Cord Blood Unit (CBU) search and distribution to Transplant Centers (TC): real-life experience from the National Cord Blood Program (NCBP)

Abstract

Background & Aim One of the most important attributes of cord blood is the prompt availability of high quality cell therapy products for clinical use. To achieve this, the NCBP has implemented a strong infrastructure supporting CBU search, selection, review and release. The key components include: - Fully integrated IT system for running searches in real-time, generating reports, receiving/sharing results and documents - Streamlined procedures for management of search requests - Expert review and search flexibility - Verification of product quality - Timely CBU release to TC - Expertise in regulatory requirements and shipment logistics Methods, Results & Conclusion We describe our recent clinical activity (period: 04/2016-12/2019) following this strategy. Our dedicated website, WebSearch, is used for CBU reservations directly by TC or requests received via registries (National Marrow Donor Program [NMDP] or International Registries). During the study period, 3943 CBU were reserved for 2831 patients from 153 TC. All reservations trigger full review of CBU information as well as confirmatory HLA typing (CT), effectively preparing the reserved CBU for shipment. Each patient's search is reviewed by a medical and an HLA expert within 48 hours to identify the best CBU and share recommendations with the TC. Further, the system is flexible, allowing “customized” searches that include TC's own selection criteria such as high CD34 counts, HLA requirements (allele level matching, patient's anti-HLA antibodies, maternal HLA), eligibility, CBU storage time, and various clinical study specifications. High resolution CT results are obtained routinely within 6 business days. All units with available segments are evaluated for potency (CD34/CD45 counts and viability and CFU) at reservation and/or shipment. During this period, 514 CBU were shipped for 501 patients to 91 TC; 53% were facilitated by the NMDP and the remaining were direct shipments. 170 CBU went to 23 International TC in 20 countries. Average time between shipment request and shipment was 5 business days (Figure 1). TC's shipment schedule requirements were met in all cases. With over 60,000 CBU available, the NCBP Inventory holds almost 8% of the world's unrelated CBU, including 11,100 FDA licensed products (HEMACORD®). The flexibility and efficiency of the search and review procedures, as well as the fact that 10% of the CBU have CT already performed and are “ready to ship”, enable us to process routine or emergency shipment requests expeditiously.