Andalusian Center for Molecular Biology and Regenerative Medicine (CABIMER), University of Pablo de Olavide-University of Seville-CSIC, Seville, Spain.
Department of Animal Biology, Faculty of Sciences, Instituto Malagueño de Biomedicina (IBIMA), Campus de Teatinos s/n, University of Málaga, Málaga, Spain.
Med Res Rev. 2020 Jul;40(4):1315-1334. doi: 10.1002/med.21659. Epub 2020 Feb 4.
Human mesenchymal stromal cells (hMSCs) are emerging as one of the most important cell types in advanced therapies and regenerative medicine due to their great therapeutic potential. The development of hMSC-based products focuses on the use of hMSCs as biological active substances, and they are considered medicinal products by the primary health agencies worldwide. Due to their regulatory status, the development of hMSC-based products is regulated by specific criteria that range from the design phase, nonclinical studies, clinical studies, to the final registration and approval. Patients should only be administered hMSC-based products within the framework of a clinical trial or after the product has obtained marketing authorization; in both cases, authorization by health authorities is usually required. Considering the above, this paper describes the current general regulatory requirements for hMSC-based products, by jurisdiction, to be implemented throughout their entire development process. These measures may provide support for researchers from both public and private entities and academia to optimize the development of these products and their subsequent marketing, thereby improving access to them by patients.
人源间充质基质细胞（hMSCs）因其巨大的治疗潜力，正在成为先进治疗和再生医学中最重要的细胞类型之一。基于 hMSC 的产品的开发主要侧重于将 hMSCs 用作生物活性物质，并且它们被全球主要卫生机构视为药品。由于其监管地位，基于 hMSC 的产品的开发受到特定标准的监管，这些标准从设计阶段、非临床研究、临床研究到最终注册和批准。只有在临床试验框架内或在产品获得市场授权后，患者才可以使用基于 hMSC 的产品；在这两种情况下，通常需要卫生当局的授权。有鉴于此，本文按管辖范围描述了当前针对整个开发过程的基于 hMSC 的产品的一般监管要求。这些措施可以为来自公共和私营实体以及学术界的研究人员提供支持，以优化这些产品的开发及其随后的营销，从而改善患者对这些产品的获取。
