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

Inclusion Criteria

• •1. Males and females 18-75 years of age
• •2. 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
• •3. Patient with medically refractory Crohn's disease as defined by a CDAI score ≥150 and/or SES-CD score ≥ 3
• •4. 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.
• •1. 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.
• •2. 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.
• •3. 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.
• •4. If receiving budesonide, the dose must have been stable for at least 2 weeks prior to receiving the first dose of study drug.
• •5. If oral 5-ASA compounds or oral corticosteroids (including budesonide) have been recently discontinued, they must have been stopped for at least 2 weeks prior to receiving the first dose of study drug.
• •5. The following medications/therapies must have been discontinued before first administration of study agent:
• •1. TNF-antagonist therapy (e.g., infliximab, etanercept, certolizumab, adalimumab, golimumab), vedolizumab, ustekinumab for at least 8 weeks.
• •2. Cyclosporine, tacrolimus, or sirolimus, for at least 4 weeks.
• •3. 6-thioguanine (6-TG) must have been discontinued for at least 4 weeks.
• •4. Rectal corticosteroids (i.e., corticosteroids \[including budesonide\] administered to the rectum or sigmoid colon via foam or enema or suppository) for at least 2 weeks.
• •5. Rectal 5-ASA compounds (i.e., 5-ASAs administered to the rectum or sigmoid colon via foam or enema or suppository) for at least 2 weeks.
• •6. Parenteral corticosteroids for at least 2 weeks.
• •7. Total parenteral nutrition (TPN) for at least 2 weeks.
• •8. Antibiotics for the treatment of CD (e.g., ciprofloxacin, metronidazole, or rifaximin) for at least 2 weeks.
• •6. No colonic dysplasia and malignancy as ruled out by colonoscopy within 90 days of first ExoFlo delivery
• •7. Ability to comply with protocol
• •8. Competent and able to provide written informed consent
• •9. Stated willingness to comply with all study procedures and availability for the duration of the study
• •10. If patient is of reproductive capacity, willing to use adequate birth control measures while they are in the study