drugset / Trial / NCT06576583
Implantation of Engineered Cartilage Grafts for Treatment of Patellofemoral Osteoarthritis Versus Surgical Comparators.
Phase 2
Recruiting
150 enrolled
University Hospital, Basel, Switzerland
Angry@Arthritis · collabClinical Trial Unit, University Hospital Basel, Switzerland · collabEuropean Union · collabFoundation National Reumafonds · collabGeistlich Pharma AG · collabMaastricht University · collabMedical University of Vienna · collabPromove-Biotec GmbH · collabTheracell Laboratories · collabUniversity of Miami · collabUniversity of Oulu · collabVideoreha · collabWuerzburg University Hospital · collab
RandomizedParallel-groupSingle-blindTreatment
Summary
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.
Timeline
- Start
- 2025-07-15
- Primary completion
- 2029-01
- Completion
- 2030-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Engineered cartilage graft | Cell therapy | — | Other |