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

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. [Display omitted] •Tissue engineered cartilage, a promising strategy for articular cartilage repair.•Nearly 20 engineered cartilage repair products in clinic based on clinical techniques.•Combination product, the classification of tissue-engineered cartilage.•Key regulatory compliance issues for combination products.