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辅料和细胞浓度对间充质干细胞活力、增殖及黏附的影响:对新型高级治疗药物产品开发的未来意义

Impact of Excipient and Cell Concentration on the Viability, Proliferation, and Adhesion of Mesenchymal Stem Cells: Future Relevance for the Development of a New Advanced Therapy Medicinal Product.

作者信息

Moñivas Ester, Aguayo Concepción, Rodera Beatriz, Zurita Mercedes

机构信息

Fundación Investigación Biomédica, Hospital Universitario Puerta de Hierro Majadahonda, 28222 Majadahonda, Spain.

Hospital Universitario Puerta de Hierro Majadahonda, 28222 Majadahonda, Spain.

出版信息

Pharmaceutics. 2025 May 13;17(5):642. doi: 10.3390/pharmaceutics17050642.

Abstract

: The preservation of mesenchymal stem cell (MSC) viability and biological activity is a key aspect in optimizing advanced therapy medicinal products (ATMPs). Evaluating various excipients to optimize MSC conservation and functionality is essential. : Five excipients with different proportions of human platelet lysate (hPL) and Hypothermosol were evaluated at two different cell concentrations (0.1 × 10 MSC/μL and 0.008 × 10 MSC/μL). Cell viability, adhesion, and proliferation capacity were assessed at 24 and 48 h under hypothermic conditions (2-8 °C). : A significant interaction was observed between cell concentration and excipient, where the 0.008 × 10 MSC/μL concentration showed better viability results. Excipients with a combination of 50-75% Hypothermosol improved cell viability and adhesion. No significant differences were found in cell proliferation among the excipients studied. Viability, adhesion, and proliferation decreased significantly at 48 h for all excipients and concentrations evaluated. : The combination of hPL and Hypothermosol enhances MSC stability and preserves their functionality, suggesting its potential as an optimized storage solution for cell-based therapies. Additionally, the impact of cell concentration on viability underscores the importance of selecting appropriate dosing. Future studies should further investigate how these findings translate into clinical outcomes, particularly in terms of therapeutic efficacy and patient safety.

摘要

间充质干细胞(MSC)活力和生物活性的保存是优化先进治疗医药产品(ATMP)的关键方面。评估各种辅料以优化MSC的保存和功能至关重要。:在两种不同的细胞浓度(0.1×10 MSC/μL和0.008×10 MSC/μL)下评估了五种不同比例的人血小板裂解物(hPL)和低温保存液的辅料。在低温条件(2-8°C)下于24小时和48小时评估细胞活力、黏附能力和增殖能力。:观察到细胞浓度和辅料之间存在显著相互作用,其中0.008×10 MSC/μL浓度显示出更好的活力结果。含有50-75%低温保存液的辅料组合提高了细胞活力和黏附能力。在所研究的辅料之间,细胞增殖未发现显著差异。对于所有评估的辅料和浓度,在48小时时活力、黏附能力和增殖能力均显著下降。:hPL和低温保存液的组合增强了MSC的稳定性并保留了其功能,表明其作为基于细胞疗法的优化储存溶液的潜力。此外,细胞浓度对活力的影响强调了选择合适剂量的重要性。未来的研究应进一步调查这些发现如何转化为临床结果,特别是在治疗效果和患者安全性方面。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f465/12115096/bacdddcc66ef/pharmaceutics-17-00642-g001.jpg

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