Characterization of Mesenchymal Stem Cells From the Colon and Small Intestine of Patients With Inflammatory Bowel Disease - The COSMIC Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Proliferation and differentiation of intestinal MSCs in IBD patients.
研究概览
简要总结
The exact origin of inflammatory bowel disease (IBD) is still unknown. The current hypothesis is that IBD is secondary to an abnormal intestinal immun response directed to all or part of the intestinal flora in genetically predisposed individuals. Several experimental studies have demonstrated the ability of mesenchymal stem cells (MSCs) from bone marrow or adipose tissue origin to control intestinal inflammation in animal models. However, to date, there are no data regarding the functions of resident MSCs in the colon and small intestine of IBD patients. We hypothesize that dysfunction of resident intestinal MSCs contributes to the disruption of intestinal homeostasis in patients with IBD causing the development of intestinal inflammation. The aim of this research project is to identify, describe and characterize at the molecular and functional level MSCs of the colon and small intestine of patients with Crohn's disease and ulcerative colitis and to compare them with a control population.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Crohn's disease patient group
Intestinal biopsies during colonoscopy or biopsies taken on surgical specimen after intestinal resection
干预措施: Intestinal biopsies during colonoscopy (Other)
Crohn's disease patient group
Intestinal biopsies during colonoscopy or biopsies taken on surgical specimen after intestinal resection
干预措施: Biopsies taken on surgical specimen (Other)
Ulcerative colitis patient group
Intestinal biopsies during colonoscopy or biopsies taken on surgical specimen after intestinal resection
干预措施: Intestinal biopsies during colonoscopy (Other)
Ulcerative colitis patient group
Intestinal biopsies during colonoscopy or biopsies taken on surgical specimen after intestinal resection
干预措施: Biopsies taken on surgical specimen (Other)
Control group
Intestinal biopsies during colonoscopy or biopsies taken on surgical specimen after intestinal resection
干预措施: Intestinal biopsies during colonoscopy (Other)
Control group
Intestinal biopsies during colonoscopy or biopsies taken on surgical specimen after intestinal resection
干预措施: Biopsies taken on surgical specimen (Other)
结局指标
主要结局
Proliferation and differentiation of intestinal MSCs in IBD patients.
时间窗: 1 month
Proliferation and differentiation of intestinal MSCs in IBD patients.
次要结局
- Comparison of MSCs between IBD patients and control patients(1 month)