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1 Whole liver regeneration A group of researchers ( Uygun et al . [1]) demonstrate d a novel approach to generate transplantable liver grafts using decellularized liver matrix. The decellularization process preserves the structural and functional characteristics of the native microvascular network, allowing efficient recellularization of the liver matrix with adult hepatocytes and subsequent perfusion for in vitro culture. The re-cellularised graft supports liver - specific function including albumin secretion and urea synthesis at comparable levels to normal liver in vitro. The re-cellularised liver grafts can be transplanted into rats, supporting hepatocyte survival and function with minimal ischemic damage. These results provide a proof of principle for the generation of a transplantable liver graft as a potential treatment for liver disease. Reference [1] Uygun BE, Soto-Gutierrez A, Yagi H, et al. Organ reengineering through development of a transplantable re-cellularised liver graft using decellularised liver matrix. Nat Med. 2010;16(7):814-820 2 Answer to the following questions What is the therapeutic product described above? What are the elements that identify such therapeutic product as a PTC? In what phase of the regulatory process for new PTCs can this PTC be localized? What are the standards that apply in this stage of the PTC process of development? What are the risks associated with this PTC (immunogenic, tumour, teratoma, infection, toxicity)? 3 Classify all the cell sources potentially usable in human patients for this therapy Cell source (based on immunogenicity) Cell type/s Advantages Criticalities It is usable? (Y/N) Note: CONVENTIONAL THERAPY: allogenic orthotropic transplantation 4 EXERCISE: In this exercise, the strategy described above is applied…