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The Institution where this reasearch will be carried out is the Hematology Unit of the "Ospedali Riuniti" of Bergamo, Italy. The clinical activity of the Unit during 2009 can be summarized as follows:
In addition 100 autologous and 40 allogeneic (sibling, unrelated and cord blood) transplants were performed.
The hematopoietic stem cell transplant is fully accredited by JACIE.
The Unit includes two wards for inpatients, one provided with 15 beds for conventional care and the other with 11 designated transplant single rooms, situated in an isolated area. Theese rooms present a positive pressure gradient and are equipped with HEPA filtered air support and with a change air system. In this Transplant area additional dedicated spaces for nurses are present and an independent laboratory with a laminar air flow cabinet for the haematopoietic stem cells thawing and drug preparation. In the same building a Day Hospital with 12 dedicated positions for chemotherapy administration are present. Each day 20 patients are admitted to this facility. A separate area for allogeneic transplantation is also present. The hematology Unit has also a structure for outpatients, that includes 4 examination rooms and one room for blood and bone marrow samples collection.
Two laboratory units are part of the Hematology Unit.
The first lab (250 mq of working area) dedicated to conventional, immunological, and molecular diagnosis (Lab. Paolo Belli). The Laboratory is located on the basement floor in the same building of the inpatient unit, and is fully equipped with with instruments for advanced diagnostic analysis and for research (all bench equipments: centrifuges, gel apparatus, power supplies, shaking and static incubators, gel dryers, water baths, freezers, fume hood etc.,required for molecular biology and immunology studies).
The second lab is dedicated to the program of hematopoietic stem cell transplantation (Lab. Gilberto Lanzani). This laboratory is fully accreditated by AIFA as an official site for cell therapy activity under GMP rules.The structure is composed of a non classified area including offices and experimental laboratories and a controlled area. The controlled area is reached by a double dressing room which allows the passage from non classified to class C environment. The corridor in class C leads into the 2 class C laboratories for regular bone marrow transplant and stem cell processing and also leads into the separate GMP production area. The laboratories contain one Biohazard laminar flow hood , one centrifuge, one fridge and 1-2 incubators, all derived into a central supervision control computer. Within the non classified area is present a room dedicated to the freezing and storage under controlled conditions of the clinical cell bags in independent nitrogen tanks.