Glycotherapeutics Group, Institute of Medical Biology, Agency for Science, Technology and Research (A*STAR), Singapore.
Department of Biomedical Engineering, National University of Singapore, Singapore.
Stem Cells Transl Med. 2017 Dec;6(12):2173-2185. doi: 10.1002/sctm.17-0129. Epub 2017 Oct 26.
Mesenchymal stem cells (MSC) hold great potential for regenerative medicine because of their ability for self-renewal and differentiation into tissue-specific cells such as osteoblasts, chondrocytes, and adipocytes. MSCs orchestrate tissue development, maintenance and repair, and are useful for musculoskeletal regenerative therapies to treat age-related orthopedic degenerative diseases and other clinical conditions. Importantly, MSCs produce secretory factors that play critical roles in tissue repair that support both engraftment and trophic functions (autocrine and paracrine). The development of uniform protocols for both preparation and characterization of MSCs, including standardized functional assays for evaluation of their biological potential, are critical factors contributing to their clinical utility. Quality control and release criteria for MSCs should include cell surface markers, differentiation potential, and other essential cell parameters. For example, cell surface marker profiles (surfactome), bone-forming capacities in ectopic and orthotopic models, as well as cell size and granularity, telomere length, senescence status, trophic factor secretion (secretome), and immunomodulation, should be thoroughly assessed to predict MSC utility for regenerative medicine. We propose that these and other functionalities of MSCs should be characterized prior to use in clinical applications as part of comprehensive and uniform guidelines and release criteria for their clinical-grade production to achieve predictably favorable treatment outcomes for stem cell therapy. Stem Cells Translational Medicine 2017;6:2173-2185.
间充质干细胞 (MSC) 因其自我更新和分化为组织特异性细胞（如成骨细胞、软骨细胞和脂肪细胞）的能力，在再生医学中具有巨大的潜力。MSC 协调组织发育、维持和修复，可用于肌肉骨骼再生疗法，以治疗与年龄相关的骨科退行性疾病和其他临床病症。重要的是，MSC 产生的分泌因子在支持植入和营养功能（自分泌和旁分泌）的组织修复中发挥关键作用。用于 MSC 的制备和表征的统一方案的开发，包括评估其生物学潜力的标准化功能测定，是其临床应用的关键因素。MSC 的质量控制和放行标准应包括细胞表面标志物、分化潜能和其他重要的细胞参数。例如，细胞表面标志物谱（表面组）、异位和原位模型中的成骨能力，以及细胞大小和粒度、端粒长度、衰老状态、营养因子分泌（分泌组）和免疫调节，应进行彻底评估，以预测 MSC 在再生医学中的应用。我们建议，在将 MSC 用于临床应用之前，应根据其全面和统一的指南以及其临床级生产的放行标准对其进行特性描述，以实现干细胞治疗可预测的有利治疗结果。《干细胞转化医学》2017 年；6:2173-2185。
