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The study was terminated early due to company reasons.
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The objective of this study is to evaluate the efficacy and safety of Chondron (Autologus Chondrocyte) in patients with cartilage defects in their ankle for 18 months
This is an open label trial, involving a total of 28 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 6* 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, x-ray, MRI tests and arthroscopy will be performed. *If tissue samples can be collected at screening visit, there will be only 5 visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autologous cultured Chondrocyte | Experimental | Subjects who give consent will be screened and those who meet trial criteria will receive CHONDRON (Autologous cultured Chondrocyte) by transplant. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CHONDRON | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Grade change of ICRS(International Cartilage Repair Society) by arthroscopy | The change of ICRS grade of the affected ankle shall be assessed at 12 months after the surgery. The results on the surgery date shall be considered the baseline data and shall be compared with those at 12 months after the surgery based on arthroscopy. For the final efficacy evaluation, the percentage of the patients (success rate) who showed Grade III or IV ICRS before the surgery and improved to Grade 0 or I after the surgery will be calculated. | 12 months after the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Score change of AOFAS(American orthopedic foot & ankle society) Score | The improvements in the AOFAS in the affected ankle at baseline and six, 12 and 18 months after the surgery will be compared. The final efficacy evaluation shall be done by calculating the difference between the AOFAS at the baseline and that 18 months after the surgery. | baseline and six, 12 and 18 months after the surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jin Su Kim, MD | Eulji General Hospital | Principal Investigator |
| Ki Hyuck Sung, MD | Myongji Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Myongji Hospital | Goyang-si | Gyeonggi-do | South Korea | |||
| Eulji General Hospital |
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| Hannover Score | The improvements in the Hannover score in the affected ankle at baseline and six, 12 and 18 months after the surgery will be compared. The final efficacy evaluation shall be done by calculating the difference between the Hannover score at the baseline and that 18 months after the surgery. | baseline and six, 12 and 18 months after the surgery |
| Score change of Evaluation by physician in charge | The improvement will be evaluated by the physician using a five-level scale six, 12 and 18 months after the Chondron grafting. | six, 12 and 18 months after the surgery |
| Score change of 100mmVAS(visual analogue scale) | The improvements of pain in the 100mmVAS in the affected ankle at baseline and six, 12 and 18 months after the surgery will be compared. The final efficacy evaluation shall be done by calculating the difference between the 100mmVAS at the baseline and that 18 months after the surgery. | baseline and six, 12 and 18 months after the surgery |
| Comparing MRI results | The morphological improvement from MRI image of the affected ankle will be assessed at 18 months after the surgery from those at baseline. For MRI image at baseline, the MRI should be performed within two weeks from the Chondron grafting for the efficacy evaluation. | baseline and 18 months after the surgery |
| Seoul |
| Seoul |
| South Korea |