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MSC Intratissular Injection in Crohn Disease Patients (MSC)

Primary Purpose

Efficacy and Safety

Status
Recruiting
Phase
Phase 1
Locations
Belgium
Study Type
Interventional
Intervention
Mesenchymal Stromal Cells
Sponsored by
University of Liege
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Efficacy and Safety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • CHU de LiègeRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mesenchymal Stromal Cells

Arm Description

Outcomes

Primary Outcome Measures

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.
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.
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
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.

Secondary Outcome Measures

Evolution of clinical disease activity index
Assess disease activity in Crohn's disease over 7 days using the Crohn's disease activity index
Evolution of Short health scale (quality of life)
min : 0 - max : 10 (worse)
Evolution of the Lemann Index (measuring cumulated intestinal damage in Crohn's disease)
which incorporates clinical, surgical, endoscopic, and imaging findings from all segments of the digestive tract into one composite score
Evolution of the " Group of Therapeutic Study of Inflammatory Disorders of the Digestive Tube" obstructive score for Crohn Disease strictures
Grade : from 0 to higher value 6

Full Information

First Posted
March 4, 2019
Last Updated
May 9, 2023
Sponsor
University of Liege
Collaborators
Centre Hospitalier Universitaire de Liege
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1. Study Identification

Unique Protocol Identification Number
NCT03901235
Brief Title
MSC Intratissular Injection in Crohn Disease Patients
Acronym
MSC
Official Title
Treatment of Refractory Crohn's Disease Lesions by Local Injection of Mesenchymal Stem Cells
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 15, 2018 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Liege
Collaborators
Centre Hospitalier Universitaire de Liege

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Efficacy and Safety

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Non-controlled, non-randomized, open label study
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mesenchymal Stromal Cells
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Mesenchymal Stromal Cells
Intervention Description
Suspension of mesenchymal stromal cells for intratissular injection
Primary Outcome Measure Information:
Title
Proportion of patients with deep ulcer healing
Description
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.
Time Frame
Week 12
Title
Proportion of patients with stricture healing
Description
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.
Time Frame
Week 12
Title
Proportion of patients with complex perianal fistula healing
Description
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
Time Frame
Week 12
Title
Safety assessed by the incidence of treatment-emergent adverse events during the study period
Description
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.
Time Frame
from week 0 to week 48
Secondary Outcome Measure Information:
Title
Evolution of clinical disease activity index
Description
Assess disease activity in Crohn's disease over 7 days using the Crohn's disease activity index
Time Frame
week 0, 12 and 48
Title
Evolution of Short health scale (quality of life)
Description
min : 0 - max : 10 (worse)
Time Frame
week 0, 12 and 48
Title
Evolution of the Lemann Index (measuring cumulated intestinal damage in Crohn's disease)
Description
which incorporates clinical, surgical, endoscopic, and imaging findings from all segments of the digestive tract into one composite score
Time Frame
week 0, 12 and 48
Title
Evolution of the " Group of Therapeutic Study of Inflammatory Disorders of the Digestive Tube" obstructive score for Crohn Disease strictures
Description
Grade : from 0 to higher value 6
Time Frame
weeks 0, 12 and 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Edouard Louis, Prof
Phone
043667256
Ext
0032
Email
edouard.louis@uliege.be
First Name & Middle Initial & Last Name or Official Title & Degree
Chantal Lechanteur
Phone
043668390
Ext
0032
Email
c.lechanteur@chuliege.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edouard Louis, Prof
Organizational Affiliation
Centre Hospitalier Universitaire de Liege
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Liège
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edouard Louis, Prof
Phone
043667256
Ext
043667256
Email
edouard.louis@uliege.be
First Name & Middle Initial & Last Name & Degree
Layla Boutaffala
Phone
043668065
Ext
0032
Email
lboutaffala@chuliege.be

12. IPD Sharing Statement

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MSC Intratissular Injection in Crohn Disease Patients

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