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

Study Overview
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Brief Summary
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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.

Detailed Description
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same as above

Official Title
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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

Conditions
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Osteochondral Lesion of Talus

Intervention / Treatment
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* Biological: Cartistem


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cartistem<br>For control group patients currently standard treatment of arthroscopic curettage and microfracture is performed, and for study group patients allogenic umbilical cord blood-derived mesenchymal stem cell product(Cartistem®) is added on the lesion after above mentioned procedure. | Biological: Cartistem<br>* Cartistem is allogenic umbilical cord blood-derived stem cell product. Cartistem is 500uL/cm2 applied according to the lesion.<br>|
| Active Comparator: standard treatment<br>standard treatment of arthroscopic curettage and microfracture for osteochondral lesion of talus | Biological: Cartistem<br>* Cartistem is allogenic umbilical cord blood-derived stem cell product. Cartistem is 500uL/cm2 applied according to the lesion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluate the efficacy of adding allogenic umbilical cord blood-derived stem cell product(Cartistem®) by American Orthopaedic Foot and Ankle Society(AOFAS) HINDFOOT/ANKLE SCALE |  | Baseline, Week 4, Week 8, Week 12, Week 24, Week 48 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluate the efficacy of adding allogenic umbilical cord blood-derived stem cell product(Cartistem®) by 100-mm VAS(Visual Analogue Scale) |  | Baseline, Week 4, Week 8, Week 12, Week 24, Week 48 |