Safety and Efficacy of Allogenic Umbilical Cord Blood-derived Mesenchymal Stem Cell Product (NCT02338375) | Clinical Trial Compass
UnknownEarly Phase 1
Safety and Efficacy of Allogenic Umbilical Cord Blood-derived Mesenchymal Stem Cell Product
South Korea28 participantsStarted 2012-12
Plain-language 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.
Who can participate
Age range20 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 â… : 0\~5㎜, Gradeâ…¡: 5\~10㎜, Grade â…¢: \>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 smo…
What they're measuring
1
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