Trial intelligence / Profile preview

ChondroCelect vs Microfracture for Femoral Condyle Cartilage Defects

NCT00414700Phase 3

Key facts

Status
Completed
Start
Feb 2002
Primary completion
Jul 2006
Countries
4
Sponsor
TiGenix
Modality
Stem Cell Therapies
Conditions
articular cartilage lesion of the femoral condyle
01

Overview

Phase 3, randomised, open-label trial of autologous cultured chondrocytes in articular cartilage lesion of the femoral condyle (2 arms), sponsored by TiGenix. Primary endpoints: Histomorphometry Safranin-O + Anti-Collagen II Antibody Staining at 12 months, Overall Histology Assessment on First Subscale of ICRS II Score at 12 months and 1 more. Started Feb 2002; status: completed.

02

Design

2 arms
Study design
RandomizedOpen-label
  • ChondroCelect

    Autologous Chondrocyte Implantation with ChondroCelect

  • Microfracture

    Microfracture procedure

03

Endpoints

Primary

  • Histomorphometry Safranin-O + Anti-Collagen II Antibody Staining

  • Overall Histology Assessment on First Subscale of ICRS II Score

  • Overall Knee Injury and Osteoarthritis Outcome Score

Secondary

  • Overall Knee Injury and Osteoarthritis Outcome Score

  • Number of Treatment Failures

  • Adverse Events

04

Results

Primary endpoints met

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