The use of cell-based medicinal products outside of a clinical trial is allowed only to treat patients for whom no other therapeutic possibilities exist. In Italy, this issue is governed by Decreto Ministeriale on 16th January 2015: “Regulation on advanced therapy medicinal products (ATMP) prepared on a non-routine basis”. “Non-routine basis preparation” means that the preparation is intended also for a cycle of treatments, according to specific quality standards and strictly used in a Public Hospital or University Hospital, under the exclusive professional responsibility of a medical practitioner, in order to comply with an individual medical prescription for a custom-made product for an individual patient.
The therapeutic use of ATMP in clinical trials is, on the other hand, regulated by Decreto Ministeriale on 8th May 2003, published on Gazzetta Ufficiale n.173, on 28th July 2003, with subsequent modifications.
The provisions of Decreto Legislativo n.191 on 6th November 2007 and Decreto Legislativo n.16 on 25th January 2010 apply to the donation, procurement and testing of human cells and tissues, as starting materials for ATMP.
Thanks to an agreement with the Cell Factory “Franco Calori” of Milano Hospital (Ospedale Maggiore Policlinico), the following ATMP have been infused:
- Infusion of umbilical cord blood-derived MSC (UCB-MSC) for the treatment of patients with acute GvHD after HSCT.
In agreement with Decreto Fazio-Turco on 2006, the first infusion of UCB-derived MSC has been performed at the Hematology Department of S. Bortolo Hospital for the treatment of steroid-refractory GvHD on 11th November 2013.
- Infusion of UCB-MSC deriving for the treatment of patients with chronic GvHD after HSCT.
Request of authorization for using ATMP on a non-routine basis has been submitted to AIFA on 26th August 2015, in agreement with Art. 3 Decreto Ministeriale “Regulation on ATMP prepared on a non-routine basis” (Gazzetta ufficiale serie generale n.56 del 9/3/2015). The Head of AIFA clinical trials office enabled S. Bortolo Hospital (as first Hospital in Italy) for the therapeutic use of UCB-MSC on a non-routine basis on 2nd September 2015.
Specific protocols of cell therapy and regenerative medicine could be also developed for other areas of interest as Oncology, Nephrology, Cardiology and Gastroenterology.