Safety and Efficacy of Allogenic Umbilical Cord Blood-derived Mesenchymal Stem Cell Product

Early Phase 1

• Conditions: Osteochondral Lesion of Talus

• 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

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2013-07-31
• Status Verified: 2015-01
• Study First Submitted QC: 2015-01-11
• Last Update Submitted: 2015-01-11
• Study First Posted: 2015-01-14
• Last Update Posted: 2015-01-14
• Primary Completion: 2015-08
• Study Completion: 2015-12

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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

Samsung Medical Center

🇰🇷Gangnam-Gu, Seoul, Korea, Republic of