Ts — Safety
Safety remains a fundamental component in the development of advanced regenerative therapies. Current evidence indicates that MSC-based products administered locally are generally well tolerated, with adverse events typically limited to mild and transient local inflammatory reactions. Comprehensive donor screening, controlled cell expansion, genomic stability assessment, sterility testing, and rigorous quality assurance procedures are essential to maintaining product consistency and minimizing biological risk. Special attention is also given to immunogenicity, biodistribution, and long-term biological behavior of regenerative products. References: EMA/CAT Reflection Paper, 2018; Cabon et al., 2019; Thompson et al., 2020.