the Safety and Efficacy Evaluation of Chondron Compared With Mircrofracture of Knee

• Conditions: Defect of Articular Cartilage; Degeneration; Articular Cartilage, Knee; Articular Cartilage Disorder of Knee

• Registration Number: NCT02524509
• Lead Sponsor: Sewon Cellontech Co., Ltd.

Brief Summary

The purpose of this study is to evaluate safety and efficacy of Chondron(autologous cultured Chondrocyte) by comparing between Chondron implantation and Microfracture.

Detailed Description

It is an open clinical trial. Among the patients who received autologous cartilage cell graft using CHONDRON (autologous cartilage cells) in the past (investigational group) or microfracture (control group), the subjects who agreed to participate in the trial voluntarily will undergo the screening process that assesses the suitability of the subjects to the clinical trial and participate in the clinical trial. During the clinical trial period, the subjects should follow the instruction of clinician in charge. Hospital visit is total 2 times\* regularly. At the visit, to evaluate the efficacy according to the protocol, the subject will be examined by clinicians, MRI test, and X-ray. If the selection time and the visit time are same, hospital visit will be one time\*.

Study Timeline

• Study Start: 2012-01
• Status Verified: 2015-08
• Primary Completion: 2015-08
• Study First Submitted: 2015-08-13
• Study First Submitted QC: 2015-08-13
• Study First Posted: 2015-08-14
• Last Update Submitted: 2015-08-28
• Last Update Posted: 2015-08-31
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 1. Patients who underwent autologous chondrocyte implantation using CHONDRON (autologous cultured chondrocyte) or patients underwent microfracture more than 2 years ago.

2. Patients who meet the above criteria 1, the patient or a guardian agreed to participate in the clinical trial, and signed a written agreement form

Exclusion Criteria

• 1. Patients with psychological disease or other patients who are determined to be unsuitable to this clinical trial by the investigators conducting the clinical trial.

2. Patients who underwent autologous chondrocyte implantation applying CHONDRON (autologous cultured chondrocyte) or microfracture, and the lesion was treated with other procedures subsequently.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Score change of KOOS(Knee Injury and Osteoarthritis Outcome)	Screening, post op 2years	comparison of the difference between a group with Chondron Implantation and a group with Microfracture.

Secondary Outcome Measures

Name	Time	Method
Score change of KSS(Knee Society Score)	Screening, Post op 2 years	Comparision the difference between a group with Chondron Implantation and a group with Microfracture.
Score change of 100 Vas(visual Analog System)	Screening, post op 2years	Comparison the difference between a group with Chondron Implantation and a group with Microfracture
Score change of IKDC (International Knee Documentation Committee)	screening, post op 2 years	comparison the difference between a group with Chondron Implantation and a group with Microfracture
Comparing MRI results	Screening, Post op 2years	Comparison the difference of morphological improvement from MRI image between a group with Chondron Implantation and a group with Microfracture

Trial Locations

Locations (1)

Inha University Medical School Hospital; 🇰🇷 Incheon, Inchoen, Korea, Republic of