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
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
Treatments tested in this trial
- Mesenchymal Stromal Cells
Treatment groups
60 Participants
are divided into 1 treatment groupSponsors and collaborators
University of Liege
Lead sponsor
Centre Hospitalier Universitaire de Liege
Collaborator
Source ClinicalTrials.gov