Intestinal Mesenchymal Stem Stells and Inflammatory Bowel Diseases (COSMIC)
Characterization of Mesenchymal Stem Cells From the Colon and Small Intestine of Patients With Inflammatory Bowel Disease - The COSMIC Study
研究概览
地位
条件
详细说明
Primary and secondary objectives:
Main Objective: Characterize morphologically, molecularly and functionally the MSCs of colon and small intestine of patients with IBD and compared to MSCs of colon and small intestine of control patients.
Secondary objectives: To study the reaction of colon and small intestine MHC in patients with IBD following stimulation with bacterial compounds.
Methodology:
Clinical study exploratory translational physiopathological. Two groups of patients with Crohn's disease and ulcerative colitis who require colonoscopy or surgery for intestinal resection will be included. These two groups will be compared to a control group consisting of patients requiring colonoscopy for screening or intestinal resection for colorectal cancer or diverticulum.
Intestinal sampling by biopsy during the colonoscopy or with surgical specimen during the surgery will be performed to isolate the MSCs.
The outcome measures will be a qualitative and quantitative analysis of MSCs by immunohistochemistry, immunofluorescence, cell proliferation and differentiation, production of pro- and anti-inflammatory cytokines in the basal state and after bacterial stimulation.
Total of 60 patients (20 in groups, 15 with colonoscopy and 5 with surgical specimens).
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
-
Montpellier、法国、34080
- Hôpital St Eloi
-
-
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:
For IBD patients :
- Age between 18 and 75 year old
- Diagnosis of Crohn's disease or ulcertaive colitis according to internationla guidelines
- Endoscopically active disease
- Indication for colonoscopy or intestinal resection according to standard of care
- Written inform consent
For control patients :
- Age between 18 and 75 year old
- Indication for screening colonoscopy for irritable bowel syndrome, diverticulum or colorectal cancer surveillance according to standard of care
- Indication for intestinal resection for diverticulum or colorectal cancer according to standard of care
- Written inform consent
Exclusion criteria:
For IBD patients :
- Active intestinal infection
- Confirmed intestinal parasitosis
- Intestinal stoma
For control patients :
- Active intestinal infection
- Confirmed intestinal parasitosis
- Intestinal inflammation at colonoscopy
- Chronic intestinal inflammation on biopsies
- Absence of healthy tissue on surgical specimen
学习计划
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他：Crohn's disease patient group
Intestinal biopsies during colonoscopy or biopsies taken on surgical specimen after intestinal resection
|
Intestinal biopsies during colonoscopy
biopsies taken on surgical specimen after intestinal resection
|
|
其他：Ulcerative colitis patient group
Intestinal biopsies during colonoscopy or biopsies taken on surgical specimen after intestinal resection
|
Intestinal biopsies during colonoscopy
biopsies taken on surgical specimen after intestinal resection
|
|
其他：Control group
Intestinal biopsies during colonoscopy or biopsies taken on surgical specimen after intestinal resection
|
Intestinal biopsies during colonoscopy
biopsies taken on surgical specimen after intestinal resection
|
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 |
|---|---|---|
|
Proliferation and differentiation of intestinal MSCs in IBD patients.
大体时间：1 month
|
Proliferation and differentiation of intestinal MSCs in IBD patients.
|
1 month
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Comparison of MSCs between IBD patients and control patients
大体时间：1 month
|
Comparison of MSCs between IBD patients and control patients using mmunohistochemistry, immunofluorescence, quantification of pro- and anti-inflammatory cytokines production.
|
1 month
|
合作者和调查者
调查人员
- 首席研究员：Guillaume Pineton de Chambrun、University Hospital, Montpellier
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 (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
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.