Efficacy and Safety of Allogenic Stem Cell Product(CARTISTEM®) for Osteochondral Lesion of Talus

Inclusion criteria

• Talar chondral/osteochondral lesion confirmed by radiographical exam at screening or diagnosis, an AOFAS score of 75 or below
• Ankle joint pain/stiffness with no response to conservative treatment for more than 12 weeks
• Ankle joint cartilage injury of defect of ICRS grade Ⅳ in MRI
• Male or female aged more than 18
• A one-sided lesion
• Appropriate function of blood clot: PT(INR) < 1.5×ULN, aPTT <1.5×ULN
• Appropriate renal function: Creatinine ≤ 2.0 ㎎/㎗, Proteinuria ≤ trace
• Appropriate hepatic function: Total bilirubin ≤ 2.0 ㎎/㎗, AST/ALT ≤ 100 IU/L
• No evidence of auto-immune disorder: According to investigator's judgement based on relevent symtom and physical exam, anti-nuclear antibody and anti-thyroglobulin antibody tests are able to performed and confirmed negative (If positive, there are possible cases according to diagnostic opinion of medical department)
• No surgery or radiotherapy for the same ankle joint within 6 weeks
• Female patients agreeing with maintenance of contraception* during study period

*hormone contraceptive, implants of intrauterine device or intrauterine system, double barrier contraception[Concurrent use of diaphragm or cervical occlusive cap and male condom], surgical sterilisation, etc.

• No chronic ligament instability more than grade Ⅲ (Grade 0: none, Grade Ⅰ: 1~5㎜, GradeⅡ: 5~10㎜, Grade Ⅲ: >10㎜)
• Patients agreeing with participation in this study and signed on informed consent by their own will

Exclusion criteria

• Degenerative arthritis in ankle(Kellgren Lawrence Grade 3-4)
• Autoimmune disease
• Infectious disease need to administration of parenteral antibiotics
• Myocardial infarction, congestive heart failure, other serious cardiac disorder or uncontrolled resistant hypertension
• Serious medical disease(Ex. Kidney disease such as chronic renal failure or Glomerulonephritis, etc., acute/chronic liver disease such as liver cirrhosis, fatty liver etc., medical history of malignancy*)

*Complete remission status is possible.

• Pregnancy or breast-feeding
• Psychiatric history or epilepsy
• Alcohol abuse
• Heavy smoker
• Chronic inflammatory disease such as rheumatoid arthritis
• Participants other clinical trials within 4 weeks
• Administration of immunosuppressing agents such as Cyclosporin A or azathioprine within 6 weeks
• Patients with acute ligament injury and clinically significant chronic ligament instability
• Patients treated with surgery or cell therapy product for the same disease
• Patients with hypersensitivity or allergy history to bovine protein, hyaluronic acid and gentamicin
• Other inappropriate patients determined by the principal investigator