NCT02338375
Unknown
Early Phase 1
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
ConditionsOsteochondral Lesion of Talus
Overview
- Phase
- Early Phase 1
- Intervention
- Not specified
- Conditions
- Osteochondral Lesion of Talus
- Sponsor
- Samsung Medical Center
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- 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
- Last Updated
- 11 years ago
Overview
Brief Summary
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
same as above
Investigators
ChulWon Ha
MD
Samsung Medical Center
Eligibility Criteria
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
Outcomes
Primary Outcomes
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
Time Frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 48
Secondary Outcomes
- 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)
Study Sites (1)
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