Safety and Efficacy of Allogenic Umbilical Cord Blood-derived Mesenchymal Stem Cell Product
NCT ID: NCT02338375
Last Updated: 2015-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
EARLY_PHASE1
28 participants
INTERVENTIONAL
2012-12-31
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
Cartistem
Cartistem is allogenic umbilical cord blood-derived stem cell product. Cartistem is 500uL/cm2 applied according to the lesion.
standard treatment
standard treatment of arthroscopic curettage and microfracture for osteochondral lesion of talus
Cartistem
Cartistem is allogenic umbilical cord blood-derived stem cell product. Cartistem is 500uL/cm2 applied according to the lesion.
Interventions
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Cartistem
Cartistem is allogenic umbilical cord blood-derived stem cell product. Cartistem is 500uL/cm2 applied according to the lesion.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
70 Years
ALL
No
Sponsors
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Samsung Medical Center
OTHER
Responsible Party
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ChulWon Ha
MD
Locations
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Samsung Medical Center
Gangnam-Gu, Seoul, South Korea
Countries
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Other Identifiers
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2012-10-078
Identifier Type: -
Identifier Source: org_study_id
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