Related Experiment Video
Updated: Sep 5, 2025
Isolation, Characterization, and Therapeutic Application of Extracellular Vesicles from Cultured Human Mesenchymal Stem Cells
Published on: September 23, 2022
Mesenchymal Stem Cell-Derived Extracellular Vesicles: Progress and Remaining Hurdles in Developing Regulatory
Jessie Kit Ern Chua1, Jiaxi Lim1, Le Hui Foong1
1Cryocord, 1, Bio X Centre, Persiaran Cyber Point Selatan, Cyberjaya, Cyberjaya, Selangor, Malaysia.
Abstract:
Regenerative medicine is shaping into a new paradigm and could be the future medicine driven by the therapeutic capabilities shown by mesenchymal stem cell-derived extracellular vesicles (MSC-EVs). Despite the advantages and promises, the therapeutic effectiveness of MSC-EVs in some clinical applications is restricted due to inconsistent manufacturing process and the lack of stringent quality control (QC) measurement. In particular, QC assays which are crucial to confirm the safety, efficacy, and quality of MSC-EVs available for end use are poorly designed. Hence, in this review, characterization of MSC-EVs and quality control guidelines for biologics are presented, with special attention given to the description of technical know-how in developing QC assays for MSC-EVs adhering to regulatory guidelines. The remaining challenges surrounding the development of potency and stability of QC assays are also addressed.
