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

Sewon Cellontech Co., Ltd.50 enrolled

Overview

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

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 Type

OBSERVATIONAL

Enrollment

Conditions

Defect of Articular Cartilage Articular Cartilage Disorder of Knee Degeneration; Articular Cartilage, Knee

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Inha University Medical School Hospital

Incheon, Inchoen, South Korea

Outcomes

Primary Outcomes

Score change of KOOS(Knee Injury and Osteoarthritis Outcome)

comparison of the difference between a group with Chondron Implantation and a group with Microfracture.

Time frame: Screening, post op 2years

Secondary Outcomes

Score change of 100 Vas(visual Analog System)

Comparison the difference between a group with Chondron Implantation and a group with Microfracture

Time frame: Screening, post op 2years

Score change of IKDC (International Knee Documentation Committee)

comparison the difference between a group with Chondron Implantation and a group with Microfracture

Time frame: screening, post op 2 years

Score change of KSS(Knee Society Score)

Comparision the difference between a group with Chondron Implantation and a group with Microfracture.

Time frame: Screening, Post op 2 years

Comparing MRI results

Comparison the difference of morphological improvement from MRI image between a group with Chondron Implantation and a group with Microfracture

Time frame: Screening, Post op 2years

Data from ClinicalTrials.gov

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