NCT00414700View on ClinicalTrials.gov

RCT of ChondroCelect® (in an ACI Procedure) vs Microfracture in the Repair of Cartilage Defects of the Knee

PHASE3CompletedINTERVENTIONAL
Enrollment

118

Participants

Timeline

Start Date

February 28, 2002

Primary Completion Date

July 31, 2006

Study Completion Date

January 31, 2010

Conditions
Articular Cartilage Lesion of the Femoral Condyle
Interventions
DRUG

ChondroCelect implantation

"10.000 cells/µl cell suspension for implantation (Autologous Chondrocyte Implantation). ChondroCelect consists of characterised autologous cartilage-forming cells expressing a specific marker profile.~The dose depends on the size of the lesion. Recommended dose is 0.8 to 1.0 million cells/cm²."

PROCEDURE

Microfracture

A procedure in which the subchondral bone is perforated to allow a bloodcloth to form scar tissue.

Trial Locations (12)

1090

Academisch Ziekenhuis, Vrije Universiteit Brussel, Department of Orthopedics, Brussels

2100

SPM Monica Antwerp, Deurne

2200

AZ St. Elisabeth, Department of Orthopedics, Herentals

2390

A.Z. Sint Jozef, Department of Orthopedics, Malle

3000

University Hospitals Leuven, Department of Orthopedics, Leuven

3584

University Medical Center Utrecht, Department of Orthopedics, Utrecht

8000

AZ St. Jan Brugge, Department of Orthopedics, Bruges

8310

AZ St Lucas Brugge, Department of Orthopedics, Bruges

8500

AZ Groeninge, Department of Orthopedics, Kortrijk

9000

Ghent University Hospital, Department of Orthopedics, Ghent

10000

Department of Orthopedic Surgery, School of Medicine, University of Zagreb, Zagreb

30625

University Hospital Hannover, Department of Orthopedics, Hanover

All Listed Sponsors
lead

TiGenix n.v.

INDUSTRY

NCT00414700 - RCT of ChondroCelect® (in an ACI Procedure) vs Microfracture in the Repair of Cartilage Defects of the Knee | Biotech Hunter | Biotech Hunter