10-years analysis of cryobag fracture in a large inventory of cellular therapy products: rates and risk factors.

IF 1.4 4区 医学 Q4 CELL BIOLOGY
André Rolim Belisário, Laura Teixeira Mendonça, Maurício Colombini Martins, Roberta Kelly de Andrade, Luciana de Almeida Costa, Karen de Lima Prata
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Abstract

Cryobags play a critical role in freezing, storing, and transporting cellular therapy products but are prone to fractures, which can disrupt patient outcomes and facility workflows. This study evaluated the incidence, risk factors, and impact of cryobag fractures in a large inventory of cellular therapy products in Brazil. A retrospective cohort study included 4514 cryobags from 2262 peripheral blood stem cell collections processed between 2015 and 2024 at a single center supporting nine transplant facilities. Cryobags were frozen at - 80 °C and stored in nitrogen tanks. Fractures and leaks were identified through routine visual inspections. Among the cryobags, 15 (0.3%) fractured, with 12 detected at processing facility and 3 after release. The fracture rate was 0.37 per 100 bag-years, with a cumulative incidence of 1% at 3.62 years. Of these, 8 were discarded, and 7 were salvaged and infused into six patients. Two salvaged cryobags underwent bedside recovery, while five were recovered aseptically in the processing facility. Positive bacterial cultures were commonly found in salvaged products. In multivariate analysis, a higher total nucleated cell count per cryobag remained an independent risk factor for fracture (OR = 1.005; 95% CI: 1.0002-1.0099; p = 0.046). Following implementation of quality improvement initiatives based on root cause analysis, no further fractures were observed. These findings highlight the importance of monitoring cell concentration and adjusting cryopreservation protocols to mitigate risks. Adding overwraps may provide additional protection for cryobags at higher risk, reducing the likelihood of microbial contamination and improving the safety and reliability of cellular therapy products.

细胞治疗产品中冷冻袋骨折的10年分析:发病率和危险因素。
冷冻袋在冷冻、储存和运输细胞治疗产品中起着至关重要的作用,但它容易断裂,这可能会破坏患者的治疗结果和设施的工作流程。本研究评估了巴西大量细胞治疗产品中冷冻袋骨折的发生率、危险因素和影响。一项回顾性队列研究包括2015年至2024年间在一个支持9个移植设施的中心收集的2262个外周血干细胞的4514个冷冻袋。冷冻袋在- 80°C下冷冻并储存在氮气罐中。通过常规目视检查确定了骨折和泄漏。在冷冻袋中,有15个(0.3%)破裂,其中12个在加工设施检测到,3个在释放后检测到。骨折率为0.37 / 100袋年,3.62年累计发生率为1%。其中8个被丢弃,7个被回收并输注于6例患者。两个被打捞的冷冻袋在床边进行了回收,而五个在处理设施中进行了无菌回收。细菌培养阳性常见于回收产品。在多变量分析中,每个冷冻袋中较高的有核细胞总数仍然是骨折的独立危险因素(OR = 1.005;95% ci: 1.0002-1.0099;p = 0.046)。在实施了基于根本原因分析的质量改进措施后,没有再发生裂缝。这些发现强调了监测细胞浓度和调整低温保存方案以降低风险的重要性。增加外包装可以为风险较高的冷冻袋提供额外的保护,减少微生物污染的可能性,提高细胞治疗产品的安全性和可靠性。
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
Cell and Tissue Banking
Cell and Tissue Banking CELL BIOLOGY-ENGINEERING, BIOMEDICAL
CiteScore
3.10
自引率
13.30%
发文量
68
审稿时长
6-12 weeks
期刊介绍: Cell and Tissue Banking provides a forum for disseminating information to scientists and clinicians involved in the banking and transplantation of cells and tissues. Cell and Tissue Banking is an international, peer-reviewed journal that publishes original papers in the following areas: basic research concerning general aspects of tissue banking such as quality assurance and control of banked cells/tissues, effects of preservation and sterilisation methods on cells/tissues, biotechnology, etc.; clinical applications of banked cells/tissues; standards of practice in procurement, processing, storage and distribution of cells/tissues; ethical issues; medico-legal issues.
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