The Effects of Stromal Vascular Fraction and Mesenchymal Stem Cells as Intra-articular Injection in Knee Joint Osteoarthritis
2020年3月16日 更新者：SCARM Institute, Tabriz, Iran
Evaluation the Effects of Intra-articular Injection of Mesenchymal Stem Cells and Stromal Vascular Fraction Patients With Knee Joint Osteoarthritis, Triple Blind Randomized Clinical Trial
Osteoarthritis of the knee is one of the most common causes of disability among elderly.
As the disease progresses the cartilage become frustrated, surrounding bone react to become thicker and inflammation occurs in subchondral bone seen in T2-weighted MRI as increase in signal density.
Patients are treated initially by pain management.
In patients who don't response to first line treatment invasive treatment like total knee replacement is done.
The investigators designed this clinical study with the aim of evaluating therapeutic effects of intra-articular injection of bone marrow Mesenchymal Stem Cells (MSC) and stromal Vascular Fraction (SVF) in patients with severe knee osteoarthritis
研究概览
详细说明
This is single center, randomized, triple blind phase II clinical study.
Patients will be divided into two groups of case and control.
All subjects will undergo bone marrow aspiration.
Mesenchymal Stem Cells will be isolated from bone marrow and stromal Vascular Fraction fram lipoaspirate, cultured and transplanted back to the knee joint.
Patients of case group will receive cell injection 1 and 4 months after bone marrow aspiration.
Placebo will be administered in this group 6 months after the first injection.
Patients of control group will receive placebo 1 and 4 months after bone marrow aspiration.
They all receive cell injection 6 months after first placebo injection.
Follow up visit will occur at 2 and 6 weeks, and 3 and 6 months after the first injection.
Radiological exams will be performed before and 6 months after the first injection by MRI.
Clinical quantitative assessment will measure joint function by the WOMAC index and pain by the visual analogue scale
研究类型
介入性
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Tabriz、伊朗伊斯兰共和国
- SCARM Institute
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
25年 至 65年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Osteoarthritis diagnosed by MRI
Exclusion Criteria:
- Pregnancy or lactating
- Positive tests for HIV, Hepatitis C virus (HCV), Hepatitis C virus (HBV)
- Active neurologic disorder
- End organ damage
- Uncontrolled endocrine disorder
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：mesenchymal stem cell
Patients with knee joint osteoarthritis who underwent intra articular mesenchymal stem cell injection
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intra articular injection of mesenchymal stem cell Other Name: stem cell transplantation
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实验性的：placebo
The patients who are in control group and underwent placebo injection
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Patients with knee joint osteoarthritis who underwent intra articular placebo injection
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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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physical function improvement
大体时间：2 weeks
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Evaluation the physical function improvement Measured by WOMAC osteoarthritis index after cell injection
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2 weeks
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Change in pain density
大体时间：2 weeks
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Evaluation the changing of pain density measured by Visual Analogue Scale after cell injection
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2 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Joint swelling
大体时间：3 months
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Evaluation the joint swelling by physical examination after intra articular cell injection
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3 months
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Joint erythema
大体时间：3 months
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Evaluation the joint erythema by physical examination after cell injection
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3 months
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Deterioration of joint function
大体时间：3 months
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Evaluation the deterioration of joint function by physical examination after intra articular cell injection
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3 months
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Allergic reactions
大体时间：3 months
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Evaluation the allergic reactions like skin rash,skin erythema, dyspnea by physical examination after cell injection
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3 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Seyed Kazem Shakouri, Physiatrist、Tabriz University of Medical Sciences
- 首席研究员：Neda keyhanvar, Ph.D、SCARM Institute
- 首席研究员：Sepideh Bastani, MSc、SCARM Institute
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Pak J, Lee JH, Park KS, Park M, Kang LW, Lee SH. Current use of autologous adipose tissue-derived stromal vascular fraction cells for orthopedic applications. J Biomed Sci. 2017 Jan 31;24(1):9. doi: 10.1186/s12929-017-0318-z.
- Pak J, Lee JH, Kartolo WA, Lee SH. Cartilage Regeneration in Human with Adipose Tissue-Derived Stem Cells: Current Status in Clinical Implications. Biomed Res Int. 2016;2016:4702674. doi: 10.1155/2016/4702674. Epub 2016 Jan 6.
- Koh YG, Choi YJ, Kwon SK, Kim YS, Yeo JE. Clinical results and second-look arthroscopic findings after treatment with adipose-derived stem cells for knee osteoarthritis. Knee Surg Sports Traumatol Arthrosc. 2015 May;23(5):1308-16. doi: 10.1007/s00167-013-2807-2. Epub 2013 Dec 11.
- Pires de Carvalho P, Hamel KM, Duarte R, King AG, Haque M, Dietrich MA, Wu X, Shah F, Burk D, Reis RL, Rood J, Zhang P, Lopez M, Gimble JM, Dasa V. Comparison of infrapatellar and subcutaneous adipose tissue stromal vascular fraction and stromal/stem cells in osteoarthritic subjects. J Tissue Eng Regen Med. 2014 Oct;8(10):757-62. doi: 10.1002/term.1565. Epub 2012 Jul 16.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (预期的)
2019年11月10日
初级完成 (预期的)
2020年8月21日
研究完成 (预期的)
2020年12月5日
研究注册日期
首次提交
2017年5月21日
首先提交符合 QC 标准的
2017年5月21日
首次发布 (实际的)
2017年5月23日
研究记录更新
最后更新发布 (实际的)
2020年3月18日
上次提交的符合 QC 标准的更新
2020年3月16日
最后验证
2019年1月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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Ohio State UniversityUniversity of Chicago; National Institutes of Health (NIH); Resilient Games Studio终止
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Oregon Research Behavioral Intervention Strategies...National Institute on Minority Health and Health Disparities (NIMHD)完全的
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