title: Is autologous chondrocyte implantation (ACI) an adequate treatment option for repair of cartilage defects in paediatric patients?
abstract: Cartilage lesions in the knee of juvenile patients require an effective repair to regain life-long functional activity of the joint. Autologous chondrocyte implantation (ACI) is discussed to be advantageous over other methods for cartilage repair regarding long-term outcome. ACI has successfully been applied in juvenile patients, although currently recommended for patients ≥18 years of age. Only few controlled clinical trials present evidence of efficacy and safety of ACI in adolescent patients. ACI products have to undergo the process of a marketing authorisation application, including the submission of a paediatric investigation plan (PIP). Data from prospective clinical studies or retrospective collection of long-term data in paediatric patients should be submitted for risk-benefit evaluation by the Paediatric Committee (PDCO).
authors.affiliation: Head Preclinical & Medical Affairs, PharmaLex GmbH, Joseph-Meyer-Straße 13-15, 68167 Mannheim, Germany. marietta.kaszkin-bettag@pharmalex.com
authors.forename: Marietta
authors.initials: M
authors.lastname: Kaszkin-Bettag
mesh_terms: D002357:Cartilage Diseases / Q000175:diagnosis / Q000601:surgery*; D002358:Cartilage, Articular / Q000002:abnormalities* / Q000473:pathology / Q000601:surgery*; D002648:Child; D019902:Chondrocytes / Q000637:transplantation*; D006801:Humans; D014182:Transplantation, Autologous; D016896:Treatment Outcome