Results of the Cord Blood Transplantation (COBLT) Study unrelated donor banking program
Results of the Cord Blood Transplantation (COBLT) Study unrelated donor banking program
复制标题
DOI：
10.1111/j.1537-2995.2005.04428.x
复制
发表时间：
2005-06-01
期刊：
影响因子：
2.9
通讯作者：
Kernan, NA
中科院分区：
文献类型：
--
作者：
Kurtzberg, J;Cairo, MS;Kernan, NA
背景资料：1996年开始的脐带血移植（COBLT）研究库项目的目标是制定脐带血（CB）供体招募和库的标准操作程序（SOP），并建立一个种族多样的非亲缘CB库以支持移植方案。该计划包括收集中心，三家银行，一个指导委员会和一个医疗协调中心（MCC），开发和验证SOP和基于Web的数据收集系统。外部监督进行了国家心脏，肺，血液研究所和MCC.Results：共34,799潜在的捐助者进行了筛选和20,710同意。1998年至2001年期间，共收集了17 207个不同族裔的单元。共有11，077（64%）个单位进行了冷冻保存和隔离。其中，79%符合资格标准，并进行了HLA分型，并进入了搜索注册表。与阴道分娩相比，剖宫产获得了更高的CB体积和细胞计数。与其他种族相比，非裔美国人的单位体积细胞计数较低。出生体重与体积和细胞含量相关。外部监督是通过数据收集系统生成的定制报告和定期实地访问完成的。在维护期间，在对其中一家银行进行现场访问时发现了违反SOP的情况。这些单位被指定为未来使用的nonclinical research.Conclusion：COBLT研究表明，SOP和数据收集可以在多个银行协调一个MCC。捐助者的人口统计和CB内容之间的关系可能是有用的其他CB银行计划的发展。
Background: The goals of the Cord Blood Transplantation (COBLT) Study banking program initiated in 1996 were to develop standard operating procedures (SOPs) for cord blood (CB) donor recruitment and banking and to build an ethnically diverse unrelated CB bank to support a transplantation protocol.Study Design and Methods: The program included collection centers, three banks, a steering committee, and a medical coordinating center (MCC) that developed and validated SOPs and a Web-based data collection system. External oversight was performed by the National Heart, Lung, and Blood Institute and the MCC.Results: A total of 34,799 potential donors were screened and 20,710 consented. A total of 17,207 ethnically diverse units were collected between 1998 and 2001. A total of 11,077 (64%) units were cryopreserved and quarantined. Of these, 79 percent met eligibility criteria and were HLA-typed and entered into the search registry. Higher CB volumes and cell counts were obtained from cesarean sections compared to vaginal deliveries. Units from African American persons contained lower cell counts per volume compared to other ethnicities. Birth weight correlated with volume and cell content. External oversight was accomplished through custom reports generated by the data collection system and periodic site visits. During maintenance, a breach in the SOPs was detected during a site visit at one of the banks. These units were designated for future use in nonclinical research.Conclusion: The COBLT Study demonstrated that SOPs and data collection can be implemented in multiple banks coordinated by one MCC. Relationships between donor demographics and CB content may be useful in the development of other CB banking programs.