Safety evaluation of repeated intra-articular injections of human adipose-derived mesenchymal stem cells in cynomolgus monkeys

were observed throughout the study. Aside from minor individual parameter fluctuations, no significant toxicological effects were observed in terms of general toxicity indicators, hematological profiles, biochemical analyses, urinalysis, immunological parameters, and macroscopic organ assessments. Both low- and high-dose haMSC groups exhibited mild to moderate inflammatory cell infiltration in the synovium. Biodistribution analysis revealed that haMSC gene copies were detectable exclusively at the injection site and were undetectable by 16 weeks post-final administration. This study affirms the safety profile of high-dose haMSCs following multiple intra-articular injections in non-human primates, offering robust safety data to bolster the clinical application of stem cell therapies in regenerative medicine.