Fuloria Shivkanya, Subramaniyan Vetriselvan, Dahiya Rajiv, Dahiya Sunita, Sudhakar Kalvatala, Kumari Usha, Sathasivam Kathiresan, Meenakshi Dhanalekshmi Unnikrishnan, Wu Yuan Seng, Sekar Mahendran, Malviya Rishabha, Singh Amit, Fuloria Neeraj Kumar
Faculty of Pharmacy, AIMST University, Kedah 08100, Malaysia.
Faculty of Medicine, Bioscience and Nursing, MAHSA University, Kuala Lumpur 42610, Malaysia.
Biology (Basel). 2021 Feb 25;10(3):172. doi: 10.3390/biology10030172.
Evidence suggests that stem cells exert regenerative potential via the release of extracellular vesicles. Mesenchymal stem cell extracellular vesicles (MSCEVs) offer therapeutic benefits for various pathophysiological ailments by restoring tissues. Facts suggest that MSCEV action can be potentiated by modifying the mesenchymal stem cells culturing methodology and bioengineering EVs. Limited clinical trials of MSCEVs have questioned their superiority, culturing quality, production scale-up and isolation, and administration format. Translation of preclinically successful MSCEVs into a clinical platform requires paying attention to several critical matters, such as the production technique, quantification/characterization, pharmacokinetics/targeting/transfer to the target site, and the safety profile. Keeping these issues as a priority, the present review was designed to highlight the challenges in translating preclinical MSCEV research into clinical platforms and provide evidence for the regenerative potential of MSCEVs in various conditions of the liver, kidney, heart, nervous system, bone, muscle, cartilage, and other organs/tissues.
有证据表明，干细胞通过释放细胞外囊泡发挥再生潜能。间充质干细胞外囊泡（MSCEV）通过修复组织为各种病理生理疾病带来治疗益处。事实表明，通过改变间充质干细胞培养方法和对细胞外囊泡进行生物工程改造，可以增强MSCEV的作用。MSCEV的有限临床试验对其优越性、培养质量、生产扩大规模及分离以及给药方式提出了质疑。将临床前成功的MSCEV转化为临床平台需要关注几个关键问题，如生产技术、定量/表征、药代动力学/靶向/向靶位点的转移以及安全性概况。鉴于这些问题的重要性，本综述旨在强调将临床前MSCEV研究转化为临床平台所面临的挑战，并为MSCEV在肝脏、肾脏、心脏、神经系统、骨骼、肌肉、软骨及其他器官/组织的各种情况下的再生潜能提供证据。
