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
Abstract
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: "Guide to the Quality and Safety of Tissues and Cells for Human Application", 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'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.