Quality Control of Mesenchymal Stem Cells for Cell Therapies in Advanced Regenerative Medicine

Mesenchymal stem cells have emerged as a practical source for autologous and allogeneic stem cell transplantation in regenerative medicine. Nevertheless, lot-release quality control must confirm the immunophenotype CD73+CD90+CD105+/CD45-CD34-, sterility, absence of mycoplasma and endotoxin, cell viability ≥80%, and potency through mixed-lymphocyte reaction and multiplex cytokine panels including vascular endothelial growth factor, hepatocyte growth factor, and interleukin-10. This review integrates analytical clinical laboratory techniques–flow cytometry, bacterial endotoxin testing, and nanoparticle-tracking analysis–and outlines the statistical acceptance criteria used in ISO 15189-accredited laboratories, such as Levey-Jennings charts and Westgard rules. This paper summarizes the cryogenic stability indicators essential for -196℃ transport: residual dimethyl sulfoxide, pH drift, and total particle count. For post-transplant monitoring, a safety panel, including complete blood count, C-reactive protein, interleukin-6, tumor necrosis factor-α, and D-dimer, is proposed at 0 hour, 24 hours, day 7, and day 28. Indication-specific efficacy biomarkers, such as C-telopeptide of type II collagen and cartilage oligomeric matrix protein for osteoarthritis, or procollagen I C-peptide for cutaneous repair, are recommended. The Korean Ministry of Food and Drug Safety guidelines were compared with the FDA and EMA standards. The integration of electronic batch records and AI-powered dashboards for real-time pharmacovigilance is discussed to support safe clinical adoption.