NCT02641860已完成1 期
A Phase I, Randomized, Single-centered, Double-blinded Clinical Trial of Allogenic Adipose Tissue-Derived Mesenchymal Progenitor Cells Therapy for Knee Osteoarthritis
Shanghai AbelZeta Ltd.1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2015年12月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- WOMAC Score
研究概览
简要总结
Evaluate the safety and efficacy of Allogenic Adipose Tissue-Derived Mesenchymal Progenitor Cells Therapy for Knee Osteoarthritis.
详细描述
A Phase I, Randomized, Single-centered, Double-blinded Clinical Trial of Allogenic Adipose Tissue-Derived Mesenchymal Progenitor Cells Therapy for Knee Osteoarthritis.
This is a randomized,single-blind, double-blinded,phase I clinical trial. Subjects who are with a clinical diagnosis of knee osteoarthritis cartilage defects and will be randomly distributed 1:1:1 to different dosage group after signing the ICF and screening tests.The treatment will accept Allogenic ReJoinTM at the first and fourth week.The duration of the therapy is 48 weeks.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Object has an allergic history or is of an allergic constitution.
- •Subjects who understand and sign the consent form for this study.
- •Age: 18-70, males and females.
- •Clinical diagnosis of degenerative arthritis by Radiographic Criteria of KellgrenLawrence:Duration of pain over Grade 4(11-point numeric scale)> 4 months.
- •Course of Knee osteoarthritis:6 months to 10 years;
- •The VAS score :3-8 points.(the data acquisition time is to stop using all analgesic at least 3 days ).
排除标准
- •The subject has an allergic history of medicine or food。.
- •The subject'BMI is over
- •The subject has uncontrolled or hard-to-control diseases of cardiovascular, liver, kidney or lung， endocrine system.
- •The subject has an history malignant tumour.
- •The subject has complications or diseases of: systemic or rheumatoid arthritis, Chondrocalcinosis articularis， Hemochromatosis，inflammatory arthropathy，avascular necrosis of femoral head，Paget's disease，hemophilic arthropathy，infectional arthritis，Charcot's disease，villonodular synovitis or synovial chondromatosis.
- •The subject has severe generalized infectious diseases or local knee infection in the 3 months prior to this trial.
- •The subject has disease of lower limbs which may be interfered knee evaluation, for example fibromyalgia, osphyalgia, lumbar disc protrusion and so on.
- •The subject has coagulation disorders.
- •The subject has received arthroscopic surgery or intra-articular operations in the 6 months prior to this trial.
- •The subject has received other intra-articular injections for KOA in the 6 months preceding the trial.
- •The subject has received aminoglucose or chondroitin sulfate in the 6 months preceding the trial.
- •The subject has plan of knee prosthesis within the trial.
- •The subject has contraindication of MRI, included but not only: the subject installed heart pacemaker、defibrillator、heart bracket、heart valve prosthesis、metal clip after aneurysm surgery、drug infusion device implanted in vivo、any electronic device implanted in the body（nerve stimulator、bone growth stimulator）、endovascular coil、strainer、ECG monitor、metal suture、shrapnel or sand of body, plate fixation and steel nail after fracture
- •- Page 4 of 4 [DRAFT] - surgery、artificial limb or joint、audiphone、artificial cochlea、middle ear shift plant、metallic intraocular foreign body etc； claustrophobia、pregnancy within 3 months、critically ill patients.
- •The subject tests positive for: HIV, hepatitis virus, syphilis or other infectious diseases.
- •The subject has history of alcoholism, drug abuse, or mental illness in the 3 years prior to this trial.
- •The subject has participated in any other clinical trial in the 3 months prior to this trial.
- •The subject is pregnant, lactating or planning to conceive within the next 6 months.
- •The subject has any other unsuitable or adverse condition to be determined by the investigator.
结局指标
主要结局
WOMAC Score
时间窗: 48 weeks
Safety, recording of Adverse Events and Serious Adverse Events
时间窗: 12 weeks,48 weeks
次要结局
- The volume of articular cartilage(48 weeks)
- WORMS Score(48 weeks)
- SF-36(48 Weeks)
- VAS Score(48 weeks)
研究者
研究点 (1)
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