Copyright: ©Author(s) 2026.
World J Stem Cells. Jul 26, 2026; 18(7): 120363
Published online Jul 26, 2026. doi: 10.4252/wjsc.120363
Published online Jul 26, 2026. doi: 10.4252/wjsc.120363
Table 4 Translational bottlenecks and mitigation approaches
| Translational challenge | Impact on clinical translation | Proposed mitigation strategy | Ref. |
| Batch heterogeneity | Variable efficacy | Standardized MSC banking | [180] |
| Donor variability | Product heterogeneity | Defined donor selection criteria | [21] |
| Low scalability | Limited clinical production | Bioreactor + TFF systems-based manufacture | [181] |
| Stability issues | Cold-chain dependence | Lyophilization with trehalose | [182] |
| Regulatory ambiguity | Delayed approval | Early regulator | [183] |
| Potency assay standardization | Difficulty assessing therapeutic activities | Functional bioassay validation | [180] |
| Comparability after process change | Regulatory approval risk | Analytical comparability testing | [177] |
| Storage stability limitations | Reduced shelf-life | Cryopreservation optimization | [182] |
| Cost effectiveness | Manufacturing feasibility concerns | Process automation | [181] |
- Citation: Khan SA, Jha SK, Tiwari P, Narang J, Gupta V, Singh SK, Anand K, Rajendran RL, Gangadaran P, Parvez S. Mesenchymal stem cell-derived extracellular vesicles as next generation drug delivery platforms. World J Stem Cells 2026; 18(7): 120363
- URL: https://www.wjgnet.com/1948-0210/full/v18/i7/120363.htm
- DOI: https://dx.doi.org/10.4252/wjsc.120363