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组织工程软骨作为治疗性组合产品的技术与监管挑战的进展与展望

Progress and prospect of technical and regulatory challenges on tissue-engineered cartilage as therapeutic combination product.

作者信息

Guo Xiaolei, Ma Yuan, Min Yue, Sun Jiayi, Shi Xinli, Gao Guobiao, Sun Lei, Wang Jiadao

机构信息

Center for Medical Device Evaluation, National Medical Products Administration, Beijing, PR China.

State Key Laboratory of Tribology, Tsinghua University, Beijing, PR China.

出版信息

Bioact Mater. 2022 Jun 27;20:501-518. doi: 10.1016/j.bioactmat.2022.06.015. eCollection 2023 Feb.

Abstract

Hyaline cartilage plays a critical role in maintaining joint function and pain. However, the lack of blood supply, nerves, and lymphatic vessels greatly limited the self-repair and regeneration of damaged cartilage, giving rise to various tricky issues in medicine. In the past 30 years, numerous treatment techniques and commercial products have been developed and practiced in the clinic for promoting defected cartilage repair and regeneration. Here, the current therapies and their relevant advantages and disadvantages will be summarized, particularly the tissue engineering strategies. Furthermore, the fabrication of tissue-engineered cartilage under research or in the clinic was discussed based on the traid of tissue engineering, that is the materials, seed cells, and bioactive factors. Finally, the commercialized cartilage repair products were listed and the regulatory issues and challenges of tissue-engineered cartilage repair products and clinical application would be reviewed.

摘要

透明软骨在维持关节功能和缓解疼痛方面起着关键作用。然而,缺乏血液供应、神经和淋巴管极大地限制了受损软骨的自我修复和再生,引发了医学上的各种棘手问题。在过去30年里,临床上已经开发并实践了许多治疗技术和商业产品,以促进缺损软骨的修复和再生。在此,将总结当前的治疗方法及其相关优缺点,特别是组织工程策略。此外,还基于组织工程的三要素,即材料、种子细胞和生物活性因子,讨论了正在研究或临床应用中的组织工程软骨的制造。最后,列出了商业化的软骨修复产品,并将对组织工程软骨修复产品的监管问题、挑战及临床应用进行综述。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8cce/9253051/05571e22d2bb/ga1.jpg

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