Randomized, Controlled, Multi-center Phase II Clinical Trial for the Treatment of Patellofemoral Osteoarthritis With Nasal Chondrocyte-based Tissue Engineered Cartilage Implantation vs Current Standard of Care
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.
• Free range of motion of the affected knee joint or ≤ 5° of extension loss and minimum 125° flexion.
• Patient is willing and able to give written informed consent to participate in the study and to comply with all study requirements, including attending all follow-up visits and assessments and to complete postoperative rehabilitation regimen.
• Minimum values for women: Haemoglobin 120g/l, Platelets 150G/l, INR\<1.3
• Minimum values for men: Haemoglobin 140g/l, Platelets 150G/l, INR\<1.3
• Patients have failed to demonstrate adequate response to non-pharmacological interventions (e.g. structured land-based exercise programs) and pharmacological first-line treatment such as topical NSAIDs