The purpose of this study is to determine the safety of using an autologous mesenchymal stromal cell (MSC) coated fistula plug in people with fistulizing Crohn's disease. Autologous means these cells to coat the plug come from the patient.
Who can participate
Age range12 Years ā 17 Years
SexALL
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Inclusion criteria
ā. Males and females 12-17 years of age.
ā. Residents of the United States.
ā. Crohn's disease with single or multiple draining complex perianal fistulae (definition as below) for at least three months despite standard therapy (definition below).
ā. Concurrent therapies with corticosteroids, 5-aminosalicylate (5-ASA) drugs, thiopurines, methotrexate (MTX), antibiotics, and anti-tumor necrosis factor (TNF) therapy are permitted.
ā. All patients should have undergone a colonoscopy in last 12 months to rule out malignant or premalignant condition
ā. Have no contraindications to MR evaluations: e.g. pacemaker or magnetically active metal fragments, claustrophobia
ā. Ability to comply with protocol
ā. Competent and able to provide written informed consent (and assent where appropriate).
Exclusion criteria
ā. Inability to obtain informed consent (and assent where appropriate).
ā. Clinically significant medical conditions within the six months before administration of MSCs: e.g. sepsis, pneumonia active serious infection or other conditions that would, in the opinion of the investigators, compromise the safety of the patient.
ā. Specific exclusions;
ā. History of cancer including melanoma (with the exception of localized skin cancers)
What they're measuring
1
Number of participants with treatment-related adverse events (safety and toxicity)