Histological evaluation of tissue regeneration using biodegradable scaffold seeded by autologous cells for tubular/hollow organ applications.

The accurate interpretation of histological outcomes is a critical endpoint in preclinical studies. Thus, the toxicologic pathologist plays a vital role in conducting a comprehensive microscopic evaluation that would ultimately help defining the safety and functionality in Tissue Engineering/Regenerative Medicinal (TERM) products. In spite of many advances in regenerative medicine, there are no specific guidelines for the histological assessment of TERM products (Jayo et al. Toxicol Pathol 36:92-96, 2008). In this chapter, we describe the methodology designed to facilitate the detection of structural and functional changes when conducting a histological assessment including tissue collection (test article extraction), sampling, processing and fixation, special stains, statistical analysis, and morphometry.