Ankle (Ligaments); Instability, Familial, Defect of Articular Cartilage, Degenerative Joint Disease of Ankle and/or Foot
Conditions
Keywords
a partial cartilage defect of ankle, Chondron, Autologus Chondrocyte
Brief summary
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
Detailed description
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.
Interventions
DRUGCHONDRON
1. Harvesting of ankle or knee cartilage 2. The cells that fill the vial are sufficiently suspended, and a sufficient amount of suspension is grafted in the defect with fibrin glue.
Sponsors
Sewon Cellontech Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female subjects aged 15 to 65 years * Patients with MRI-confirmed partial cartilage defects of the ankle (≤15 cm² single lesion, ≤20 cm² multiple lesions) * Patients who have undergone correction for malalignment, ligament instability, or bone defects (if applicable) * Patients with normal surrounding cartilage * Patients with ICRS Grade III or IV cartilage defects * Subjects who provide written informed consent
Exclusion criteria
* Hypersensitivity to bovine protein or gentamicin * Inflammatory or autoimmune arthritis (e.g., rheumatoid arthritis, gout) * Pregnant, breastfeeding, or planning pregnancy * Tumors or serious comorbid conditions * History of radiotherapy or chemotherapy within 2 years * Uncontrolled diabetes or diabetes with complications * Active infection requiring antibiotics * Current corticosteroid therapy * Patients with mental illness or other conditions deemed unsuitable for this study by the clinical trial manager
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Grade change of ICRS(International Cartilage Repair Society) by arthroscopy | 12 months after the surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Score change of AOFAS(American orthopedic foot & ankle society) Score | baseline and six, 12 and 18 months after the surgery | 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. |
| Hannover Score | baseline and six, 12 and 18 months after the surgery | 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. |
| Score change of Evaluation by physician in charge | six, 12 and 18 months after the surgery | The improvement will be evaluated by the physician using a five-level scale six, 12 and 18 months after the Chondron grafting. |
| Score change of 100mmVAS(visual analogue scale) | baseline and six, 12 and 18 months after the surgery | 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. |
| Comparing MRI results | baseline and 18 months after the surgery | 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. |
Countries
South Korea
Contacts
PRINCIPAL_INVESTIGATORJin Su Kim, MD
Eulji General Hospital
PRINCIPAL_INVESTIGATORKi Hyuck Sung, MD
Myongji Hospital
Outcome results
None listed