Organoids and organs-on-chips for accelerating R&D and clinical translation in Orthopaedics: Emerging opportunities and regulatory pathways

作者：Yiting Lei, Yuwei Zhang, Liangbin Zhou, Zhilong Zhou, Mario Rothbauer, Long Bai, Jiankun Xu, Denghui Xie, Ali Mobasheri, Xin Zhang, Dongquan Shi, Changhai Ding, Jiake Xu, Wei E. Huang, Shiqing Feng, Yang Liu, Yuxiao Lai, Guanghua Lei, Zhuojing Luo, Chenzhong Li, Jiacan Su, David J. Hunter, Chang Chen, Zhongze Gu, Ling Qin, Rocky S. Tuan, Zhong Li · 发表于：Journal of Orthopaedic Translation · 年份：2025 · DOI：10.1016/j.jot.2025.10.013 · 被引用次数：7 · 研究领域：3D Printing in Biomedical Research、Pluripotent Stem Cells Research、Biomedical Ethics and Regulation

models of orthopaedic conditions have yielded valuable insights into disease mechanisms and drug efficacy, only a few discoveries have been successfully translated to clinical practice. Organoids and organs-on-chips (OoCs) are transforming orthopaedic translation by providing 3D customizable models that aim to faithfully recapitulate musculoskeletal (MSK) (patho)physiology. Using joint-mimicking OoCs and skeletal muscle organoids as examples, we review the evolution of these systems that have been developed to model the pathogenesis, progression, prognosis, and treatment of orthopaedic conditions. We highlight how organoid and OoC models recapitulate multi-tissue crosstalk, drug responses, and disease heterogeneity. Furthermore, we summarize and discuss the global regulatory landscape for organoids and OoCs. Current global regulatory trends support the potential of these human-centric platforms as alternatives, or even future replacements for animal testing. Looking ahead, organoids and OoCs are gaining increasing attention in AI-guided drug development, patient stratification, and regenerative medicine evaluation. The ongoing rapid developments are expected to position organoids and OoCs at the forefront of precision orthopaedics. The translational potential of this article: This article accelerates the clinical translation of orthopaedic discoveries by demonstrating how OoCs and organoids can be positioned as regulatory-ready alternatives to animal studies. Using joint-on-a...