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A clinical trial to evaluate the long-term efficacy and safety of Chondron (Autologous cultured Chondrocyte) administered through arthroscopy from the drug's 48 weeks efficacy and safety evaluation with 96 weeks follow-up in patients with knee cartilage defects.
This is an open trial, involving a total of 10 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 through arthroscopy |
|
| 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 compared to that at 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 baseline and 48weeks 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 |
|---|---|---|
| Sung Jae Kim, MD | Severance Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yonsei University Severance Hospital | Seoul | Seoul | South Korea |
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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 before 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 48weeks after the surgery and 12, 24 and 96 weeks after the surgery |
| Change of MRI and mMOCART result | The morphological improvement from MRI iamge of affected knee will be assessed at 48 weeks after the surgery from image at baseline (and 12, 24, and 96 weeks 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 at baseline, 12, 24 and 96 weeks after the surgery will be assessed. | baseline and 12, 24 and 96 weeks after the surgery |