Recent trends in modified mesenchymal stromal cells: engineering approaches and international regulatory landscape

Mesenchymal stromal cells (MSCs) have demonstrated significant potential for various clinical applications; however, several challenges limit their therapeutic efficacy. These include donor variability, poor homing and survival after transplantation, reduced proliferative and differentiation potential during in vitro expansion, and the inflammatory microenvironment at the injury site. This review summarizes current strategies used to enhance the therapeutic potential of MSCs and discusses approaches to overcome these limitations. It also highlights key challenges and gaps in the existing literature that require further investigation. In addition, this structured review provides an overview of current research trends involving different MSC sources, disease models, preconditioning strategies, emerging gene modification approaches, and other methods to improve MSC function. Finally, regulatory considerations and the roles of global and regional regulatory authorities in ensuring the safety and quality of modified MSC-based therapies are briefly discussed.