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

Articular Cartilage Lesion of the Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03545269
• Other study ID #: MCTT-CTL-021
• Status: Completed
• Phase: Phase 2
• Start date: February 3, 2014
• Est. completion date: February 23, 2017

Study information

• Verified date: May 2018
• Source: Biosolution Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 23, 2017
• Est. primary completion date: February 23, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Articular Cartilage Lesion of the Knee

Intervention

Drug:
• CartiLife®
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.

Procedure:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
Biosolution Co., Ltd.	Ewha Womans University, Gangnam Severance Hospital, Kyunghee University Medical Center, Severance Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MOCART (Magnetic Resonance Observation of Cartilage Repair Tissue)	Changes in MOCART scores during each visit	Baseline to 48 weeks
Secondary	Lysholm Score	Changes in Lysholm Scores during each visit	Baseline to 48 weeks
Secondary	IKDC (International Knee Documentation Committee Score)	Changes in IKDC scores during each visit	Baseline to 48 weeks
Secondary	KOOS (Knee injury Osteoarthritis Outcome Score)	Changes in KOOS during each visit	Baseline to 48 weeks
Secondary	VAS (100 mm Pain Visual Analogue Scale)	Changes in VAS during each visit	Baseline to 48 weeks
Secondary	ROM (Range Of Motion)	Changes in ROM during each visit	Baseline to 48 weeks
Secondary	Adverse events	Number of adverse events	Baseline to 48 weeks
Secondary	X-ray	Changes in structure during each visit	Baseline to 48 weeks