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Clinical Trial for the Regeneration of Cartilage Lesions in the Knee

NCT02673905 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2025-03-30

No results posted yet for this study

Summary

The purpose of this study is to investigate the efficacy of an engineered cartilage transplant (N-TEC) in comparison to a cell-activated matrix (N-CAM) for the treatment of articular cartilage lesions in the knee. The main innovations in this trial are the use of nasal chondrocytes and the implantation of a tissue in contrast to cells seeded on a matrix. The goals of the trial are to: (i) evaluate whether implantation of a more mature graft (tissue therapy) is beneficial for the quality and durability of the repair tissue and the clinical outcome, (ii)determine the potential of the mature graft to integrate with the adjacent cartilage and form hyaline repair tissue and (iii) assess the efficacy of each treatment in correlation to the characteristics of the defect (e.g. "acute" versus "chronic" setting).

Conditions

  • Tear; Knee, Cartilage, Articular

Interventions

OTHER

Tissue Engineered Product

Implantation of tissue engineered products

Sponsors & Collaborators

  • University Hospital Freiburg

    collaborator OTHER

  • I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

    collaborator OTHER

  • General Hospital Sveti Duh

    collaborator OTHER

  • Fraunhofer-Institut für Silicatforschung ISC

    collaborator UNKNOWN

  • Orthopaedische Klinik Koenig-Ludwig-Haus

    collaborator OTHER

  • University Hospital, Basel, Switzerland

    lead OTHER

Principal Investigators

  • Marcel Jakob, Prof. Dr. · University Hospital, Basel, Switzerland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2022-11-15
Completion
2022-11-15

Countries

  • Croatia
  • Germany
  • Italy
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02673905 on ClinicalTrials.gov