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

摘要

The processess of procurement, processing, storage and distribution of cells and tissues of human origin usedfor clinical application are regulated in the European Union member states by the Directive of the EuropeanParliament and Council No.2004/23/EC harmonized in the Czech Republic by the Act No. 296/2008 Coll. andthe Decree of the Ministry of Health No. 422/2008 Coll. These norms settled minimal requirements for thepractice of Procurement and Tissue Establishment (TE) licensed and regularly inspected by the nationalcompetent authorities, such as the State Institute for Drug Control in the Czech Republic. In the framework ofevaluation of fulfilling of requirements of the above mentioned Directive in individual member statesperformed in 2019 the European Commission pointed out the significance of the document: “Guide to theQuality and Safety of Tissues and Cells for Human Application“, the 4th Edition, issued by the EuropeanDirectoriate for the Quality of Medicines in 2019. The document includes specifications of cryopreservedhaematopoietic progenitor cells derived from bone marrow, peripheral blood and cord blood as well as of nonmobilizedperipheral blood mononuclear cells. The cryoprotectant dimethyl sulfoxide (DMSO) isrecommended to be used in concentrations 5 – 10 % (v/v) and in the daily dose not exceeding 1 g per kg of thepatient´s weight. DMSO removal before clinical administration is recommended to be performed in specificsituations defined in the standard operating procedures of the TE. A guide defining Good Tissue Practice is apart of this document. It can be expected that the document represents a basis for the planed upgrade of theDirective 2004/23/EC and of the Commission Directives 2006/17/EC and 2006/86/EC.