制造用于治疗犬类骨关节炎的间充质基质细胞:挑战与建议

Manufacturing Mesenchymal Stromal Cells for the Treatment of Osteoarthritis in Canine Patients: Challenges and Recommendations.

作者信息

Ivanovska Ana, Wang Mengyu, Arshaghi Tarlan Eslami, Shaw Georgina, Alves Joel, Byrne Andrew, Butterworth Steven, Chandler Russell, Cuddy Laura, Dunne James, Guerin Shane, Harry Rob, McAlindan Aidan, Mullins Ronan A, Barry Frank

机构信息

Regenerative Medicine Institute (REMEDI), Biosciences, National University of Ireland Galway, Galway, Ireland.

ValleyVets, Cardiff, United Kingdom.

出版信息

Front Vet Sci. 2022 Jun 10;9:897150. doi: 10.3389/fvets.2022.897150. eCollection 2022.

Abstract

The recent interest in advanced biologic therapies in veterinary medicine has opened up opportunities for new treatment modalities with considerable clinical potential. Studies with mesenchymal stromal cells (MSCs) from animal species have focused on characterization (mostly following protocols developed for human application), experimental testing in controlled studies and clinical use in veterinary patients. The ability of MSCs to interact with the inflammatory environment through immunomodulatory and paracrine mechanisms makes them a good candidate for treatment of inflammatory musculoskeletal conditions in canine species. Analysis of existing data shows promising results in the treatment of canine hip dysplasia, osteoarthritis and rupture of the cranial cruciate ligament in both sport and companion animals. Despite the absence of clear regulatory frameworks for veterinary advanced therapy medicinal products, there has been an increase in the number of commercial cell-based products that are available for clinical applications, and currently the commercial use of veterinary MSC products has outpaced basic research on characterization of the cell product. In the absence of quality standards for MSCs for use in canine patients, their safety, clinical efficacy and production standards are uncertain, leading to a risk of poor product consistency. To deliver high-quality MSC products for veterinary use in the future, there are critical issues that need to be addressed. By translating standards and strategies applied in human MSC manufacturing to products for veterinary use, in a collaborative effort between stem cell scientists and veterinary researchers and surgeons, we hope to facilitate the development of quality standards. We point out critical issues that need to be addressed, including a much higher level of attention to cell characterization, manufacturing standards and release criteria. We provide a set of recommendations that will contribute to the standardization of cell manufacturing methods and better quality assurance.

摘要

近期兽医学对先进生物疗法的关注为具有巨大临床潜力的新治疗方式带来了机遇。对来自动物物种的间充质基质细胞(MSCs)的研究主要集中在特性表征(大多遵循为人类应用制定的方案)、对照研究中的实验测试以及兽医临床应用。MSCs通过免疫调节和旁分泌机制与炎症环境相互作用的能力使其成为治疗犬类炎症性肌肉骨骼疾病的理想候选者。对现有数据的分析表明,在治疗运动犬和伴侣犬的髋关节发育不良、骨关节炎和前交叉韧带断裂方面取得了有前景的结果。尽管缺乏针对兽用先进治疗药品的明确监管框架,但可用于临床应用的基于细胞的商业产品数量有所增加,目前兽用MSC产品的商业应用已超过对细胞产品特性表征的基础研究。在缺乏用于犬类患者的MSCs质量标准的情况下,其安全性、临床疗效和生产标准尚不确定,导致产品一致性差的风险。为了在未来提供高质量的兽用MSC产品,有一些关键问题需要解决。通过将人类MSC制造中应用的标准和策略转化为兽用产品,干细胞科学家与兽医研究人员及外科医生共同努力,我们希望促进质量标准的制定。我们指出了需要解决的关键问题,包括对细胞表征、制造标准和放行标准给予更高水平的关注。我们提供了一系列建议,这将有助于细胞制造方法的标准化和更好的质量保证。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5ff0/9230578/bb71cec14914/fvets-09-897150-g0001.jpg

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