New recommendations for the quality and safety of tissues and cells for clinical application and its significance for the practice of tissue establishments performing cryopreservation

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00179906%3A_____%2F21%3A10438980" target="_blank" >RIV/00179906:_____/21:10438980 - isvavai.cz</a>

Alternative codes found

RIV/00216208:11150/21:10438980

Result on the web

<a href="https://doi.org/10.18462/iir.cryo.2021.0038" target="_blank" >https://doi.org/10.18462/iir.cryo.2021.0038</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.18462/iir.cryo.2021.0038" target="_blank" >10.18462/iir.cryo.2021.0038</a>

Result language

angličtina

Original language name

New recommendations for the quality and safety of tissues and cells for clinical application and its significance for the practice of tissue establishments performing cryopreservation

Original language description

The processes of procurement, processing, storage and distribution of cells and tissues of human origin used for clinical application are regulated in the European Union member states by the Directive of the European Parliament and Council No.2004/23/EC harmonized in the Czech Republic by the Act No.296/2008 Coll. and the Decree of the Ministry of Health No. 422/2008 Coll. In the Evaluation report from 2019 dealing with fulfilling of requirements of the above mentioned Directive in individual member states, the European Commission pointed out the significance of the document: &quot;Guide to the Quality and Safety of Tissues and Cells for Human Application&quot;, the 4th Edition, issued by the European Directorate for the Quality of Medicines in 2019. This document includes specifications of cryopreserved haematopoietic progenitor cells derived from bone marrow, peripheral blood and cord blood as well as of non-mobilized peripheral blood mononuclear cells. The cryoprotectant dimethylsulphoxide (DMSO) is recommended to be used in concentrations 5 - 10 % (v/v) and in the daily dose not exceeding 1 g per kg of the patient&apos;s weight. DMSO removal before clinical administration is recommended to be performed in specific situations defined in the standard operating procedures of the tissue establishment. A guide defining Good Tissue Practice is a part of this document. The authors expect that the above cited document represents a basis for the planed upgrade of the Directive 2004/23/EC and of the Commission Directives 2006/17/EC and 2006/86/EC.

Czech name

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Czech description

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Type

D - Article in proceedings

CEP classification

—

OECD FORD branch

30205 - Hematology

Project

—

Continuities

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Publication year

2021

Confidentiality

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Article name in the collection

Cryogenics 2021 online. The 16th Cryogenics 2021 IIR International Conference, October 5-7, 2021. Proceedings

ISBN

978-2-36215-047-0

ISSN

0151-1637

e-ISSN

—

Number of pages

6

Pages from-to

167-172

Publisher name

International Institute of Refrigeration

Place of publication

Paris

Event location

Czech Republic

Event date

Oct 5, 2021

Type of event by nationality

WRD - Celosvětová akce

UT code for WoS article

001304907400021