Isolation, Biological Characterization, and Quality Inspection of Human Umbilical Cord-derived Mesenchymal Stem Cells for Clinical Research

Background: Human umbilical cord mesenchymal stem cells (hUCMSCs) represent a valuable and versatile cell type derived from the umbilical cord tissue of newborns. These cells exhibit diverse characteristics, including multipotent differentiation potential and low immunogenicity. hUCMSCs hold promise for clinical applications, yet concerns persist regarding their chromosomal stability. This study employs short tandem repeat (STR) analysis to assess genomic integrity. By focusing on chromosomal stability, the study aims to enhance confidence in the clinical viability of hUCMSCs, contributing to their safe and effective use in regenerative medicine. hUCMSCs were extracted from healthy newborn umbilical cords using tissue block adherence and enzyme digestion. The third generation of hUCMSCs undergoes biological characterization and quality checks, including examinations of cell morphology, viability, growth curves, surface markers, cell cycle, and multi-lineage differentiation potential. The result of the present study shows that hUCMSCs exhibit mesenchymal stem cell characteristics, with robust growth and high viability. Positive surface markers are expressed at rates exceeding 95%, while negative markers are ≤2%. Cell karyotyping analysis, STR spectrum identification, and chromosomal microarray analysis confirm genetic stability. Microbial testing shows the absence of contaminants, and immunological studies demonstrate the immunomodulatory capabilities of hUCMSCs. Specific residues, such as trypsin, were not detected. In conclusion, hUCMSCs produced under strict GLP and GMP conditions meet the quality guidelines for clinical application in various stem cell therapies. The findings support the clinical application of hUCMSCs in various medical contexts.