Articular Cartilage Lesion of the Knee
Conditions
Keywords
Degenerative Arthritis, Autologous Chondrocyte Implantation, Cartilage defects, Cartilage lesion, Arthritis
Brief summary
The purpose of this study is to assess the safety and efficacy of implanting bead-type autologous chondrocyte (CartiLife®) obtained by culturing expanded costal chondrocytes of the patient with a chondral defect in the knee. The patients will be assessed clinically using MRI, clinical, biochemical and International Knee Documentation Committee(IKDC) outcomes preoperatively as well as 8, 24 and 48 weeks postoperatively to assess the relief of symptoms and joint function.
Interventions
DRUGCartiLife®
CartiLife® is beads (1.0 to 1.5 mm in diameter) in suspension, developed from autologous chondrocytes. The beads are implanted the volume of 1 cm3 per the capacity of the syringe to the affected area through injection with fibrin adhesive through minimal arthrotomy.
PROCEDUREMicrofracture
The surgery is performed by arthroscopy, after the joint is cleaned of calcified cartilage. Through use of an awl, the surgeon creates tiny fractures in the subchondral bone plate.
Sponsors
Kyunghee University Medical Center
Gangnam Severance Hospital
Severance Hospital
Ewha Womans University
Biosolution Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Biological: CartiLife® Procedure: CartiLife® is beads (1.0 to 1.5 mm in diameter) in suspension, developed from autologous chondrocytes. The beads are implanted in a volume of 1 cm3 per the capacity of the syringe to the affected area through injection along with a fibrin adhesive through minimal arthrotomy. Active comparator: Microfracture The surgery is performed by arthroscopy, after the joint is cleaned of calcified cartilage. Through use of an awl, the surgeon creates tiny fractures in the subchondral bone plate.
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Adult men and women aged between 19 and 65 * Defect size: 2 to 10 ㎠ on the unilateral knee cartilage (up to 4 ㎤ in volume) * Defect: isolated International Cartilage Repair Society(ICRS) Grade III or IV single defect chondral lesion on articular cartilage * The joint space is maintained over 50% relative to baseline * Patients that are able to walk without aid * Patients that agree to abide by strict rehabilitation protocols and follow-up programs * Patients who provide written consent to the participation of the clinical trial
Exclusion criteria
* Patients with inflammatory articular diseases such as rheumatoid arthritis or gouty arthritis * Kellgren and Lawrence grade ≥ 3 * Patients with arthritis associated with autoimmune diseases * Patients hypersensitive to bovine protein * Patients with Haemophilia or markedly reduced immune function * Patients hypersensitive to antibiotics like gentamicin * Patients with arterial bleeding and severe venous bleeding * Patients with other diseases including tumors except for cartilaginous defects of joints * Patients with a history of radiation treatment and chemotherapy within the past two years * Patients who are pregnant, nursing a baby or likely to get pregnant * Patients who participate in concurrent clinical trials or previous clinical trials within 30 days of administration * Other cases where the investigator deems the patient ineligible for participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MOCART (Magnetic Resonance Observation of Cartilage Repair Tissue) | Baseline to 48 weeks | Changes in MOCART scores during each visit |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| IKDC (International Knee Documentation Committee Score) | Baseline to 48 weeks | Changes in IKDC scores during each visit |
| KOOS (Knee injury Osteoarthritis Outcome Score) | Baseline to 48 weeks | Changes in KOOS during each visit |
| VAS (100 mm Pain Visual Analogue Scale) | Baseline to 48 weeks | Changes in VAS during each visit |
| Lysholm Score | Baseline to 48 weeks | Changes in Lysholm Scores during each visit |
| Adverse events | Baseline to 48 weeks | Number of adverse events |
| X-ray | Baseline to 48 weeks | Changes in structure during each visit |
| ROM (Range Of Motion) | Baseline to 48 weeks | Changes in ROM during each visit |
Outcome results
None listed