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
|Condition or disease||Intervention/treatment||Phase|
|Efficacy and Safety||Biological: Mesenchymal Stromal Cells||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Non-controlled, non-randomized, open label study|
|Masking:||None (Open Label)|
|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|
|Experimental: Mesenchymal Stromal Cells||
Biological: Mesenchymal Stromal Cells
Suspension of mesenchymal stromal cells for intratissular injection
- 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.
- 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.
- 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
- 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.
- 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
- Evolution of Short health scale (quality of life) [ Time Frame: week 0, 12 and 48 ]min : 0 - max : 10 (worse)
- 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
- 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
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
|Contact: Edouard Louis, Prof||043667256 ext email@example.com|
|Contact: Chantal Lechanteur||043668390 ext firstname.lastname@example.org|
|Principal Investigator:||Edouard Louis, Prof||Centre Hospitalier Universitaire de Liege|