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RECRUITING
NCT06576583
PHASE2

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

Sponsor: University Hospital, Basel, Switzerland

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2025-07-15

Completion Date

2030-01

Last Updated

2026-03-24

Healthy Volunteers

No

Interventions

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.

Locations (11)

Orthopedic Hospital Vienna-Speising

Vienna, Austria

University Hospital Sveti Duh

Zagreb, Croatia

Evangelisches Waldkrankenhaus Spandau

Berlin, Germany

Orthopedic Clinic König-Ludwig-Haus

Würzburg, Germany

IRCCS Ospedale Galeazzi-Sant'Ambrogio

Milan, Italy

Fondazione Policlinico Universitario Campus Bio-Medico

Rome, Italy

Maastricht University Medical Center

Maastricht, Netherlands

Zeromski hospital

Krakow, Poland

Department of Orthopaedics, University of Gothenburg (UGOT)

Mölndal, Sweden

University Hospital Basel

Basel, Switzerland

Crossklinik

Basel, Switzerland