RecruitingPhase 1Phase 2NCT03901235
MSC Intratissular Injection in Crohn Disease Patients
Treatment of Refractory Crohn's Disease Lesions by Local Injection of Mesenchymal Stem Cells
Sponsor
University of Liege
Enrollment
60 participants
Start Date
Jan 15, 2018
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 Years
Inclusion Criteria6
- 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 Criteria11
- 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
Interventions
BIOLOGICALMesenchymal Stromal Cells
Suspension of mesenchymal stromal cells for intratissular injection
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT03901235