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Cell Bank - Europe PMC

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Last Updated: 10 September 2022

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Abstract 27 Limitations of Current Human Cell, Tissue, and Cellular-based Product Donor Eligibility Guidance: Analyzing the Impact on a Large Public Cord Blood Bank

Abstract Introduction The U. S. Food and Drug Administration has listed cord blood as a human cell, tissue, and cell-based drug and it is available as a Biological Licensing Application. Cord blood units require less precise donor tissue matching than other stem cell sources, which raises their possibility for racial/ethnic minorities. The updating of FDA donor eligibility policies may increase licensed CBU supply and cord blood bank profitability. Objective Two of this report were to investigate the effects of Zika virus donor screening recommendations on banked CBUs' licensing status and to recommend updated policy solutions. Methods An retrospective review of Cord Blood Bank results was carried out to determine CBU eligibility and shipment status, as well as shipment status. In 2020, there were 174 ZIKV-risk CBUs in 2020 compared to 63 in 2021, which shows that the number of CBUs with ZIKV risk banked annually has reduced dramatically since 2020. Despite FDA removal of ZIKV from the relevant transfusion-transmitted infections in 2021, the HCT/P ZIKV guidelines have not been updated since 2018, despite FDA removal of ZIKV from the relevant transfusion-transmitted infections in 2021. Banked with ZIKV risk 689 Banked for Infused, Unlicensed 1,308 Banked, unlicensed. 158 Infused, licensed, insured, single banked, Hepatitis B core antibody positive4,877 Banked, licensed with ZIKV risk 689 Infused, Caucasian donor828 Infused, unlicensed, licensed with Hepatitis B core antibody positivity, 2014 to raise blood banked, in January 2016 Infused, tis banked, Infused, 82 Infused, unlicensed, Banked, Infused, Banked, ZIKV, unlicensed, tis Banked, unlicensed, Infused, Banked, unlicensed, banked, Hepatitis B core antibody positive, Banked, unlicensed To revise the HCT/P donor screening recommendations, the FDA must consider new findings.

Source link: https://europepmc.org/article/MED/PMC9446955


A hub-and-spoke model to deliver effective access to chimeric antigen receptor T-cell therapy in a public health network: the Catalan Blood and Tissue Bank experience.

Background and Objectives: To explore whether a hub-and-spoke organizational model could effectively provide access to chimeric antigen receptor T-cell therapy within a network of academic hospitals, and address the increasing demands of this diverse and specialized field. Methods The authors conducted a retrospective analysis of the Catalan Blood and Tissue Bank network, which was established for hematopoietic stem cell transplantation, was established for six CAR T-cell transplantation programs in academic hospitals of the Catalan Health Service, serving six CAR T-cell programs. After production, 313 CAR T-cell kits were returned to the central cryogenic medicine warehouse in the hub. Conclusions: A hub-and-spoke organizational model based on an existing hematopoietic stem cell transplantation scheme is highly effective in incorporating CAR T-cell therapy into a public health hospital network. During the study period, 281 patients were able to obtain CAR T cells thanks to rapid access and support of increasing population.

Source link: https://europepmc.org/article/MED/36041984

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions