Table 4 Key safety risks and mitigation strategies in MSC-AR therapy
Risk | Evidence | Mitigation Strategy |
|---|---|---|
Tumorigenicity | No tumors in 12-month AR models | Limit passages (≤ 5), genomic stability assays |
Immune Rejection | 5–10% anti-HLA antibody incidence | Autologous/HLA-matched MSCs, exosome-based therapy |
Nasal Irritation | 15% transient inflammation (Phase I) | Hydrogel encapsulation, mucoadhesive formulations |
Systemic Biodistribution | MSCs detected in liver/lungs | Dose optimization, imaging-guided delivery |