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Sponsored by: |
TiGenix n.v. |
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Information provided by: | TiGenix n.v. |
ClinicalTrials.gov Identifier: | NCT00414700 |
This is a phase III, multicenter, open-label, randomized controlled trial of ChondroCelect® (in an Autologous Chondrocyte Transplantation procedure) compared to the procedure of microfracture (MF) in the repair of symptomatic cartilage lesions of the knee. Eligible patients attended two screening visits and were booked for arthroscopy approximately 2 weeks later. At that time, patients were randomized to either ACT with ChondroCelect® (also called Characterized Chondrocyte Implantation, CCI) or to MF, a procedure in which the subchondral bone is perforated to allow a bloodcloth to form scar tissue. Patients randomized to MF had the procedure performed at the time of their arthroscopy; those randomized to CCI had their cells harvested during the arthroscopy and then returned to the clinic approximately 4 weeks later for an open knee procedure, during which the CCI procedure was performed. Patients subsequently followed the same rehabilitation program and had follow-up assessments up to 12 months post-surgery. The 12-month visit was the end-of-study visit for the TIG/ACT/01/2000 protocol. Subject to satisfying the eligibility criteria, patients who had participated in the initial 12 month trial could enter the extension trial (TIG/ACT/01/2000 EXT). The 12-month visit for the initial study was the baseline visit for the extension study. During the extension study, patients had follow-up assessments up to 60 months post-surgery.
Condition | Intervention | Phase |
---|---|---|
Articular Cartilage Lesion of the Femoral Condyle |
Drug: ChondroCelect Procedure: Characterized Chondrocyte Implantation |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Prospective Multicenter Randomized Controlled Trial of ChondroCelect® (in an Autologous Chondrocyte Transplantation Procedure) vs Microfracture (as Procedure) in the Repair of Symptomatic Cartilaginous Defects of the Femoral Condyles of the Knee |
Estimated Enrollment: | 112 |
Study Start Date: | March 2002 |
Estimated Study Completion Date: | December 2009 |
cf brief summary
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Belgium | |
University Hospitals Leuven, Department of Orthopedics | |
Leuven, Belgium, 3000 | |
AZ St Lucas Brugge, Department of Orthopedics | |
Brugge, Belgium, 8310 | |
A.Z. Sint Jozef, Department of Orthopedics | |
Malle, Belgium, 2390 | |
AZ St. Elisabeth, Department of Orthopedics | |
Herentals, Belgium, 2200 | |
Ghent University Hospital, Department of Orthopedics | |
Ghent, Belgium, 9000 | |
AZ St. Jan Brugge, Department of Orthopedics | |
Brugge, Belgium, 8000 | |
Academisch Ziekenhuis, Vrije Universiteit Brussel, Department of Orthopedics | |
Brussels, Belgium, 1090 | |
SPM Monica Antwerp | |
Deurne, Belgium, 2100 | |
AZ Groeninge, Department of Orthopedics | |
Kortrijk, Belgium, 8500 | |
Croatia | |
Department of Orthopedic Surgery, School of Medicine, University of Zagreb | |
Zagreb, Croatia, 10000 | |
Germany | |
University Hospital Hannover, Department of Orthopedics | |
Hannover, Germany, 30625 | |
Netherlands | |
University Medical Center Utrecht, Department of Orthopedics | |
Utrecht, Netherlands, 3584 |
Principal Investigator: | Daniël Saris, M.D., Ph.D. | University Medical Center Utrecht, Department of Orthopedics, Heidelberglaan 100, 3584 CX Utrecht, The Netherlands. |
Principal Investigator: | Johan Vanlauwe, M.D. | University Hospitals Leuven, Department of Orthopedics, Herestraat 49, 3000 Leuven, Weligerveld 1, 3212 Pellenberg, Belgium. |
Study Chair: | Nancy Veulemans, Ir., M.S. | VP Clinical and Regulatory Affairs, 4C Partner for TiGenix n.v. |
Study Chair: | Ludo Haazen, M.D. | Medical Advisor, Envision bvba for TiGenix n.v. |
Study Director: | Frank P Luyten, M.D., Ph.D. | Division of Rheumatology, Department of Muskuloskeletal Sciences, University Hospitals, Katholieke Universiteit Leuven, Herestraat 49, 3000 Leuven, Belgium |
Study ID Numbers: | TIG/ACT/01/2000, TIGACT01 |
Study First Received: | December 21, 2006 |
Last Updated: | December 21, 2006 |
ClinicalTrials.gov Identifier: | NCT00414700 |
Health Authority: | United States: Food and Drug Administration; Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment; France: Afssaps - French Health Products Safety Agency; Netherlands: Dutch Health Care Inspectorate; Germany: Paul-Ehrlich-Institut; Croatia: Ministry of Health and Social Care |
Cartilage Articular Femoral Knee |