Abstract

<h3>Introduction</h3> Umbilical cord blood (UCB) is a vital source of hematopoietic stem and progenitor cells (HSPCs). Since 1991, UCB has been collected and stored in public cord blood banks to be primarily used as a source for allogeneic hematopoietic stem cell transplantation (HSCT). Since the seminal UCB transplant reported in 1988 by Gluckman et al., UCB has contributed to advances in HSCT and clinical trials. However, UCB-derived cells remain costly and difficult to procure for pre-clinical research. Here we present a protocol for a multidisciplinary, self-sustaining cord blood program dedicated to biomedical research: The Binns Program for Cord Blood Research, piloted at the Stanford University School of Medicine. <h3>Objectives</h3> The primary objective of this study was to educate others on the benefits of implementing a self-sustaining cord blood program that increases biomedical research throughout the medical community. <h3>Methods</h3> Eligible donors are identified using IRB-approved inclusion criteria. UCB samples are then collected in utero, with informed consent, by obstetric providers at the time of delivery. Within 24-48 hours of isolation, deidentified samples are processed into three fractions: (1) plasma, (2) hematopoietic stem and progenitor cells (HSPCs) by immunomagnetic separation, and (3) non-HSPC cellular flow-through. UCB-derived fractions are then distributed to researchers upon request. <h3>Results</h3> Between November 2015 and April 2019, 1,385 women gave informed consent to donate their cord blood following delivery. Of those participants, 1,147 (83%) samples were collected and 927 (81%) distributed for research purposes. The median post-enrichment cell count per cord following positive selection for CD34+ HSPCs was 1.25 × 10<sup>6</sup> (Figure 1). Corresponding median post-enrichment sample purity was 90% following single-step purification. By October 2016, a protocol had been developed and optimized for the Binns Program to begin providing UCB-derived products to six laboratories. Now, the program supports 47 laboratories across Stanford. The research being supported spans a broad array of topics including normal and abnormal hematopoiesis, genetic engineering, and novel approaches to HCST. <h3>Conclusions</h3> After initial start-up funding, the Binns Program became self-sustaining, representing a feasible model for cord blood banking to support the advancement of research by providing fresh or cryopreserved UCB-derived cells to the research community. We hope this model may be useful for other institutions and centers where the need to support research is high and the traditional model for public cord blood banking may not be a suitable option.

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