Mesenchymal Stem Cells for the Treatment of Perianal Fistulizing Crohn's Disease (NCT04519671) | Clinical Trial Compass
TerminatedPhase 1/2
Mesenchymal Stem Cells for the Treatment of Perianal Fistulizing Crohn's Disease
Stopped: PI left Cleveland Clinic
United States25 participantsStarted 2020-11-19
Plain-language summary
The purpose of this study is to determine the safety and efficacy of using adult allogeneic bone marrow derived mesenchymal stem cells (MSCs), to treat people for medically refractory perianal fistulizing Crohn's disease.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Men and Women 18-75 years of age 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 (\>2 months) corticosteroids, 5- ASA drugs, immunomodulators, anti-TNF therapy, anti-integrin and anti-interleukin therapies are permitted
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.
✕. Specific exclusions:
✕. Hepatitis B or C
✕. HIV
✕. Abnormal AST or ALT at screening(defined as \>/= 2x ULN)