title: One-Year Clinical and Radiological Results of a Prospective, Investigator-Initiated Trial Examining a Novel, Purely Autologous 3-Dimensional Autologous Chondrocyte Transplantation Product in the Knee.
abstract: BACKGROUND
  The 3-dimensional autologous chondrocyte transplantation (ACT3D) comprises isolation of chondrocytes from cartilage biopsies, cultivation to spheroids, and transplantation into the cartilage defect.
  
  
  OBJECTIVE
  To evaluate the patients' general health and functionality and to assess the defect repair after ACT3D with spheroids by MRI and MOCART scoring.
  
  
  METHODS
  Thirty-seven patients with isolated chondral lesions of the knee underwent ACT3D with spheroids through medial arthrotomy. Patient-administered scores were assessed at baseline (day before transplantation), at 6 weeks, and at 3, 6, and 12 months. MRI and MOCART scoring were performed at 3 and 12 months after ACT3D.
  
  
  RESULTS
  Patients were diagnosed with full-thickness patellofemoral (n = 16), femoral condylar (n = 18), or both defect types (n = 3), International Cartilage Repair Society (ICRS) grade 3 or 4, with defect sizes between 1.0 and 12.0 cm(2). On average, 59.5 spheroids/cm(2) in defect size were transplanted. An overall statistically significant improvement from baseline to 12 months was observed for all assessment scores (Lysholm, International Knee Documentation Committee [IKDC], SF-36, Tegner) combined with a significant reduction in the visual analog scale (VAS) for pain and an advanced defect filling. Subgroup analyses revealed a positive clinical outcome independent on defect size, defect locations, spheroid dosage, age, duration of symptoms, and severity of complaints at baseline. Seven patients experienced in total 8 adverse events, of which knee joint effusion and blocking were assessed as possibly or probably related to ACT3D.
  
  
  CONCLUSIONS
  The patient-administered assessment scores along with the fast defect filling with ACT3D using spheroids demonstrated an increase in activity level and quality of life after a 1-year follow-up.
authors.affiliation: Orthopaedic and Trauma Surgery Center, University Medical Center Mannheim, University of Heidelberg, Mannheim, Germany.
authors.forename: Stefan
authors.initials: S
authors.lastname: Fickert
authors.affiliation: Orthopaedic and Trauma Surgery Center, University Medical Center Mannheim, University of Heidelberg, Mannheim, Germany.
authors.forename: Philip
authors.initials: P
authors.lastname: Gerwien
authors.affiliation: Orthopaedic and Trauma Surgery Center, University Medical Center Mannheim, University of Heidelberg, Mannheim, Germany.
authors.forename: Benjamin
authors.initials: B
authors.lastname: Helmert
authors.affiliation: Orthopaedic and Trauma Surgery Center, University Medical Center Mannheim, University of Heidelberg, Mannheim, Germany.
authors.forename: Torsten
authors.initials: T
authors.lastname: Schattenberg
authors.affiliation: Department of Clinical Radiology, University Hospital Munich-Grosshadern Campus, Munich, Germany.
authors.forename: Sabine
authors.initials: S
authors.lastname: Weckbach
authors.affiliation: PharmaLex GmbH, Mannheim, Germany.
authors.forename: Marietta
authors.initials: M
authors.lastname: Kaszkin-Bettag
authors.affiliation: Orthopaedic and Trauma Surgery Center, University Medical Center Mannheim, University of Heidelberg, Mannheim, Germany.
authors.forename: Lars
authors.initials: L
authors.lastname: Lehmann
keywords: ACT; ACT3D; IKDC; Lysholm; SF-36; Tegner; VAS; autologous chondrocytes; cartilage defect; spheroids