Background - 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.
Materials and methods - 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).
Results - 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.
Discussion - 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.
Elsa Garcia-González
- Neonatology Department, Hospital Clínic de Barcelona, BCNatal (Barcelona Center for Maternal Fetal and Neonatal Medicine), Barcelona, Spain; Faculty of Medicine and Health Sciences, University of Barcelona, Barcelona, Spain
https://orcid.org/0000-0002-3060-0010
Dinara Samarkanova
- Faculty of Medicine and Health Sciences, University of Barcelona, Barcelona, Spain; Blood and Tissue Bank (Banc de Sang i Teixits), Barcelona, Spain; Transfusion Medicine Research Group, Vall d’Hebron Research Institute (VHIR), Barcelona, Spain
https://orcid.org/0000-0001-5196-2507
Carmen Azqueta
- Blood and Tissue Bank (Banc de Sang i Teixits), Barcelona, Spain; Transfusion Medicine Research Group, Vall d’Hebron Research Institute (VHIR), Barcelona, Spain
https://orcid.org/0000-0002-9621-0891
Elena Valdivia
- Blood and Tissue Bank (Banc de Sang i Teixits), Barcelona, Spain; Transfusion Medicine Research Group, Vall d’Hebron Research Institute (VHIR), Barcelona, Spain
Elisenda Farssac
- Blood and Tissue Bank (Banc de Sang i Teixits), Barcelona, Spain; Transfusion Medicine Research Group, Vall d’Hebron Research Institute (VHIR), Barcelona, Spain
Nuria Martinez-LLonch
- Blood and Tissue Bank (Banc de Sang i Teixits), Barcelona, Spain; Transfusion Medicine Research Group, Vall d’Hebron Research Institute (VHIR), Barcelona, Spain
https://orcid.org/0009-0000-0523-2853
Mireia Santos-Gómez
- Blood and Tissue Bank (Banc de Sang i Teixits), Barcelona, Spain; Transfusion Medicine Research Group, Vall d’Hebron Research Institute (VHIR), Barcelona, Spain
https://orcid.org/0009-0007-2157-2998
Margarita Codinach
- Blood and Tissue Bank (Banc de Sang i Teixits), Barcelona, Spain; Transfusion Medicine Research Group, Vall d’Hebron Research Institute (VHIR), Barcelona, Spain
Eva Alonso-Nogues
- Blood and Tissue Bank (Banc de Sang i Teixits), Barcelona, Spain; Transfusion Medicine Research Group, Vall d’Hebron Research Institute (VHIR), Barcelona, Spain
Jose Manuel González de Aledo
- Division of Inborn Errors of Metabolism-IBC, Biochemistry and Molecular Genetics Department, CDB, Hospital Clínic de Barcelona, Barcelona, Spain; August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Barcelona, Spain
https://orcid.org/0000-0002-7622-417X
Nina Houben
- Division of Neonatology, Willem-Alexander Children’s Hospital, Leiden University Medical Center, Leiden, the Netherlands
https://orcid.org/0000-0001-7605-4927
Miguel Alsina-Casanova
- Neonatology Department, Hospital Clínic de Barcelona, BCNatal (Barcelona Center for Maternal Fetal and Neonatal Medicine), Barcelona, Spain; Faculty of Medicine and Health Sciences, University of Barcelona, Barcelona, Spain; August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Barcelona, Spain
https://orcid.org/0000-0002-0139-7279
Jesus Fernández-Sojo
- Blood and Tissue Bank (Banc de Sang i Teixits), Barcelona, Spain; Transfusion Medicine Research Group, Vall d’Hebron Research Institute (VHIR), Barcelona, Spain
https://orcid.org/0000-0002-4016-0020
, Dinara Samarkanova
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