Pharmacopoeial standards ensure quality control of established medicines. It is widely believed that translation of cell therapy medicines will be facilitated by defining and adopting relevant standards. Mesenchymal stromal cells (MSCs) are used extensively for multiple indications in regenerative medicine. They are highly heterogeneous in terms of their biological characteristics and their mechanisms of action, making standardization a challenging undertaking. Furthermore, the use of MSCs in therapy appears to attract diverse views, ranging from concern and caution to enthusiastic positivity. We conducted semi-structured interviews with 20 expert stakeholders from academia, industry, regulatory agencies, non-governmental organizations and clinicians to explore their views, experiences, recommendations, and concerns regarding standardization of MSCs. Qualitative thematic analysis of transcribed records led to development of a consensus framework, which identified 5 key themes to facilitate exploration of the interviews' content. On the basis of our findings, we conclude that (1) there is undoubtedly an appetite for standardization, particularly in development of assays that enable comparison or benchmarking across manufacturers, processes, and cell sources; (2) stakeholder groups are not homogeneous in their concerns and attitudes; (3) careful consideration must be given to the points along the development timeline at which different standardization approaches could be beneficial; and (4) the roles of standards could be promoted further for specific aspects of advanced therapy medicinal product (ATMP) development and regulation such as qualification of decentralized manufacturing sites. A unified cross-stakeholder approach will help to advance MSC therapeutics and other cell therapy medicines.

中文翻译：

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对间充质基质细胞标准化的态度——专家观点的定性探索。

药典标准确保既定药品的质量控制。人们普遍认为，制定和采用相关标准将促进细胞治疗药物的转化。间充质基质细胞（MSC）广泛用于再生医学的多种适应症。它们的生物学特性和作用机制具有高度异质性，这使得标准化成为一项具有挑战性的任务。此外，间充质干细胞在治疗中的使用似乎吸引了不同的观点，从担忧和谨慎到热情积极。我们对来自学术界、工业界、监管机构、非政府组织和临床医生的 20 名专家利益相关者进行了半结构化访谈，探讨他们对 MSC 标准化的观点、经验、建议和担忧。对转录记录的定性主题分析促成了共识框架的制定，该框架确定了 5 个关键主题，以促进访谈内容的探索。根据我们的研究结果，我们得出结论：（1）毫无疑问存在对标准化的需求，特别是在开发能够跨制造商、工艺和细胞来源进行比较或基准测试的检测方法方面；(2) 利益相关者群体的关注点和态度不一致；(3) 必须仔细考虑开发时间表上不同标准化方法可能受益的点；(4) 在先进治疗药品 (ATMP) 开发和监管的具体方面，例如分散生产场所的资格，可以进一步提升标准的作用。统一的跨利益相关者方法将有助于推进 MSC 疗法和其他细胞治疗药物。