Efficacy and SafetyPhase 1/2MSCNCT03901235
MSC Intratissular Injection in Crohn Disease Patients
A Phase 1/2 study testing Mesenchymal Stromal Cells in people with Efficacy and Safety, run by University of Liege at 1 site in Belgium.
Trial summary
The main objective is to assess the efficacy of local injection of MSC on the healing of refractory intestinal and perianal lesions in crohn disease. The second co-primary endpoint is safety. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Efficacy and Safety
- What is being tested?
- Mesenchymal Stromal Cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Jan 2018to 31 Dec 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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
- Patients ≥ 18 years of age
- Signing the informed consent
- Diagnosis of Crohn Disease for more than 6 months
- Presence of at least one Crohn Disease lesion refractory to conventional therapies (azathioprine, 6-mercaptopurine or methotrexate) and to biologic treatments (anti-Tumor Necrosis Factor therapies, vedolizumab, or ustekinumab).
- Refractory lesion defined by (1) a stricture with a length of 2 to 5cm of the colon or the ileum accessible by ileocolonoscopy (i.e. a lesion identified during a colonoscopy with a lumen narrowing non passable by the colonoscope), (2) unhealed deep ulcer of the colon or the ileum accessible to ileocolonoscopy, or (3) actively draining perianal fistula(s).
- Twenty patients with stricture(s), 20 patients with unhealed deep ulcer(s), and 20 patients with an actively draining perianal fistula(s) will be included
Who cannot join
- Indication for immediate luminal surgery
- Intestinal obstruction
- Intra-abdominal fistulas or abscess
- Intestinal/colonic stricture or deep unhealed ulcer not accessible to ileocolonoscopy
- Undrained peri-anal abscess
- Pregnant women or planning pregnancy within one year
Show all 11Show fewer
- Positive stool culture/toxin for clostridium difficile pathogen or other pathogens
- Renal failure (anuria, serious fluid overload, Glomerular Filtration Rate < 30 ml/min, dialysis) or hepatic failure (Fulminant liver failure, cirrhosis of the liver with evidence of portal hypertension, alcoholic hepatitis, esophageal varices, a history of bleeding esophageal varices, hepatic encephalopathy, uncorrectable hepatic synthetic dysfunction evinced by prolongation of the prothrombin time, ascites related to portal hypertension, bacterial or fungal liver abscess, biliary obstruction, chronic viral hepatitis with total serum bilirubin >3 mg/dL)
- documented human immunodeficiency virus infection; active hepatitis B, C, or tuberculosis
- an opportunistic infection within 6 months before screening or a serious infection in the previous 3 months
- malignancy within the past 5 years; or a history of lymphoproliferative disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
CHU de Liège
Liège, Liège, 4000
Edouard Louis, Prof, 043667256 ext. 043667256, edouard.louis@uliege.be
Layla Boutaffala, 043668065 ext. 0032, lboutaffala@chuliege.be
About this study
Official title: Treatment of Refractory Crohn's Disease Lesions by Local Injection of Mesenchymal Stem Cells
The main objective is to assess the efficacy of local injection of MSC on the healing of refractory intestinal and perianal lesions in crohn disease. The second co-primary endpoint is safety.
- Conditions
- Efficacy and Safety
- Being tested
- Mesenchymal Stromal Cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesenchymal Stromal CellsBiological
Suspension of mesenchymal stromal cells for intratissular injection
| Study group | Role | What they receive |
|---|---|---|
| Mesenchymal Stromal Cells | Experimental | Not described Receives: Biological: Mesenchymal Stromal Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with deep ulcer healing
Complete deep ulcer healing is defined by the disappearance of the ulcer; partial healing is defined by a decrease in the depth or the diameter of the ulcer.
Measured: Week 12
Proportion of patients with stricture healing
Complete stricture healing is defined by the ability to pass the ileocolonoscope through the stricture; partial healing is defined by the increase in the diameter of the stricture.
Measured: Week 12
Proportion of patients with complex perianal fistula healing
Complete complex perianal fistula healing is defined by the complete closure of the external fistula opening, no drainage upon gentle pressure, no abscess. And by looking at the size of the fistulous track, presence of collection, and gadolinium enhancement by MRI
Measured: Week 12
Safety assessed by the incidence of treatment-emergent adverse events during the study period
Assessment of the incidence of adverse and serious adverse events over the 48 weeks study period. Toxicity grade of adverse events is determined using the Common Terminology Criteria for Adverse Events (version 4.0). Relationship to the therapeutic procedure will systematically be assessed.
