Abstract
Introduction
Autologous chondrocyte implantation presents a viable alternative to microfracture in the repair of damaged articular cartilage of the knee; however, outcomes for patellar lesions have been less encouraging. ChondroCelect (CC) is an innovative, advanced cell therapy product consisting of autologous cartilage cells expanded ex vivo through a highly controlled and consistent manufacturing process.
Purpose
To assess the effect of CC in the treatment of patellofemoral lesions, for which standard treatment options had failed and/or no other treatment options were considered feasible.
Methods
CC was administered to 61 patients with patellar lesions (predominantly secured with a biological membrane; mean lesion size: 3.6 cm2; aged 32.4 years). Efficacy was assessed with validated scales of Clinical Global Impression for Improvement (CGI-I) and Therapeutic Effect (CGI-E) and stratified by the postoperative follow-up period (<18 months vs >18 months).
Results
CC resulted in therapeutic and clinical improvement in 87% of patients. Long-term follow-up showed a modest shift towards worse CGI-I and CGI-E scores, with the ‘very much improved’ subgroup (CGI-I) during the first 18 months (38.5%) moderately reduced after 18 months (25.0%); however, the proportion of improved patients remained consistent. The most commonly reported adverse events (knee pain [23%], joint crepitation [13.1%], joint range of motion decreased [13.1%], arthrofibrosis [8.2%] and tendon disorder [8.2%]) were reported at incidences higher than those associated with femoral condyle and trochlea lesions. There were no reports of cartilage hypertrophy.
Conclusion
CC was effective in the treatment of patellofemoral lesions, with results comparable to outcomes for femoral condyle and trochlear lesions. The higher incidence of some adverse events suggests that the risk-benefit balance of CC varies with lesion location. However, there were no major safety concerns and the safety profile of CC was greatly enhanced by absence of cartilage hypertrophy, demonstrating that collagen membranes can eliminate periosteum-associated events.
