Mesenchymal stem/stromal cells (MSCs) are a promising resource for cell-based therapy because of their high immunomodulation ability, tropism towards inflamed and injured tissues, and their easy access and isolation. Currently, there are more than 1200 registered MSC clinical trials globally. However, a lack of standardized methods to characterize cell safety, efficacy, and biodistribution dramatically hinders the progress of MSC utility in clinical practice. In this review, we summarize the current state of MSC-based cell therapy, focusing on the systemic safety and biodistribution of MSCs. MSC-associated risks of tumor initiation and promotion and the underlying mechanisms of these risks are discussed. In addition, MSC biodistribution methodology and the pharmacokinetics and pharmacodynamics of cell therapies are addressed. Better understanding of the systemic safety and biodistribution of MSCs will facilitate future clinical applications of precision medicine using stem cells.

中文翻译：

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间充质干/基质细胞疗法：精准临床应用的机制、系统安全性和生物分布

间充质干/基质细胞 (MSCs) 是一种很有前景的细胞疗法资源，因为它们具有高免疫调节能力、对发炎和受伤组织的趋向性以及易于获取和分离。目前，全球有超过 1200 项注册的 MSC 临床试验。然而，缺乏表征细胞安全性、有效性和生物分布的标准化方法极大地阻碍了 MSC 在临床实践中的应用进展。在这篇综述中，我们总结了基于 MSC 的细胞疗法的现状，重点关注 MSC 的全身安全性和生物分布。讨论了与 MSC 相关的肿瘤发生和促进风险以及这些风险的潜在机制。此外，还讨论了 MSC 生物分布方法以及细胞疗法的药代动力学和药效学。