Safety IssuesPhase 2NCT06317818
Is Local Injection of Mesenchymal Stem Cells After Endoscopic Dilation Safe and Does it Improve the Outcome of Intestinal Stricture in Patients With Crohn's Disease?
A Phase 2 study testing Mesenchymal Stem Cells in people with Safety Issues and Efficacy, run by Centre Hospitalier Universitaire de Liege at 1 site in Belgium.
Trial summary
This is an exploratory phase II study, to evaluate the impact of these Mesenchymal Stem Cells (MSCs) on strictures in Crohn's disease patients with symptomatic intestinal stricture eligible to endoscopic dilatation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Safety Issues, Efficacy
- What is being tested?
- Mesenchymal Stem Cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- 6 Jun 2023to Aug 2025
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient aged ≥ 18 years with Crohn's Disease diagnosed more than 6 months ago
- Background treatment, for Crohn's Disease, stable for 4 months
- Presence of stricture (whether de novo or anastomotic), meeting the radiological definition of stenosis, i.e. a combination of the following criteria: (1) localized luminal narrowing (reduction of luminal diameter by at least less than 50% compared to adjacent healthy bowel segment), (2) bowel wall thickening (25% increase in wall thickness compared to adjacent unaffected bowel) and pre-stenotic dilation (luminal diameter greater than 3 cm)
- Presence of symptomatic stricture with abdominal pain after meals and limitations on the amount or type of food at screening
- Presence of a stenosis accessible by ileo-colonoscopy, not passable (i.e. not allowing the passage of the adult ileo-colonoscope), of a length less than 5 cm, eligible for endoscopic dilation
- Patient accepting the study protocol and having signed an informed consent
- Patient capable of undergoing entero-MRI
Who cannot join
- Patient liable for immediate surgery
- Patient with intra-abdominal fistula or abscess
- Patient with a stenosis not accessible to ileocolonoscopy
- Patient presenting ≥ 2 strictures with impossibility of determining which stenosis is "dominant" and responsible for the symptoms (based on dilation in entero-MRI)
- Patient with a stenosis longer than 5 cm
- Patient with a contraindication to performing an entero-MRI or to the use of contrast product injection in entero-MRI (Gadolinium)
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- Pregnant woman or planning a pregnancy in the year
- Patient with kidney insufficiency (with anuria, glomerular filtration rate < 30 ml/min or on dialysis), hepatic insufficiency (presence of fulminant hepatitis, cirrhosis with signs of portal hypertension, acute alcoholic hepatitis, esophageal varices, history of gastrointestinal bleeding following rupture of esophageal varices, hepatic encephalopathy, prolonged prothrombin time, ascites secondary to portal hypertension, bacterial or fungal liver abscess, biliary obstruction, chronic viral hepatitis with a total serum bilirubin level > 3 mg/dL)
- Patient with documented human immunodeficiency virus (HIV) infection, active hepatitis B or C or tuberculosis
- Patient having presented an opportunistic infection in the 6 months preceding inclusion or a serious infection in the previous 3 months
- Patient who has developed a malignant tumor with a history of lymphoproliferative disease with the exception of: non-melanoma skin cancer, carcinoma in situ (e.g. skin, cervix, bladder, breast) and in remission for at least 3 years prior to screening, superficial bladder cancer, asymptomatic low-grade or localized curatively treated prostate cancer for which the "watch-and-wait" approach is the standard of care as well as any other cancer that has been in remission for ≥ 3 years prior to enrollment.
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
CHU de Liège
Liège, 4000
Sophie Vieujean, MD, + 32 4 323 72 56, s.vieujean@chuliege.be
Layla Boutaffala, +32 4 323 38 10, lboutaffala@chuliege.be
About this study
This is an exploratory phase II study, to evaluate the impact of these Mesenchymal Stem Cells (MSCs) on strictures in Crohn's disease patients with symptomatic intestinal stricture eligible to endoscopic dilatation. The impact of combined treatment by endoscopic dilation and local injection of MSCs will be compared with that of a control group.
