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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Articular Cartilage Lesion of Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CartiLife

Drug

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.

Primary outcomes

Adverse events

Time frame: 48 weeks

Number of adverse events

Secondary outcomes

IKDC (International Knee Documentation Committee)

Time frame: 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

Time frame: Baseline 48 weeks

Changes in structure during each visit

Sponsors and collaborators

Lead sponsor

Biosolution Co., Ltd.

Industry

Collaborators

Kyung Hee University Hospital

Registry information

Official study title

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

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2013
First posted: May 7, 2018
Registry last updated: May 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed