MSC Intratissular Injection in Crohn Disease Patients | NCT03901235

NCT03901235

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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No data is available for this block.

Document Section

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No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
Centre Hospitalier Universitaire de Liege	OTHER

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Label	Type	Description	Intervention Names
Mesenchymal Stromal Cells	Experimental		Biological: Mesenchymal Stromal Cells

Name	Type	Description	Arm Group Labels	Other Names
Mesenchymal Stromal Cells	Biological	Suspension of mesenchymal stromal cells for intratissular injection	Mesenchymal Stromal Cells

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportion of patients with deep ulcer healing	Complete deep ulcer healing is defined by the disappearance of the ulcer; partial healing is defined by a decrease in the depth or the diameter of the ulcer.	Week 12
Proportion of patients with stricture healing	Complete stricture healing is defined by the ability to pass the ileocolonoscope through the stricture; partial healing is defined by the increase in the diameter of the stricture.	Week 12
Proportion of patients with complex perianal fistula healing	Complete complex perianal fistula healing is defined by the complete closure of the external fistula opening, no drainage upon gentle pressure, no abscess. And by looking at the size of the fistulous track, presence of collection, and gadolinium enhancement by MRI	Week 12
Safety assessed by the incidence of treatment-emergent adverse events during the study period	Assessment of the incidence of adverse and serious adverse events over the 48 weeks study period. Toxicity grade of adverse events is determined using the Common Terminology Criteria for Adverse Events (version 4.0). Relationship to the therapeutic procedure will systematically be assessed.	from week 0 to week 48

Secondary Outcomes

Measure	Description	Time Frame
Evolution of clinical disease activity index	Assess disease activity in Crohn's disease over 7 days using the Crohn's disease activity index	week 0, 12 and 48
Evolution of Short health scale (quality of life)

Eligibility Module

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

Name	Role	Phone	Extension	Email
Edouard Louis, Prof	Contact	043667256	0032	edouard.louis@uliege.be
Chantal Lechanteur	Contact	043668390	0032	c.lechanteur@chuliege.be