Intestinal Mesenchymal Stem Stells and Inflammatory Bowel Diseases (COSMIC)
Primary Purpose
Inflammatory Bowel Diseases
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Intestinal biopsies during colonoscopy
Biopsies taken on surgical specimen
Sponsored by
About this trial
This is an interventional basic science trial for Inflammatory Bowel Diseases focused on measuring Crohn's disease, ulcerative colitis, mesenchymal stem cells, intestinal inflammation
Eligibility Criteria
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
Sites / Locations
- Hopital St Eloi
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
Crohn's disease patient group
Ulcerative colitis patient group
Control group
Arm Description
Intestinal biopsies during colonoscopy or biopsies taken on surgical specimen after intestinal resection
Intestinal biopsies during colonoscopy or biopsies taken on surgical specimen after intestinal resection
Intestinal biopsies during colonoscopy or biopsies taken on surgical specimen after intestinal resection
Outcomes
Primary Outcome Measures
Proliferation and differentiation of intestinal MSCs in IBD patients.
Proliferation and differentiation of intestinal MSCs in IBD patients.
Secondary Outcome Measures
Comparison of MSCs between IBD patients and control patients
Comparison of MSCs between IBD patients and control patients using mmunohistochemistry, immunofluorescence, quantification of pro- and anti-inflammatory cytokines production.
Full Information
NCT ID
NCT03115749
First Posted
April 10, 2017
Last Updated
December 27, 2021
Sponsor
University Hospital, Montpellier
1. Study Identification
Unique Protocol Identification Number
NCT03115749
Brief Title
Intestinal Mesenchymal Stem Stells and Inflammatory Bowel Diseases
Acronym
COSMIC
Official Title
Characterization of Mesenchymal Stem Cells From the Colon and Small Intestine of Patients With Inflammatory Bowel Disease - The COSMIC Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Terminated
Why Stopped
end of inclusion period and recruitment difficulties
Study Start Date
November 21, 2018 (Actual)
Primary Completion Date
February 13, 2019 (Actual)
Study Completion Date
February 13, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases
Keywords
Crohn's disease, ulcerative colitis, mesenchymal stem cells, intestinal inflammation
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Crohn's disease patient group
Arm Type
Other
Arm Description
Intestinal biopsies during colonoscopy or biopsies taken on surgical specimen after intestinal resection
Arm Title
Ulcerative colitis patient group
Arm Type
Other
Arm Description
Intestinal biopsies during colonoscopy or biopsies taken on surgical specimen after intestinal resection
Arm Title
Control group
Arm Type
Other
Arm Description
Intestinal biopsies during colonoscopy or biopsies taken on surgical specimen after intestinal resection
Intervention Type
Other
Intervention Name(s)
Intestinal biopsies during colonoscopy
Intervention Description
Intestinal biopsies during colonoscopy
Intervention Type
Other
Intervention Name(s)
Biopsies taken on surgical specimen
Intervention Description
biopsies taken on surgical specimen after intestinal resection
Primary Outcome Measure Information:
Title
Proliferation and differentiation of intestinal MSCs in IBD patients.
Description
Proliferation and differentiation of intestinal MSCs in IBD patients.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Comparison of MSCs between IBD patients and control patients
Description
Comparison of MSCs between IBD patients and control patients using mmunohistochemistry, immunofluorescence, quantification of pro- and anti-inflammatory cytokines production.
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guillaume Pineton de Chambrun
Organizational Affiliation
University Hospital, Montpellier
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital St Eloi
City
Montpellier
ZIP/Postal Code
34080
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Intestinal Mesenchymal Stem Stells and Inflammatory Bowel Diseases
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