Osteochondral Lesion of Talus
Conditions
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
Interventions
BIOLOGICALCartistem
Cartistem is allogenic umbilical cord blood-derived stem cell product. Cartistem is 500uL/cm2 applied according to the lesion.
Sponsors
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Other
| Measure | Time frame |
|---|---|
| evaluate the efficacy of adding allogenic umbilical cord blood-derived stem cell product(Cartistem®) by ICRS arthroscopic scale for repair of articular cartilage | Baseline, Week 4, Week 8, Week 12, Week 24, Week 48 |
Countries
South Korea
Outcome results
None listed