An Open-label, Non-Randomized, Multi-Center Study to Assess the Safety and Effects of Autologous Adipose-Derived Stromal Cells Delivered Intra- Articularly in Patients With Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Change from Baseline in Visual Analogue Scale (VAS)
研究概览
简要总结
This will be an open-label, non-randomized, multi-center, patient sponsored study of Adipose-Derived Stromal Vascular Fraction (AD-SVF) implantation performed intra-articularly to affected joints.
The intent of this clinical study is to answer the questions: 1) Is the proposed treatment safe and 2) Is treatment effective in improving the disease pathology of patients with diagnosed Osteoarthritis.
详细描述
AD-SVF will be collected from the patient's adipose-derived tissue (body fat). Using local anesthesia, Liposuction will be performed to collect the adipose tissue specimen. The adipose tissue is then transferred to the laboratory for separation of AD-SVF. In addition, patient's peripheral blood will be collected for isolation of platelet rich plasma (PRP), which are then combined with the AD-SVF for intra-articular administration of affected joint.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and Females between Age 18 and 80 years.
- •Patient with current proven diagnosis of Osteoarthritis, with consistent symptomatology
- •Up to date on all age and gender appropriate cancer screening per American Cancer Society.
排除标准
- •Females who are pregnant or nursing or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study.
- •Life expectancy < 6 months due to concomitant illnesses.
- •Exposure to any investigational drug or procedure within 1 month prior to study entry or enrolled in a concurrent study that may confound results of this study.
- •Active infectious disease. Patients known to have tested positive for HIV, HTLV, HBV, HCV, CMV (IgM > IgG) and/or syphilis will have an expert consultation as to patient eligibility based on the patient's infectious status
- •Any illness which, in the Investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results
- •Patients on chronic immunosuppressive transplant therapy
- •Systolic blood pressure (supine) ≤90 mm Hg or greater than 180mmHg
- •Resting heart rate > 100 bpm;
- •Known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or who in the opinion of the investigator are not suitable to participate.
- •History of cancer (other than non-melanoma skin cancer or in-situ cervical cancer) in the last five years.
- •Active clinical infection
- •Unwilling and/or not able to give written informed consent.
研究组 & 干预措施
Autologous Adipose-derived Stromal Vascular Fraction infusion
Intervention: AD-SVF infusion directly into affected joints.
干预措施: Liposuction with Local Anesthesia (Procedure)
Autologous Adipose-derived Stromal Vascular Fraction infusion
Intervention: AD-SVF infusion directly into affected joints.
干预措施: Intra articular infusion of AD-SVF (Biological)
结局指标
主要结局
Change from Baseline in Visual Analogue Scale (VAS)
时间窗: 3 months, 6 months
For pain score, functional rating index, visual analog scale (VAS), physical therapy (PT), and range of motion (ROM) were determined as previously described. The patient was restricted from taking steroids, aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs) for one week prior to the procedure.
Number of adverse events reported
时间窗: 6 months
Change from Baseline of Quality of life scores
时间窗: 3 months, and 6 months
Change from Baseline of Reduction in analgesics
时间窗: Baseline, 3 months, 6 months
次要结局
- Change from Baseline in x-ray, sonogram, or MRI imaging of affected joint compared to baseline.(6 months)