Organoids and organs-on-chips for accelerating R&D and clinical translation in Orthopaedics: Emerging opportunities and regulatory pathways - PubMed
3 hours ago
- #Orthopaedics
- #Organoids
- #Organs-on-Chips
- Organoids and organs-on-chips (OoCs) are emerging as innovative tools for accelerating R&D and clinical translation in orthopaedics.
- These 3D customizable models aim to replicate musculoskeletal (MSK) physiology and pathology more accurately than conventional models.
- Examples include joint-mimicking OoCs and skeletal muscle organoids, which model disease pathogenesis, progression, and treatment responses.
- These platforms can recapitulate multi-tissue crosstalk, drug responses, and disease heterogeneity, enhancing their translational potential.
- Global regulatory agencies (FDA, EMA, NMPA, PMDA) are increasingly supporting these human-centric models as alternatives to animal testing.
- Organoids and OoCs are gaining traction in AI-guided drug development, patient stratification, and regenerative medicine evaluation.
- The article provides a clear regulatory pathway for adopting these technologies within the 3Rs (Replacement, Reduction, Refinement) framework.