Inflammatory Bowel DiseasesCOSMICNCT03115749
Intestinal Mesenchymal Stem Stells and Inflammatory Bowel Diseases
A study testing Intestinal biopsies during colonoscopy and Biopsies taken on surgical specimen in people with Inflammatory Bowel Diseases, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- Intestinal biopsies during colonoscopy and Biopsies taken on surgical specimen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteFrance
- Study dates
- 21 Nov 2018to 13 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- For IBD patients :
- Active intestinal infection
- Confirmed intestinal parasitosis
- Intestinal stoma
- For control patients :
- Active intestinal infection
Show all 10Show fewer
- Confirmed intestinal parasitosis
- Intestinal inflammation at colonoscopy
- Chronic intestinal inflammation on biopsies
- Absence of healthy tissue on surgical specimen
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Characterization of Mesenchymal Stem Cells From the Colon and Small Intestine of Patients With Inflammatory Bowel Disease - The COSMIC Study
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.
Read the 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).
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- Intestinal biopsies during colonoscopy, Biopsies taken on surgical specimen
- Keywords
- Crohn's disease, ulcerative colitis, mesenchymal stem cells, intestinal inflammation
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intestinal biopsies during colonoscopyOther
Intestinal biopsies during colonoscopy
Biopsies taken on surgical specimenOther
biopsies taken on surgical specimen after intestinal resection
| Study group | Role | What they receive |
|---|---|---|
| Crohn's disease patient group | Other | Intestinal biopsies during colonoscopy or biopsies taken on surgical specimen after intestinal resection Receives: Other: Intestinal biopsies during colonoscopy; Other: Biopsies taken on surgical specimen |
| Ulcerative colitis patient group | Other | Intestinal biopsies during colonoscopy or biopsies taken on surgical specimen after intestinal resection Receives: Other: Intestinal biopsies during colonoscopy; Other: Biopsies taken on surgical specimen |
| Control group | Other | Intestinal biopsies during colonoscopy or biopsies taken on surgical specimen after intestinal resection Receives: Other: Intestinal biopsies during colonoscopy; Other: Biopsies taken on surgical specimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proliferation and differentiation of intestinal MSCs in IBD patients.
Proliferation and differentiation of intestinal MSCs in IBD patients.
Measured: 1 month
Secondary outcomes (1)
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study start21 Nov 2018
- Primary completion13 Feb 2019
- Study completion13 Feb 2019
Why it stopped: end of inclusion period and recruitment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume Pineton de Chambrun, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03115749
- Sponsor's protocol ID
- 9755
- Acronym
- COSMIC
- Status last verified
- Dec 2021
- First submitted
- 10 Apr 2017
- Last updated
- 28 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Mesenchymal Stem Cells From the Colon and Small Intestine of Patients With Inflammatory Bowel Disease - The COSMIC Study
- ClinicalTrials.gov ID
- NCT03115749
- Acronym / sponsor ID
- COSMIC / 9755
- Conditions
- Inflammatory Bowel Diseases
- Keywords
- Crohn's disease, ulcerative colitis, mesenchymal stem cells, intestinal inflammation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: end of inclusion period and recruitment difficulties
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 21 Nov 2018 (actual)
- Primary completion
- 13 Feb 2019 (actual)
- Study completion
- 13 Feb 2019 (actual)
- First posted
- 14 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Crohn's disease patient group | Other | Other: Intestinal biopsies during colonoscopy, Other: Biopsies taken on surgical specimenIntestinal biopsies during colonoscopy or biopsies taken on surgical specimen after intestinal resection |
| Ulcerative colitis patient group | Other | Other: Intestinal biopsies during colonoscopy, Other: Biopsies taken on surgical specimenIntestinal biopsies during colonoscopy or biopsies taken on surgical specimen after intestinal resection |
| Control group | Other | Other: Intestinal biopsies during colonoscopy, Other: Biopsies taken on surgical specimenIntestinal biopsies during colonoscopy or biopsies taken on surgical specimen after intestinal resection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- For IBD patients :
- For control patients :
Key exclusion criteria (10 listed)
- For IBD patients :
- For control patients :
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intestinal biopsies during colonoscopyIntestinal biopsies during colonoscopy | Other | Control group, Crohn's disease patient group, Ulcerative colitis patient group |
| Biopsies taken on surgical specimenbiopsies taken on surgical specimen after intestinal resection | Other | Control group, Crohn's disease patient group, Ulcerative colitis patient group |
Primary outcome
Proliferation and differentiation of intestinal MSCs in IBD patients.
Time frame: 1 month
Proliferation and differentiation of intestinal MSCs in IBD patients.
1 secondary outcome
Comparison of MSCs between IBD patients and control patients
Time frame: 1 month
Results and safety
The study was stopped early (reason given: end of inclusion period and recruitment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillaume Pineton de Chambrun principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intestinal biopsies during colonoscopy and Biopsies taken on surgical specimen in people with Inflammatory Bowel Diseases, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: end of inclusion period and recruitment difficulties). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proliferation and differentiation of intestinal MSCs in IBD patients. (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2021.