Study to Assess the Efficacy and Safety of Treatment of Articular Cartilage Lesions With CartiLife®

Study Overview
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Brief Summary
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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.

Official Title
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A Multi-Center, Active-Controlled, Open-Label, Phase Ⅱ Trial to Compare the Efficacy and Safety for Treatment of Autologous Chondrocytes Implantation With CartiLife Versus Microfracture for Patient With Chondral Defects in the Knee

Conditions
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Articular Cartilage Lesion of the Knee

Intervention / Treatment
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* Drug: CartiLife®
* Procedure: Microfracture


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CartiLife®<br> | Drug: CartiLife®<br>* 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.<br>|
| Active Comparator: Microfracture<br> | Procedure: Microfracture<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MOCART (Magnetic Resonance Observation of Cartilage Repair Tissue) | Changes in MOCART scores during each visit | Baseline to 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lysholm Score | Changes in Lysholm Scores during each visit | Baseline to 48 weeks | 
| IKDC (International Knee Documentation Committee Score) | Changes in IKDC scores during each visit | Baseline to 48 weeks | 
| KOOS (Knee injury Osteoarthritis Outcome Score) | Changes in KOOS during each visit | Baseline to 48 weeks | 
| VAS (100 mm Pain Visual Analogue Scale) | Changes in VAS during each visit | Baseline to 48 weeks | 
| ROM (Range Of Motion) | Changes in ROM during each visit | Baseline to 48 weeks | 
| Adverse events | Number of adverse events | Baseline to 48 weeks | 
| X-ray | Changes in structure during each visit | Baseline to 48 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Degenerative Arthritis, Autologous Chondrocyte Implantation, Cartilage defects, Cartilage lesion, Arthritis