Efficacy and Safety of Chondron (Autologus Chondrocyte) in Patients With Cartilage Defects in The… (NCT02537067) | Clinical Trial Compass
TerminatedPhase 3
Efficacy and Safety of Chondron (Autologus Chondrocyte) in Patients With Cartilage Defects in Their Ankle
Stopped: The study was terminated early due to company reasons.
South Korea28 participantsStarted 2010-01
Plain-language 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
Who can participate
Age range15 Years – 65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Grade change of ICRS(International Cartilage Repair Society) by arthroscopy