Clinical trial NCT02524509: the Safety and Efficacy Evaluation of Chondron Compared With Mircrofracture of Knee
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Defect of Articular Cartilage
Articular Cartilage Disorder of Knee
Degeneration; Articular Cartilage, Knee
Keywords: Chonodron
Microfracture
autologous cultured chondrocyte
cartilage defect of knee
Lead sponsor: Sewon Cellontech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-08-14
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Total 50 patients. Patients who received autologous chondrocyte implantation using CHONDRON (autologous cultured chondrocyte) for knee osteoarthritis or patients underwent microfracture. There are total 28 patients who get CHONDRON grafting until now. Considering dropout rate, the selected number of investigational group is total 25, and 25 of equivalent control group is planned.

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\*.

Eligibility criteria: 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.

Primary outcomes:
measure: Score change of KOOS(Knee Injury and Osteoarthritis Outcome)
timeFrame: Screening, post op 2years
Secondary outcomes:
measure: Score change of 100 Vas(visual Analog System)
timeFrame: Screening, post op 2years
measure: Score change of IKDC (International Knee Documentation Committee)
timeFrame: screening, post op 2 years
measure: Score change of KSS(Knee Society Score)
timeFrame: Screening, Post op 2 years
measure: Comparing MRI results
timeFrame: Screening, Post op 2years
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Inha University Medical School Hospital
state: Inchoen
Study officials:
affiliation: Inha University Medical School Hospital
name: Myung Goo Kim, MD
role: PRINCIPAL_INVESTIGATOR
References: