A Phase I Study of ExoFlo an ex vivo Culture-expanded Adult Allogeneic Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicle Isolate Product for the Treatment of Medically Refractory Ulcerative Colitis

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Ulcerative Colitis
  • Age: Between 18 Year(s) - 75 Year(s)
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Ulcerative colitis of at least 6 months duration with medically refractory symptoms
      • Failed to have improvement of disease while receiving at least one monoclonal antibody (infliximab, adalimumab, certolizumab, golimumab, vedolizumab, ustekinumab) or tofacitinib for 8 weeks duration prior to enrollment.
      • Or is intolerant or has a contra-indication to monoclonal antibodies
    2. 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 be on a stable dose for at least 4 weeks prior to receiving the first dose of the study drug. li>
      • If AZA, 6-MP, or MTX has been recently discontinued, it must have been stopped for atleast 4 weeks prior to receiving the first dose of the study drug.
      • If receiving oral 5-ASA compounds, the dose must have been stable for at least 4 weeks prior to receiving the first dose of the study drug.
      • 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 the study drug.
      • If receiving budesonide, the dose must have been stable for at least 2 weeks prior to receiving the first dose of the study drug.
      • 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 the study drug.
    3. The following medications/therapies must have been discontinued before first administration of study agent:
      • TNF-antagonist therapy (e.g. infliximab, etanercept, certolizumab, adalimumab, golimumab, vedolizumab, ustekinumab) for at least 8 weeks.
      • Cyclosporine, tacrolimus, or sirolimus, for at least 4 weeks.
      • 6-thioguanine (6-TG) must have been discontinued for at least 4 weeks.
      • Rectal corticosteroids (ie, corticosteroids [including budesonide] administered to the rectum or sigmoid colon via foam or enema or suppository) for at least 2 weeks.
      • Rectal 5-ASA compounds (ie, 5-ASAs administered to the rectum or sigmoid colon viafoam or enema or suppository) for at least 2 weeks.
      • Parenteral corticosteroids for at least 2 weeks
      • Total parenteral nutrition (TPN) for at least 2 weeks.
      • Antibiotics for the treatment of UC (eg, ciprofloxacin, metronidazole, or rifaximin) for atleast 2 weeks.
    4. No colonic dysplasia and malignancy as ruled out by colonoscopy within 30 days of MSC delivery
    5. Ability to comply with protocol
    6. Competent and able to provide written informed consent
    7. Stated willingness to comply with all study procedures and availability for the duration of the study
    8. If patient is of reproductive capacity, willing to use adequate birth control measures while they are in the study

You may not be eligible for this study if the following are true:

    1. Inability to give informed consent.
    2. Clinically significant medical conditions within the six months before administration of ExoFlo: 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 patient.
    3. Patients with confirmed HIV, Hepatitis B, or Hepatitis C infections
    4. History of cancer including melanoma (with the exception of localized skin cancers) within 5 years of study enrollment
    5. Investigational drug within one year of study enrollment
    6. Pregnant or breast feeding.
    7. If patient is of reproductive capacity, unwilling to use adequate birth control measures while they are in the study
    8. Fulminant colitis requiring emergency surgery
    9. Concurrent active clostridium difficile infection of the colon
    10. Concurrent CMV infection of the colon via colonic biopsy with CMV stain taken within 90 days
    11. Evidence of colonic perforation
    12. Massive hemorrhage from the colon requiring emergent surgery in the 6 months prior to screening.
    13. Crohn’s colitis or indeterminate colitis
    14. Microscopic, ischemic or infectious colitis
    15. Neoplasia of the colon and preoperative biopsy
    16. Presence of an ostomy
    17. Prior small bowel resection
    18. Previous colonic resection
    19. Colonic stricture that unable to pass an adult colonoscope
    20. Active or latent tuberculosis
    21. Unable to wean off corticosteroids
    22. Patients with extra colonic ulcerative colitis including primary sclerosing cholangitis
    23. Patients with history of or current evidence of alcohol or drug abuse or dependence, recreational use of illicit drug or prescription medications, or have use of medical marijuana within 90 days of study entry
    24. Patients with known allergy to local anesthetics
    25. Patients taking anticoagulant medications (e.g. warfarin, heparin) or clopidogrel (Plavix) to reduce the risk of bleeding/ hemarthrosis
    26. Individuals with previously diagnosed, known inherited or acquired hypercoagulable states



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