Autologous Adipose-Derived Stromal Cells Delivered Intra-articularly in Patients With Osteoarthritis.
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
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.
研究概览
详细说明
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Florida
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Aventura、Florida、美国、33180
- Ageless Institute LLC
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Autologous Adipose-derived Stromal Vascular Fraction infusion
Intervention: AD-SVF infusion directly into affected joints.
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Liposuction under tumescent anesthesia for adipose tissue harvesting.
其他名称:
Adipose tissue is available in most patients for harvest through minimally invasive procedures such as liposuction. AD-SVF can be obtained in large quantities after processing of adipose tissue in the laboratory.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change from Baseline in Visual Analogue Scale (VAS)
大体时间:3 months, 6 months
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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.
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3 months, 6 months
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Change from Baseline of Quality of life scores
大体时间:3 months, and 6 months
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3 months, and 6 months
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Change from Baseline of Reduction in analgesics
大体时间:Baseline, 3 months, 6 months
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Baseline, 3 months, 6 months
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报告的不良事件数
大体时间:6个月
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6个月
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Change from Baseline in x-ray, sonogram, or MRI imaging of affected joint compared to baseline.
大体时间:6 months
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6 months
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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