AJTR Copyright © 2009-All rights reserved. Published by e-Century Publishing Corporation, Madison, WI 53711
Am J Translational Res 2010;2(3):285-295

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.

Key words: "Good Manufacturing Practice”,  “Acute Myocardial Infarction”, “Peripheral Vascular Disease”, “Stem
Cells”, “Advanced Therapy Medicinal Products”, “Cell Factory”

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Address all correspondence to:
Giuseppe Astori, PhD
Cell Therapy Unit
Foundation Cardiocentro Ticino
Via Tesserete 48, CH-6900 Lugano
Tel. +41 (0) 91 805 3810, Fax
+41 (0) 91 805 3213