Clinical trial NCT02338375: Safety and Efficacy of Allogenic Umbilical Cord Blood-derived Mesenchymal Stem Cell Product
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Osteochondral Lesion of Talus
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2015-01-14
Enrollment: 28
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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
* 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

Primary outcomes:
measure: 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
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 48
Secondary outcomes:
measure: evaluate the efficacy of adding allogenic umbilical cord blood-derived stem cell product(Cartistem®) by 100-mm VAS(Visual Analogue Scale)
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 48
Other outcomes:
measure: evaluate the efficacy of adding allogenic umbilical cord blood-derived stem cell product(Cartistem®) by ICRS arthroscopic scale for repair of articular cartilage
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 48
Locations:
city: Gangnam-Gu
country: Korea, Republic of
facility: Samsung Medical Center
state: Seoul
Study officials:
References: