MSC Intratissular Injection in Crohn Disease Patients
Phase 1 / Phase 2 · Testing Mesenchymal Stromal Cells · 1 site · University of Liege
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Mesenchymal Stromal Cells (a biologic) as a possible treatment. Condition(s) listed: Efficacy and Safety.
It is open-label: participants know what they are receiving.
Phase 2 studies test whether a treatment shows signs of working, and keep checking safety, in a larger group of people with the condition.
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- Patients ≥ 18 years of age
- Signing the informed consent
- Diagnosis of Crohn Disease for more than 6 months
Plus 3 more requirement(s). There are also 11 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 60 participants are expected to take part.
- Start date: 2018-01-15.
- Main results expected around 2025-12-31 (estimate from the record).
- 1 study site listed (1 marked recruiting) in Belgium.
Main thing being measured
- Proportion of patients with deep ulcer healing (Week 12)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Phase 1 / Phase 2 |
| Study type | Interventional |
| Conditions | Efficacy and Safety |
| Lead sponsor | University of Liege |
| Collaborators | Centre Hospitalier Universitaire de Liege |
| Enrollment | 60 (estimated) |
| Start date | 2018-01-15 |
| Primary completion (est.) | 2025-12-31 |
| First posted | 2019-04-03 |
| Last updated | 2024-12-12 |
| Official title | Treatment of Refractory Crohn's Disease Lesions by Local Injection of Mesenchymal Stem Cells |
| ClinicalTrials.gov ID | NCT03901235 |
Interventions
- Mesenchymal Stromal Cells (Biological)
Suspension of mesenchymal stromal cells for intratissular injection
Full eligibility criteria (from the record)
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| CHU de Liège | Liège, Liège | Belgium | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.