Study of ExoFlo for the Treatment of Medically Refractory Crohn's Disease

Inclusion criteria

• ✓. Males and females 18-75 years of age
• ✓. Crohn's colitis of at least 6 months duration with medically refractory symptoms who has failed one monoclonal antibody therapy (failed to have improvement of disease while receiving at least one monoclonal antibody for 8 weeks duration prior to enrollment, including, but not limited to, Infliximab, Adalimumab, Certolizumab, Golimumab, Vedolizumab, Ustekinumab and Tofacitinib), or is intolerant, or has a contraindication to monoclonal antibody therapy with a next step of subtotal colectomy or escalation in medical management
• ✓. Patient with medically refractory Crohn's disease as defined by a CDAI score ≥150 and/or SES-CD score ≥ 3
• ✓. Exposure to corticosteroids, 5-ASA drugs, thiopurines, methotrexate, anti-TNF therapy, anti-integrin and anti-interleukin in the past are permitted but a washout period of 8 weeks for any monoclonal antibody is necessary.
• ✓. If receiving conventional immunomodulators (ie, AZA, 6-MP, or MTX), must have been taking them for ≥12 weeks, and on a stable dose for at least 4 weeks prior to receiving the first dose of the study drug.
• ✓. If AZA, 6-MP, or MTX has been recently discontinued, it must have been stopped for at least 4 weeks prior to receiving the first dose of study drug.
• ✓. If receiving oral 5-ASA compounds, the dose must have been stable for at least 4 weeks. If receiving oral corticosteroids, the dose must be ≤20 mg/day prednisone or its equivalent and must have been stable for at least 4 weeks prior to receiving the first dose of study drug.