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

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

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.

Sponsors & Collaborators

• Clinical Trial Unit, University Hospital Basel, Switzerland

  collaborator OTHER

• Wuerzburg University Hospital

  collaborator OTHER

• Medical University of Vienna

  collaborator OTHER

• Videoreha

  collaborator UNKNOWN

• University of Oulu

  collaborator OTHER

• Theracell Laboratories

  collaborator UNKNOWN

• Promove-Biotec GmbH

  collaborator UNKNOWN

• Maastricht University

  collaborator OTHER

• Foundation National Reumafonds

  collaborator UNKNOWN

• Angry@Arthritis

  collaborator UNKNOWN

• University of Miami

  collaborator OTHER

• Geistlich Pharma AG

  collaborator INDUSTRY

• European Union

  collaborator OTHER

• University Hospital, Basel, Switzerland

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-07-15

Primary Completion

2029-01-31

Completion

2030-01-31

Countries

• Austria
• Croatia
• Germany
• Italy
• Netherlands
• Poland
• Sweden
• Switzerland

Study Locations