Efficacy and Safety of Chondron (Autologus Chondrocyte) in Patients With Cartilage Defects in Their Ankle

A Phase III Clinical Trial to Evaluate the Efficacy and Safety of Chondron (Autologus Chondrocyte) in Patients With Cartilage Defects in Their Ankle for 18 Months

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.

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