| Role of the blood service in cellular therapy. | |
| | |
MedLine Citation:
|
PMID: 22063066 Owner: NLM Status: Publisher |
Abstract/OtherAbstract:
|
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:
|
Paolo Rebulla; Rosaria Giordano |
Related Documents
:
|
20580196 - Current practice patterns in primary hip and knee arthroplasty among members of the ame... 18619796 - Factors distinguishing general practitioners who more readily participated in a large r... 18061776 - Putting it all together: the efficient, profitable orthopedic practice. 20333916 - In praise of nursing's collective practice. 8155856 - Gaia: goddess and idea. 12318346 - Mrs. obi's new acceptors: a case for analyzing service summaries. |
Publication Detail:
|
Type: JOURNAL ARTICLE Date: 2011-11-5 |
Journal Detail:
|
Title: Biologicals : journal of the International Association of Biological Standardization Volume: - ISSN: 1095-8320 ISO Abbreviation: - Publication Date: 2011 Nov |
Date Detail:
|
Created Date: 2011-11-8 Completed Date: - Revised Date: - |
Medline Journal Info:
|
Nlm Unique ID: 9004494 Medline TA: Biologicals Country: - |
Other Details:
|
Languages: ENG Pagination: - Citation Subset: - |
Copyright Information:
|
Copyright © 2011 The International Alliance for Biologicals. Published by Elsevier Ltd. All rights reserved. |
Affiliation:
|
Centre of Transfusion Medicine, Cellular Therapy and Cryobiology, Department of Regenerative Medicine, Foundation Ca' Granda Ospedale Maggiore Policlinico, via Francesco Sforza 35, 20122 Milan, Italy. |
Export Citation:
|
APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
|
|
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
Previous Document: Plasma leptin in growing lambs as a potential predictor for carcass composition and daily gain.
Next Document: The kinetics of cooked meat haemoprotein formation in meat and model systems.