Over the past two decades, mesenchymal stem/stromal cell (MSC) therapy has made substantial strides, transitioning from experimental clinical applications to commercial products. MSC therapies hold considerable promise for treating refractory and critical conditions such as acute graft-versus-host disease, amyotrophic lateral sclerosis, and acute respiratory distress syndrome. Despite recent successes in clinical and commercial applications, MSC therapy still faces challenges when used as a commercial product. Current detection methods have limitations, leaving the dynamic biodistribution, persistence in injured tissues, and ultimate fate of MSCs in patients unclear. Clarifying the relationship between the pharmacokinetic characteristics of MSCs and their therapeutic effects is crucial for patient stratification and the formulation of precise therapeutic regimens. Moreover, the development of advanced imaging and tracking technologies is essential to address these clinical challenges. This review provides a comprehensive analysis of the kinetic properties, key regulatory molecules, different fates, and detection methods relevant to MSCs and discusses concerns in evaluating MSC druggability from the perspective of integrating pharmacokinetics and efficacy. A better understanding of these challenges could improve MSC clinical efficacy and speed up the introduction of MSC therapy products to the market.

在过去的二十年中，间充质干细胞/基质细胞（MSC）疗法取得了长足的进步，从实验性临床应用过渡到商业产品。间充质干细胞疗法在治疗急性移植物抗宿主病、肌萎缩侧索硬化症和急性呼吸窘迫综合征等难治性和危重疾病方面具有广阔的前景。尽管最近在临床和商业应用中取得了成功，但间充质干细胞疗法在用作商业产品时仍然面临挑战。目前的检测方法存在局限性，导致间充质干细胞在患者体内的动态生物分布、在受损组织中的持久性以及最终命运尚不清楚。阐明间充质干细胞的药代动力学特征与其治疗效果之间的关系对于患者分层和制定精准治疗方案至关重要。此外，先进成像和跟踪技术的发展对于解决这些临床挑战至关重要。该综述对MSCs的动力学特性、关键调控分子、不同命运和检测方法进行了全面分析，并从药代动力学和疗效相结合的角度讨论了评价MSCs成药性的问题。更好地了解这些挑战可以提高 MSC 的临床疗效并加快 MSC 治疗产品推向市场的速度。