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
试验速览
- 阶段
- 1 期
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
same as above
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
standard treatment
standard treatment of arthroscopic curettage and microfracture for osteochondral lesion of talus
干预措施: Cartistem (Biological)
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.
干预措施: Cartistem (Biological)
结局指标
主要结局
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
时间窗: Baseline, Week 4, Week 8, Week 12, Week 24, Week 48
次要结局
- 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)