- Conditions
- Safety Issues, Efficacy
- Being tested
- Mesenchymal Stem Cells, Comparative placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesenchymal Stem CellsOther
Suspension of mesenchymal stromal cells for intratissular injection
Comparative placeboOther
Cell-free cell suspension solution devoid of cells for intratissular injection
| Study group | Role | What they receive |
|---|---|---|
| "MSCs" group | Experimental | One local injection of MSCs (3*10^7 cells) after endoscopic dilatation of the stricture Receives: Other: Mesenchymal Stem Cells |
| "control" group | Placebo comparator | One local injection of the placebo (cell-free cell suspension solution devoid of cells) after endoscopic dilatation of the stricture Receives: Other: Comparative placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of safety of local MSCs injection, in association with endoscopic dilation, in strictures of patients with Crohn's disease.
Recording of occurrence of adverse events (serious or not) up to week 48
Measured: From Week 0 to Week 48
Assessment of efficacy of local MSCs injection, in association with endoscopic dilation, in strictures of patients with Crohn's disease by evaluating symptomatic clinical response
The symptomatic clinical response will be assessed by a composite score, calculated over an average of 7 days, taking up 2 of the 16 questions of the S-PRO or Stenosis Patient Reported Outcome in English (also called Stricturing Crohn's Disease Questionnaire). A score for postprandial abdominal pain < 2 and an average score, out of 7 days, for amount of types of food <2 also.
Measured: Between Week 0, Week 24 and Week 48
Assessment of efficacy of local MSCs injection, in association with endoscopic dilation, in strictures of patients with Crohn's disease by evaluating endoscopic response
The endoscopic response will be defined by the ability to pass an adult colonoscope (complete endoscopic response) or an increase in lumen diameter (partial endoscopic response) measured in comparison with the size of an open biopsy forceps (7mm)
Measured: Between Week 0, Week 24 and Week 48
Assessment of efficacy of local MSCs injection, in association with endoscopic dilation, in strictures of patients with Crohn's disease by evaluating radiological response
The radiological response will be defined by the presence of 3 of the 4 following criteria: (1) an improvement in luminal narrowing (improvement greater than 50% and/or reduction in luminal diameter of less than 50%); (2) improvement in pre-stenotic dilation (pre-stenotic dilation reduced by 50%, bowel diameter equal to normal bowel and/or pre-stenotic dilation improved to less than 2.5 cm); (3) reduction in wall thickening (50% improvement in gut wall thickening); (4) a reduction in the length of the stricture (50% improvement)
Measured: Between Week 0, Week 24 and Week 48
Secondary outcomes (1)
Evaluation of studying, in addition to biomarkers (CRP and fecal calprotectin),
Evaluation of evolution of biomarkers (CRP and fecal calprotectin) over the time by blood and stool samples analysis
Measured: Weeks 0, 4, 12, 24, 36 and 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start6 Jun 2023
- Primary completionAug 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety IssuesStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, controlled study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sophie Vieujean, Centre Hospitalier Universitaire de Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06317818
- Sponsor's protocol ID
- TJT2301
- Status last verified
- Mar 2024
- First submitted
- 8 Feb 2024
- Last updated
- 19 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Local Injection of Mesenchymal Stem Cells After Endoscopic Dilation Safe and Does it Improve the Outcome of Intestinal Stricture in Patients With Crohn's Disease?
- ClinicalTrials.gov ID
- NCT06317818
- Acronym / sponsor ID
- TJT2301
- Conditions
- Safety Issues, Efficacy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de LiegeUniversity, hospital or other
- Study start
- 6 Jun 2023 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 19 Mar 2024 (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.
