Clinical information
Clinical utility
Hematopoietic progenitor cells (HPCs) from umbilical cord blood (UCB) have been shown to be a rich source of HPCs for hematopoietic reconstitution. Currently, the minimum range of nucleated cells (NC) accepted for hematopoietic progenitor cell transplantation (HPCT) is 2-3E7 NC/kg.
Method
Automated UCB HPC processing is faster and less operator-dependent than manual processing. Moreover, since it is carried out in a closed system, the risk of contamination is lower.
The Banc de Sang i Teixits (Blood and Tissue Bank, BST) uses the Sepax system, which consists of a centrifuge system and disposable equipment. The centrifuge allows separation of the UCB into different components. The addition of a sedimentation solution (HES) facilitates separation of the UCB components. At the end of the separation, the cryoprotectant solution is added automatically (Smart-Max). Once the processing is finished, segments are created for quality control; the primary bag is wrapped in a secondary bag for freezing.
Reference values
The processing time for UCB HPC is 30-45 minutes, depending on the initial volume.
The expected post-processing recoveries for UCB are 80% NC and 86% HPC (CD34+).
Hematocrit < 40%.
Specimen information
Product: Cryopreserved UCB HPC.
Tube: segments to perform quality controls.
Volume: volume between 20 and 50 ml.
Shelf life: not defined.
Transport instructions: < -150 °C.
Storage instructions: < -150 °C.
Administrative information
BST code: BCB008
Test description: automated cord blood hematopoietic progenitor cell processing and cryopreservation.
Synonyms: UCB-HPC.
Section: Cell Therapy Service. Cell Therapy Laboratory.
Service: the fee includes the automated processing of cord blood hematopoietic progenitor cells and their automated freezing with the Bioarchive system.
References
Areman, E. M.; Loper, K., editors. Cellular therapy: Principles, methods, and regulations. 2nd ed. Bethesda (MD): AABB Press, 2016.
Quality
The BST has ISO 9001, ISO 14001, OSHAS 18001 and European Seal of Excellence 500+ quality certifications. The BST is accredited by CAT, JACIE-FACT, FACT-NETCORD and EFI. It complies with the guidelines of good manufacturing and good distribution practices.
