RCT of ChondroCelect® (in an ACI Procedure) vs Microfracture in the Repair of Cartilage Defects of the Knee (TIGACT01)
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ClinicalTrials.gov Identifier: NCT00414700 |
Recruitment Status
:
Completed
First Posted
: December 22, 2006
Results First Posted
: January 18, 2010
Last Update Posted
: September 26, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Articular Cartilage Lesion of the Femoral Condyle | Drug: ChondroCelect implantation Procedure: Microfracture | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 118 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Prospective Multicenter Randomized Controlled Trial of ChondroCelect® (Via Autologous Chondrocyte Implantation) vs Microfracture (as Procedure) in the Repair of Symptomatic Cartilaginous Defects of the Femoral Condyles |
Study Start Date : | February 2002 |
Actual Primary Completion Date : | July 2006 |
Actual Study Completion Date : | January 2010 |
Arm | Intervention/treatment |
---|---|
Experimental: ChondroCelect |
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. Other Name: CCI
|
Active Comparator: Microfracture |
Procedure: Microfracture
A procedure in which the subchondral bone is perforated to allow a bloodcloth to form scar tissue.
Other Name: subchondral drilling
|
- Histomorphometry Safranin-O + Anti-Collagen II Antibody Staining [ Time Frame: 12 months post-surgery ]Histomorphometry on end point biopsies at 12 months post-surgery. Safranin-O (ratio 0-1)+ anti-Collagen II antibody (ratio 0-1) stain signal expressed as a ratio of the total cartilage surface area (Saf O + anti Coll II divided by total surface = ratio 0-2). Safranin-O stains proteoglycans and anti-Collagen II antibody reflects the presence of Collagen II.
- Overall Histology Assessment on First Subscale of ICRS II Score [ Time Frame: 12 months post-surgery ]Overall histology assessment of cartilage repair, first subscale of International Cartilage Repair Society II (ICRS II) score by two blinded independant histopathologists on a visual analogue scale (VAS 0-100mm) from worst (0) to best (100)
- Change From Baseline in Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) at 12-18 Months (Average) [ Time Frame: Average change from baseline in Overall KOOS at 12-18 months post-surgery ]Overall Knee injury and Osteoarthritis Outcome score (average of 4 KOOS subdomains, Sports not included) at the average of 12-18 months (calculated by averaging change from baseline measurements at 12 and 18 months). Best score = 100; worst score = 0. The analysis was the average of the change from baseline at the 12 and 18 months timepoints.
- Change From Baseline in Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) at 36 Months [ Time Frame: Change from baseline in Overall KOOS at 36 months post-surgery ]Overall Knee injury and Osteoarthritis Outcome score (average of 4 KOOS subdomains: Activities of Daily Living, Quality of Life, Symptoms and Stiffness Pain; Sports not included) at 36 months (change from baseline). Best = 100; worst = 0.
- Number of Treatment Failures at 36 Months [ Time Frame: Continuous ]
Participants with failed treatment - defined as the number of patients who underwent a reintervention of the index lesion - at 36 months.
The index lesion is the lesion that was initially treated in the study.
- Safety: Adverse Events [ Time Frame: continuous up to 60 months ]Side effects are recorded as the number of patients with adverse events. These events are coded according to the Medical Dictionary for Regulatory Affairs (MedDRA terms).

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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Signed patient informed consent
- Symptomatic cartilage single lesion of the femoral condyle
- Lesion on femoral condyle between 1 and 5 cm²
- Agree to participate actively in a strict rehabilitation protocol and follow-up programme
- Agree to only use paracetamol mono-or combination preparation (max 4g/d) and Non-Steroidal Anti Inflammatory Drugs (NSAIDS) during the study and to discontinue this medication 2 weeks before the baseline visit and the follow-up visits. The use of paracetamol mono-preparation (max 4g/d) is allowed up to one week before the baseline visit and the follow-up visits.
