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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chondron Implantation | Experimental | Chondron Implantation for the subject with cartilage defect |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chondron Implantation | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 48 weeks after the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | baseline and 48 weeks after the surgery and 12, 24 and 96 weeks after the surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Myung Ku Kim, MD | Inha University Hospital | Principal Investigator |
| Jae Doo Yoo, MD | Ewha Womans University Mokdong Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inha Univerisity Hospital | Incheon | Incheon | South Korea | |||
| Ewha Womans University Mokdong Hospital |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| 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). | 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 | 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). | 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). | 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. | baseline, 12, 24 and 96 weeks after the surgery |
| Seoul |
| Seoul |
| South Korea |