Abstract
Most public cord blood banking programs are currently facing financial difficulties due to a progressive decline in the number of cord blood transplants performed worldwide and to a high discard rate of the donated units caused by progressively increasing thresholds of the stem cell dose required to perform safe and effective hemopoietic cord blood transplants. Recycling a proportion of unused cord blood units to prepare novel cord blood components obtained with minimal manipulation (platelets, plasma, red blood cells) and to develop more technologically complex products regulated in the US as Cellular and Gene Therapy Products and in Europe as Advanced Therapy Medicinal Products [e.g. virus-specific T cells (VST), natural killer (NK) cells, induced pluripotent stem cells (iPSCs) is a promising strategy to increase the therapeutic value and reduce the financial deficits of public cord blood banking. Based on encouraging preliminary evidences reported in the literature, additional laboratory studies, large multicenter clinical trials and international regulatory harmonization are necessary to achieve these important goals. This article describes organizational, methodological and regulatory advancements developed in Italy and Spain to promote the clinical use of cord blood platelets, plasma and red blood cells.
Highlights
During the last 3 decades, newborn’s blood remaining in the placenta after term deliveries has been collected from the umbilical cord, processed and cryopreserved in public cord blood (CB) banking programs implemented following the first successful hemopoietic CB transplants pioneered by Eliane Gluckman, Hal Broxmeyer and Joanne Kurtzberg in the late 1980s
Multiple studies have conclusively shown that the clinical outcome of CB transplant is positively associated with the hemopoietic stem cells administered dose
This evidence led to the identification of a progressively increasing threshold of the minimum total nucleated cells (TNC) and CD34+ cell count required before starting expensive procedures for banking and long term cryopreservation, which currently can determine disposal rates of the collected CB units as high as 90%
Summary
During the last 3 decades, newborn’s blood remaining in the placenta after term deliveries has been collected from the umbilical cord, processed and cryopreserved in public cord blood (CB) banking programs implemented following the first successful hemopoietic CB transplants pioneered by Eliane Gluckman, Hal Broxmeyer and Joanne Kurtzberg in the late 1980s. Following the ratio of use decreased by 20% in the last 5 years and the re-orientation of PNSCU requiring researching in new applications, Barcelona CBB and the program Concordia BST, including the banking activity of six donation programmes in six autonomous regions of Spain plus Andorra, started the development of new therapeutic products from units not suitable for transplantation. In this regard a processing method to generate a new product based on CB platelets and plasma was validated (Samarkanova et al, 2020a). The different national interpretation of industrial preparation or manufacturing is highlighted as a cause of divergent classifications, which can explain why in Spain autologous based products have a different regulatory status as compared with non-autologous products
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