Review Article Bone marrow derived stem cells in regenerative medicine as Advanced Therapy Medicinal Products
Giuseppe Astori, Sabrina Soncin, Viviana Lo Cicero, Francesco Siclari, Daniel Sürder, Lucia Turchetto, Gianni Soldati, and Tiziano Moccetti
Cell Therapy Unit, Foundation Cardiocentro Ticino, Via Tesserete 48, CH-6900 Lugano, Switzerland Cardiac Surgery, Foundation Cardiocentro Ticino, Via Tesserete 48, CH-6900 Lugano, Switzerland Cardiology, Foundation Cardiocentro Ticino, Via Tesserete 48, CH-6900 Lugano, Switzerland
Received March 17, 2010; accepted March 22, 2010, available online March 25, 2010
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. (AJTR1004003).