MSC Intratissular Injection in Crohn Disease Patients

University of Liege

Status and phase

Enrolling

Phase 2

Phase 1

Conditions

Efficacy and Safety

Treatments

Biological: Mesenchymal Stromal Cells

Study type

Interventional

Funder types

Other

Identifiers

NCT03901235

TJT1707P1

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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