MSC Intratissular Injection in Crohn Disease Patients

NCT03901235 | Recruiting Phase 1

• 1 other identifier: TJT1707P1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Efficacy and Safety

Outcome Measures

Primary Outcomes (4)

• 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 (4)

• Evolution of clinical disease activity index

  week 0, 12 and 48

• Evolution of Short health scale (quality of life)

  week 0, 12 and 48

• Evolution of the Lemann Index (measuring cumulated intestinal damage in Crohn's disease)

  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

  weeks 0, 12 and 48

Study Arms (1)

Mesenchymal Stromal Cells

EXPERIMENTAL

Biological: Mesenchymal Stromal Cells

Interventions

Mesenchymal Stromal Cells BIOLOGICAL

Suspension of mesenchymal stromal cells for intratissular injection

Mesenchymal Stromal Cells

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Liege: lead
• Centre Hospitalier Universitaire de Liege: collaborator

Study Sites (1)

CHU de Liège

Liège, Liège, 4000, Belgium

RECRUITING

Study Officials

• Edouard Louis, Prof

  Centre Hospitalier Universitaire de Liege

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Edouard Louis, Prof

CONTACT

043667256; edouard.louis@uliege.be

Chantal Lechanteur

CONTACT

043668390; c.lechanteur@chuliege.be

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Model Details: Non-controlled, non-randomized, open label study

Study Record Dates

• First Submitted: March 4, 2019
• First Posted: April 3, 2019
• Study Start: January 15, 2018
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 12, 2024

Record last verified: 2024-12

Locations

BE (1)