Emerging technologies

Regulatory Developments in Xenotransplantation in Italy


Responsible Ministries/Agencies

The National Committee for Biosafety and Biotechnologies - appointed by the Executive Council of Ministers - has instituted a working group that has issued a working document on the regulation of Xenotransplantation in Italy. This document has been transmitted to the Minister of Health who will see to it that the relevant decrees are issued. For the time being no Interministerial Commission has been appointed.

Six centres have been authorised by decree of the Minister of Health to perform clinical trials using bioartificial liver systems. These bioartificial liver systems are an extracorporeal treatment which resembles a dialysis machine. During treatment, the patient's plasma is circulated through a cartridge containing thousands of hollow fibre membranes surrounded by living, sterile pig liver cells (hepatocytes). The patient's own plasma cells may be detoxified by oxygen-rich hepatocytes, which are capable of performing many of the metabolic functions of a healthy liver. One treatment session lasts seven hours; treatments can be administered at eight hour intervals for up to 14 days.

Additional Relevant Laws/ Regulations/ Rules

Decreto legislativo 3 marzo 1993 n. 92. (90/220/CEE) (Supplemento ordinario alla Gazzetta ufficiale n. 78 del aprile 1993)
Decreto Ministeriale 28 febbraio 1995 (90/15/CE) (Gazz. Uff. n. 112 dell 6 maggio 1995)
Decreto Ministeriale 28 luglio 1997 (97/35/CE) (Gazz. Uff. n. 237 del 10 ottobre 1997)

Contact Points

Istituto Superiore di Sanità
Viale Regina Elena 229
00161 Roma


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