Regenerative Medicine refers to innovative therapies aimed at the permanent restoration of diseased tissues and organs. Tissue integrity and regeneration depend on a population of self-renewing somatic stem cells, above all in constantly renewing tissues.
Thus, Regenerative Medicine requires a deep knowledge of the biology of tissue-specific stem cells and the development of technologies allowing their maintenance in culture and their clinical application (cell therapy). In case of genetic diseases, stem cells need to be genetically modified before their delivery onto patients (gene therapy).
Stem cells generate an intermediate population of committed progenitors, often referred to as transit amplifying (TA) cells, that terminally differentiate after a limited number of cell divisions. Three types of clonogenic keratinocytes endowed with different capacity for multiplication have been identified in human squamous epithelia and are referred to as holoclones, meroclones and paraclones. Holoclones are generated by stem cells, whilst meroclones and paraclones have properties of transit amplifying progenitors.
During the last two decades, holoclones have been characterized also at a molecular level. Epithelial cultures containing holoclone-forming cells are now widely used in Regenerative Medicine, both as consolidated cell therapies and in Phase I/II clinical trials.
According to recent European regulations (2007), stem cell-based cultures are Advanced Therapy Medical Products (ATMPs). Therefore, the cultivation of cells destined to clinical application (both for clinical trials and established therapies) is strictly regulated and has to be performed under GMP (Good Manufacturing Practices) conditions.
Holostem Terapie Avanzate runs a 2.000 sq meters GMP facility located into the Centre for Regenerative Medicine “Stefano Ferrari” of the University of Modena and Reggio Emilia, one of the biggest research centers in the world entirely dedicated to epithelial stem cells cultures.