NCT03901235 MSC Intratissular Injection in Crohn Disease Patients
| NCT ID | NCT03901235 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | University of Liege |
| Condition | Efficacy and Safety |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2018-01-15 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 60 participants in total. It began in 2018-01-15 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Edouard Louis, Prof
PRINCIPAL INVESTIGATOR
Centre Hospitalier Universitaire de Liege
Frequently Asked Questions
Who can join the NCT03901235 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Efficacy and Safety. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03901235 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT03901235 currently recruiting?
Yes, NCT03901235 is actively recruiting participants. Contact the research team at edouard.louis@uliege.be for enrollment information.
Where is the NCT03901235 trial being conducted?
This trial is being conducted at Liège, Belgium.
Who is sponsoring the NCT03901235 clinical trial?
NCT03901235 is sponsored by University of Liege. The principal investigator is Edouard Louis, Prof at Centre Hospitalier Universitaire de Liege. The trial plans to enroll 60 participants.