Document Detail


Bone marrow derived stem cells in regenerative medicine as advanced therapy medicinal products.
MedLine Citation:
PMID:  20589167     Owner:  NLM     Status:  PubMed-not-MEDLINE    
Abstract/OtherAbstract:
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:
Giuseppe Astori; Sabrina Soncin; Viviana Lo Cicero; Francesco Siclari; Daniel Sürder; Lucia Turchetto; Gianni Soldati; Tiziano Moccetti
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Publication Detail:
Type:  Journal Article     Date:  2010-05-15
Journal Detail:
Title:  American journal of translational research     Volume:  2     ISSN:  1943-8141     ISO Abbreviation:  Am J Transl Res     Publication Date:  2010  
Date Detail:
Created Date:  2010-06-30     Completed Date:  2010-08-12     Revised Date:  2013-05-29    
Medline Journal Info:
Nlm Unique ID:  101493030     Medline TA:  Am J Transl Res     Country:  United States    
Other Details:
Languages:  eng     Pagination:  285-95     Citation Subset:  -    
Affiliation:
Cell Therapy Unit, Foundation Cardiocentro Ticino, Via Tesserete 48, CH-6900 Lugano, Switzerland. Giuseppe.Astori@cardiocentro.org
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