Intestinal Mesenchymal Stem Stells and Inflammatory Bowel Diseases

Not Applicable

Terminated

• Conditions: Inflammatory Bowel Diseases
• Interventions: Other: Intestinal biopsies during colonoscopy; Other: Biopsies taken on surgical specimen

• Registration Number: NCT03115749
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

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.

Detailed Description

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).

Study Timeline

• Study First Submitted: 2017-04-10
• Study First Submitted QC: 2017-04-10
• Study First Posted: 2017-04-14
• Study Start: 2018-11-21
• Primary Completion: 2019-02-13
• Study Completion: 2019-02-13
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-27
• Last Update Posted: 2021-12-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Crohn's disease patient group	Intestinal biopsies during colonoscopy	Intestinal biopsies during colonoscopy or biopsies taken on surgical specimen after intestinal resection
Ulcerative colitis patient group	Biopsies taken on surgical specimen	Intestinal biopsies during colonoscopy or biopsies taken on surgical specimen after intestinal resection
Ulcerative colitis patient group	Intestinal biopsies during colonoscopy	Intestinal biopsies during colonoscopy or biopsies taken on surgical specimen after intestinal resection
Crohn's disease patient group	Biopsies taken on surgical specimen	Intestinal biopsies during colonoscopy or biopsies taken on surgical specimen after intestinal resection
Control group	Intestinal biopsies during colonoscopy	Intestinal biopsies during colonoscopy or biopsies taken on surgical specimen after intestinal resection
Control group	Biopsies taken on surgical specimen	Intestinal biopsies during colonoscopy or biopsies taken on surgical specimen after intestinal resection

Primary Outcome Measures

Name	Time	Method
Proliferation and differentiation of intestinal MSCs in IBD patients.	1 month	Proliferation and differentiation of intestinal MSCs in IBD patients.

Secondary Outcome Measures

Name	Time	Method
Comparison of MSCs between IBD patients and control patients	1 month	Comparison of MSCs between IBD patients and control patients using mmunohistochemistry, immunofluorescence, quantification of pro- and anti-inflammatory cytokines production.

Trial Locations

Locations (1)

Hopital St Eloi; 🇫🇷 Montpellier, France