Measured: from week 0 to week 48
Secondary outcomes (4)
Evolution of clinical disease activity index
Assess disease activity in Crohn's disease over 7 days using the Crohn's disease activity index
Measured: week 0, 12 and 48
Evolution of Short health scale (quality of life)
min : 0 - max : 10 (worse)
Measured: week 0, 12 and 48
Evolution of the Lemann Index (measuring cumulated intestinal damage in Crohn's disease)
which incorporates clinical, surgical, endoscopic, and imaging findings from all segments of the digestive tract into one composite score
Measured: week 0, 12 and 48
Evolution of the " Group of Therapeutic Study of Inflammatory Disorders of the Digestive Tube" obstructive score for Crohn Disease strictures
Grade : from 0 to higher value 6
Measured: weeks 0, 12 and 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study start15 Jan 2018
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Efficacy and SafetyStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Non-controlled, non-randomized, open label study
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Universitaire de Liege
- Responsible party
- Principal investigator, Edouard Louis, University of Liege
- Investigators
- Edouard Louis, Prof, Principal investigator, Centre Hospitalier Universitaire de Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03901235
- Sponsor's protocol ID
- TJT1707P1
- Acronym
- MSC
- Status last verified
- Dec 2024
- First submitted
- 4 Mar 2019
- Last updated
- 12 Dec 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 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Refractory Crohn's Disease Lesions by Local Injection of Mesenchymal Stem Cells
- ClinicalTrials.gov ID
- NCT03901235
- Acronym / sponsor ID
- MSC / TJT1707P1
- Conditions
- Efficacy and Safety
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Collaborators
- Centre Hospitalier Universitaire de Liege
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 3 Apr 2019 (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 main objective is to assess the efficacy of local injection of MSC on the healing of refractory intestinal and perianal lesions in crohn disease. The second co-primary endpoint is safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Non-controlled, non-randomized, open label study
| Arm | Type | Receives |
|---|---|---|
| Mesenchymal Stromal Cells | Experimental | Biological: Mesenchymal Stromal Cells |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients ≥ 18 years of age
- Signing the informed consent
- Diagnosis of Crohn Disease for more than 6 months
- Presence of at least one Crohn Disease lesion refractory to conventional therapies (azathioprine, 6-mercaptopurine or methotrexate) and to biologic treatments (anti-Tumor Necrosis Factor therapies, vedolizumab, or ustekinumab).
- Refractory lesion defined by (1) a stricture with a length of 2 to 5cm of the colon or the ileum accessible by ileocolonoscopy (i.e. a lesion identified during a colonoscopy with a lumen narrowing non passable by the colonoscope), (2) unhealed deep ulcer of the colon or the ileum accessible to ileocolonoscopy, or (3) actively draining perianal fistula(s).
Key exclusion criteria (11 listed)
- Indication for immediate luminal surgery
- Intestinal obstruction
- Intra-abdominal fistulas or abscess
- Intestinal/colonic stricture or deep unhealed ulcer not accessible to ileocolonoscopy
- Undrained peri-anal abscess
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 Stromal CellsSuspension of mesenchymal stromal cells for intratissular injection | Biological | Mesenchymal Stromal Cells |
Primary outcome
Proportion of patients with deep ulcer healing
Time frame: Week 12
Complete deep ulcer healing is defined by the disappearance of the ulcer; partial healing is defined by a decrease in the depth or the diameter of the ulcer.
Proportion of patients with stricture healing
Time frame: Week 12
Complete stricture healing is defined by the ability to pass the ileocolonoscope through the stricture; partial healing is defined by the increase in the diameter of the stricture.
Proportion of patients with complex perianal fistula healing
Time frame: Week 12
Complete complex perianal fistula healing is defined by the complete closure of the external fistula opening, no drainage upon gentle pressure, no abscess. And by looking at the size of the fistulous track, presence of collection, and gadolinium enhancement by MRI
Safety assessed by the incidence of treatment-emergent adverse events during the study period
Time frame: from week 0 to week 48
Assessment of the incidence of adverse and serious adverse events over the 48 weeks study period. Toxicity grade of adverse events is determined using the Common Terminology Criteria for Adverse Events (version 4.0). Relationship to the therapeutic procedure will systematically be assessed.
4 secondary outcomes
Evolution of clinical disease activity index
Time frame: week 0, 12 and 48
Evolution of Short health scale (quality of life)
Time frame: week 0, 12 and 48
Evolution of the Lemann Index (measuring cumulated intestinal damage in Crohn's disease)
Time frame: week 0, 12 and 48
Evolution of the " Group of Therapeutic Study of Inflammatory Disorders of the Digestive Tube" obstructive score for Crohn Disease strictures
Time frame: weeks 0, 12 and 48
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 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.
Edouard Louis, Prof principal investigator
Centre Hospitalier Universitaire de Liege
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Mesenchymal Stromal Cells in people with Efficacy and Safety, run by University of 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 6 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: looking for participants now, as of the sponsor's last update on 12 Dec 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Edouard Louis, Prof (043667256 ext. 0032, edouard.louis@uliege.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with deep ulcer healing (time frame: Week 12). 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 12 Dec 2024.