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©Author(s) (or their employer(s)) 2026.
World J Stem Cells. Feb 26, 2026; 18(2): 116184
Published online Feb 26, 2026. doi: 10.4252/wjsc.v18.i2.116184
Table 3 Translational barriers in clinical development of mesenchymal stem cell-derived extracellular vesicle therapies for pain
Challenges
Concerns
Study designLack of placebo/sham controls; open label designs dominate
Limited inference of true clinical effect
Follow up duration< 6 months endpoints
Short for chronic pain assessment
Dosing and potencyNo standardized unit of potency
Prevents cross-trial comparison
ManufacturingHeterogeneity in EV isolation protocols, and hence, unpredictable therapeutic consistency
Inconsistent EV product quality
Inconsistent therapeutic predictability
RegulatoryUnclear categorization (biologic vs cell-derived drug vs advanced therapy)
Unclear oversight requirements


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