|Abstract: ||The recent important advances in engineering and medicine at the molecular, cellular, and tissue
levels together with the significant modifications in people life style, the rapid aging, and the
improved life quality expectations for the world population make urgent for the scientific
committee to learn more about human body functions at a macro-, micro-, and nano-scale. In this
context, Biomedical Engineering has emerged: it uses methods and techniques proper of the
engineer field to describe, understand, and solve medical and biological issues and it allows the
cooperation among engineers, bio-physicists, physicians, and biologists.
Tissue engineering is one of the main branches of Biomedical Engineering and it has sprout to
satisfy the need of designing and building living biological tissues in vitro. This is for sure a
promising alternative to transplantation, especially to autologous transplantation. This strategy of
growing and using autologous tissues as grafts possibly makes available tissues/organs
immunologically compatible with the recipient, thus avoiding immunosuppressive therapies and
partially solving the constant shortage of donor tissues and organs. Among recent strategies to
obtain tissues in vitro, decellularization has developed. This method aims at producing acellular
biological matrices to be used as scaffolds for new organs suitable for transplantation. The first part
of PhD has dealt with the optimization of a decellularization protocol for ovine carotids, designed to
obtain an adequate biological matrix for small vascular graft.
Besides, progresses and growth of Biomedical Engineering imply the rapid spreading of innovative
materials. As a consequence, in order to guarantee the appropriate protection of human health and
of the environment, it is essential to foresee eventual adverse effects of the exposure to such new
materials, and evaluate their potential risk, both with toxicological analyses and preclinical and
clinical studies. In particular, this is a crucial issue within one of the most recent fields of
Biomedical Engineering, i.e. nanotechnologies, which are still lacking a specific regulation.
This is the reason why the second part of PhD thesis is focused on the development of a new acute
oral toxicological test in vitro, based on the use of human mesenchymal stem cells (hMSCs) and
designed according to ICCVAM guidelines. These were drafted during the validation process of the
two in vitro tests which are now approved and used, despite their limits, to evaluate acute oral
toxicology and to predict the starting dose for acute toxicity tests in vivo (ICCVAM, 2006).
Considering the promising results obtained, the hMSC test was adopted to estimate nanoparticle