Toward clinical use of allogeneic red cell concentrates from umbilical cord blood: feasibility and process optimization.

Authors

Elsa García-González, Dinara Samarkanova, Carmen Azqueta, Elena Valdivia, Elisenda Farssac, Nerea Castillo-Flores, Sergi Querol, Nuria Martinez-Llonch, Mireia Santos-Gómez, Margarita Codinach, Gemma Aran, Eva Alonso-Nogues, Jose M González de Aledo, Nina Houben, Miguel Alsina-Casanova, Jesus Fernández-Sojo

Published in

Blood transfusion = Trasfusione del sangue. Sep 11, 2026. Epub Sep 11, 2026.

Abstract

Umbilical cord blood has clinical applications beyond hematopoietic stem cell transplantation, making it possible to use donations more efficiently. Cord blood (CB)-derived red cell concentrates (CB-RCCs) may offer physiological advantages for extremely preterm infants (born <28 weeks' gestation), who commonly require transfusion during the first weeks after birth. Prior to clinical implementation, CB-RCC collection and processing protocols must be validated within the blood bank to ensure consistent quality, safety, efficacy, and adequate supply.
We conducted an open-label, nonrandomized, single-centre pilot trial between September 13, 2023, and July 12, 2025, evaluating the use of CB-RCCs for transfusion in extremely preterm infants. The present manuscript does not report the clinical safety or efficacy outcomes of the trial. Instead, it focuses on CB-RCC availability, inventory management, and the processing workflow, including fractionation, leukoreduction, storage, and pretransfusion irradiation. We also described the characteristics of the final product with predefined quality controls (volume, hematocrit, hemolysis, residual leukocyte content, and sterility assurance procedures).
During the study period, 161 CB units were processed for CB-RCCs, producing 187 aliquots after fractionation. The availability of the product for clinical application was 78.6% of all requested units. Median final volume of CB-RCC units released for clinical use was 25.3 mL [IQR: 23.9-26.8]. After processing, 159/187 aliquots met all acceptance criteria, corresponding to an overall release rate of 85%. The most common cause of discard was failure to meet microbiological safety requirements.
The implementation of an internal cord blood bank protocol demonstrated that CB-RCC units can be processed in a feasible and reproducible manner, with high release rates and sustained availability, supporting the potential for large-scale production to meet transfusion needs in extremely preterm infants.

PMID:
42970327
Bibliographic data and abstract were imported from PubMed on 03 Nov 2026.

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