Tests stem cell injections for hard-to-heal Crohn's disease lesions
Tests stem cell injections into lesions in adults with Crohn's disease.
Plain-language title generated from the registry record
Registry title: MSC Intratissular Injection in Crohn Disease Patients
Key facts
- Where
- Liège, BelgiumSee the site
- Phase
- Phase 1/2
Where in Belgium
- Centre Hospitalier Universitaire de LiègeLiège, BelgiumNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Liege
- Trial code
- NCT03901235EU 2024-514033-37-00
- Record updated
- 12 December 2024
- Original description
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 full original descriptionShow less
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.
Inclusion: 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: Indication for immediate luminal surgery; an opportunistic infection within 6 months before screening or a serious infection in the previous 3 months; Intestinal/colonic stricture or deep unhealed ulcer not accessible to ileocolonoscopy; documented human immunodeficiency virus infection; active hepatitis B, C, or tuberculosis; malignancy within the past 5 years; or a history of lymphoproliferative disease; 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); Intestinal obstruction; Intra-abdominal fistulas or abscess; Undrained peri-anal abscess; Pregnant women or planning pregnancy within one year; Positive stool culture/toxin for clostridium difficile pathogen or other pathogens.