MSC Intratissular Injection in Crohn Disease Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 22 May 2023
• Main ID: NCT03901235
• Date of registration: 04/03/2019
• Prospective Registration: No
• Primary sponsor: University of Liege
• Public title: MSC Intratissular Injection in Crohn Disease Patients MSC
• Scientific title: Treatment of Refractory Crohn's Disease Lesions by Local Injection of Mesenchymal Stem Cells
• Date of first enrolment: January 15, 2018
• Target sample size: 60
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03901235
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1/Phase 2

Countries of recruitment

Belgium

Contacts

• Name: Edouard Louis, Prof

• Name: Edouard Louis, Prof

• Name: Edouard Louis, Prof
• Affiliation: Centre Hospitalier Universitaire de Liege

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Efficacy and Safety

Intervention(s)

Biological: Mesenchymal Stromal Cells

Primary Outcome(s)

Proportion of patients with complex perianal fistula healing [Time Frame: Week 12]

Proportion of patients with stricture healing [Time Frame: Week 12]

Safety assessed by the incidence of treatment-emergent adverse events during the study period [Time Frame: from week 0 to week 48]

Proportion of patients with deep ulcer healing [Time Frame: Week 12]

Secondary Outcome(s)

Evolution of the Lemann Index (measuring cumulated intestinal damage in Crohn's disease) [Time Frame: week 0, 12 and 48]

Evolution of clinical disease activity index [Time Frame: week 0, 12 and 48]

Evolution of Short health scale (quality of life) [Time Frame: week 0, 12 and 48]

Evolution of the " Group of Therapeutic Study of Inflammatory Disorders of the Digestive Tube" obstructive score for Crohn Disease strictures [Time Frame: weeks 0, 12 and 48]

Secondary ID(s)

TJT1707P1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Centre Hospitalier Universitaire de Liege