Abstract
BACKGROUND: Diabetes mellitus (DM) is a global health concern, characterized by insulin resistance and β-cell dysfunction. Traditional treatments often fail to address underlying mechanisms, necessitating alternative therapies. Mesenchymal stem cell (MSC)-based therapies have shown promise due to their regenerative and immunomodulatory properties. However, evidence on their efficacy and safety in type 2 DM remains limited and further evaluation is needed. AIM: To evaluate the safety, efficacy and therapeutic potential of MSC-based therapies in type 2 DM. METHODS: This systematic review analyzed studies published between 2000 and 2025, focusing on autologous and allogeneic MSC therapies in DM. Studies were identified from various databases, including clinical and preclinical trials. Outcomes related to glycemic control, insulin requirements, β-cell function, and safety were assessed. RESULTS: MSC-based therapies significantly improved glycemic control, reduced insulin requirements and enhanced β-cell function in both clinical and preclinical settings. Safety profiles were favorable, with minimal adverse effects observed, primarily transient and self-limiting. No fatal events were reported. Variability in treatment outcomes and the need for standardized protocols were challenges. CONCLUSION: MSC-based therapies offer a promising alternative to conventional DM treatments, significantly improving glycemic control and safety. Further research is needed to refine protocols and confirm long-term efficacy.