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

NCT06576583 | Recruiting Phase 2

• 1 other identifier: 2024-513683-25-00
• Study Type: interventional
• Target: 150
• Locations: 8 countries
• Sites: 11

Brief 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.

Conditions

Patellofemoral Osteoarthritis

Keywords

Nasal chondrocytes; Tissue engineering; Knee cartilage; Patellofemoral osteoarthritis; Autologous Matrix Induced Chondrogenesis (AMIC); Patellofemoral arthroplasty (PFA)

Outcome Measures

Primary Outcomes (1)

• Knee Injury and Osteoarthritis Outcome Score (KOOS)-5

  Difference in 2-year change (baseline to 24 month follow-up) in the KOOS -5 score between patients undergoing N-TEC tissue implantation and patients receiving AMIC or PFA. Minimum score: 0 Maximum score: 100 (higher score means no knee problems)

  24 months

Secondary Outcomes (11)

• Knee Injury and Osteoarthritis Outcome questionnaire

  until 24 months

• Knee Injury and Osteoarthritis Outcome questionnaire

  Until 24 months

• Kujala questionnaire

  Until 24 months

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score

  Until 24 months

• EQ-5D-5L questionnaire

  Until 24 months

Study Arms (4)

Engineered cartilage graft (N-TEC)-Iwano grade 1-2

EXPERIMENTAL

N-TEC is based on autologous nasal chondrocytes expanded and further cultured on type I/III collagen membranes for 2 weeks to allow cells to produce extracellular matrix containing cartilage specific proteins. The IMP is implanted in the knee at the patellofemoral joint.

Biological: Engineered cartilage graft (N-TEC)

Autologous Matrix Induced Chondrogenesis-Iwano grade 1-2

ACTIVE COMPARATOR

AMIC® Chondro-Gide® combines microfracturing (MFx) with the use of Chondro-Gide®, which covers and protects both the super clot resulting from MFx and the repair tissue.

Procedure: Autologous Matrix Induced Chondrogenesis (AMIC)

Engineered cartilage graft (N-TEC)-Iwano grade 3-4

EXPERIMENTAL

N-TEC is based on autologous nasal chondrocytes expanded and further cultured on type I/III collagen membranes for 2 weeks to allow cells to produce extracellular matrix containing cartilage specific proteins. The IMP is implanted in the knee at the patellofemoral joint.

Biological: Engineered cartilage graft (N-TEC)

Patellofemoral Arthroplasty (PFA)-Iwano grade 3-4

ACTIVE COMPARATOR

Patellofemoral Joint Prosthesis

Procedure: Patellofemoral Arthroplasty (PFA)

Interventions

Engineered cartilage graft (N-TEC) BIOLOGICAL

Nasal chondrocytes based tissue engineered cartilage

Engineered cartilage graft (N-TEC)-Iwano grade 1-2; Engineered cartilage graft (N-TEC)-Iwano grade 3-4

Autologous Matrix Induced Chondrogenesis (AMIC) PROCEDURE

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

Autologous Matrix Induced Chondrogenesis-Iwano grade 1-2

Patellofemoral Arthroplasty (PFA) PROCEDURE

Surgical implantation of a medical device, Zimmer Gender Solutions Patellofemoral Joint Prosthesis.

Patellofemoral Arthroplasty (PFA)-Iwano grade 3-4

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient age is ≥18 and ≤ 70 years at time of screening.
• Symptomatic PFOA grade 1-4 according to Iwano Classification
• Chondropathy Grade 3-4 according to ICRS classification of the patella, trochlea femoris or both
• Baseline score of \<75 on the KOOS-5 subjective knee evaluation.
• Free range of motion of the affected knee joint or ≤ 5° of extension loss and minimum 125° flexion.
• Patient is willing and able to give written informed consent to participate in the study and to comply with all study requirements, including attending all follow-up visits and assessments and to complete postoperative rehabilitation regimen.
• Minimum values for women: Haemoglobin 120g/l, Platelets 150G/l, INR\<1.3
• Minimum values for men: Haemoglobin 140g/l, Platelets 150G/l, INR\<1.3
• Patients have failed to demonstrate adequate response to non-pharmacological interventions (e.g. structured land-based exercise programs) and pharmacological first-line treatment such as topical NSAIDs

