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Exosome-based therapeutics in bone regeneration: from fundamental biology to clinical translation

Fatemeh Tajafrooz,Sepehr Ghofrani,Fatemeh Sadeghghomi,Ali El Hadi Chamas,N. Rahimi,Arshia Mirakhor,Mohammad Hosseini Hooshiar,Amir Raee

Published 2025 in Stem cell research & therapeutics

ABSTRACT

Bone deficiencies are a major clinical issue for millions worldwide, with challenges to treatment because of donor site morbidity, immunological rejection, and limited integration. Exosomes are endogenously secreted extracellular vesicles and have potential as cell-free therapeutics. Exosomes derived from mesenchymal stromal cells (MSCs), bone marrow cells, and other cell-derived exosomes transmit bone morphogenetic proteins, growth factors, and immunoregulatory microRNAs to initiate osteogenic pathways. These exosomes stimulate and orchestrate vascularization and bone formation. Engineering strategies such as cargo optimization, surface functionalization, and cellular preconditioning further augment therapeutic promise. Clinical translation for exosome therapy has hurdles in manufacturing standardization and regulatory routes. Exosomes deliver osteogenic proteins (BMP-2, RUNX2), angiogenic factors (VEGF, FGF-2), and immunoregulatory molecules (miR-21, TGF-β) for comprehensive bone healing. Surface functionalization, genetic modification, and cargo optimization techniques enhance exosome targeting specificity and therapeutic efficacy. Hydrogel-ceramic composites, electrospun nanofibers, and 3D-printed scaffolds provide controlled exosome release and mechanical support for bone regeneration. Cell-free exosome therapy offers reduced immunogenicity and eliminates risks associated with cellular therapies, including tumor formation and vascular occlusion. Exosomes deliver osteogenic proteins (BMP-2, RUNX2), angiogenic factors (VEGF, FGF-2), and immunoregulatory molecules (miR-21, TGF-β) for comprehensive bone healing. Surface functionalization, genetic modification, and cargo optimization techniques enhance exosome targeting specificity and therapeutic efficacy. Hydrogel-ceramic composites, electrospun nanofibers, and 3D-printed scaffolds provide controlled exosome release and mechanical support for bone regeneration. Cell-free exosome therapy offers reduced immunogenicity and eliminates risks associated with cellular therapies, including tumor formation and vascular occlusion.

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