors, may bring significant progress. At this point, tissue engineering come close to biobanking, which meets this need. By the most general terms, biobanking means collecting all types of biological material, such as blood, tissue, cells, RNA or DNA, preferably in connection with the data related to the samples. For health research, biobanking material of human origin is now considered an extremely important tool. In particular, acquisition, preparation and storage of well-characterized biological material from multiple donors - under the control of quality standards - is the response of the scientific community to reports stigmatizing the lack of repeatability of preclinical studies. Strong collaboration between tissue engineers – model beneficiaries and at the same time potential suppliers of biological material for biobanks and biobankers - who provide biological material of confirmed quality necessary for research, opens new possibilities for the development of well-defined TEPs of repeatable properties.
Some examples illustrating the problems mentioned here, based on our own experience from clinical trial on TEPs carried out with the participation of 100 volunteers will be discussed. On the other hand, the activities of BBMRI-ERIC - a European research infrastructure for biobanking will also be presented. The combination of both of these issues will be shown in the context of a possible common added value of significant importance for medical research.

Supported by the National Center for Research and Development (grant number STRATEGMED2/267976/13/NCBR/2015) and by the Ministry of Science and Higher Education in Poland (Grant DIR/WK/2017/2018/01-1)."


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