Lužnik Zala, Bertolin Marina, Breda Claudia, Ferrari Barbara, Barbaro Vanessa, Schollmayer Petra, Ferrari Stefano
Eye Hospital, University Medical Centre, Ljubljana, Slovenia.
Fondazione Banca degli Occhi del Veneto, Venice, Italy.
Adv Exp Med Biol. 2016;951:179-189. doi: 10.1007/978-3-319-45457-3_15.
Significant advances have been made in the field of ocular regenerative medicine. Promising stem cell-based therapeutic strategies have been translated into the clinical practice over the last few decades. These new stem cell-based therapies offer the possibility of permanently restoring corneal epithelium in patients with severe disabling and blinding ocular surface disease. The European Union has already classified stem cell-based therapies as "medicinal products". Therefore, manipulation is strictly regulated according to the defined conditions of good manufacturing practice, with the production of stem cell therapeutics at only accredited production sites authorized by the national regulatory agencies. In this regard, as first medical products are licensed for commercial use in Europe enabling a more widespread access to a stem cell-based therapy, the need for safe, validated and reproducible techniques for ex vivo cultured tissue preservation and distribution are coming to the forefront of research. However, these provide various new challenges for biobanking industry such as the retention of viability, good functionality of stem cells and sterility issues. This chapter provides an overview of the current advances in the field of corneal/limbal epithelial stem cell culture preservation techniques using either hypothermic storage or cryopreservation methods, that were used in different culturing steps (from stem cell isolation to the ex vivo epithelial graft preparation), with the reported impact on the post-thawing product recovery.
眼再生医学领域已取得重大进展。在过去几十年中，基于干细胞的有前景的治疗策略已转化为临床实践。这些新的基于干细胞的疗法为患有严重致残性和致盲性眼表疾病的患者永久性恢复角膜上皮提供了可能性。欧盟已将基于干细胞的疗法归类为“医药产品”。因此，操作严格按照良好生产规范的既定条件进行监管，干细胞治疗产品仅在国家监管机构授权的认可生产场所生产。在这方面，随着首批医疗产品在欧洲获得商业使用许可，使基于干细胞的疗法能够更广泛地应用，对用于体外培养组织保存和分发的安全、经过验证且可重复的技术的需求正成为研究的前沿。然而，这些给生物样本库行业带来了各种新挑战，如干细胞活力的保持、良好的功能以及无菌问题。本章概述了角膜/角膜缘上皮干细胞培养保存技术领域的当前进展，这些技术使用低温保存或冷冻保存方法，用于不同的培养步骤（从干细胞分离到体外上皮移植物制备），并报告了对解冻后产品恢复的影响。
