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Trial record 1 of 1 for:    NCT03901235
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MSC Intratissular Injection in Crohn Disease Patients (MSC)

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ClinicalTrials.gov Identifier: NCT03901235
Recruitment Status : Recruiting
First Posted : April 3, 2019
Last Update Posted : November 26, 2021
Sponsor:
Collaborator:
Centre Hospitalier Universitaire de Liege
Information provided by (Responsible Party):
Edouard Louis, University of Liege

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.

Condition or disease Intervention/treatment Phase
Efficacy and Safety Biological: Mesenchymal Stromal Cells Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Non-controlled, non-randomized, open label study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Refractory Crohn's Disease Lesions by Local Injection of Mesenchymal Stem Cells
Actual Study Start Date : January 15, 2018
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arm Intervention/treatment
Experimental: Mesenchymal Stromal Cells Biological: Mesenchymal Stromal Cells
Suspension of mesenchymal stromal cells for intratissular injection




Primary Outcome Measures :
  1. Proportion of patients with deep ulcer healing [ Time Frame: Week 12 ]
    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.

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

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

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


Secondary Outcome Measures :
  1. Evolution of clinical disease activity index [ Time Frame: week 0, 12 and 48 ]
    Assess disease activity in Crohn's disease over 7 days using the Crohn's disease activity index

  2. Evolution of Short health scale (quality of life) [ Time Frame: week 0, 12 and 48 ]
    min : 0 - max : 10 (worse)

  3. Evolution of the Lemann Index (measuring cumulated intestinal damage in Crohn's disease) [ Time Frame: week 0, 12 and 48 ]
    which incorporates clinical, surgical, endoscopic, and imaging findings from all segments of the digestive tract into one composite score

  4. 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 ]
    Grade : from 0 to higher value 6



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03901235


Contacts
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Contact: Edouard Louis, Prof 043667256 ext 0032 edouard.louis@uliege.be
Contact: Chantal Lechanteur 043668390 ext 0032 c.lechanteur@chuliege.be

Locations
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Belgium
CHU de Liège Recruiting
Liège, Belgium, 4000
Contact: Edouard Louis, Prof    043667256 ext 043667256    edouard.louis@uliege.be   
Contact: Layla Boutaffala    043668065 ext 0032    lboutaffala@chuliege.be   
Sponsors and Collaborators
University of Liege
Centre Hospitalier Universitaire de Liege
Investigators
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Principal Investigator: Edouard Louis, Prof Centre Hospitalier Universitaire de Liege
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Responsible Party: Edouard Louis, Prof, University of Liege
ClinicalTrials.gov Identifier: NCT03901235    
Other Study ID Numbers: TJT1707P1
First Posted: April 3, 2019    Key Record Dates
Last Update Posted: November 26, 2021
Last Verified: November 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases