NCT06576583

Implantation of Engineered Cartilage Grafts for Treatment of Patellofemoral Osteoarthritis Versus Surgical Comparators.

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: University Hospital, Basel, Switzerland · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Knee osteoarthritis (OA) is one of the most common causes for pain and disability with over 260 million people affected worldwide. Recent studies found that knee OA often starts in the patello-femoral compartment of the knee (PFOA) and is diagnosed in \~39% of people with knee pain aged above 30 years. Thus, PFOA and progression to full OA plays a crucial role in the reduction of quality of life of many people and in the raise of healthcare costs. The goal of this multi-center phase II trial is to (i) 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 based on patient self-assessed questionnaires (Knee Injury and Osteoarthritis Outcome Score, KOOS) and (ii) verify the postulated mode of action, which is expected to be of regenerative nature and will be assessed by evaluation of disease-modification by x- ray and structural regeneration of the osteoarthritic joint destruction by MRI analysis. A total of 150 patients with early stage of PFOA (Iwano grade 1-2; 75 patients) or late stage of PFOA (Iwano grade 3-4; 75 patients) will be enrolled in 11 clinical centers and randomized to either N-TEC implantation or active comparator (AMIC or PFA).

Conditions

• Patellofemoral Osteoarthritis

Interventions

Type	Name	Description
BIOLOGICAL	Engineered cartilage graft (N-TEC)	Nasal chondrocytes based tissue engineered cartilage
PROCEDURE	Autologous Matrix Induced Chondrogenesis (AMIC)	Autologous Matrix Induced Chondrogenesis is performed through bone drilling and covering with Chondro-Gide® to attract bone marrow stem cells
PROCEDURE	Patellofemoral Arthroplasty (PFA)	Surgical implantation of a medical device, Zimmer Gender Solutions Patellofemoral Joint Prosthesis.

Timeline

• Start date: 2025-07-15
• Primary completion: 2029-01-01
• Completion: 2030-01-01
• First posted: 2024-08-28
• Last updated: 2026-03-24

Locations

11 sites across 8 countries: Austria, Croatia, Germany, Italy, Netherlands, Poland, Sweden, Switzerland