NCT02784964已完成1 期
A Phase I/II Study to Evaluate the Safety and Efficacy of the Allogeneic Injection of Expanded Adipose-derived Stem Cells to Patients With Knee Osteoarthritis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 4
- 主要终点
- Changes from baseline to post-treatment visit of WOMAC pain score at week 24 after treatment
研究概览
简要总结
- To assess the safety of allogeneic injection of expanded ADSCs to patients with knee osteoarthritis
- To assess the efficacy of allogeneic injection of expanded ADSCs to patients with knee osteoarthritis
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 40-80 years (inclusive)
- •Kellgren-Lawrence grading I-III, as determined by American College of Rheumatology (ACR) criteria for osteoarthritis of the knee
- •Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score of 7-17 in the study knee even if treated with chronic doses of non steroidal anti-inflammatory drugs
- •Having provided informed consent
排除标准
- •With previous surgery of articular fracture, ligament reconstruction, meniscal reconstruction, and knee arthroplasty on the target knee joint
- •With previous intra-articular intervention on the target knee joint within past 3 months (e.g. steroid, anaesthetic, sodium hyaluronate)
- •Known or suspected infection of the target knee joint
- •Ascertained hypersensitivity to any component used in the study
- •Administered with systemic anti-inflammatory drugs (e.g. non-steroidal anti-inflammatory drug or steroid ) or topical anti-inflammatory drugs on target knee within 7 days prior to administration in the study
- •With serious prior or ongoing medical conditions (e.g. concomitant illness such as cardiovascular (e.g. New York Heart Association grade III or IV), hepatic (e.g. Child-Pugh Class C), psychiatric condition, alcoholism, drug abuse), medical history, physical findings, , or laboratory abnormality that in the investigators' opinion could interfere with the results of the trial or adversely affect the safety of the patient
- •With any evidence of malignant disease with life expectancy of less than 1 year
- •Pregnant or lactating women or planning to be pregnant during the study period
- •With body mass index (BMI) greater or equal to 35 kg/m2
- •With joint diseases except knee osteoarthritis considered by investigator not eligible to enter the study
- •With known history of human immunodeficiency virus (HIV) infection.
- •Judged to be not applicable to this study by investigator such as difficulty of follow-up observation
- •With any other serious diseases/medical history considered by the investigator not in the condition to enter the trial
- •Having participated other investigational study within 4 weeks of entering this study
- •With known history of claustrophobia
- •Having any existing active/inactive implanted medical devices, such as cardiac pacemaker, cochlear, intracranial vascular clips or neurostimulator, etc...
- •Having any existing metallic intraocular foreign body
结局指标
主要结局
Changes from baseline to post-treatment visit of WOMAC pain score at week 24 after treatment
时间窗: Weeks 0, 24
Incidence of adverse events (AEs) and serious adverse events (SAEs)
时间窗: Week 48
次要结局
- Total non-steroidal anti-inflammatory drug (NSAID) consumption amount during the first 48 weeks and week 48 to week 96(Weeks 0, 2, 4, 12, 24)
- Changes from baseline to week 96 visit in cartilage thickness in the total femorotibial joint by centralized (independent) imaging interpretation.(Weeks 0, 24, 48, 72, 96)
- Number of patients with clinically abnormal laboratory values and/or adverse events that are related to treatment(Weeks 0, 2, 4, 12, 24, 36, 48, 72, 96)
- Time to subject first time consumes acetaminophen(Weeks 0, 2, 4, 12, 24)
- Changes from baseline to post-treatment visits of MRI examination results(Weeks 0, 24, 48, 72, 96)
- Changes from baseline to post-treatment visits of total score, and sub-scores of all sections in WOMAC(Weeks 0, 2, 4, 12, 36, 48)
- Changes from baseline to post-treatment visits of scores of sections in Knee Society Clinical Rating System (KSCRS) Score(Weeks 0, 2, 4, 12, 24, 36, 48)
- Time to subject first time consumes non-steroidal anti-inflammatory drug (NSAID)(Weeks 0, 2, 4, 12, 24)
- Changes from baseline to post-treatment visits of Visual Analogue Scale (VAS) to measure Pain Levels(Weeks 0, 2, 4, 12, 24, 36, 48)
- Total acetaminophen consumption amount during the first 48 weeks and week 48 to week 96(Week 0, 2, 4, 12, 24, 48, 96)
- Number of patients with clinically abnormal vital signs and/or adverse events that are related to treatment(Weeks 0, 2, 4, 12, 24, 36, 48, 72, 96)
研究者
研究点 (4)
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