You may not qualify if:

• Patient is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol or in a dependency or employment with the sponsor.
• Patient is unwilling, unable or lacking the capacity to provide informed consent
• Patient is unable to undergo magnetic resonance imaging (MRI)
• Prior surgical treatment of the target knee within 12 months (Note: prior diagnostic arthroscopy with debridement and lavage are acceptable within 12 months).
• Radiologically apparent degenerative joint disease of the tibiofemoral joint as determined by X-ray (Kellgren and Lawrence grade \> 2) or MRI or pain in the tibiofemoral joint as assessed by clinical examination
• Patient has excessive varus or valgus deformity (\>5°), unless corrected during implantation
• Patient has a symptomatic meniscus lesion (or removal exceeding ½), as indicated by clinical examination (joint line tenderness and McMurray test positive) and MRI.
• Patient has a body mass index (BMI) \>35 kg/m2.
• Patient has chronic rheumatoid arthritis, and/or infectious arthritis
• Any concomitant painful or disabling disease of the spine, hips, or lower limbs that would interfere with evaluation of the afflicted knee.
• Patient has a known immunological suppressive disorder or is taking systemic immunosuppressives.
• Patient had any intra-articular injections into the affected knee within the last 3 months before baseline visit
• Instability of anterior, posterior and/or collateral ligaments
• The patient has a HIV/AIDS infection. (regulatory requirement)
• The patient has an acute Treponema pallidum (syphilis) infection. (regulatory requirement)

Sponsors & Collaborators

• Clinical Trial Unit, University Hospital Basel, Switzerland: collaborator
• University Hospital, Basel, Switzerland: lead
• Wuerzburg University Hospital: collaborator
• Medical University of Vienna: collaborator
• Videoreha: collaborator
• University of Oulu: collaborator
• Theracell Laboratories: collaborator
• Promove-Biotec GmbH: collaborator
• Maastricht University: collaborator
• Foundation National Reumafonds: collaborator
• Angry@Arthritis: collaborator
• University of Miami: collaborator
• Geistlich Pharma AG: collaborator
• European Union: collaborator

Study Sites (11)

Orthopedic Hospital Vienna-Speising

Vienna, 1130, Austria

RECRUITING

University Hospital Sveti Duh

Zagreb, 10000, Croatia

NOT YET RECRUITING

Evangelisches Waldkrankenhaus Spandau

Berlin, 13589, Germany

NOT YET RECRUITING

Orthopedic Clinic König-Ludwig-Haus

Würzburg, 97074, Germany

RECRUITING

IRCCS Ospedale Galeazzi-Sant'Ambrogio

Milan, 20157, Italy

RECRUITING

Fondazione Policlinico Universitario Campus Bio-Medico

Rome, 00128, Italy

NOT YET RECRUITING

Maastricht University Medical Center

Maastricht, 6229 HX, Netherlands

NOT YET RECRUITING

Zeromski hospital

Krakow, 31-913, Poland

RECRUITING

Department of Orthopaedics, University of Gothenburg (UGOT)

Mölndal, 80, Sweden

RECRUITING

University Hospital Basel

Basel, 4031, Switzerland

RECRUITING

Crossklinik

Basel, 4054, Switzerland

RECRUITING

Central Study Contacts

Marcus Mumme, MD

CONTACT

+41 44 387 29 77; marcus.mumme@usb.ch

Gyözö Lehoczky, MD

CONTACT

+41 61 704 2615; Gyözö.Lehoczky@ukbb.ch

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: August 28, 2024
• Study Start: July 15, 2025
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2030
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1); IT (2); CH (2); CR (1); DE (2); SE (1); PL (1); AU (1)