Study of Mesenchymal Stem Cells for Pediatric Perianal Fistulizing Crohn's Disease (NCT04791878) | Clinical Trial Compass
TerminatedPhase 1
Study of Mesenchymal Stem Cells for Pediatric Perianal Fistulizing Crohn's Disease
Stopped: PI left institution
United States6 participantsStarted 2021-04-01
Plain-language summary
This study plans to enroll 10 patients aged 13-17 years of age with refractory perianal fistulizing disease. Patients will be treated by direct injection to the fistula tract(s) with 75 million allogeneic bone marrow derived mesenchymal stem cells at baseline and again after 3 months if not completely healed.
Who can participate
Age range13 Years – 17 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Males and females aged 13-17 with a diagnosis of Crohn's disease for at least six months duration.
✓. Single and Multi-tract Perianal fistula, with or without previous failed surgical repair.
✓. Have no contraindications to MR evaluations: e.g. pacemaker or magnetically active metal fragments, claustrophobia
✓. Ability to comply with protocol
✓. Competent and able to provide written informed consent
✓. Concurrent Crohn's-related therapies with stable doses corticosteroids, 5- ASA drugs, immunomodulators, anti-TNF therapy, anti-integrin and anti-interleukin therapies are permitted.
✓. Agree to use birth control or abstinence to avoid pregnancy during the study
Exclusion criteria
✕. Inability to give informed consent.
✕. Clinically significant medical conditions within the six months before administration of MSCs: e.g. myocardial infarction, active angina, congestive heart failure or other conditions that would, in the opinion of the investigators, compromise the safety of the subject.