ArticleLife (Basel, Switzerland)2026
Predicting ACI Outcomes with GMP In-Process Control Kinetic Metrics: Initial Chondrocyte Yield and Population Doubling Time as Prognostic Clinical Biomarkers.
Article in Life (Basel, Switzerland), 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
purposeTo determine whether specific in vitro biologic characteristics and manufacturing kinetics of cultured human articular chondrocytes (HACs) can serve as predictive biomarkers for patient-reported and structural outcomes following second-generation autologous chondrocyte implantation (ACI) in the knee. MATERIALS AND
methodsThis prospective cohort study evaluated 67 patients (mean age 25.1 ± 8.3 years) treated with second-generation ACI for large focal cartilage defects (mean size 5.4 ± 2.5 cm
resultsStatic biosynthetic markers (
conclusionsThe intrinsic proliferative vigor of the HAC cellular payload (shorter PDT) and higher initial cell yields are robust kinetic biomarkers associated with markedly superior mid-term clinical outcomes following second-generation ACI for large focal chondral defects in the knee. In contrast, standard morphological and gene expression metrics failed to predict in vivo functional success. These findings advocate for a risk-based paradigm shift in GMP quality control methodologies, emphasizing dynamic HAC growth kinetics over static cellular features to optimize patient-specific regenerative potential.
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