This is an exploratory phase II study, to evaluate the impact of these Mesenchymal Stem Cells (MSCs) on strictures in Crohn's disease patients with symptomatic intestinal stricture eligible to endoscopic dilatation. The impact of combined treatment by endoscopic dilation and local injection of MSCs will be compared with that of a control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double-blind, controlled study
| Arm | Type | Receives |
|---|---|---|
| "MSCs" group | Experimental | Other: Mesenchymal Stem CellsOne local injection of MSCs (3*10^7 cells) after endoscopic dilatation of the stricture |
| "control" group | Placebo comparator | Other: Comparative placeboOne local injection of the placebo (cell-free cell suspension solution devoid of cells) after endoscopic dilatation of the stricture |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient aged ≥ 18 years with Crohn's Disease diagnosed more than 6 months ago
- Background treatment, for Crohn's Disease, stable for 4 months
- Presence of stricture (whether de novo or anastomotic), meeting the radiological definition of stenosis, i.e. a combination of the following criteria: (1) localized luminal narrowing (reduction of luminal diameter by at least less than 50% compared to adjacent healthy bowel segment), (2) bowel wall thickening (25% increase in wall thickness compared to adjacent unaffected bowel) and pre-stenotic dilation (luminal diameter greater than 3 cm)
- Presence of symptomatic stricture with abdominal pain after meals and limitations on the amount or type of food at screening
- Presence of a stenosis accessible by ileo-colonoscopy, not passable (i.e. not allowing the passage of the adult ileo-colonoscope), of a length less than 5 cm, eligible for endoscopic dilation
Key exclusion criteria (11 listed)
- Patient liable for immediate surgery
- Patient with intra-abdominal fistula or abscess
- Patient with a stenosis not accessible to ileocolonoscopy
- Patient presenting ≥ 2 strictures with impossibility of determining which stenosis is "dominant" and responsible for the symptoms (based on dilation in entero-MRI)
- Patient with a stenosis longer than 5 cm
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 |
|---|---|---|
| Mesenchymal Stem CellsSuspension of mesenchymal stromal cells for intratissular injection | Other | "MSCs" group |
| Comparative placeboCell-free cell suspension solution devoid of cells for intratissular injection | Other | "control" group |
Primary outcome
Assessment of safety of local MSCs injection, in association with endoscopic dilation, in strictures of patients with Crohn's disease.
Time frame: From Week 0 to Week 48
Recording of occurrence of adverse events (serious or not) up to week 48
Assessment of efficacy of local MSCs injection, in association with endoscopic dilation, in strictures of patients with Crohn's disease by evaluating symptomatic clinical response
Time frame: Between Week 0, Week 24 and Week 48
The symptomatic clinical response will be assessed by a composite score, calculated over an average of 7 days, taking up 2 of the 16 questions of the S-PRO or Stenosis Patient Reported Outcome in English (also called Stricturing Crohn's Disease Questionnaire). A score for postprandial abdominal pain < 2 and an average score, out of 7 days, for amount of types of food <2 also.
Assessment of efficacy of local MSCs injection, in association with endoscopic dilation, in strictures of patients with Crohn's disease by evaluating endoscopic response
Time frame: Between Week 0, Week 24 and Week 48
The endoscopic response will be defined by the ability to pass an adult colonoscope (complete endoscopic response) or an increase in lumen diameter (partial endoscopic response) measured in comparison with the size of an open biopsy forceps (7mm)
Assessment of efficacy of local MSCs injection, in association with endoscopic dilation, in strictures of patients with Crohn's disease by evaluating radiological response
Time frame: Between Week 0, Week 24 and Week 48
The radiological response will be defined by the presence of 3 of the 4 following criteria: (1) an improvement in luminal narrowing (improvement greater than 50% and/or reduction in luminal diameter of less than 50%); (2) improvement in pre-stenotic dilation (pre-stenotic dilation reduced by 50%, bowel diameter equal to normal bowel and/or pre-stenotic dilation improved to less than 2.5 cm); (3) reduction in wall thickening (50% improvement in gut wall thickening); (4) a reduction in the length of the stricture (50% improvement)
1 secondary outcome
Evaluation of studying, in addition to biomarkers (CRP and fecal calprotectin),
Time frame: Weeks 0, 4, 12, 24, 36 and 48
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mesenchymal Stem Cells in people with Safety Issues and Efficacy, run by Centre Hospitalier Universitaire de Liege at 1 site in Belgium.
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 7 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 19 Mar 2024. 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 Belgium. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sophie Vieujean, MD (+32 4 323.72.56, s.vieujean@chuliege.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of safety of local MSCs injection, in association with endoscopic dilation, in strictures of patients with Crohn's disease. (time frame: From Week 0 to Week 48). The study lists 4 primary outcomes in all. 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 19 Mar 2024.