This trial is active, not recruiting.

Conditions defect of articular cartilage, articular cartilage disorder of knee, degeneration; articular cartilage, knee
Phase phase 4
Sponsor Sewon Cellontech Co., Ltd.
Start date January 2012
End date August 2015
Trial size 50 participants
Trial identifier NCT02524509, 07CON


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Patients who already received autologous chondrocyte implantation using CHONDRON (Autologous Cultured Chondrocyte) for knee cartilage defects
patients already underwent microfracture

Primary Outcomes

Score change of KOOS(Knee Injury and Osteoarthritis Outcome)
time frame: Screening, post op 2years

Secondary Outcomes

Score change of 100 Vas(visual Analog System)
time frame: Screening, post op 2years
Score change of IKDC (International Knee Documentation Committee)
time frame: screening, post op 2 years
Score change of KSS(Knee Society Score)
time frame: Screening, Post op 2 years
Comparing MRI results
time frame: Screening, Post op 2years

Eligibility Criteria

Male or female participants of any age.

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.

Additional Information

Official title An Inverstigational Clinical Trial for the Safety and Efficacy Evaluation of Chondron(Autologous Cultured Chondrocyte)Compared With Mircrofracture Surgery in Subjects With Cartilage Defects of the Knee Joint
Principal investigator Myung Goo Kim, MD
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*.
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Sewon Cellontech Co., Ltd..