John Theurer Cancer Center, Hackensack University Medical Center, Hackensack, New Jersey, USA.
Weill Cornell Medicine, New York-Presbyterian Hospital, New York, New York, USA.
Transfusion. 2022 Mar;62(3):651-662. doi: 10.1111/trf.16820. Epub 2022 Mar 20.
The AABB-ISCT Joint Working Group Stability Project Team (SPT) was assigned to roadmap a path toward standardization of cryopreserved hematopoietic stem/progenitor cell (HSPC) stability programs. HSPC stability encompasses a broad scope of conditions including non-frozen ("fresh") and cryopreserved cell products, and varying methods for storage, thaw, and administration. This report assessed current practices and focused solely on cryopreserved HSPC cell therapy products to establish preliminary recommendations for a stability program roadmap.
A survey was prepared by the SPT and distributed to ISCT and AABB members. Survey results were summarized and recommendations were outlined based on the responses from the survey. This report highlights current practices for cryopreserved HSPC stability programs, including additional considerations and recommendations.
Eighty-two (82) centers worldwide participated in the survey. Survey results indicate variability across programs. HSPC stability depends on multiple factors within the processing facility (e.g., cryopreservation techniques, reagents used, and storage temperature) and independent variables (e.g., donor-related factors and starting material variability). While retention of hematopoietic engraftment potential is the primary goal for cryopreserved HSPC stability, engraftment results should not be used as the sole metric for stability programs. Based on the survey results, the SPT provides recommendations for consideration.
The SPT recommendations for best practices are not intended to replace existing standards. The survey results emphasize the need for the community to optimize best practices and consider initiating collaborative projects to improve the standardization of cryopreserved HSPC stability programs for cell therapy products.
美国血库协会-国际干细胞治疗学会联合工作组稳定性项目团队（SPT）被指定为制定冷冻保存造血干细胞/祖细胞（HSPC）稳定性方案标准化路线图。HSPC 稳定性涵盖了广泛的条件，包括非冷冻（“新鲜”）和冷冻保存的细胞产品，以及不同的储存、解冻和给药方法。本报告评估了当前的实践，并仅专注于冷冻保存的 HSPC 细胞治疗产品，以建立稳定性方案路线图的初步建议。
SPT 编写了一份调查并分发给 ISCT 和 AABB 成员。总结了调查结果，并根据调查的答复概述了建议。本报告重点介绍了冷冻保存 HSPC 稳定性方案的当前实践，包括其他考虑因素和建议。
全球 82 个中心参与了调查。调查结果表明方案存在差异。HSPC 稳定性取决于处理设施内的多个因素（例如，冷冻保存技术、使用的试剂和储存温度）和独立变量（例如，供体相关因素和起始材料的可变性）。虽然冷冻保存 HSPC 稳定性的主要目标是保持造血植入潜力，但植入结果不应作为稳定性方案的唯一指标。基于调查结果，SPT 提供了可供考虑的建议。
SPT 的最佳实践建议并非旨在取代现有标准。调查结果强调了社区需要优化最佳实践，并考虑启动合作项目，以提高细胞治疗产品冷冻保存 HSPC 稳定性方案的标准化。
