NCT03166410Unknown不适用
Use of Autologous Adipose-Derived Stromal Vascular Fraction To Treat Osteoarthritis of Hip, Knee, Ankle, and Thumb Joints
Texas Plastic Surgery2 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2017年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Safety - Incidence of Treatment-Emergent Adverse Events
研究概览
简要总结
This study will examine the safety and efficacy of autologous adipose-derived stromal vascular fraction (SVF) cells for treatment of hip, knee and thumb osteoarthritis (OA); monitoring adverse events and measuring pain, function and stiffness in the joints of osteoarthritic subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Grade II through Grade IV hip, knee, ankle osteoarthritis using Kellgren-Lawrence grading scale (K-L Grade) as diagnosed using weight bearing X-ray, physician review, and/or pre-op MRI
- •Stage II through IV carpometacarpal (CMC) osteoarthritis using Eaton-Little's staging of CMC OA as diagnosed by X-ray and physical examination
- •Study Subjects must be willing to voluntarily give written Informed Consent to participate in the study and sign the Health Insurance Portability and Accountability Act (HIPAA) authorization before any study procedures are performed
- •Subjects with ASA grade I, II, or III
- •Males and females 25-85 years old
- •Subjects must have continued pain in their targeted/treatment joint despite conservative therapies for at least 3 months
排除标准
- •Subjects that are allergic to lidocaine, epinephrine or valium
- •Subjects with a history of bleeding disorders, anticoagulation therapy that cannot be stopped as follows prior to injection; Thrombolytics and anti-platelet medication including but not limited to Coumadin (warfarin) for 3 days, Plavix (clopidogrel) for 3 days, acetylsalicylic acid (ASA)/NSAIDs/fish oil supplements for 7 days, Xeralta® (rivaroxaban) for 24 hours
- •Subjects with systemic immunosuppressant use within six (6) weeks from screening and subjects with HIV/viral hepatitis
- •Subjects with chondrocalcinosis, Paget's disease and Villonodular synovitis
- •Women that are pregnant or planning to become pregnant during the study
- •Subjects on long term use of oral steroids
- •History of any chemotherapy or radiation therapy on the targeted/treatment joint or adipose harvest site
结局指标
主要结局
Safety - Incidence of Treatment-Emergent Adverse Events
时间窗: 1 year
Subjects will be monitored for adverse events
次要结局
- Efficacy - Change in Pain Scores at All Follow-up Visits(3 months, 6 months, 1 year, 2 years)
研究者
Jaime R. Garza, MD
Principal Investigator
Texas Plastic Surgery
研究点 (2)
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