Study of ExoFlo for the Treatment of Perianal Fistulas (NCT05836883) | Clinical Trial Compass
TerminatedPhase 1/2
Study of ExoFlo for the Treatment of Perianal Fistulas
Stopped: Enrollment challenges.
United States5 participantsStarted 2023-08-28
Plain-language summary
To evaluate the safety and feasibility of ExoFlo as a treatment for 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 (CD) for at least six months duration.
✓. Single and/or Multi-tract Perianal fistula(s).
✓. Failed at least one medical therapy within the last year including, but not limited to, antibiotics, immunomodulators (6-MP, methotrexate, azathioprine), monoclonal antibodies (infliximab, adalimumab, certolizumab, ustekinumab, golimumab, vedolizumab), or small molecule inhibitors.
✓. Previous failed surgical intervention, including seton placement at least two weeks prior, or are not candidates for surgical intervention or are not willing to undergo surgical intervention for the management of their fistula.
✓. Medical therapy for CD stable for at least 2 months prior to administration of IMP. Changes in dosing or dosing intervals related to serum drug levels are permitted.
✓. Ability to comply with protocol.
✓. Competent and able to provide written informed consent.
Exclusion criteria
✕. Active perianal abscess or infection at the time of screening, enrollment, or at the time of investigational product administration
✕. Clinically significant medical conditions within the six months before administration of IMP that would, in the opinion of the investigators, compromise the safety of the subject.
✕. History of cancer including melanoma (with the exception of localized skin cancers) within one year of screening.