Safety and Efficacy of Allogenic Umbilical Cord Blood-derived Mesenchymal Stem Cell Product
Early Phase 1
- Conditions
- Osteochondral Lesion of Talus
- Interventions
- Biological: Cartistem
- Registration Number
- NCT02338375
- Lead Sponsor
- Samsung Medical Center
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 28
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
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description standard treatment Cartistem standard treatment of arthroscopic curettage and microfracture for osteochondral lesion of talus Cartistem Cartistem 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.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (1)
Samsung Medical Center
🇰🇷Gangnam-Gu, Seoul, Korea, Republic of