Safety and Efficacy of Allogenic Umbilical Cord Blood-derived Mesenchymal Stem Cell Product

Clinical Trial of the Safety and Efficacy of Allogenic Umbilical Cord Blood-derived Mesenchymal Stem Cell Product With Microfracture for Osteochondral Lesion of Talus Patients

The purpose of this study is to evaluate the safety and efficacy of adding allogenic umbilical cord blood-derived stem cell product(Cartistem®) on currently standard treatment of arthroscopic curettage and microfracture for osteochondral lesion of talus.

same as above

Inclusion Criteria:

• Non-responder to conservative treatment for radiographically confirmed (by MRI) osteochondral lesion of talus with ankle pain and/or stiffness and less than 75 of the AOFAS score
• Age between 20 and 70 year-old
• Appropriate function of blood clot PT(INR) < 1.5, APTT <1.5×control
• Appropriate renal function Creatinine ≤ 2.0 ㎎/㎗, proteinuria less than trace with Dipstick urine test
• Appropriate hepatic function Bilirubin ≤ 2.0 ㎎/㎗, AST/ALT ≤ 100 IU/L
• No evidence of autoimmue disorder As screening test anti-nuclear antibody and/or anti-thyroglobulin antibody, if positive rheumatologist referral needed to confirm diagnosis
• No surgery or radiotherapy for the same ankle joint within 6 weeks
• Female patients agreeing with maintenance of contraception during study period
• No ligament instability greater than grade II (Grade 0 : none, Grade Ⅰ: 0~5㎜, GradeⅡ: 5~10㎜, Grade Ⅲ: >10㎜) with physical exam
• Patients agreeing with participation in this study and signed on informed consent by their own will

Exclusion Criteria:

• Degenerative ankle arthritis patients
• Patients with autoimmune disease
• Patients with infectious disease needed parenteral antibiotics
• Patients with myocardial infarction, congestive heart failure, other serious heart diseases or uncontrollable hypertion
• Patients with other serious medical illness
• Pregnancy or breast feeding patients
• Past history related with psychiatric illness or epilepsy
• Alcoholic abuse
• Heavy smoker
• Chronic inflammatory disease including rheumatoid arthritis
• Participants of other clinical trial within 4 weeks
• Patients treated with immunosuppressing agents such as Cyclosporin A or azathioprine within 6 weeks
• Unstable ankle joint(lesion site) greater than grade II at physical exam (Grade 0 : none, grade Ⅰ: 0~5㎜, GradeⅡ: 5~10㎜, Grade Ⅲ: >10㎜)
• Other inappropriate patients determined by the prinicipal investigator