Exploratory Study of the Efficacy of HuMoSCs (Human Monocyte-derived Suppressor Cells) on Glandular Involvement in Sjögren's Syndrome (Immuno-DRYve)
Sjögren's syndrome is an autoimmune disease.
Dry syndrome is a key feature of this condition, almost always leading to dryness of the mouth and eyes. It manifests as a decrease in the production of saliva and tears, causing discomfort for patients. This chronic dryness contributes to oral and ocular conditions.
It is caused by lymphocytic infiltration of the exocrine glands, leading to their inflammation and subsequent fibrosis, which results in a decrease in fluid production by these glands.
This chronic inflammation causes fatigue in the patient. Furthermore, in 30 to 60% of cases, Sjögren's syndrome may involve extra-glandular involvement, most commonly affecting the joints, but also involving the lungs, nervous system, and kidneys. Additionally, patients with thisdisease have a higher risk of developing lymphoma compared to unaffected individuals.
The current treatment for Sjögren's syndrome is the same as that for dry eye syndrome; it is primarily symptomatic, involving lifestyle and dietary changes, the use of eye drops or oral lubricants, and medication to stimulate saliva production. To date, there is no medication available to treat Sjögren's syndrome and thus the cause of dry eye syndrome.
In our laboratory (INSERM 1098, UMR Right), we have developed cells that suppress the immune system (immunosuppressive cells) derived from human monocytes cultured ex vivo using a patented process called HuMoSC (Human Monocyte -derived Suppressor Cells). These cells possess strong immunosuppressive capacity, already demonstrated in vitro and in vivo in mouse models.
The aim of this study is to evaluate whether HuMoSCs can reduce the accumulation of immune cells and thereby decrease chronic inflammation and, in the longer term, limit the development of fibrosis (hardening with tissue destruction and scarring) in the salivary glands.
Biopsy of the accessory salivary glands is already part of the diagnostic process for Sjögren's syndrome. During this biopsy, additional accessory salivary glands will be collected and sent to the laboratory for this study. These glands will be cultured in the presence of HuMoSC supernatant, and the impact of this treatment will be analyzed.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Bernard BONNOTTE
- 电话号码:+33 03 80 29 34 32
- 邮箱:bernard.bonnotte@chu-dijon.fr
学习地点
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Dijon、法国、21000
- CHU Dijon Bourgogne
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接触:
- Bernard BONNOTTE
- 电话号码:+33 03 80 29 34 32
- 邮箱:bernard.bonnotte@chu-dijon.fr
-
-
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:
- A person who has given verbal consent
- A person exhibiting symptoms consistent with Sjögren's syndrome who is scheduled to undergo diagnostic testing
Exclusion Criteria:
- A person who is not enrolled in or eligible for a social security program
- A person subject to a legal guardianship order (curatorship, guardianship)
- A person subject to a court-ordered protective measure
- Pregnant women, women in labor, or breastfeeding women
- An adult who is legally incapacitated or unable to give consent
- A minor
学习计划
研究是如何设计的?
设计细节
- 主要用途:其他
- 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:Patients with Sjögren's syndrome
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Collect 4 green tubes for cells and 2 tubes for serum Sampling of two accessory salivary glands |
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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Percentage of the various subclasses of lymphocytes and macrophages
大体时间:24 months
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To identify, using immunohistochemistry and cytokine analysis, a reduction in inflammatory infiltration (lymphocytes and macrophages) of the accessory salivary glands in the presence of HuMoSC supernatant. |
24 months
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Concentrations of inflammatory and anti-inflammatory cytokines in the culture supernatants of accessory salivary glands cultured with or without HuMoSC supernatant.
大体时间:24 months
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24 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 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
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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