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.

中文翻译：

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基于间充质基质细胞的医药产品的国际监管框架概述：从实验室到患者。

由于其巨大的治疗潜力，人类间充质基质细胞 (hMSC) 正在成为先进疗法和再生医学中最重要的细胞类型之一。基于 hMSC 的产品的开发侧重于使用 hMSC 作为生物活性物质，它们被世界各地的初级卫生机构视为医药产品。由于其监管地位，基于 hMSC 的产品的开发受到从设计阶段、非临床研究、临床研究到最终注册和批准的特定标准的监管。患者只能在临床试验框架内或在产品获得上市许可后使用基于 hMSC 的产品；在这两种情况下，通常都需要卫生当局的授权。综上所述，本文描述了当前对基于 hMSC 的产品的一般监管要求，按管辖区划分，将在其整个开发过程中实施。这些措施可以为公共和私人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后续营销，从而改善患者对它们的获取。