RecruitingPhase 2NCT06576583

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


Sponsor

University Hospital, Basel, Switzerland

Enrollment

150 participants

Start Date

Jul 15, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Autologous Matrix Induced Chondrogenesis (AMIC), a biological treatment called Engineered cartilage graft (N-TEC), and others for people with patellofemoral osteoarthritis. The study is currently recruiting participants at 11 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALEngineered cartilage graft (N-TEC)

Nasal chondrocytes based tissue engineered cartilage

PROCEDUREAutologous Matrix Induced Chondrogenesis (AMIC)

Autologous Matrix Induced Chondrogenesis is performed through bone drilling and covering with Chondro-Gide® to attract bone marrow stem cells

PROCEDUREPatellofemoral 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

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NCT06576583


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