- Females of childbearing age should use a proven method to prevent pregnancy
Exclusion Criteria:
- Participation in concurrent trials
- Participation in previous trials within 3 months
- Subjects with hepatitis, HIV or syphilis
- Malignancy
- Alcohol or drug (medication) abuse
- Poor general health as judged by Investigator
- Clinically relevant second cartilage lesion on the patella
- Patellofemoral cartilage lesion
- Osteochondritis Dissecans (OCD) : recent OCD (within 1 year before baseline), depth of lesion > 0.5cm, subchondral slerosis
- Advanced osteoarthritis (OA) : radiographic atlas of OA grade 2-3
- Known allergy to gentamicin or penicillins (or presence of multiple severe allergies)
- Complex ligamentous instability of the knee
- Meniscal transplant
- Meniscal suture with meniscal arrows (ipsilateral)
- Meniscus resection : if < 1 yr before baseline - lateral meniscus resection or medial meniscus resection of more than 50%. If > 1 yr before baseline - ipsilateral meniscus resection of more than 50%, controlateral meniscus resection of more than 50% if ipsilateral meniscus is not intact, combination of medial and lateral meniscus resection and one of both > 50%.
- Varus or valgus malalignment of more than 5°
- Mosaicplasty
- Microfracture performed less than 1 yr before baseline
- Having received hyaluronic acid intra-articular injections in the affected knee within the last 6 months of baseline
- Taking specific OA drugs such as chondroïtin sulfate, diacerein, n-glucosamine, piascledine, capsaicin within 2 weeks of the baseline visit
- Corticosteroïd treatment by systemic or intra-articular route within the last month of baseline or intramuscular or oral corticosteroïds within the last 2 weeks of baseline
- Chronic use of anticoagulants
- Uncontrolled diabetes
- Any concomitant painful or disabling disease of the spine,hips or lower limbs that would interfere with evaluation of the afflicted knee
- Any clinically significant or symptomatic vascular or neurologic disorder of the lower extremities
- Any evidence of the following diseases in the target joint : septic arthritis, inflammatory joint disease, gout, recurrent episodes of pseudogout, Paget's disease of bone, ochronosis, acromegaly, hemochromatosis, Wilson's disease, primary osteochondromatosis, heritable disorders, collagen gene mutation
- Current diagnosis of osteomyelitis
- Liver enzymes (SGOT, SGPT, Alkaline Phosphatase) of more then two times the upper limit of normal or any other result that is clinically important according to the Investigator
- CRP > 10 mg/l

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00414700
Belgium | |
AZ St. Jan Brugge, Department of Orthopedics | |
Brugge, Belgium, 8000 | |
AZ St Lucas Brugge, Department of Orthopedics | |
Brugge, Belgium, 8310 | |
Academisch Ziekenhuis, Vrije Universiteit Brussel, Department of Orthopedics | |
Brussels, Belgium, 1090 | |
SPM Monica Antwerp | |
Deurne, Belgium, 2100 | |
Ghent University Hospital, Department of Orthopedics | |
Ghent, Belgium, 9000 | |
AZ St. Elisabeth, Department of Orthopedics | |
Herentals, Belgium, 2200 | |
AZ Groeninge, Department of Orthopedics | |
Kortrijk, Belgium, 8500 | |
University Hospitals Leuven, Department of Orthopedics | |
Leuven, Belgium, 3000 | |
A.Z. Sint Jozef, Department of Orthopedics | |
Malle, Belgium, 2390 | |
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 BF 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 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 |
Publications of Results:
Other Publications:
Responsible Party: | TiGenix n.v. |
ClinicalTrials.gov Identifier: | NCT00414700 History of Changes |
Other Study ID Numbers: |
TIG/ACT/01/2000&Extension BB IND 12491 0007 ( Other Identifier: CBER ) |
First Posted: | December 22, 2006 Key Record Dates |
Results First Posted: | January 18, 2010 |
Last Update Posted: | September 26, 2011 |
Last Verified: | September 2011 |
Keywords provided by TiGenix n.v.:
Cartilage Articular Femoral Knee |
Additional relevant MeSH terms:
Fractures, Stress Fractures, Bone Wounds and Injuries |