Impact of FDA's HCT/P ZIKV Recommendations on Cord Blood Unit Eligibility and Utilization in a Large Public Cord Blood Bank.

IF 5.4 2区医学 Q1 CELL & TISSUE ENGINEERING

Stem Cells Translational Medicine Pub Date : 2024-05-14 DOI:10.1093/stcltm/szae008

Dana S Guggenheim, Joanne Kurtzberg, Beth H Shaz

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引用次数: 0

Abstract

Background: Cord blood units (CBUs) that are ineligible for licensure due to incomplete compliance with FDA recommendations may be used for hematopoietic stem cell transplantation under urgent medical need and an Investigational Drug Application. The largest reason for CBU donor ineligibility is Zika virus (ZIKV) risk. The study's objective was to analyze the impact of current FDA recommendations for ZIKA risk on a large public cord blood bank and propose updated recommendations.

Methods: We performed a retrospective analysis of Carolinas Cord Blood Bank (CCBB), an FDA licensed public CBB, using data from January 1, 2016 to November 21, 2023 and compared FDA recommendations for transfusion transmitted infections (TTI) for blood products and relevant communicable disease agents or diseases for human cell, tissue, or cellular or tissue-based products (HCT/Ps).

Results: CCBB: 9057 (84.3% licensed) CBUs were banked. 984/1682 (58.5%) of unlicensed CBUs had ZIKV risk. 22.0% of CBUs with ZIKV risk were from Hispanic parents, compared to 16.1% of all units. 31 of IND CBUs (11 due to ZIKV risk without reported ZIKV transmission) were safely infused. FDA Guidance: HCT/P ZIKV, HIV, and vCJD recommendations have not been updated since 2018 in contrast to FDA removal of ZIKV as a relevant TTI in 2021 and updating HIV and vCJD guidance related to TTI in 2023 and 2022, respectively.

Discussion: The FDA should consider new data to revise the HCT/P donor eligibility recommendations, which will increase the number of eligible HCT/P donors, and potentially improve access to therapies for a more diverse patient population.

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FDA 的 HCT/P ZIKV 建议对大型公共脐带血库中脐带血单位资格和使用的影响。

背景：因不完全符合美国食品及药物管理局建议而不符合许可条件的脐带血单位（CBU），可根据紧急医疗需求和研究药物申请用于造血干细胞移植。CBU捐献者不符合资格的最大原因是寨卡病毒（ZIKV）风险。本研究的目的是分析目前美国食品药品管理局关于寨卡病毒风险的建议对一家大型公共脐带血库的影响，并提出更新的建议：我们使用 2016 年 1 月 1 日至 2023 年 11 月 21 日的数据对获得 FDA 许可的公共脐带血库卡罗莱纳脐带血库（CCBB）进行了回顾性分析，并比较了 FDA 针对血液制品输血传播感染（TTI）和人体细胞、组织或细胞或组织基产品（HCT/Ps）相关传染病病原体或疾病的建议：中国血站：9057 个 CBU（84.3%获得许可）已入库。984/1682（58.5%）个无证 CBU 存在 ZIKV 风险。在有 ZIKV 风险的 CBU 中，22.0% 来自西班牙裔父母，而在所有 CBU 中，这一比例为 16.1%。31 个 IND CBU（11 个因 ZIKV 风险而未报告 ZIKV 传播）已安全输注。FDA 指南：自 2018 年以来，HCT/P ZIKV、HIV 和 vCJD 建议一直未更新，相比之下，FDA 于 2021 年将 ZIKV 取消为相关 TTI，并于 2023 年和 2022 年分别更新了与 TTI 相关的 HIV 和 vCJD 指南：FDA 应考虑新数据以修订 HCT/P 捐赠者资格建议，这将增加符合条件的 HCT/P 捐赠者数量，并有可能改善更多样化患者群体获得治疗的机会。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Stem Cells Translational Medicine CELL & TISSUE ENGINEERING-

CiteScore

12.90

自引率

3.30%

发文量

140

审稿时长

6-12 weeks

期刊介绍： STEM CELLS Translational Medicine is a monthly, peer-reviewed, largely online, open access journal. STEM CELLS Translational Medicine works to advance the utilization of cells for clinical therapy. By bridging stem cell molecular and biological research and helping speed translations of emerging lab discoveries into clinical trials, STEM CELLS Translational Medicine will help move applications of these critical investigations closer to accepted best patient practices and ultimately improve outcomes. The journal encourages original research articles and concise reviews describing laboratory investigations of stem cells, including their characterization and manipulation, and the translation of their clinical aspects of from the bench to patient care. STEM CELLS Translational Medicine covers all aspects of translational cell studies, including bench research, first-in-human case studies, and relevant clinical trials.