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

Phase 1

Completed

• Conditions: Articular Cartilage Lesion of Knee
• Interventions: Drug: CartiLife

• Registration Number: NCT03517046
• Lead Sponsor: Biosolution Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07-17
• Primary Completion: 2013-12-10
• Study Completion: 2013-12-10
• Status Verified: 2018-03
• Study First Submitted: 2018-03-08
• Study First Submitted QC: 2018-04-24
• Last Update Submitted: 2018-04-24
• Study First Posted: 2018-05-07
• Last Update Posted: 2018-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CartiLife (low-dose group)	CartiLife	Total defect volume in low-dose group is less than 2 ㎤. Low- and high-dose group are sequentially processed.
CartiLife (high-dose group)	CartiLife	Total defect volume in High-dose group is 2 \~ 4 ㎤.

Primary Outcome Measures

Name	Time	Method
Adverse events	48 weeks	Number of adverse events

Secondary Outcome Measures

Name	Time	Method
IKDC (International Knee Documentation Committee)	Baseline to 48 weeks	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
X-ray	Baseline 48 weeks	Changes in structure during each visit