NCT04310215已完成3 期
A Multi-center, Single-blind, Randomized, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Adding CARTISTEM® on Microfracture in Patients With Talar Chondral or Osteochondral Defect
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 6
- 主要终点
- ICRS-Cartilage Repair Assessment Total Score
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of adding CARTISTEM®(allogenic umbilical cord blood-derived stem cell product) on microfracture, a currently standard treatment for OLT, in patients with talar chondral or osteochondral defect.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Talar chondral/osteochondral lesion confirmed by radiographical exam at screening or diagnosis, an AOFAS score of 75 or below
- •Ankle joint pain/stiffness with no response to conservative treatment for more than 12 weeks
- •Ankle joint cartilage injury of defect of ICRS grade Ⅳ in MRI
- •Male or female aged more than 18
- •A one-sided lesion
- •Appropriate function of blood clot: PT(INR) < 1.5×ULN, aPTT <1.5×ULN
- •Appropriate renal function: Creatinine ≤ 2.0 ㎎/㎗, Proteinuria ≤ trace
- •Appropriate hepatic function: Total bilirubin ≤ 2.0 ㎎/㎗, AST/ALT ≤ 100 IU/L
- •No evidence of auto-immune disorder: According to investigator's judgement based on relevent symtom and physical exam, anti-nuclear antibody and anti-thyroglobulin antibody tests are able to performed and confirmed negative (If positive, there are possible cases according to diagnostic opinion of medical department)
- •No surgery or radiotherapy for the same ankle joint within 6 weeks
- •Female patients agreeing with maintenance of contraception* during study period
- •*hormone contraceptive, implants of intrauterine device or intrauterine system, double barrier contraception[Concurrent use of diaphragm or cervical occlusive cap and male condom], surgical sterilisation, etc.
- •No chronic ligament instability more than grade Ⅲ (Grade 0: none, Grade Ⅰ: 1~5㎜, GradeⅡ: 5~10㎜, Grade Ⅲ: >10㎜)
- •Patients agreeing with participation in this study and signed on informed consent by their own will
排除标准
- •Degenerative arthritis in ankle(Kellgren Lawrence Grade 3-4)
- •Autoimmune disease
- •Infectious disease need to administration of parenteral antibiotics
- •Myocardial infarction, congestive heart failure, other serious cardiac disorder or uncontrolled resistant hypertension
- •Serious medical disease(Ex. Kidney disease such as chronic renal failure or Glomerulonephritis, etc., acute/chronic liver disease such as liver cirrhosis, fatty liver etc., medical history of malignancy*)
- •*Complete remission status is possible.
- •Pregnancy or breast-feeding
- •Psychiatric history or epilepsy
- •Alcohol abuse
- •Heavy smoker
- •Chronic inflammatory disease such as rheumatoid arthritis
- •Participants other clinical trials within 4 weeks
- •Administration of immunosuppressing agents such as Cyclosporin A or azathioprine within 6 weeks
- •Patients with acute ligament injury and clinically significant chronic ligament instability
- •Patients treated with surgery or cell therapy product for the same disease
- •Patients with hypersensitivity or allergy history to bovine protein, hyaluronic acid and gentamicin
- •Other inappropriate patients determined by the principal investigator
研究组 & 干预措施
Microfracture + CARTISTEM®
Experimental
CARTISTEM® is added on the lesion as a single dose of 500 ㎕/㎠ according to the defect size after arthroscopic curettage and microfracture.
干预措施: CARTISTEM® (Biological)
Microfracture
Active Comparator
Standard treatment of arthroscopic curettage and microfracture is performed for cartilage defect.
干预措施: Microfracture (Procedure)
结局指标
主要结局
ICRS-Cartilage Repair Assessment Total Score
时间窗: Week 48
Arthroscopic evaluation of articular cartilage repair : The score range from 12(normal) to 1(severely abnormal) where lower scores indicate more severity of injury
次要结局
- ICRS-Cartilage Repair Assessment Overall Grade(Week 48)
- Improvement degree of Cartilage Repair by MRI(Week 0 and 48)
- Degree of Functional improvement in FAOS(Foot & Ankle Outcome Score)(Week 0, 24 and 48)
- Degree of Functional improvement in AOFAS(The American Orthopaedic Foot & Ankle Score)(Week 0, 24 and 48)
- Degree of Functional improvement in Tegner activity score(Week 0, 24 and 48)
- Degree of Quality of Life improvement in SF-36(Short Form Health Survey-36)(Week 0, 24 and 48)
- Degree of pain improvement in 100 mm VAS(Visual Analogue Scale)(Week 0, 24 and 48)
研究者
研究点 (6)
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