Stem Cell Rev and Rep DOI 10.1007/s12015-014-9520-5

Current status of Cord Blood Banking During First Two Years of ‘National Government-Assigned Public Cord Blood Banks Operation’ in Korea Eun Youn Roh & Jung Lim Lee & Jong Hyun Yoon & Su Yeon Kim & Kyung Eun Lee & Do Young Song & Tai Gyu Kim & Sue Shin

# Springer Science+Business Media New York 2014

Abstract Cord blood (CB) has become a viable stem cell source for hematopoietic stem cell transplantation (HSCT), and public cord blood banks (CBBs) have been established to manage donated cord blood units (CBUs) for unrelated HSCT. As the potential uses for CB continue to grow, there is a global tendency to encourage public CBBs. The aim of this study was to investigate the current status of public CBBs that were designated and supported by the Korean national government. We analyzed 6,168 CBUs preserved at the 3 GovernmentAssigned Public CBBs during their first two years of operation (2012–2013) and the standard operating procedures for CB processing at each CBB. CBU inventories at ALLCORD, E. Y. Roh : J. H. Yoon : S. Shin (*) Department of Laboratory Medicine, Seoul National University Boramae Medical Center, 425, Shindaebang-dong, Dongjak-gu, Seoul 156-707, South Korea e-mail: [email protected] E. Y. Roh e-mail: [email protected] J. H. Yoon e-mail: [email protected] E. Y. Roh : J. H. Yoon : S. Shin ALLCORD - Seoul Metropolitan Government Public Cord Blood Bank, 425, Shindaebang-dong, Dongjak-gu, Seoul 156-707, South Korea S. Y. Kim : T. G. Kim (*) Catholic Hematopoietic Stem Cell Bank, Department of microbiology, The Catholic University of Korea, 222, Banpo-Daero, Seocho-Gu, Seoul 137-701, South Korea e-mail: [email protected] S. Y. Kim e-mail: [email protected] J. L. Lee : K. E. Lee : D. Y. Song Daegu Fatima Hospital Public Cord Blood Bank, 183, Ayang-ro, Dong-gu, Daegu, South Korea

Catholic HSC Bank and Fatima Public CBB were 4,022, 1,207 and 939 units, respectively. Total nucleated cell (TNC) counts per unit were 11.0×108 at ALLCORD, 10.7×108 at Fatima and 9.8×108 at Catholic, and all far exceeded the requirement for cryopreservation under the law (7.0×108). CD34 + cell counts and % were as follows: 3.5 × 10 6 (0.31 %) in ALLCORD, 2.2×106 (0.20 %) in Fatima and 2.2×106 (0.22 %) in Catholic. All the three banks observed the ‘CB Act’ in dealing with CBUs, including collection, processing, laboratory tests and cryopreservation. Government supported and strictly law-abiding public CBBs in Korea have considerable CBU inventories of high quality in terms of efficacy and safety. Legislation and accompanying government-support will be helpful for establishing CB standardization, vitalizing CBT and improving clinical outcomes. Keywords Public cord blood bank . Korean . Government-Assigned . Cord blood unit . Total nucleated cell

Introduction In the last 20 years, umbilical cord blood (CB) that had previously been discarded as medical waste has increasingly become a viable stem cell source for hematopoietic progenitor cell (HPC) transplantation. The advantages of cryopreserved CB such as rapid availability, lower risk of graft versus host disease, and, most importantly, numerous potential donors, make it an attractive alternative to bone marrow (BM) [1, 2]. Public cord blood banks (CBBs) are established to manage donated cord blood units (CBUs) with their processing and cryopreservation ready for unrelated HPC transplantation. These banks have been operated with funding from university affiliated medical centers, philanthropic institutes, regional governments or national support. Private preservation is not

Stem Cell Rev and Rep

recommended for individuals without a specific family history of certain disorders, such as RBC disorders [3, 4]. Instead, CB donation and public CBBs are encouraged throughout the world. Large CB inventory in public CBBs and the high quality of preserved CBUs are crucial factors for improving cord blood transplantation (CBT) outcomes. Thus, increasing governmental support to vitalize public CBBs has been a global trend for years. The United States (US) and Japan have shown the most representative and successful examples of public CBB support systems that are funded by national government budgets. The US government officially recognized a CBB project along with a marrow donor registry project based on the “Stem Cell Act—C.W. Bill Young Cell Transplantation Program” in 2005 and secured 60 million USD in the national budget for the preservation of 150,000 CBUs [5]. The Japanese government has provided a considerable amount of national budget funding for managing BM and CB projects several times [6]. Since 1997, commercial CBBs have been more dominant than public CBBs in Korea, until the first large-scale public CBB (ALLCORD) was launched with the support of the regional governmental and a networking system for 7 public CBBs (KoreaCORD) was established in 2006 [7]. Prior to the “CB Act,” there was no legal regulation of CB and the “Cord Blood Bank Standard Operating Procedure” in 2005 was the only official, but noncompulsory reference announced in Korea. However, several public CBBs (e.g., ALLCORD) established strict standard operating procedures (SOPs) based on the NetCord-FACT international standards and other related Korean Acts, such as the “Blood Management Act,” “Safety and Management of Human Tissue Act,” and the “Bioethics and Safety Act” [8–11]. Based on these guidelines, new legislation, the “Act on Cord Blood Management and Research” (or the “CB Act”), was enacted in 2011 to establish a quality assurance system and governmental support for public CBBs [12]. According to the “CB Act,” “CB management” defines the procedures from collection to cryopreservation and transplantation. Thus, every CB-related action, such as CB collection, processing, preservation and registry management, that had not been regulated before enactment is now applied to the “CB Act.” Accompanying the legislation, three public CBBs were designated as “Korean Government-Assigned Public CBBs” in 2012 after a proper and thorough examination, which included ALLCORD (Seoul Metropolitan Government Public Cord Blood Bank), Catholic Hematopoietic Stem Cell Bank and Daegu Fatima Hospital Public Cord Blood Bank. We aimed to investigate the current status of public CB banking during the first two years of the “GovernmentAssigned Public CBBs Operation” in Korea to assess the quality of CBUs and the management of CB banking.

Materials and Methods Subjects and Methods Three public CBBs were assigned and supported by the Korean National Government beginning in 2012. We analyzed CBUs in three public CBBs based on the standard operating procedures (SOPs) of CBBs and the CB data from the Korean Cord Blood Coordinating Center (CBCC). All of the CBUs were voluntarily donated from adult women who gave informed consent and completed self-administered medical questionnaires. Labor and delivery records were provided by the obstetricians. The documents and test results of donated CBs and/or mothers were reviewed by the medical director of the CBBs. Analyzed data covered TNC, CD34+ cell count, CD34+ cell percentage, laboratory test results for infectious disease and records of each processing step. Statistical Analysis Independent t-tests were used to analyze potential differences in cell counts of stored CBs based on the storage year. ANOVA or the Kruskal–Wallis test was used for TNC and CD34+ cell differences between banks (IBM SPSS Statistics 20). The level of statistical significance was set at p

Current status of cord blood banking during first two years of 'National Government-Assigned Public Cord Blood Banks Operation' in Korea.

Cord blood (CB) has become a viable stem cell source for hematopoietic stem cell transplantation (HSCT), and public cord blood banks (CBBs) have been ...
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