Organoids and organs-on-chips for accelerating R&D and clinical translation in Orthopaedics: Emerging opportunities and regulatory pathways
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-chip systems and skeletal muscle organoid as examples, we review the technological development of these platforms. By connecting recent policy shifts from key global regulators, including the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), China National Medical Products Administration (NMPA), and Pharmaceuticals and Medical Devices Agency (PMDA), to practical model qualification steps, we provide clinicians, industry, and regulators with a clear pathway to adopt OoCs and organoids. This process will facilitate their use as human-centric systems for patient stratification, implant safety evaluation, and disease-modifying drug development within the 3Rs (Replacement, Reduction, and Refinement) framework.
Authors
- Wei E. Huang (ORCID: https://orcid.org/0000-0003-1302-6528)
- Mario Rothbauer (ORCID: https://orcid.org/0000-0002-9928-3631)
- Ali Mobasheri (ORCID: https://orcid.org/0000-0001-6261-1286)
- Changhai Ding (ORCID: https://orcid.org/0000-0002-9479-730X)
- Denghui Xie (ORCID: https://orcid.org/0000-0001-5414-3152)
- Liangbin Zhou (ORCID: https://orcid.org/0000-0003-4153-4984)
- Yiting Lei (ORCID: https://orcid.org/0000-0001-5359-4103)
- Dongquan Shi (ORCID: https://orcid.org/0000-0002-4769-7816)
- Rocky S. Tuan (ORCID: https://orcid.org/0000-0001-6067-6705)
- Jiake Xu (ORCID: https://orcid.org/0000-0003-2021-8309)
- David John Hunter (ORCID: https://orcid.org/0000-0003-3197-752X)
- Shiqing Feng (ORCID: https://orcid.org/0000-0001-9437-7674)
- Zhongze Gu
- Yuxiao Lai (ORCID: https://orcid.org/0000-0002-8648-6595)
- Long Bai (ORCID: https://orcid.org/0000-0002-5807-7997)
- Zhuojing Luo (ORCID: https://orcid.org/0000-0002-0671-8553)
- Yuwei Zhang (ORCID: https://orcid.org/0000-0001-5992-4644)
- Xin Zhang (ORCID: https://orcid.org/0000-0002-8777-0168)
- Yang Liu (ORCID: https://orcid.org/0000-0002-6388-9674)
- Zhong Alan Li (ORCID: https://orcid.org/0000-0002-6009-629X)
- Chang Chen (ORCID: https://orcid.org/0000-0003-1674-973X)
- Zhilong Zhou (ORCID: https://orcid.org/0009-0004-7434-1606)
- Ling Qin
- Jiankun Xu
- Chenzhong Li (ORCID: https://orcid.org/0000-0002-0486-4530)
- Jiacan Su (ORCID: https://orcid.org/0000-0001-7080-263X)
- Gang Lei (ORCID: https://orcid.org/0000-0002-7872-4784)
Institutions
- Shanghai University (CN)
- Central South University (CN)
- Shandong University (CN)
- University of Liège (BE)
- Sun Yat-sen University (CN)
- Chinese University of Hong Kong (HK)
- Chinese Academy of Sciences (CN)
- Peking University (CN)
- Royal North Shore Hospital (AU)
- Hong Kong Science and Technology Parks Corporation (HK)
- Third Affiliated Hospital of Southern Medical University (CN)
- State Research Institute Centre for Innovative Medicine (LT)
- Nanjing Drum Tower Hospital (CN)
- Institute for Musculoskeletal Health (AU)
- Chinese University of Hong Kong, Shenzhen (CN)
- Zhujiang Hospital (CN)
- The First Affiliated Hospital, Sun Yat-sen University (CN)
- The Affiliated Yongchuan Hospital of Chongqing Medical University (CN)
- Peking University Third Hospital (CN)
- Shenzhen Institutes of Advanced Technology (CN)
- Beijing Tsinghua Chang Gung Hospital (CN)
- Xijing Hospital (CN)
- Xiangya Hospital Central South University (CN)
- Qilu Hospital of Shandong University (CN)
- State Key Laboratory of Digital Medical Engineering (CN)
- Medical University of Vienna (AT)
- Southeast University (CN)
- Chongqing Medical University (CN)
- University of Oulu (FI)
- Air Force Medical University (CN)
Publication Details
- Journal
- Journal of Orthopaedic Translation
- Published
- 2025-12-01
- DOI
- https://doi.org/10.1016/j.jot.2025.10.013
- Citations
- 1
- Primary Topic
- 3D Printing in Biomedical Research
- Type
- article
- Field-Weighted Citation Impact
- 0.67