Hybrid Cord Blood Bank: A Comprehensive Approach for Sustainability: StemCyte India Perspective

Abstract

17 Introduction Evidence that cord blood is capable of reconstituting a patient’s blood and immune system led to the establishment of cord blood banks; however, the lack of a comprehensive approach has created challenges. Since 2010, StemCyte India has used plasma depletion technology and adopted a hybrid (private + public) banking model as a comprehensive approach for sustainability. Objective The aim of this study was to evaluate different categories of private cord blood unit volumes against the FACT (Foundation for the Accreditation of Cellular Therapy) set standards for public cord blood units (NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration, 6th edition). Methods Total nucleated cell count (TNCC), CD34 count, and CD34 viability criteria were from FACT’s specific requirements for cord blood units stored for clinical administration (FACT, unrelated specification). A total of 4,985 private cord blood units stored from April 2018 to June 2021 were selected and grouped in different sets by volume (from 20 ml to 129 ml). From each group, the percentage of the sample that qualified against the set standardwas determined (Table 1). Results Results showed that larger volume cord blood units had higher percentages and fulfilled most of the criteria and that smaller volume cord blood units are a rich source of hematopoietic stem cells. Cord blood collection volume can be used as a quality tool for better outcomes. Discussion Private banking allows for a different range of cord blood units to be stored, whereas public bank cord blood units need to fulfill sets of criteria before taken into inventory. The hybrid banking model provides better access toward worldwide cord blood transplant and personalized banking. Based on human leukocyte antigen match, the hybrid model can provide critical support when there is additional unit requirement and in cases for which autologous cord blood unit transplant is not possible. The number of units in public inventory is subjective. High cell dose and better accessibility for cord blood units is important for the customer, and this helps to create value for sustaining the business. Public inventory can also be beneficial to keep up with futuristic requirements, such as hematopoietic stem cell culture for transplant and cellular immunotherapy. Table 1 Percentage of post-processed sample that qualified against the FACT standard for Public Bank Group no. Absolute CB volume (ml) Number in sample (n) Average volume (ml) Average CD34 (10) Average TNCC (10) % of sample TNCC ≥500 × 10 (FACT) % of sample CD34 ≥1.25 × 10 (FACT) % of sample CD34 viability ≥85% (FACT) 1 20-29 223 24.8 0.71 275.7 3.6 13.9 99.6 2 30-39 279 34.6 0.92 393.2 21.5 24.7 99.3 3 40-49 726 43.6 1.32 500.1 42.8 38.3 99.9 4 50-59 690 54.3 1.78 629.2 70.1 59.9 99.9 5 60-69 740 64 2.18 763.8 82.8 69.2 100.0 6 70-79 654 74.3 2.53 913.5 93.9 80.3 100.0 7 80-89 529 83.9 2.84 995.3 97.4 84.9 100.0 8 90-99 413 94.2 3.26 1124.8 97.6 86.7 100.0 9 100-109 502 104.3 3.73 1342.3 99.2 93.0 100.0 10 110-119 148 112.1 4.1 1457.6 100.0 97.3 100.0 11 120-129 81 122.5 4.2 1602.3 100.0 93.8 100.0 STEM CELLS TRANSLATIONAL MEDICINE | StemCellsTM.com © AlphaMed Press 2021 CORD BLOOD BANK MANAGEMENT, ADMINISTRATION, AND SUSTAINABILITY