NCT05526898尚未招募不适用
Multi-Center, Randomized Controlled Trial Evaluating the Effect of Adipose Tissue Processed With the SyntrFuge™ System for Knee Osteoarthritis
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 180
- 试验地点
- 4
- 主要终点
- WOMAC
研究概览
简要总结
This is an multi-center study with the aim of evaluating the efficacy of adipose tissue processed with the SyntrFuge™ system in Orthopedic Surgery, specifically Knee Osteoarthritis. Patients will be enrolled to the treatment group with adipose tissue processed with the SyntrFuge™ system followed by an injection of autologous microsized adipose tissue in the treatment sites or Standard of Care.
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 (Outcomes Assessor)
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
- 是
入选标准
- •Subjects aged of 35-80 years old
- •Patients with knee osteoarthritis grade II, III, and IV Kellgren-Lawrence
- •Chronic knee pain or symptoms for at least 3 months
- •BMI between 20 and 34.9
- •Willing and able to read and sign the informed consent and other study materials
- •Written informed consent has been obtained prior to any study-related procedures
- •Written Authorization for Use and Release of Health and Research Study Information has been signed
- •Subjects are ambulatory
- •Subject is willing and able to comply with study instructions and commit to all follow-up visits for the duration of the study
- •Females of childbearing potential must have a negative urine pregnancy test result and not be lactating
- •Subject is in good general health and free of any systemic disease state or physical condition that might impair evaluation or which in the Investigator's opinion, exposes the Subject to an unacceptable risk by study participation
排除标准
- •Subjects with previous traumatic lesion (tibial fracture, osteothomy) of the knee
- •Subjects with osteonecrosis
- •Subjects with meniscal surgery in the previous 6 weeks
- •Subjects with gout, hyperlipidemia
- •Subjects without decisional capacity
- •Subjects with inflammatory arthritis
- •Subjects with active infection
- •Subjects with any uncontrolled systemic disease
- •Subjects with a history of severe allergic/anaphylactic reactions or multiple allergies
- •Subjects planning to become pregnant, are pregnant, or are breast-feeding
- •Subjects with history or current evidence of drug or alcohol abuse within 36 months prior to screening visit
- •Subjects who have active autoimmune disease
- •Subjects who have coagulation disorders
- •Subjects who have received any other therapy, which, in the opinion of the investigator, could interfere with safety or efficacy evaluations
- •Subjects with current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study
- •Subjects with any other condition that, in the opinion of the investigator, makes the subject inappropriate to take part in this study
- •Subjects who have received anti-coagulation, anti-platelet, or thrombolytic medications (e.g., warfarin), anti- inflammatory drugs (NSAIDs, e.g., aspirin, ibuprofen), or other substances known to increase coagulation time from 7 days pre- to 3 days post injection. A wash out period of 7 days is allowed
- •Subjects who have undergone immunosuppressive therapy, chemotherapy, biologics or systemic corticosteroids within 3 months prior to each study visit.
- •No intra-articular injection of corticosteroids within the last 24 weeks
- •No intra-articular injection of any other cellular therapy within the last 24 weeks
研究组 & 干预措施
SyntrFuge System
Experimental
Adipose tissue microsized via the SyntrFuge System
干预措施: SyntrFuge System (Device)
Standard of Care
Other
Steroid Injection
干预措施: Triamcinolone Injection (Drug)
结局指标
主要结局
WOMAC
时间窗: 6 months, 12 months, 24 months
Change of WOMAC Score from Baseline
次要结局
- Knee Injury and Osteoarthritis Outcomes Score (KOOS)(6 months, 12 months, 24 months)
- Single Assessment Numerical Evaluation(6 months, 12 months, 24 months)
研究者
研究点 (4)
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