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1.  Advanced Therapy Medicinal Products – a Multiple Challenge 
doi:10.1159/000357305
PMCID: PMC3901633  PMID: 24474887
3.  Tissue Banking and Transfusion Medicine – a Suitable Cooperation Model 
doi:10.1159/000335157
PMCID: PMC3267996  PMID: 22407058
6.  Quality of Cell Products: Authenticity, Identity, Genomic Stability and Status of Differentiation 
Summary
Cellular therapies that either use modifications of a patient's own cells or allogeneic cell lines are becoming in vogue. Besides the technical issues of optimal isolation, cultivation and modification, quality control of the generated cellular products are increasingly being considered to be more important. This is not only relevant for the cell's therapeutic application but also for cell science in general. Recent changes in editorial policies of respected journals, which now require proof of authenticity when cell lines are used, demonstrate that the subject of the present paper is not a virtual problem at all. In this article we provide 2 examples of contaminated cell lines followed by a review of the recent developments used to verify cell lines, stem cells and modifications of autologous cells. With relative simple techniques one can now prove the authenticity and the quality of the cellular material of interest and therefore improve the scientific basis for the development of cells for therapeutic applications. The future of advanced cellular therapies will require production and characterization of cells under GMP and GLP conditions, which include proof of identity, safety and functionality and absence of contamination.
doi:10.1159/000284401
PMCID: PMC2914413  PMID: 20737047
Primary human cells; Cross-contamination; Cell identity; DNA typing; Karyotype
7.  Current Regulations for the Production of Multipotent Mesenchymal Stromal Cells for Clinical Application 
Summary
In this review, the appropriate legislation on the expansion of multipotent mesenchymal stromal cells (MSCs) in Europe is described. The collection of cells and the manufacturing of MSCs are being regulated by European Directives (EUDs). Recently, the Regulation on Advanced Therapies Medicinal Products (ATMPs) is being published, which is of importance for the production of MSCs in Europe, and this legislation is not yet ready, but it is in its final stage. MSCs are currently being used in clinical trials, mostly in academic hospitals, for patients suffering from a wide variety of diseases. Companies (small and medium-sized enterprises) are becoming more and more involved in the production of MSCs for human use, and since marketing authorisation is the scope of the Regulation it was decided to install a Committee on Advanced Therapies (CAT) within European Medicines Agency (EMEA). This CAT will formulate a draft opinion on quality, safety and efficacy of ATMPs and will have an advisory and scientific role for the Committee for Medicinal Products for human use. The aim of this review is to outline the current legislation which is important for the manufacturing of MSCs.
doi:10.1159/000144043
PMCID: PMC3076362  PMID: 21512645
MSC; Regulatory issues; Advanced therapy medicinal products
12.  Cumulative effect in transfusion related acute lung injury 
Saudi Journal of Anaesthesia  2012;6(3):313-314.
doi:10.4103/1658-354X.101240
PMCID: PMC3498686  PMID: 23162421

Results 1-13 (13)