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MSC Intratissular Injection in Crohn Disease Patients

ConditionEfficacy and Safety
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Liege

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

Indication for immediate luminal surgery

Intestinal obstruction

Intra-abdominal fistulas or abscess

Intestinal/colonic stricture or deep unhealed ulcer not accessible to ileocolonoscopy

Trial design

Design model

Single group

Treatments tested in this trial

  • Mesenchymal Stromal Cells

    Biological/Vaccine

    Suspension of mesenchymal stromal cells for intratissular injection

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: Mesenchymal Stromal CellsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Week 12
2

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.

Time frame
Week 12
3

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

Time frame
Week 12
4

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.

Time frame
from week 0 to week 48

Secondary outcomes

1

Evolution of clinical disease activity index

Assess disease activity in Crohn's disease over 7 days using the Crohn's disease activity index

Time frame
week 0, 12 and 48
2

Evolution of Short health scale (quality of life)

min : 0 - max : 10 (worse)

Time frame
week 0, 12 and 48
3

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

Time frame
week 0, 12 and 48
4

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

Time frame
weeks 0, 12 and 48

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Liege

Lead sponsor

Centre Hospitalier Universitaire de Liege

Collaborator

Source ClinicalTrials.gov
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