Mesenchymal stem cell-derived exosomes and the Wnt/β-catenin pathway: Unifying mechanisms of multi-organ regeneration and the path to precision clinical translation

Table 1 Economic considerations for mesenchymal stem cell-derived exosome therapies

Cost driver	Description	Potential strategies for cost reduction	Implications for public/private health systems
Production and isolation	High cost and complexity in isolating exosomes using techniques such as ultracentrifugation and microfluidics[29,30]	Scale-up manufacturing, automation, and integration of combined methods (e.g., TFF + SEC)[38]	Reduced production costs could enable large-scale manufacturing, improving affordability and access[36]
Quality control and standardization	Ensuring batch-to-batch consistency and meeting strict regulatory criteria increases costs[42]	Development and adoption of standardized protocols and international guidelines (e.g., ISEV-MISEV)[42]	Enhanced safety and reproducibility may facilitate better insurance coverage and reimbursement prospects[36]
Storage and distribution	Maintaining exosome stability and integrity during storage and transport adds to the cost[35]	Optimization of lyophilization and encapsulation techniques to improve shelf-life[35]	Improved logistics and reduced overall treatment costs enhance the feasibility of widespread clinical use[36]
Regulatory compliance and safety	Extensive preclinical and clinical testing, along with the regulatory approval process, drive up expenses[36]	Streamlined regulatory pathways and early-phase collaborative trials to reduce development timelines[36]	Faster market entry could encourage both public and private investments, boosting therapeutic adoption[36]
Delivery methods and dosing optimization	Complexities in ensuring targeted delivery and optimal dosing further add to the cost challenges[40,41]	Advanced engineering for targeted delivery (e.g., surface modifications and sustained-release systems)[40,41]	Improved therapeutic efficacy may justify initial investments and support diverse funding models[36]

TFF: Tangential flow filtration; SEC: Size exclusion chromatography; ISEV: International Society for Extracellular Vesicles; MISEV: Minimal Information for Studies of Extracellular Vesicles.