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

Inclusion Criteria

• •1. Talar chondral/osteochondral lesion confirmed by radiographical exam at screening or diagnosis, an AOFAS score of 75 or below
• •2. Ankle joint pain/stiffness with no response to conservative treatment for more than 12 weeks
• •3. Ankle joint cartilage injury of defect of ICRS grade Ⅳ in MRI
• •4. Male or female aged more than 18
• •5. A one-sided lesion
• •6. Appropriate function of blood clot: PT(INR) \< 1.5×ULN, aPTT \<1.5×ULN
• •7. Appropriate renal function: Creatinine ≤ 2.0 ㎎/㎗, Proteinuria ≤ trace
• •8. Appropriate hepatic function: Total bilirubin ≤ 2.0 ㎎/㎗, AST/ALT ≤ 100 IU/L
• •9. 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)
• •10. No surgery or radiotherapy for the same ankle joint within 6 weeks
• •11. 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.
• •12. No chronic ligament instability more than grade Ⅲ (Grade 0: none, Grade Ⅰ: 1\~5㎜, GradeⅡ: 5\~10㎜, Grade Ⅲ: \>10㎜)
• •13. Patients agreeing with participation in this study and signed on informed consent by their own will