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

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

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.

Study Overview

• Status: Completed
• Conditions: Articular Cartilage Lesion of Knee
• Intervention / Treatment: Drug: CartiLife

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: CartiLife (low-dose group); Total defect volume in low-dose group is less than 2 ㎤. Low- and high-dose group are sequentially processed.	Drug: CartiLife; 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.
EXPERIMENTAL: CartiLife (high-dose group); Total defect volume in High-dose group is 2 ~ 4 ㎤.	Drug: CartiLife; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Biosolution Co., Ltd.
• Collaborators: Kyung Hee University Hospital
• Investigators: Principal Investigator: Kyoung Ho Yoon, MD, PhD, Kyunghee University Medical Center

Publications and helpful links

General Publications

• Yoon KH, Park JY, Lee JY, Lee E, Lee J, Kim SG. Costal Chondrocyte-Derived Pellet-Type Autologous Chondrocyte Implantation for Treatment of Articular Cartilage Defect. Am J Sports Med. 2020 Apr;48(5):1236-1245. doi: 10.1177/0363546520905565. Epub 2020 Mar 3.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 17, 2012
• Primary Completion (ACTUAL): December 10, 2013
• Study Completion (ACTUAL): December 10, 2013

Study Registration Dates

• First Submitted: March 8, 2018
• First Submitted That Met QC Criteria: April 24, 2018
• First Posted (ACTUAL): May 7, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 7, 2018
• Last Update Submitted That Met QC Criteria: April 24, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Arthritis; Autologous Chondrocyte Implantation; Degenerative Arthritis; Cartilage Defect; Articular Cartilage; Cartilage Lesion
• Other Study ID Numbers: MCTT-CTL-I

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No