Corsi Carlos Alexandre Curylofo, Scarpelini Katia Carmen Gabriel, Bento Rodolfo Leandro, Del Pádua Joel Bel, Zitei-Baptista Luis Fernando, Assunção-Luiz Alan Vinicius, Cintra Álefe Saloum, Dos Lima Denissani Aparecida Ferrari Santos, Garcia Flávio Luís, Picado Celso Herminio Ferraz, Martins Luís Gustavo Gazoni
Kornea- und Gewebebank Schwerin gGmbH (HSN), Deutsche Gesellschaft für Gewebetransplantation gGmbH (DGFG) (German Society for Tissue Transplantation - DGFG), Schwerin, Mecklenburg-Vorpommern, Germany.
Human Tissue Bank, Hospital das Clínicas, Faculty of Medicine of Ribeirão Preto, University São Paulo (HC-FMRP/USP), Ribeirão Preto - São Paulo, Brazil.
Cell Tissue Bank. 2025 Sep 1;26(3):38. doi: 10.1007/s10561-025-10185-0.
Human Tissue Banks (BTH) must validate the storage of collected/processed tissues ensuring physical integrity, sterility, and microbial protection for up to 5 years. (1) Is it safe to use bone tissue for transplants collected by a BTH after 5 years of storage? (2) Do the packaging of stored tissues present physical integrity, sterility, and microbial protection after 5 years? (3) What are the morphological results of bone tissues after 5 years?. 20 femoral heads were used with a storage time of between 9 and 10 years at -80 °C. From each femoral head, the following were carried out: microbiological tests for aerobic and anaerobic bacteria and fungi, collecting 3 fragments of bone tissue, 3 Stuart swabs from the inner surface of the packaging, and a sample of 0.9% SF for Bioburden examination; tissue histology; the quantitative and qualitative mechanical resistance test and pyrogenicity/cytotoxicity test were used on the packaging, pre and post storage. No bone tissue samples showed pathogenicity. Histological findings showed morphologically preserved osteocytes with points of bone degeneration and necrotic adipose tissue. No packaging showed contamination, cytotoxicity, or pyrogenicity. The mechanical properties of these packages demonstrated uniformity in thickness, high tension, and relative stiffness even after storage (p = 0.001). It is concluded that the packaging used in the study presented physical integrity, sterility, and microbial protection for bone tissues after 9 and 10 years of storage. A possible increase in the shelf life of fabrics is contemplated to up to 10 years. Such results expand future research directions to continuously improve the quality of products and services offered by BTH.
人体组织库（BTH）必须验证所收集/处理组织的储存情况，确保其物理完整性、无菌性以及长达5年的微生物防护。（1）BTH储存5年后收集的骨组织用于移植是否安全？（2）储存5年后，储存组织的包装是否具备物理完整性、无菌性以及微生物防护？（3）5年后骨组织的形态学结果如何？使用了20个股骨头，在-80°C下储存时间为9至10年。对每个股骨头进行了以下操作：对需氧菌、厌氧菌和真菌进行微生物检测，采集3块骨组织碎片、从包装内表面采集3支Stuart拭子以及一份用于生物负载检查的0.9% SF样本；进行组织病理学检查；对包装在储存前后进行定量和定性的机械抗性测试以及热原性/细胞毒性测试。没有骨组织样本显示出致病性。组织学检查结果显示，骨细胞形态保存，但存在骨退化点和坏死脂肪组织。没有包装显示出污染、细胞毒性或热原性。这些包装的机械性能即使在储存后也显示出厚度均匀、高张力和相对刚度（p = 0.001）。结论是，研究中使用的包装在储存9年和10年后为骨组织提供了物理完整性、无菌性和微生物防护。考虑将织物的保质期可能延长至10年。这些结果拓展了未来的研究方向，以不断提高BTH提供的产品和服务质量。
