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).
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