title: Role of the blood service in cellular therapy.
abstract: Cellular therapy is a novel form of medical or surgical treatment using cells in place of or in addition to traditional chemical drugs. The preparation of cellular products - called advanced therapy medicinal products - ATMP in Europe, requires compliance with good manufacturing practices (GMP). Based on long-term experience in blood component manufacturing, product traceability and hemovigilance, selected blood services may represent ideal settings for the development and experimental use of ATMP. International harmonization of the protocols and procedures for the preparation of ATMP is of paramount importance to facilitate the development of multicenter clinical trials with adequate sample size, which are urgently needed to determine the clinical efficacy of ATMP. This article describes European regulations on cellular therapy and summarizes the activities of the 'Franco Calori' Cell Factory, a GMP unit belonging to the department of regenerative medicine of a large public university hospital, which acquired a certification for the GMP production of ATMP in 2007 and developed nine experimental clinical protocols during 2003-2011.
authors: Centre of Transfusion Medicine, Cellular Therapy and Cryobiology, Department of Regenerative Medicine, Foundation Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy. prebulla@policlinico.mi.it
authors: Paolo
authors: P
authors: Rebulla
authors: Rosaria
authors: R
authors: Giordano
mesh_terms: D058731:Blood Safety / Q000379:methods / Q000592:standards*; D064987:Cell- and Tissue-Based Therapy / Q000379:methods / Q000592:standards*; D002986:Clinical Trials as Topic / Q000379:methods / Q000592:standards; D005060:Europe; D006801:Humans; D015337:Multicenter Studies as Topic / Q000379:methods / Q000592:standards; D044968:Regenerative Medicine / Q000379:methods / Q000592:standards*