title: Bone marrow derived stem cells in regenerative medicine as advanced therapy medicinal products.
abstract: Bone marrow derived stem cells administered after minimal manipulation represent an important cell source for cell-based therapies. Clinical trial results, have revealed both safety and efficacy of the cell reinfusion procedure in many cardiovascular diseases. Many of these early clinical trials were performed in a period before the entry into force of the US and European regulation on cell-based therapies. As a result, conflicting data have been generated on the effectiveness of those therapies in certain conditions as acute myocardial infarction. As more academic medical centers and private companies move toward exploiting the full potential of cell-based medicinal products, needs arise for the development of the infrastructure necessary to support these investigations. This review describes the regulatory environment surrounding the production of cell based medicinal products and give practical aspects for cell isolation, characterization, production following Good Manufacturing Practice, focusing on the activities associated with the investigational new drug development.
authors.affiliation: Cell Therapy Unit, Foundation Cardiocentro Ticino, Via Tesserete 48, CH-6900 Lugano, Switzerland. Giuseppe.Astori@cardiocentro.org
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Astori
authors.forename: Sabrina
authors.initials: S
authors.lastname: Soncin
authors.forename: Viviana
authors.initials: V
authors.lastname: Lo Cicero
authors.forename: Francesco
authors.initials: F
authors.lastname: Siclari
authors.forename: Daniel
authors.initials: D
authors.lastname: Sürder
authors.forename: Lucia
authors.initials: L
authors.lastname: Turchetto
authors.forename: Gianni
authors.initials: G
authors.lastname: Soldati
authors.forename: Tiziano
authors.initials: T
authors.lastname: Moccetti