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重新评估长期冷冻保存策略,以提高同种异体真皮祖细胞的质量、安全性和临床应用。

Reassessing Long-Term Cryopreservation Strategies for Improved Quality, Safety, and Clinical Use of Allogeneic Dermal Progenitor Cells.

机构信息

Unit of Regenerative Therapy, Lausanne University Hospital, University of Lausanne, Epalinges, Switzerland.

Unit of Regenerative Therapy, Lausanne University Hospital, University of Lausanne, Epalinges, Switzerland; Manufacturing Department, TEC-PHARMA SA, Bercher, Switzerland.

出版信息

J Invest Dermatol. 2024 Oct;144(10):2125-2135. doi: 10.1016/j.jid.2024.06.1285. Epub 2024 Aug 31.

Abstract

In regenerative medicine, ongoing advancements in cell culture techniques, including isolation, expansion, banking, and transport, are crucial for clinical success. Cryopreservation ensures off-the-freezer availability of living cells, enabling long-term storage and transport. Customizing cryopreservation techniques and cryoprotective agents (CPAs) for specific cell types is crucial for cell source quality, sustainability, safety, and therapeutic intervention efficiency. As regenerative medicine progresses, it becomes imperative that the scientific community and industry provide a comprehensive, cell-specific landscape of available and effective cryopreservation techniques, preventing trial-and-error approaches and unlocking the full potential of cell-based therapies. Open-sharing data could lead to safer, more efficient cell therapies and treatments. Two decades of dermal progenitor cell use for burn wound treatment and Good Manufacturing Practice-compliant technology transfers have highlighted the need for further cryopreservation optimization in manufacturing workflows. In this paper, we present experimental data assessing 5 different cryopreservation formulae for long-term storage of clinical-grade FE002 primary progenitor fibroblasts, emphasizing the crucial difference between DMSO-based and DMSO-free CPAs. Our findings suggest that CryoOx, a DMSO-free CPA, is a promising alternative yielding cell viability similar to that of established commercial CPAs. This research highlights the importance of secure, robust, and efficient cryopreservation techniques in cell banking for maximizing quality, ensuring patient safety, and advancing regenerative medicine.

摘要

在再生医学中,细胞培养技术的不断进步,包括细胞的分离、扩增、储存和运输,对于临床成功至关重要。冷冻保存确保了活细胞的随时可用,实现了长期储存和运输。针对特定细胞类型定制冷冻保存技术和冷冻保护剂(CPA)对于细胞源质量、可持续性、安全性和治疗干预效率至关重要。随着再生医学的发展,科学界和工业界必须提供全面、针对特定细胞的可用和有效冷冻保存技术的综合景观,以防止反复试验的方法,并释放基于细胞的治疗的全部潜力。开放共享数据可以实现更安全、更有效的细胞疗法和治疗。二十年来,真皮祖细胞一直被用于烧伤创面治疗,符合良好生产规范的技术转让突显了在制造工作流程中进一步优化冷冻保存的必要性。在本文中,我们提出了评估 5 种不同冷冻保存配方用于长期储存临床级 FE002 原代祖细胞的实验数据,强调了基于 DMSO 和无 DMSO 的 CPA 之间的关键区别。我们的研究结果表明,CryoOx 是一种有前途的无 DMSO CPA,其细胞活力与已建立的商业 CPA 相当。这项研究强调了在细胞储存中使用安全、稳健和高效的冷冻保存技术对于最大化质量、确保患者安全和推进再生医学的重要性。

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