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

Phase 2

Completed

• Conditions: Articular Cartilage Lesion of the Knee
• Interventions: Drug: CartiLife®; Procedure: Microfracture

• Registration Number: NCT03545269
• Lead Sponsor: Biosolution Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02-03
• Primary Completion: 2017-02-23
• Study Completion: 2017-02-23
• Study First Submitted: 2018-03-08
• Status Verified: 2018-05
• Study First Submitted QC: 2018-05-22
• Last Update Submitted: 2018-05-22
• Study First Posted: 2018-06-04
• Last Update Posted: 2018-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CartiLife®	CartiLife®	-
Microfracture	Microfracture	-

Primary Outcome Measures

Name	Time	Method
MOCART (Magnetic Resonance Observation of Cartilage Repair Tissue)	Baseline to 48 weeks	Changes in MOCART scores during each visit

Secondary Outcome Measures

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