ENCANTO is a randomized, controlled, multi-center phase II clinical trial for the treatment of patellofemoral osteoarthritis (PFOA) with an Advanced Therapy Medicinal Product (ATMP), nasal chondrocyte-based tissue engineered cartilage (N-TEC) implantation in comparison with current standard of care depending on the stage of osteoarthritis. The goal of this phase II trial is to evaluate the efficacy of N-TEC treatment in comparison to an active comparator Autologous Matrix Induced Chondrogenesis (AMIC) for early stage PFOA or patellofemoral arthroplasty (PFA) for late stage PFOA.
The N-TEC engineered cartilage graft is obtained by culturing expanded autologous nasal chondrocytes within a collagen type I/III membrane.
Patient age is ≥18 and ≤ 70 years at time of screening.
Symptomatic PFOA grade 1-4 according to Iwano Classification
Chondropathy Grade 3-4 according to ICRS classification of the patella, trochlea femoris or both
Baseline score of <75 on the KOOS-5 subjective knee evaluation.
Patient is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol or in a dependency or employment with the sponsor.
Patient is unwilling, unable or lacking the capacity to provide informed consent
Patient is unable to undergo magnetic resonance imaging (MRI)
Prior surgical treatment of the target knee within 12 months (Note: prior diagnostic arthroscopy with debridement and lavage are acceptable within 12 months).
Parallel
Engineered cartilage graft (N-TEC)
Biological/VaccineNasal chondrocytes based tissue engineered cartilage
Autologous Matrix Induced Chondrogenesis (AMIC)
Procedure/SurgeryAutologous Matrix Induced Chondrogenesis is performed through bone drilling and covering with Chondro-Gide® to attract bone marrow stem cells
Patellofemoral Arthroplasty (PFA)
Procedure/SurgerySurgical implantation of a medical device, Zimmer Gender Solutions Patellofemoral Joint Prosthesis.
Knee Injury and Osteoarthritis Outcome Score (KOOS)-5
Difference in 2-year change (baseline to 24 month follow-up) in the KOOS -5 score between patients undergoing N-TEC tissue implantation and patients receiving AMIC or PFA. Minimum score: 0 Maximum score: 100 (higher score means no knee problems)
Knee Injury and Osteoarthritis Outcome questionnaire
patient self reported questionnaire for pain
Knee Injury and Osteoarthritis Outcome questionnaire
patient self reported questionnaire for symptoms, activity of daily life, sports and quality of life Minimum score: 0 Maximum score: 100 (higher score means no knee problems)
Kujala questionnaire
patient self reported questionnaire for Anterior Knee Pain scale. Minimum score: 0 Maximum score: 100 (no knee problems)
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score
Self reported questionnaire to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. The instrument contains 24 items measuring 3 sub-scales: physical function (17 items), pain (5 items), and stiffness (2 items). Minimum score: 0 (no knee problems) Maximum score: 96 (worst knee problems)
Click on the lead sponsor to view all of their trials.
University Hospital, Basel, Switzerland
Lead sponsor
Clinical Trial Unit, University Hospital Basel, Switzerland
Collaborator
Wuerzburg University Hospital
Collaborator
Medical University of Vienna
Collaborator
Videoreha
Collaborator
University of Oulu
Collaborator
Theracell Laboratories
Collaborator
Promove-Biotec GmbH
Collaborator
Maastricht University
Collaborator
Foundation National Reumafonds
Collaborator
Angry@Arthritis
Collaborator
University of Miami
Collaborator
Geistlich Pharma AG
Collaborator
European Union
Collaborator
