For patients

As end-users, patients represent the ultimate beneficiaries of the technologies developed in the project. Patients play an essential role in clinical trial design and patient representatives will be included in communication/dissemination, and health economics analysis.

ENCANTO is expected to bring the first regenerative therapy for PFOA to the market. To maximize the impact on patients, patient representative Steve O’Keeffe, the founder of Angry@Arthritis platform, along with Corné Baatenburg de Jong from Dutch Arthritis Society (ReumaNederland), will be an integral part of the project, providing patient-centered development through the integration into the consortium.

This is my inspiration for Angry@Arthritis – I don’t want others to feel helpless.

Steve O’ Keeffe

Learn more at: https://www.angryarthritis.org/

Aims of the clinical trial and how to participate as the patient

Initial studies have shown the safety and efficacy of using Nasal chondrocyte Tissue Engineered Cartilage (N-TEC) to heal focal cartilage defects in the knee, alleviate patient’s symptoms, and thus improve quality of life. Based on these findings, the new study ENCANTO has been initiated.

We are planning to start a randomized clinical phase II study on patellofemoral osteoarthritis (PFOA) at the beginning of 2025 to demonstrate the efficacy of our innovative treatment. The study design will include two groups of patients based on their stage of osteoarthritis: a group for early to moderate PFOA and a group for advanced PFOA. In the early PFOA group of patients, we will compare our innovative treatment (N-TEC) to a surgical procedure (autologous matrix-induced chondrogenesis, AMIC). In the group of patients with advanced stages, we will compare N-TEC to (partial) knee endoprosthesis (joint replacement). After assessment of the stage of PFOA, patients will be randomly assigned to one of the treatment groups. The follow-up will continue for two years to assess the clinical efficacy of the treatment.

The study is funded by the European Union within the frame of the Horizon Europe projects. The study will be carried out in 11 European clinical centers of excellence.

The main inclusion criteria are:

  • Symptomatic PFOA Iwano grade 1-4
  • Cartilage defect Grade 3-4 of the patella, trochlea femoris, or both

The main exclusion criteria are:

  • Prior surgical treatment of the target knee within 12 months
  • Degenerative joint disease of the tibiofemoral joint (towards the shin)
  • Symptomatic meniscus lesion
  • Patient has chronic rheumatoid arthritis, and/or infectious arthritis
  • Osteoarthritis on the medial or lateral compartment