首页 / 院系成果 / 成果详情页

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

编号：

1F05A588FC22586EDE73387B4539311C
作者：

Lei, Yiting#^[1,2]Zhang, Yuwei^[1];Zhou, Liangbin^[1];Zhou, Zhilong^[1];Rothbauer, Mario^[3];Bai, Long^[4];Xu, Jiankun^[5,6];Xie, Denghui^[7];Mobasheri, Ali^[8,9,10,11];Zhang, Xin^[12];Shi, Dongquan^[13];Ding, Changhai^[14,15];Xu, Jiake^[16,17];Huang, Wei^[2];Feng, Shiqing(冯世庆)^[18]Yang, Liu^[19];Lai, Yuxiao^[17];Lei, Guanghua^[20];Luo, Zhuojing^[19];Li, Chenzhong^[21];Su, Jiacan^[4];Hunter, David J.^[22,23];Chen, Di^[16,17];Gu, Zhongze*^[24]Qin, Ling*^[5,6]Tuan, Rocky S.*^[1,25,26]Li, Zhong Alan*^[1,25,26,27]
语种：

英文
期刊：

JOURNAL OF ORTHOPAEDIC TRANSLATION ISSN：2214-031X 2026 年 56 卷 ; JAN
收录：
关键词：

Organoids Organs-on-Chips Musculoskeletal regeneration Regulatory pathways Precision medicine Orthopaedic translation
摘要：

While conventional in vitro and in vivo 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-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.
推荐引用方式
GB/T 7714：

Lei Yiting,Zhang Yuwei,Zhou Liangbin, et al. Organoids and organs-on-chips for accelerating R&D and clinical translation in Orthopaedics: Emerging opportunities and regulatory pathways [J].JOURNAL OF ORTHOPAEDIC TRANSLATION,2026,56.
APA：

Lei Yiting,Zhang Yuwei,Zhou Liangbin,Zhou Zhilong,&Li Zhong Alan.(2026).Organoids and organs-on-chips for accelerating R&D and clinical translation in Orthopaedics: Emerging opportunities and regulatory pathways .JOURNAL OF ORTHOPAEDIC TRANSLATION,56.
MLA：

Lei Yiting, et al. "Organoids and organs-on-chips for accelerating R&D and clinical translation in Orthopaedics: Emerging opportunities and regulatory pathways" .JOURNAL OF ORTHOPAEDIC TRANSLATION 56(2026).
入库时间：

4/1/2026 10:03:25 PM
更新时间：

4/1/2026 10:03:25 PM

浏览次数：13  下载次数：0

分享到：

浏览次数：13

下载次数：0

打印次数：0