Study to Assess the 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 chondrocytes (CartiLife®) obtained by culturing expanded costal chondrocytes of the patient with a chondral defect in the knee. The patients will be assessed clinically using clinical, biochemical and IKDC (International Knee Documentation Committee) outcomes preoperatively as well as 4, 8, 24 and 48 weeks postoperatively to assess the relief of symptoms and joint function.

Official Title
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A Multi-center, Open-label, Phase I Trial to Assess the Safety for Treatment of Autologous Chondrocytes Implantation With CartiLife for Patients With Chondral Defects in the Knee

Conditions
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Articular Cartilage Lesion of Knee

Intervention / Treatment
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* Drug: CartiLife


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients at least 19 years old Defect size: 2 to 10 ㎠ on the unilateral knee cartilage (up to 4 ㎤ in volume) Defect: isolated ICRS (International Cartilage Repair Society) 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 Patients with arthritis associated with autoimmune disease Patients hypersensitive to bovine protein Patients with Haemophilia or markedly reduced immune function Patients hypersensitive to antibiotics such as 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

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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CartiLife (low-dose group)<br>Total defect volume in low-dose group is less than 2 ㎤. Low- and high-dose group are sequentially processed. | Drug: CartiLife<br>* 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 with a fibrin adhesive through minimal arthrotomy.<br>|
| Experimental: CartiLife (high-dose group)<br>Total defect volume in High-dose group is 2   4 ㎤. | Drug: CartiLife<br>* 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 with a fibrin adhesive through minimal arthrotomy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Number of adverse events | 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IKDC (International Knee Documentation Committee) | Changes in IKDC scores during each visit The IKDC Score is a subjective questionnaire filled out by the patient ranges from 0-100, where a score of 100 is interpreted to mean no limitation with sporting activities or daily living and the complete absence of symptoms | Baseline to 48 weeks | 
| X-ray | Changes in structure during each visit | Baseline 48 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cartilage Lesion, Cartilage Defect, Arthritis, Articular Cartilage, Autologous Chondrocyte Implantation, Degenerative Arthritis