A Clinical Study of Decellularized Tissue Engineering Hyaline Cartilage Graft (dLhCG) for Articular Cartilage Repair

Current clinical approaches for knee cartilage repair are often limited by hypertrophy and fibrosis in the regenerated tissues. A decellularized tissue-engineered hyaline cartilage graft (dLhCG), composed of a type II collagen-based extracellular matrix, has been developed to overcome this limitation. Extensive preclinical studies have demonstrated the ability of dLhCG to achieve hyaline cartilage repair and maintain a stable hyaline phenotype. In this prospective, first-in-human, exploratory clinical study (ChiCTR2400094194, ChiCTR2500100526, and ChiCTR2500105847), dLhCG was implanted to treat full-thickness knee articular cartilage defects (Outerbridge grade III/IV) in 17 patients. Stable graft integration with the surrounding native tissue was observed up to 18 months postoperatively. Significant improvements were noted in clinical outcome scores and MOCART scores. MRI T2 mapping evaluated as the ratio of repair-tissue echo time to adjacent healthy cartilage, yielded values approaching 1, suggesting hyaline-like biochemical and structural characteristics. No serious clinical adverse events were reported; asymptomatic imaging abnormalities, including bone marrow edema, were noted in some cases. These findings provide preliminary evidence of the feasibility, short-term safety, and encouraging outcomes of dLhCG for hyaline-like cartilage repair, warranting further investigation in controlled clinical trials.