A clinical trial to evaluate the long-term efficacy and safety of a CHONDRON (Autologous cultured Chondrocyte) for 48weeks, and additional 96weeks in patients with cartilage defects in their knees.
This is an open trial, involving a total of 24 subjects. Subjects who give consent will be screened and those who meet trial criteria will receive CHONDRON (Autologous cultured Chondrocyte) by transplant. During the trial period, subjects must follow the instructions given by principal investigator. Subjects will make 8\* hospital visits on a regular basis inclusive of hospitalization. During these visits subjects will be examined. For the evaluation of safety and efficacy of CHONDRON, examination with doctors, blood samples, x-ray, MRI tests, observation with the naked eyes and arthroscopy will be performed. \*If tissue samples can be collected at screening visit, there will be only 7 visits.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
In one vial (0.4 ml), Main ingredient: 1.2 million or more autologous chondrocytes Culture solution: Adequate amount of Dulbecco's modified Eagle medium (DMEM) The cells that fill the vial are sufficiently suspended, and a sufficient amount of suspension is grafted in the defect with fibrin glue.
Inha Univerisity Hospital
Incheon, Incheon, South Korea
Ewha Womans University Mokdong Hospital
Seoul, Seoul, South Korea
change in pain of 100mm Visual Analog Scale
The primary endpoint for the analysis is the change in the 100mmVAS at 48 weeks after the surgery from that of baseline.
Time frame: 48 weeks after the surgery
change of IKDC (International Knee Documentation Committee)
The IKDC values of the affected knee at basleine and 48 weeks after the surgery will be primarily compared based on the evaluations by the subjects and the investigators (and 12, 24 and 96 weeks after the surgery).
Time frame: baseline and 48 weeks after the surgery and 12, 24 and 96 weeks after the surgery
Chnage of KSS(Knee Society Score)
The primary endpoint for the analysis is the change in the KSS at baseline and 48 weeks after the surgery (and 12, 24 and 96 weeks after the surgery).
Time frame: baseline and 48 weeks after the surgery and 12, 24 and 96 weeks after the surgery
Chnage of ICRS(International Cartilage Repair Society) score
The ICRS grades of the affected knee at baseline and 48 weeks after the surgery will be primarily compared
Time frame: baseline and 48 weeks after the surgery
Chnage of KOOS(Knee injury and osteoarthritis outcome) score
The primary endpoint for the analysis is the change in the KOOS at baseline and 48 weeks after the surgery (and 12, 24 and 96 weeks after the surgery).
Time frame: baseline and 48 weeks after the surgery and 12, 24 and 96 weeks after the surgery
Change of MRI and mMOCART result
The morphological improvement of MRI image for the affected knee at baseline will be compared with those at 48 weeks after the surgery (and 12, 24, and 96weeks after the surgery). The primary endpoint for the analysis is the change in the mMOCART at baseline and 48 weeks after the surgery (and 12, 24 and 96 weeks after the surgery).
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Time frame: baseline and 48 weeks after the surgery and 12, 24 and 96 weeks after the surgery
change in pain of 100mm Visual Analog Scale
The change in the 100mmVAS will be assessed at baseline and 12, 24 and 96 weeks after the surgery.
Time frame: baseline, 12, 24 and 96 weeks after the surgery